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Qualitative designs and methodologies for business, management, and organizational research.

• Robert P. Gephart Robert P. Gephart Alberta School of Business, University of Alberta
•  and  Rohny Saylors Rohny Saylors Carson College of Business, Washington State University
• https://doi.org/10.1093/acrefore/9780190224851.013.230
• Published online: 28 September 2020

Qualitative research designs provide future-oriented plans for undertaking research. Designs should describe how to effectively address and answer a specific research question using qualitative data and qualitative analysis techniques. Designs connect research objectives to observations, data, methods, interpretations, and research outcomes. Qualitative research designs focus initially on collecting data to provide a naturalistic view of social phenomena and understand the meaning the social world holds from the point of view of social actors in real settings. The outcomes of qualitative research designs are situated narratives of peoples’ activities in real settings, reasoned explanations of behavior, discoveries of new phenomena, and creating and testing of theories.

A three-level framework can be used to describe the layers of qualitative research design and conceptualize its multifaceted nature. Note, however, that qualitative research is a flexible and not fixed process, unlike conventional positivist research designs that are unchanged after data collection commences. Flexibility provides qualitative research with the capacity to alter foci during the research process and make new and emerging discoveries.

The first or methods layer of the research design process uses social science methods to rigorously describe organizational phenomena and provide evidence that is useful for explaining phenomena and developing theory. Description is done using empirical research methods for data collection including case studies, interviews, participant observation, ethnography, and collection of texts, records, and documents.

The second or methodological layer of research design offers three formal logical strategies to analyze data and address research questions: (a) induction to answer descriptive “what” questions; (b) deduction and hypothesis testing to address theory oriented “why” questions; and (c) abduction to understand questions about what, how, and why phenomena occur.

The third or social science paradigm layer of research design is formed by broad social science traditions and approaches that reflect distinct theoretical epistemologies—theories of knowledge—and diverse empirical research practices. These perspectives include positivism, interpretive induction, and interpretive abduction (interpretive science). There are also scholarly research perspectives that reflect on and challenge or seek to change management thinking and practice, rather than producing rigorous empirical research or evidence based findings. These perspectives include critical research, postmodern research, and organization development.

Three additional issues are important to future qualitative research designs. First, there is renewed interest in the value of covert research undertaken without the informed consent of participants. Second, there is an ongoing discussion of the best style to use for reporting qualitative research. Third, there are new ways to integrate qualitative and quantitative data. These are needed to better address the interplay of qualitative and quantitative phenomena that are both found in everyday discourse, a phenomenon that has been overlooked.

• qualitative methods
• research design
• methods and methodologies
• interpretive induction
• interpretive science
• critical theory
• postmodernism
• organization development

Introduction

Qualitative research uses linguistic symbols and stories to describe and understand actual behavior in real settings (Denzin & Lincoln, 1994 ). Understanding requires describing “specific instances of social phenomena” (Van Maanen, 1998 , p. xi) to determine what this behavior means to lay participants and to scientific researchers. This process produces “narratives-non-fiction division that link events to events in storied or dramatic fashion” to uncover broad social science principles at work in specific cases (p. xii).

A research design and/or proposal is often created at the outset of research to act as a guide. But qualitative research is not a rule-governed process and “no one knows” the rules to write memorable and publishable qualitative research (Van Maanen, 1998 , p. xxv). Thus qualitative research “is anything but standardized, or, more tellingly, impersonal” (p. xi). Design is emergent and is often created as it is being done.

Qualitative research is also complex. This complexity is addressed by providing a framework with three distinct layers of knowledge creation resources that are assembled during qualitative research: the methods layer, the logic layer, and the paradigmatic layer. Research methods are addressed first because “there is no necessary connection between research strategies and methods of data collection and analysis” (Blaikie, 2010 , p. 227). Research methods (e.g., interviews) must be adapted for use with the specific logical strategies and paradigmatic assumptions in mind.

The first, or methods, layer uses qualitative methods to “collect data.” That is, to observe phenomena and record written descriptions of observations, often through field notes. Established methods for description include participant and non-participant observation, ethnography, focus groups, individual interviews, and collection of documentary data. The article explains how established methods have been adapted and used to answer a range of qualitative research questions.

The second, or logic, layer involves selecting a research strategy—a “logic, or set of procedures, for answering research questions” (Blaikie, 2010 , p. 18). Research strategies link research objectives, data collection methods, and logics of analysis. The three logical strategies used in qualitative organizational research are inductive logic, deductive logic and abductive logic (Blaikie, 2010 , p. 79). 1 Each logical strategy makes distinct assumptions about the nature of knowledge (epistemology), the nature of being (ontology), and how logical strategies and assumptions are used in data collection and analysis. The task is to describe important methods suitable for each logical strategy, factors to consider when selecting methods (Blaikie, 2010 ), and illustrates how data collection and analysis methods are adapted to ensure for consistency with specific logics and paradigms.

The third, or paradigms, layer of research design addresses broad frameworks and scholarly traditions for understanding research findings. Commitment to a paradigm or research tradition entails commitments to theories, research strategies, and methods. Three paradigms that do empirical research and seek scientific knowledge are addressed first: positivism, interpretive induction, and interpretive abduction. Then, three scholarly and humanist approaches that critique conventional research and practice to encourage organizational change are discussed: critical theory and research, postmodern perspectives, and organization development (OD). Paradigms or traditions provide broad scholarly contexts that make specific studies comprehensible and meaningful. Lack of grounding in an intellectual tradition limits the ability of research to contribute: contributions always relate to advancing the state of knowledge in specific unfolding research traditions that also set norms for assessing research quality. The six research designs are explained to show how consistency in design levels can be achieved for each of the different paradigms. Further, qualitative research designs must balance the need for a clear plan to achieve goals with the need for adaptability and flexibility to incorporate insights and overcome obstacles that emerge during research.

Our general goal has been to provide a practical guide to inspire and assist readers to better understand, design, implement, and publish qualitative research. We conclude by addressing future challenges and trends in qualitative research.

The Substance of Research Design

A research design is a written text that can be prepared prior to the start of a research project (Blaikie, 2010 , p. 4) and shared or used as “a private working document.” Figure 1 depicts the elements of a qualitative research design and research process. Interest in a topic or problem leads researchers to pose questions and select relevant research methods to fulfill research purposes. Implementation of the methods requires use of logical strategies in conjunction with paradigms of research to specify concepts, theories, and models. The outcomes, depending on decisions made during research, are scientific knowledge, scholarly (non-scientific) knowledge, or applied knowledge useful for practice.

Figure 1. Elements of qualitative research design.

Research designs describe a problem or research question and explain how to use specific qualitative methods to collect and analyze qualitative data that answer a research question. The purposes of design are to describe and justify the decisions made during the research process and to explain how the research outcomes can be produced. Designs are thus future-oriented plans that specify research activities, connect activities to research goals and objectives, and explain how to interpret the research outcomes using paradigms and theories.

In contrast, a research proposal is “a public document that is used to obtain necessary approvals for a research proposal to proceed” (Blaikie, 2010 , p. 4). Research designs are often prepared prior to creating a research proposal, and research proposals often require the inclusion of research designs. Proposals also require greater formality when they are the basis for a legal contract between a researcher and a funding agency. Thus, designs and proposals are mutually relevant and have considerable overlap but are addressed to different audiences. Table 1 provides the specific features of designs and proposals. This discussion focuses on designs.

Table 1. Decisions Necessitated by Research Designs and Proposals

Source: Based on Blaikie ( 2010 ), pp. 12–34.

The “real starting point” for a research design (or proposal) is “the formulation of the research question” (Blaikie, 2010 , p. 17). There are three types of research questions: “what” questions seek descriptions; “why” questions seek answers and understanding; and “how” questions address conditions where certain events occur, underlying mechanisms, and conditions necessary for change interventions (p. 17). It is useful to start with research questions rather than goals, and to explain what the research is intended to achieve (p. 17) in a technical way.

The process of finding a topic and formulating a useful research question requires several considerations (Silverman, 2014 , pp. 31–33, 34–40). Researchers must avoid settings where data collection will be difficult (pp. 31–32); specify an appropriate scope for the topic—neither too wide or too narrow—that can be addressed (pp. 35–36); fit research questions into a relevant theory (p. 39); find the appropriate level of theory to address (p. 42); select appropriate designs and research methods (pp. 42–44); ensure the volume of data can be handled (p. 48); and do an effective literature review (p. 48).

A literature review is an important way to link the proposed research to current knowledge in the field, and to explain what was previously known or what theory suggests to be the case (Blaikie, 2010 , p. 17). Research questions can used to bound and frame the literature review while the literature review often inspires research questions. The review may also provide bases for creating new hypotheses and for answering some of the initial research questions (Blaikie, 2010 , p. 18).

Layers of Research Design

There are three layers of research design. The first layer focuses on research methods for collecting data. The second layer focuses on the logical frameworks used for analyzing data. The third layer focuses on the paradigm used to create a coherent worldview from research methods and logical frameworks.

Layer One: Design as Research Methods

Qualitative research addresses the meanings people have for phenomena. It collects narratives of organizational activity, uses analytical induction to create coherent representations of the truths and meanings in organizational contexts, and then creates explanations of this conduct and its prevalence (Van Maanan, 1998 , pp. xi–xii). Thus qualitative research involves “doing research with words” (Gephart, 2013 , title) in order to describe the linguistic symbols and stories that members use in specific settings.

There are four general methods for collecting qualitative data and creating qualitative descriptions (see Table 2 ). The in-depth case study approach provides a history of an event or phenomenon over time using multiple data sources. Observational strategies use the researcher to observe and describe behavior in actual settings. Interview strategies use a format where a researcher asks questions of an informant. And documentary research collects texts, documents, official records, photographs, and videos as data—formally written or visually recorded evidence that can be replayed and reviewed (Creswell, 2014 , p. 190). These methods are adapted to fit the needs of specific projects.

Table 2. Qualitative Data Collection Methods

The In-Depth Case Study Method

The in-depth case study is a key strategy for qualitative research (Piekkari & Welch, 2012 ). It was the most common qualitative method used during the formative years of the field, from 1956 to 1965 , when 48% of qualitative papers published in the Administrative Science Quarterly used the case study method (Van Maanen, 1998 , p. xix). The case design uses one or more data collection strategies to describe in detail how a single event or phenomenon, selected by a researcher, has changed over time. This provides an understanding of the processes that underlie changes to the phenomenon. In-depth case study methods use observations, documents, records, and interviews that describe the events in the case unfolded and their implications. Case studies contextualize phenomena by studying them in actual situations. They provide rich insights into multiple dimensions of a single phenomenon (Campbell, 1975 ); offer empirical insights into what, how, and why questions related to phenomena; and assist in the creation of robust theory by providing diverse data collected over time (Gephart & Richardson, 2008 , p. 36).

Maniha and Perrow ( 1965 ) provide an example of a case study concerned with organizational goal displacement, an important issue in early organizational theorizing that proposed organizations emerge from rational goals. Organizational rationality was becoming questioned at the time that the authors studied a Youth Commission with nine members in a city of 70,000 persons (Maniha & Perrow, 1965 ). The organization’s activities were reconstructed from interviews with principals and stakeholders of the organization, minutes from Youth Commission meetings, documents, letters, and newspaper accounts (Maniha & Perrow, 1965 ).

The account that emerged from the data analysis is a history of how a “reluctant organization” with “no goals to guide it” was used by other aggressive organizations for their own ends. It ultimately created its own mission (Maniha & Perrow, 1965 ). Thus, an organization that initially lacked rational goals developed a mission through the irrational process of goal slippage or displacement. This finding challenged prevailing thinking at the time.

Observational Strategies

Observational strategies involve a researcher present in a situation who observes and records, the activities and conversations that occur in the setting, usually in written field notes. The three observational strategies in Table 2 —participant observation, ethnography, and systematic self-observation—differ in terms of the role of the researcher and in the data collection approach.

Participant observation . This is one of the earliest qualitative methods (McCall & Simmons, 1969 ). One gains access to a setting and an informant holding an appropriate social role, for example, client, customer, volunteer, or researcher. One then observes and records what occurs in the setting using field notes. Many features or topics in a setting can become a focus for participant observers. And observations can be conducted using continuum of different roles from the complete participant, observer as participant, and participant observer, to the complete observer who observes without participation (Creswell, 2014 , Table 9.2, p. 191).

Ethnography . An ethnography is “a written representation of culture” (Van Maanen, 1988 ) produced after extended participation in a culture. Ethnography is a form of participant observation that focuses on the cultural aspects of the group or organization under study (Van Maanen, 1988 , 2010 ). It involves prolonged and close contact with group members in a role where the observer becomes an apprentice to an informant to learn about a culture (Agar, 1980 ; McCurdy, Spradley, & Shandy, 2005 ; Spradley, 1979 ).

Ethnography produces fine-grained descriptions of a micro-culture, based on in-depth cultural participation (McCurdy et al., 2005 ; Spradley, 1979 , 2016 ). Ethnographic observations seek to capture cultural members’ worldviews (see Perlow, 1997 ; Van Maanen, 1988 ; Watson, 1994 ). Ethnographic techniques for interviewing informants have been refined into an integrated developmental research strategy—“the ethno-semantic method”—for undertaking qualitative research (Spradley, 1979 , 2016 ; Van Maanen, 1981 ). The ethnosemantic method uses a structured approach to uncover and confirm key cultural features, themes, and cultural reasoning processes (McCurdy et al., 2005 , Table 3 ; Spradley, 1979 ).

Systematic Self-Observation . Systematic self-observation (SSO) involves “training informants to observe and record a selected feature of their own everyday experience” (Rodrigues & Ryave, 2002 , p. 2; Rodriguez, Ryave, & Tracewell, 1998 ). Once aware that they are experiencing the target phenomenon, informants “immediately write a field report on their observation” (Rodrigues & Ryave, 2002 , p. 2) describing what was said and done, and providing background information on the context, thoughts, emotions, and relationships of people involved. SSO generates high-quality field notes that provide accurate descriptions of informants’ experiences (pp. 4–5). SSO allows informants to directly provide descriptions of their personal experiences including difficult to capture emotions.

Interview Strategies

Interviews are conversations between researchers and research participants—termed “subjects” in positivist research and informants in “interpretive research.” Interviews can be conducted as individual face-to-face interactions (Creswell, 2014 , p. 190) or by telephone, email, or through computer-based media. Two broad types of interview strategies are (a) the individual interview and (b) the group interview or focus group (Morgan, 1997 ). Interviews elicit informants’ insights into their culture and background information, and obtain answers and opinions. Interviews typically address topics and issues that occur outside the interview setting and at previous times. Interview data are thus reconstructions or undocumented descriptions of action in past settings (Creswell, 2014 , p. 191) that provide descriptions that are less accurate and valid descriptions than direct, real-time observations of settings.

Structured and unstructured interviews. Structured interviews pose a standardized set of fixed, closed-ended questions (Easterby-Smith, Thorpe, & Jackson, 2012 ) to respondents whose responses are recorded as factual information. Responses may be forced choice or open ended. However, most qualitative research uses unstructured or partially structured interviews that pose open-ended questions in a flexible order that can be adapted. Unstructured interviews allow for detailed responses and clarification of statements (Easterby-Smith et al., 2012 ; McLeod, 2014 )and the content and format can be tailored to the needs and assumptions of specific research projects (Gephart & Richardson, 2008 , p. 40).

The informant interview (Spradley, 1979 ) poses questions to informants to elicit and clarify background information about their culture, and to validate ethnographic observations. In interviews, informants teach the researcher their culture (Spradley, 1979 , pp. 24–39). The informant interview is part of a developmental research sequence (McCurdy et al., 2005 ; Spradley, 1979 ) that begins with broad “grand tour” questions that ask an informant to describe an important domain in their culture. The questions later narrow to focus on details of cultural domains and members’ folk concepts. This process uncovers semantic relationships among concepts of members and deeper cultural themes (McCurdy et al., 2005 ; Spradley, 1979 ).

The long interview (McCracken, 1988 ) involves a lengthy, quasi-structured interview sessions with informants to acquire rapid and efficient access to cultural themes and issues in a group. Long interviews differ ethnographic interviews by using a “more efficient and less obtrusive format” (p. 7). This creates a “sharply focused, rapid and highly intense interview process” that avoids indeterminate and redundant questions and pre-empts the need for observation or involvement in a culture. There are four stages in the long interview: (a) review literature to uncover analytical categories and design the interview; (b) review cultural categories to prepare the interview guide; (c) construct the questionnaire; and (d) analyze data to discover analytical categories (p. 30, fig. 1 ).

The active interview is a dynamic process where the researcher and informant co-construct and negotiate interview responses (Holstein & Gubrium, 1995 ). The goal is to uncover the subjective meanings that informants hold for phenomenon, and to understand how meaning is produced through communication. The active approach is common in interpretive, critical, and postmodern research that assumes a negotiated order. For example, Richardson and McKenna ( 2000 ) explored how ex-patriate British faculty members themselves interpreted and explained their expatriate experience. The researchers viewed the interview setting as one where the researchers and informants negotiated meanings between themselves, rather than a setting where prepared questions and answers were shared.

Documentary, Photographic, and Video Records as Data

Documents, records, artifacts, photographs, and video recordings are physically enduring forms of data that are separable from their producers and provide mute evidence with no inherent meaning until they are read, written about, and discussed (Hodder, 1994 , p. 393). Records (e.g., marriage certificate) attest to a formal transaction, are associated with formal governmental institutions, and may have legally restricted access. In contrast, documents are texts prepared for personal reasons with fewer legal restrictions but greater need for contextual interpretation. Several approaches to documentary and textual data analysis have been developed (see Table 3 ). Documents that researchers have found useful to collect include public documents and minutes of meetings; detailed transcripts of public hearings; corporate and government press releases; annual reports and financial documents; private documents such as diaries of informants; and news media reports.

Photographs and videos are useful for capturing “accurate” visual images of physical phenomena (Ray & Smith, 2012 ) that can be repeatedly reexamined and used as evidence to substantiate research claims (LeBaron, Jarzabkowski, Pratt, & Fetzer, 2018 ). Photos taken from different positions in space may also reveal different features of phenomena. Videos show movement and reveal activities as processes unfolding over time and space. Both photos and videos integrate and display the spatiotemporal contexts of action.

Layer Two: Design as Logical Frameworks

The second research design layer links data collection and analysis methods (Tables 2 and 3 ) to three logics of enquiry that answer specific questions: inductive, deductive, and abductive logical strategies (see Table 4 ). Each logical strategy focuses on producing different types of knowledge using distinctive research principles, processes, and types of research questions they can address.

Table 3. Data Analysis and Integrated Data Collection and Analysis Strategies

Table 4. Logical Strategies for Answering Qualitative Research Questions with Evidence

Based in part on Blaikie ( 1993 ), ch. 5 & 6; Blaikie ( 2010 ), p. 84, table 4.1

The Inductive Strategy

Induction is the scientific method for many scholars (Blaikie, 1993 , p. 134), and an essential logic for qualitative management research (Pratt, 2009 , p. 856). Inductive strategies ask “what” questions to explore a domain to discover unknown features of a phenomenon (Blaikie, 2010 , p. 83). There are four stages to the inductive strategy: (a) observe and record all facts without selection or anticipating their importance; (b) analyze, compare, and classify facts without employing hypotheses; (c) develop generalizations inductively based on the analyses; and (d) subject generalizations to further testing (Blaikie, 1993 , p. 137).

Inductive research assumes a real world outside human thought that can be directly sensed and described (Blaikie, 2010 ). Principles of inductive research reflect a realist and objectivist ontology. The selection, definition, and measurement of characteristics to be studied are developed from an objective, scientific point of view. Facts about organizational features need to be obtained using unbiased measurement. Further, the elimination method is used to find “the characteristics present in all the positive cases, which are absent in all the negative cases, and which vary in appropriate degrees” (Blaikie, 1993 , p. 135). This requires data collection methods that provide unbiased evidence of the objective facts without pre-supposing their importance.

Induction can establish limited generalizations about phenomena based solely on the observations collected. Generalizations need to be based on the entire sample of data, not on selected observations from large data sets, to establish their validity. The scope of generalization is limited to the sample of data itself. Induction creates evidence to increase our confidence in a conclusion, but the conclusions do not logically follow from premises (Blaikie, 1993 , p. 164). Indeed, inferences from induction cannot be extended beyond the original set of observations and no logical or formal process exists to establish the universality of inferences.

Key data collection methods for inductive designs include observational strategies that allow the researcher to view behavior without making a priori hypotheses, to describe behavior that occurs “naturally” in settings, and to record non-impressionistic descriptions of behavior. Interviews can also elicit descriptions of settings and behavior for inductive qualitative research. Data analysis methods need to describe actual interactions in real settings including discourse among members. These methods include ethnosemantic analysis to uncover key terms and validate actual meanings used by members; analyses of conversational practices that show how meaning is negotiated through sequential turn taking in discourse; and grounded theory-based concept coding and theory development that use the constant comparative method.

Facts or descriptions of events can be compared to one another and generalizations can be made about the world using induction (Blaikie, 2010 ). Outcomes from inductive analysis include descriptions of features in a limited domain of social action that are inferred to exist in other similar settings. Propositions and broader insights can be developed inductively from these descriptions.

The Deductive Strategy

Deductive logic (Blaikie, 1993 , 2010 ) addresses “why” questions to explain associations between concepts that represent phenomena of interest. Researchers can use induction, abduction, or any means, to develop then test the hypotheses to see if they are valid. Hypotheses that are not rejected are temporarily corroborated. The outcomes from deduction are tested hypotheses. Researchers can thus be very creative in hypothesis construction but they cannot discover new phenomena with deduction that is based only on phenomena known in advance (Blaikie, 2010 ). And there is also no purely logical or mechanical process to establish “the validity of [inductively constructed] universal statements from a set of singular statements” from which deductive hypotheses were formed (Hempel, 1966 , p. 15 cited in Blaikie, 1993 , p. 140).

The deductive strategy uses a realist and objectivist ontology and imitates natural science methods. Useful data collection methods include observation, interviewing, and collection of documents that contain facts. Deduction addresses the assumedly objective features of settings and interactions. Appropriate data analysis methods include content coding to identify different types, features, and frequencies of observed phenomena; grounded theory coding and analytical induction to create categories in data, determine how categories are interrelated, and induce theory from observations; and pattern recognition to compare current data to prior models and samples. Content analysis and non-parametric statistics can be used to quantify qualitative data and make it more amenable to analysis, although quantitative analysis of qualitative data is not, strictly speaking, qualitative research (Gephart, 2004 ).

The Abductive Strategy

Abduction is “the process used to produce social scientific accounts of social life by drawing on the concepts and meanings used by social actors, and the activities in which they engage” (Blaikie, 1993 , p. 176). Abductive reasoning assumes that the socially meaningful world is the world experienced by members. The first abductive task is to discover the insider view that is basic to the actions of social actors (p. 176) by uncovering the subjective meanings held by social actors. Subjective meaning (Schutz, 1973a , 1973b ) refers to the meaning that actions hold for the actors themselves and that they can express verbally. Subjective meaning is not inexpressible ideas locked in one’s mind. Abduction starts with lay descriptions of social life, then moves to technical, scientific descriptions of social life (Blaikie, 1993 , p. 177) (see Table 4 ). Abduction answers “what” questions with induction, why questions with deduction, and “how” questions with hypothesized processes that explain how, and under what conditions, phenomena occur. Abduction involves making a logical leap that infers an explanatory process to explain an outcome in an oscillating logic. Deductive, inductive, and inferential processes move recursively from actors’ accounts to social science accounts and back again in abduction (Gephart, 2018 ). This process enables all theory and second-order scientific concepts to be grounded in actors’ first-order meanings.

The abductive strategy contains four layers: (a) everyday concepts and meanings of actors, used for (b) social interaction, from which (c) actors provide accounts, from which (d) social scientific descriptions are made, or theories are generated and applied, to interpret phenomena (Blaikie, 1993 , p. 177). The multifaceted research process, described in Table 4 , requires locating and comprehending members’ important everyday concepts and theories before observing or creating disruptions that force members to explain the unstated knowledge behind their action. The researcher then integrates members’ first-order concepts into a general, second-order scientific theory that makes first-order understandings recoverable.

Abduction emerged from Weber’s interpretive sociology ( 1978 ) and Peirce’s ( 1936 ) philosophy. But Alfred Schutz ( 1973a , 1973b ) is the contemporary scholar who did the most to extend our understanding of abduction, although he never used the term “abduction” (Blaikie, 1993 , 2010 ; Gephart, 2018 ). Schutz conceived abduction as an approach to verifiable interpretive knowledge that is scientific and rigorous (Blaikie, 1993 ; Gephart, 2018 ). Abduction is appropriate for research that seeks to go beyond description to explanation and prediction (Blaikie, 1993 , p. 163) and discovery (Gephart, 2018 ). It employs an interpretive ontology (Schutz, 1973a , 1973b ) and social constructionist epistemology (Berger & Luckmann, 1966 ), using qualitative methods to discover “why people do what they do” (Blaikie, 1993 ).

Dynamic data collection methods are needed for abductive research to capture descriptions of interactions in actual settings and their meanings to members. Observational and interview approaches that elicit members’ concepts and theories are particularly relevant to abductive understanding (see Table 2 ). Data analysis methods must analyze situated, first-order (common sense) discourse as it unfolds in real settings and then systematically develop second-order concepts or theories from data. Relevant approaches to produce and validate findings include ethnography, ethnomethodology, and grounded theorizing (see Table 3 ). The combination of what, why, and how questions used in abduction produces a broader understanding of phenomena than do what and why deductive and inductive questions.

Layer Three: Paradigms of Research

Scholarly paradigms integrate methods, logics, and intellectual worldviews into coherent theoretical perspectives and form the most abstract level of research design. Six paradigms are widely used in management research (Burrell & Morgan, 1979 ; Cunliffe, 2011 ; Gephart, 2004 , 2013 ; Gephart & Richardson, 2008 ; Hassard, 1993 ). The first three perspectives—positivism, interpretive induction, and interpretive abduction—build on logics of design and seek to produce rigorous empirical research that constitutes evidence (see Table 5 ). Three additional perspectives pursue philosophical, critical, and practical knowledge: critical theory, postmodernism, and organization development (see Table 6 ). Tables 5 and 6 describe important features of each research design to show similarities and differences in the processes through which theoretical meaning is bestowed on research results in management and organization studies.

Table 5. Paradigms, Logical Strategies, and Methodologies for Empirical Research

Sources: Based on and adapted and extended from Blaikie ( 1993 , pp. 137, 145, & 152); Blaikie ( 2010 , Table 4.1, p. 84); Gephart ( 2013 , Table 9.1, p. 291) and Gephart ( 2018 , Table 3.1, pp. 38–39).

Table 6. Alternative Paradigms, Logical Strategies, and Methodologies

Based in part on Gephart ( 2004 , 2013 , 2018 ).

The Positivist Approach

The qualitative positivist approach makes assumptions equivalent to those of quantitative research (Gephart, 2004 , 2018 ). It assumes the world is objectively describable and comprehensible using inductive and deductive logics. And rigor is important and achieved by reliability, validity, and generalizability of findings (Kirk & Miller, 1986 ; Malterud, 2001 ). Qualitative positivism mimics natural science logics and methods using data recorded as words and talk rather than numerals.

Positivist research (Bitektine, 2008 ; Su, 2018 ) starts with a hypothesis. This can, but need not, be based in data or inductive theory. The research process, aimed at publication in peer-reviewed journals, requires researchers to (a) identify variables to measure, (b) develop operational definitions of the variables, (c) measure (describe) the variables and their inter-relationships, (d) pose hypotheses to test relationships among variables, then (e) compare observations to hypotheses for testing (Blaikie, 2010 ). When data are consistent with theory, theory passes the test. Otherwise the theory fails. This theory is also assessed for its logical correctness and value for knowledge. The positivist approach can assess deductive and inductive generalizations and provide evidence concerning why something occurs—if proposed hypotheses are not rejected.

Positivists view qualitative research as highly subject to biases that must be prevented to ensure rigor, and 23 methodological steps are recommended to enhance rigor and prevent bias (Gibbert & Ruigrok, 2010 , p. 720). Replicability is another concern because methodology descriptions in qualitative publications “insufficiently describe” how methods are used (Lee, Mitchell, & Sablynski, 1999 , p. 182) and thereby prevent replication. To ensure replicability, a qualitative “article’s description of the method must be sufficiently detailed to allow a reader . . . to replicate that reported study either in a hypothetical or actual manner.”

Qualitative research allows positivists to observe naturally unfolding behavior in real settings and allow “the real world” of work to inform research and theory (Locke & Golden-Biddle, 2004 ). Encounters with the actual world provide insights into meaning construction by members that cannot be captured with outsider (etic) approaches. For example, past quantitative research provided inconsistent findings on the importance of pre- and post-recruitment screening interviews for job choices of recruits. A deeper investigation was thus designed to examine how recruitment impacts job selection (Rynes, Bretz, & Gerhart, 1991 ). To do so, students undergoing recruitment were asked to “tell us in their own words” how their recruiting and decision processes unfolded (Rynes et al., 1991 , p. 399). Using qualitative evidence, the researchers found that, in contrast to quantitative findings, “people do make choices based on how they are treated” (p. 509), and the choices impact recruitment outcomes. Rich descriptions of actual behavior can disconfirm quantitative findings and produce new findings that move the field forward.

An important limitation of positivism is its common emphasis on outsiders’ or scientific observers’ objective conceptions of the world. This limits the attention positivist research gives to members’ knowledge and allows positivist research to impose outsiders’ meanings on members’ everyday behavior, leading to a lack of understanding of what the behavior means to members. Another limitation is that no formal, logical, or proven techniques exist to assess the strength of “relationships” among qualitative variables, although such assessments can be formally done using well-formed quantitative data and techniques. Thus, qualitative positivists often provide ambiguous or inexplicit quantitative depictions of variable relations (e.g., “strong relationship”). Alternatively, the analysts quantify qualitative data by assigning numeric codes to categories (Greckhamer, Misngyi, Elms, & Lacey, 2008 ), using non-parametric statistics, or quantitative content analysis (Sonpar & Golden-Biddle, 2008 ) to create numerals that depict associations among variables.

An illustrative example of positivist research . Cole ( 1985 ) studied why and how organizations change their working structures from bureaucratic forms to small, self-supervised work teams that allow for worker participation in shop floor activities. Cole found that existing research on workplace change focused on the micropolitical level of organizations. He hypothesized that knowledge could be advanced differently, by examining the macropolitical change in industries or nations. Next, a testable conclusion was deduced: a macro analysis of the politics of change can better predict the success of work team implementation, measured as the spread of small group work structures, than an examination of the micropolitics of small groups ( 1985 ). Three settings were selected for the research: Japan, Sweden, and the United States. Japanese data were collected from company visits and interviews with employment officials and union leaders. Swedish documentary data on semiautonomous work groups were used and supplemented by interviews at Volvo and Saab, and prior field research in Sweden. U.S. data were collected through direct observations and a survey of early quality circle adopters.

Extensive change was observed in Sweden and Japan but changes to small work groups were limited in the United States (Cole, 1985 ). This conclusion was verified using records of the experiences of the three nations in work reform, compared across four dimensions: timing and scope of changes, managerial incentives to innovate, characteristics of mobilization, and political dimensions of change. Data revealed the United States had piecemeal experimentation and resistance to reform through the 1970s; diffusion emerged in Japan in the early 1960s and became extensive; and Swedish workplace reform started in the 1960s and was widely and rapidly diffused.

Cole then answered the questions of “why” and “how” the change occurred in some countries but not others. Regarding why Japanese and Swedish managers were motivated to introduce workplace change due to perceived managerial problems and the changing national labor market. Differences in the political processes also influenced change. Management, labor, and government interest in workplace change was evident in Japan and Sweden but not in the United States where widespread resistance occurred. As to how, the change occurred through macropolitical processes (Cole, 1985 , p. 120), specifically, the commitment of the national business leadership to the change and whether or not the change was contested or uncontested by labor impacted the adoption of change. Organizational change usually occurs through broad macropolitical processes, hence “the importance of macro-political variables in explaining these outcomes” (p. 122).

Interpretive Induction

Two streams of qualitative research claim the label of “interpretive research” in management and organization studies. The first stream, interpretive induction, emphasizes induction as its primary logical strategy (e.g., Locke, 2001 , 2002 ; Pratt, 2009 ). It assumes a “real world” that is inherently objective but interpreted through subjective lenses, hence different people can perceive or report different things. This research is interpretive because it addresses the meanings and interpretations people give to organizational phenomena, and how this meaning is provided and used. Interpretive induction contributes to scientific knowledge by providing empirical descriptions, generalizations, and low-level theories about specific contexts based on thick descriptions of members’ settings and interactions (first-order understandings) as data.

The interpretive induction paradigm addresses “what” questions that describe and explain the existence and features of phenomena. It seeks to uncover the subjective, personal knowledge that subjects have of the objective world and does so by creating descriptive accounts of the activities of organizational members. Interpretive induction creates inductive theories based on limited samples that provide low-scope, abstract theory. Limitations (Table 5 ) include the fact that inductive generalizations are limited to the sample used for induction and need to be subjected to additional tests and comparisons for substantiation. Second, research reports often fail to provide details to allow replication of the research. Third, formal methods for assessing the accuracy and validity of results and findings are limited. Fourth, while many features of scientific research are evident in interpretive induction research, the research moves closer to humanistic knowledge than to science when the basic assumptions of inductive analysis are relaxed—a common occurrence.

An illustrative example of interpretive induction research . Adler and Adler ( 1988 , 1998 ) undertook a five-year participant-observation study of a college basketball program (Adler, 1998 , p. 32). They sought to “examine the development of intense loyalty in one organization.” Intense loyalty evokes “devotional commitment of . . . (organizational) members through a subordination that sometime borders on subservience” (p. 32). The goal was to “describe and analyze the structural factors that emerged as most related” to intense loyalty (p. 32).

The researchers divided their roles. Peter Adler was the active observer and “expert” who undertook direct observations while providing counsel to players (p. 33). Patricia Adler took the peripheral role of “wife” and debriefed the observer. Two research questions were posed: (a) “what” kinds of organizational characteristics foster intense loyalty? (b) “how” do organizations with intense loyalty differ structurally from those that lack intense loyalty?

The first design stage (Table 5 ) recorded unbiased observations in extensive field notes. Detailed “life history” accounts were obtained from 38 team members interviewed (Adler & Adler, 1998 , p. 33). Then analytical induction and the constant comparative method (Glaser & Strauss, 1967 ) were used to classify and compare observations (p. 33). Once patterns emerged, informants were questioned about variations in patterns (p. 34) to develop “total patterns” (p. 34) reflecting the collective belief system of the group. This process required a “careful and rigorous means of data collection and analysis” that was “designed to maximize both the reliability and validity of our findings” (p. 34). The study found five conceptual elements were essential to the development of intense loyalty: domination, identification, commitment, integration, and goal alignment (p. 35).

The “what” question was answered by inducing a generalization (stage 3): paternalistic organizations with charismatic leadership seek people who “fit” the organization’s style and these people require extensive socialization to foster intense loyalty. This description contrasts with rational bureaucratic organizations that seek people who fit specific, generally known job descriptions and require limited socialization (p. 46). The “how” question is answered by inductive creation of another generalization: organizations that control the extra-organizational activities of members are more likely to evoke intense loyalty by forcing members to subordinate all other interests to those of the organization (p. 46).

The Interpretive Abduction Approach

The second stream of interpretive research—interpretive abduction—produces scientific knowledge using qualitative methods (Gephart, 2018 ). The approach assumes that commonsense knowledge is foundational to how actors know the world. Abductive theory is scientifically built from, and refers to, everyday life meanings, in contrast to positivist and interpretive induction research that omits concern with the worldview of members. Further, interpretive abduction produces second-order or scientific theory and concepts from members’ first-order commonsense concepts and meanings (Gephart, 2018 , p. 34; Schutz, 1973a , 1973b ).

The research process, detailed in Table 5 (process and stages), focuses on collecting thick descriptive data on organizations, identifying and interpreting first-order lay concepts, and creating abstract second-order technical constructs of science. The second-order concepts describe the first-order principles and terms social actors use to organize their experience. They compose scientific concepts that form a theoretical system to objectively describe, predict, and explain social organization (Gephart, 2018 , p. 35). This requires researchers to understand the subjective view of the social actors they study, and to develop second-order theory based on actors’ subjective meanings. Subjective meaning can be shared with others through language use and communication and is not private knowledge.

A central analytical task for interpretive abduction is creating second-order, ideal-type models of social roles, motives, and interactions that describe the behavioral trajectories of typical actors. Ideal-type models can be objectively compared to one another and are the special devices that social science requires to address differences between social phenomena and natural phenomena (Schutz, 1973a , 1973b ). The models, once built, are refined to preserve actors’ subjective meanings, to be logically consistent, and to present human action from the actor’s point of view. Researchers can then vary and compare the models to observe the different outcomes that emerge. Scientific descriptions can then be produced, and theories can be created. Interpretive abduction (Gephart, 2018 , p. 35) allows one to addresses what, why, and how questions in a holistic manner, to describe relationships among scientific constructs, and to produce “empirically ascertainable” and verifiable relations among concepts (Schutz, 1973b , p. 65) that are logical, hold practical meaning to lay actors, and provide abstract, objective meaning to interpretive scientists (Gephart, 2018 , p. 35). Abduction produces knowledge about socially shared realities by observing interactions, uncovering members’ first-order meanings, and then developing technical second-order or scientific accounts from lay accounts.

Interpretive abduction (Gephart, 2018 ) uses well-developed methods to create, refine, test, and verify second-order models, and it provides well-developed tools to support technical, second-level analyses. Research using the interpretive abduction approach includes a study of how technology change impacts sales automobile practices (Barley, 2015 ) and an investigation study of how abduction was used to develop new prescription drugs (Dunne & Dougherty, 2016 ).

An illustrative example of the interpretive abduction approach . Perlow ( 1997 ) studied time management among software engineers facing a product launch deadline. Past research verified the widespread belief that long working hours for staff are necessary for organizational success. This belief has adversely impacted work life and led to the concept of a “time bind” faced by professionals (Hochschild, 1997 ). One research question that subsequently emerged was, “what underlies ‘the time bind’ experienced by engineers who face constant deadlines and work interruptions?” (Perlow, 1997 , p. xvii). This is an inductive question about the causes and consequences of long working hours not answered in prior research that is hard to address using induction or deduction. Perlow then explored assumption underlying the hypothesis, supported by lay knowledge and management literature, that even if long working hours cause professionals to destroy their life style, long work hours “further the goals of our organizations” and “maximize the corporation’s bottom line” (Perlow, 1997 , p. 2).

The research commenced (Table 5 , step 1) when Perlow gained access to “Ditto,” a leader in implementing flexible work policies (Perlow, 1997 , p. 141) and spent nine months doing participant observation four days a week. Perlow collected descriptive data by walking around to observe and converse with people, attended meetings and social events, interviewed engineers at work and home and spouses at home, asked participants to record activities they undertook on selected working days (Perlow, 1997 , p. 143), and made “thousands of pages of field notes” (p. 146) to uncover trade-offs between work and home life.

Perlow ( 1997 , pp. 146–147) analyzed first-order concepts uncovered through his observations and interviews from 17 stories he wrote for each individual he had studied. The stories described workstyles, family lives, and traits of individuals; provided objective accounts of subjective meanings each held for work and home; offered background information; and highlighted first-order concepts. Similarities and differences in informant accounts were explored with an empirically grounded scheme for coding observations into categories using grounded theory processes (Gioia, Corley, & Hamilton, 2012 ). The process allowed Perlow to find key themes in stories that show work patterns and perceptions of the requirements of work success, and to create ideal-type models of workers (step 3). Five stories were selected for detailed analysis because they reveal important themes Perlow ( 1997 , p. 147). For example, second-order, ideal-type models of different “roles” were constructed in step 3 including the “organizational superstar” (pp. 15–21) and “ideal female employee” (pp. 22–32) based on first-order accounts of members. The second-order ideal-type scientific models were refined to include typical motives. The models were compared to one another (step 4) to describe and understand how the actions of these employee types differed from other employee types and how these variations produced different outcomes for each trajectory of action (steps 4 and 5).

Perlow ( 1997 ) found that constant help-seeking led engineers to interrupt other engineers to get solutions to problems. This observation led to the abductively developed hypothesis that interruptions create a time crisis atmosphere for engineers. Perlow ( 1997 ) then created a testable, second-order ideal-type (scientific) model of “the vicious working cycle” (p. 96), developed from first-order data, that explains the productivity problems that the firm (and other research and development firms)—commonly face. Specifically, time pressure → crisis mentality → individual heroics → constant interruptions of others’ work to get help → negative consequences for individual → negative consequences for the organization.

Perlow ( 1997 ) then tested the abductive hypothesis that the vicious work cycle caused productivity problems (stage 5). To do so, the vicious work cycle was transformed into a virtuous cycle using scheduling quiet times to prevent work interruptions: relaxed work atmosphere → individuals focus on own work completion → few interruptions → positive consequences for individual and organization. To test the hypothesis, an experiment was conducted (research process 2 in Table 5 ) with engineers given scheduled quiet times each morning with no interruptions. The experiment was successful: the project deadline was met. The hypothesis about work interruptions and the false belief that long hours are needed for success were supported (design stage 6). Unfortunately, the change was not sustained and engineers reverted to work interruptions when the experiment ended.

There are three additional qualitative approaches used in management research that pursue objectives other than producing empirical findings and developing or testing theories. These include critical theory and research, postmodernism, and change intervention research (see Table 6 ).

The Critical Theory and Research Approach

The term “critical” has many meanings including (a) critiques oriented to uncovering ideological manifestations in social relations (Gephart, 2013 , p. 284); (b) critiques of underlying assumptions of theories; and (c) critique as self-reflection that reflexively encapsulates the investigator (Morrow, 1994 , p. 9). Critical theory and critical management studies bring these conceptions of critical to bear on organizations and employees.

Critical theory and research extend the theories Karl Marx, and the Frankfurt School in Germany (Gephart & Kulicki, 2008 ; Gephart & Pitter, 1995 ; Habermas, 1973 , 1979 ; Morrow, 1994 ; Offe, 1984 , 1985 ). Critical theory and research assume that social science research differs from natural science research because social facts are human creations and social phenomena cannot be controlled as readily as natural phenomena (Gephart, 2013 , p. 284; Morrow, 1994 , p. 9). As a result, critical theory often uses a historical approach to explore issues that arise from the fundamental contradictions of capitalism. Critical research explores ongoing changes within capitalist societies and organizations, and analyzes the objective structures that constrain human imagination and action (Morrow, 1994 ). It seeks to uncover the contradictions of advanced capitalism that emerge from the fundamental contradiction of capitalism: owners of capital have the right to appropriate the surplus value created by workers. This basic contradiction produces further contradictions that become sources of workplace oppression and resistance that create labor issues. Thus contradictions reveal how power creates consciousness (Poutanen & Kovalainen, 2010 ). Critical reflection is used to de-reify taken-for-granted structures that create power inequities and to motivate resistance and critique and escape from dominant structures (see Table 6 ).

Critical management studies build on critical theory in sociology. It seeks to transform management and provide alternatives to mainstream theory (Adler, Forbes, & Willmott, 2007 ). The focus is “the social injustice and environmental destruction of the broader social and economic systems” served by conventional, capitalist managers (Adler et al., 2007 , p. 118). Critical management research examines “the systemic corrosion of moral responsibility when any concern for people or for the environment . . . requires justification in terms of its contribution to profitable growth” (p. 4). Critical management studies goes beyond scientific skepticism to undertake a radical critique of socially divisive and environmentally destructive patterns and structures (Adler et al., 2007 , p. 119). These studies use critical reflexivity to uncover reified capitalist structures that allow certain groups to dominate others. Critical reflection is used to de-reify and challenge the facts of social life that are seen as immutable and inevitable (Gephart & Richardson, 2008 , p. 34). The combination of dialogical inquiry, critical reflection, and a combination of qualitative and quantitative methods and data are common in this research (Gephart, 2013 , p. 285). Some researchers use deductive logics to build falsifiable theories while other researchers do grounded theory building (Blaikie, 2010 ). Validity of critical research is assessed as the capability the research has to produce critical reflexivity that comprehends dominant ideologies and transforms repressive structures into democratic processes and institutions (Gephart & Richardson, 2008 ).

An illustrative example of critical research . Barker ( 1998 , p. 130) studied “concertive control” in self-managed work teams in a small manufacturing firm. Concertive control refers to how workers collaborate to engage in self-control. Barker sought to understand how control practices in the self-managed team setting, established to allow workers greater control over their work, differed from previous bureaucratic processes. Interviews, observations, and documents were used as data sources. The resultant description of work activities and control shows that rather than allowing workers greater control, the control process enacted by workers themselves became stronger: “The iron cage becomes stronger” and almost invisible “to the workers it incarcerates” (Barker, 1998 , p. 155). This study shows how traditional participant observation methods can be used to uncover and contest reified structures and taken-for-granted truths, and to reveal the hidden managerial interests served.

Postmodern Perspectives

The postmodern perspective (Boje, Gephart, & Thatchenkery, 1996 ) is based in philosophy, the humanities, and literary criticism. Postmodernism, as an era, refers to the historical stage following modernity that evidences a new cultural worldview and style of intellectual production (Boje et al., 1996 ; Jameson, 1991 ; Rosenau, 1992 ). Postmodernism offers a humanistic approach to reconceptualize our experience of the social world in an era where it is impossible to establish any foundational underpinnings for knowledge. The postmodern perspective assumes that realities are contradictory in nature and value-laden (Gephart & Richardson, 2008 ; Rosenau, 1992 , p. 6). It addresses the values and contradictions of contemporary settings, how hidden power operates, and how people are categorized (Gephart, 2013 ). Postmodernism also challenges the idea that scientific research is value free, and asks “whose values are served by research?”

Postmodern essays depart from concerns with systematic, replicable research methods and designs (Calas, 1987 ). They seek instead to explore the values and contradictions of contemporary organizational life (Gephart, 2013 , p. 289). Research reports have the character of essays that seek to reconceptualize how people experience the world (Martin, 1990 ; Rosenau, 1992 ) and to disrupt this experience by producing “reading effects” that unsettle a community (Calas & Smircich, 1991 ).

Postmodernism examines intertextual relations—how texts become embedded in other texts—rather than causal relations. It assumes there are no singular realities or truths, only multiple realities and multiple truths, none of which are superior to other truths (Gephart, 2013 ). Truth is conceived as the outcome of language use in a context where power relations and multiple realities exist.

From a methodological view, postmodern research tends to focus on discourse: texts and talk. Data collection (in so far as it occurs) focuses on records of discourse—texts of spoken and written verbal communication (Fairclough, 1992 ). Use of formal or official records including recordings, texts and transcripts is common. Analytically, scholars tend to use critical discourse analysis (Fairclough, 1992 ), narrative analysis (Czarniawska, 1998 ; Ganzin, Gephart, & Suddaby, 2014 ), rhetorical analysis (Culler, 1982 ; Gephart, 1988 ; McCloskey, 1984 ) and deconstruction (Calais & Smircich, 1991 ; Gephart, 1988 ; Kilduff, 1993 ; Martin, 1990 ) to understand how categories are shaped through language use and come to privilege or subordinate individuals.

Postmodernism challenges models of knowledge production by showing how political discourses produce totalizing categories, showing how categorization is a tool for social control, and attempting to create opportunities for alternative representations of the world. It thus provides a means to uncover and expose discursive features of domination, subordination, and resistance in society (Locke & Golden-Biddle, 2004 ).

An illustrative example of postmodern research . Martin ( 1990 ) deconstructed a conference speech by a company president. The president was so “deeply concerned” about employee well-being and involvement at work that he encouraged a woman manager “to have her Caesarian yesterday” so she could participate in an upcoming product launch. Martin deconstructs the story to reveal the suppression of gender conflict in the dialogue and how this allows gender conflict and subjugation to continue. This research established the existence of important domains of organizational life, such as tacit gender conflict, that have not been adequately addressed and explored the power dynamics therein.

The Organization Development Approach

OD involves a planned and systematic diagnosis and intervention into an organizational system, supported by top management, with the intent of improving the organization’s effectiveness (Beckhard, 1969 ; Palmer, Dunford, & Buchanan, 2017 , p. 282). OD research (termed “clinical research” by Schein, 1987 ) is concerned with changing attitudes and behaviors to instantiate fundamental values in organizations. OD research often follows the general process of action research (Lalonde, 2019 ) that involves working with actors in an organization to help improve the organization. OD research involves a set of stages the OD practitioner (the leader of the intervention) uses: (a) problem identification; (b) consultation between OD practitioner and client; (c) data collection and problem diagnosis; (d) feedback; (e) joint problem diagnosis; (f) joint action planning; (g) change actions; and (h) further data gathering to move recursively to a refined step 1.

An illustrative example of the organization development approach . Numerous OD techniques exist to help organizations change (Palmer et al., 2017 ). The OD approach is illustrated here by the socioeconomic approach to management (SEAM) (Buono & Savall, 2007 ; Savall, 2007 ). SEAM provides a scientific approach to organizational intervention consulting that integrates qualitative information on work practices and employee and customer needs (socio) with quantitative and financial performance measures (economics). The socioeconomic intervention process commences by uncovering dysfunctions that require attention in an organization. SEAM assumes that organizations produce both (a) explicit benefits and costs and (b) hidden benefits and costs. Hidden costs refer to economic implications of organizational dysfunctions (Worley, Zardet, Bonnet, & Savall, 2015 , pp. 28–29). These include problems in working conditions; work organization; communication, co-ordination, and co-operation; time management; integrated training; and strategy implementation (Savall, Zardet, & Bonnet, 2008 , p. 33). Explicit costs are emphasized in management decision-making but hidden costs are ignored. Yet hidden costs from dysfunctions often greatly outstrip explicit costs.

For example, a fishing company sought to protect its market share by reducing the price and quality of products, leading to the purchase of poor-quality fish (Savall et al., 2008 , pp. 31–32). This reduced visible costs by €500,000. However, some customers stopped purchasing because of the lower-quality product, producing a loss of sales of €4,000,000 in revenue or an overall drop in economic performance of €3,500,000. The managers then changed their strategy to focus on health and quality. They implemented the SEAM approach, assessed the negative impact of the hidden costs on value added and revenue received, and purchased higher-quality fish. Visible costs (expenses) increased by €1,000,000 due to the higher cost for a better-quality product, but the improved quality (performance) cut the hidden costs by increasing loyalty and increased sales by €5,000,000 leaving an increased profit of €4,000,000.

SEAM allows organizations to uncover hidden costs in their operations and to convert these costs into value-added human potential through a process termed “qualimetrics.” Qualimetrics assesses the nature of hidden costs and organizational dysfunctions, develops estimates of the frequencies and amounts of hidden costs in specific organizational domains, and develops actions to reduce the hidden costs and thereby release additional value added for the organization (Savall & Zardet, 2011 ). The qualimetric process is participative and involves researchers who use observations, interviews and focus groups of employees to (a) describe, qualitatively, the dysfunctions experienced at work (qualitative data); (b) estimate the frequencies with which dysfunctions occur (quantitative data); and (c) estimate the costs of each dysfunction (financial data). Then, strategic change actions are developed to (a) identify ways to reduce or overcome the dysfunction, (b) estimate how frequently the dysfunction can be remedied, and (c) estimate the overall net costs of removing the hidden costs to enhance value added. The economic balance is then assessed for changes to transform the hidden costs into value added.

OD research creates actionable knowledge from practice (Lalonde, 2019 ). OD intervention consultants use multistep processes to change organizations that are flexible practices not fixed research designs. OD plays an important role in developing evidence-based practices to improve organizational functioning and performance. Worley et al. ( 2015 ) provide a detailed example of the large-scale implementation of the SEAM OD approach in a large, international firm.

Here we discuss implication of qualitative research designs for covert research, reporting qualitative work and novel integrations of qualitative and quantitative work.

Covert Research

University ethics boards require researchers who undertake research with human participants to obtain informed consent from the participants. Consent requires that all participants must be informed of details of the research procedure in which they will be involved and any risks of participation. Researchers must protect subjects’ identities, offer safeguards to limit risks, and insure informant anonymity. This consent must be obtained in the form of a signed agreement from the participant, obtained prior to the commencement of research observations (McCurdy et al., 2005 , pp. 29–32).

Covert research that fails to fully disclose research purposes or practices to participants, or that is otherwise deceptive by design or tacit practice, has long been considered “suspect” in the field (Graham, 1995 ; Roulet, Gill, Stenger, & Gill, 2017 ). This is changing. Research methodologists have shown that the over/covert dimension is a continuum, not a dichotomy, and that unintended covert elements occur in many situations (Roulet et al., 2017 ). Thus all qualitative observation involves some degree of deception due practical constraints on doing observations since it is difficult to do fully overt research, particularly in observational contexts with many people, and to gain advance consent from everyone in the organization one might encounter.

There are compelling benefits to covert research. It can provide insights not possible if subjects are fully informed of the nature or existence of the research. For example, the year-long, covert observational study of an asylum as a “total institution” (Goffman, 1961 ) showed how ineffective the treatment of mental illness was at the time. This opened the field of mental health to social science research (Roulet et al., 2017 , p. 493). Covert research can also provide access to institutions that researchers would otherwise be excluded from, including secretive and secret organizations (p. 492). This could allow researchers to collect data as an insider and to better see and experience the world from members’ perspective. It could also reduce “researcher demand effects” that occur when informants obscure their normal behavior to conform to research expectations. Thus, the inclusion of covert research data collection in research designs and proposals is an emerging trend and realistic possibility. Ethics applications can be developed that allow for aspects of covert research, and observations in many public settings do not require informed consent.

The Appropriate Style for Reporting Qualitative Work

The appropriate style for reporting qualitative research has become an issue of concern. For example, editors of the influential Academy of Management Journal have noted the emergence of an “AMJ style” for qualitative work (Bansal & Corley, 2011 , p. 234). They suggest that all qualitative work should use this style so that qualitative research can “benefit” from: “decades of refinement in the style of quantitative work.” The argument is that most scholars can assess the empirical and theoretical contributions of quantitative work but find it difficult to do so for qualitative research. It is easier for quantitatively trained editors and scholars “to spot the contribution of qualitative work that mimics the style of quantitative research.” Further, “the majority of papers submitted to . . . AMJ tend to subscribe to the paradigm of normal science that aims to find relationships among valid constructs that can be replicated by anyone” (Bansal, Smith, & Vaara, 2018 , p. 1193). These recommendations appear to explicitly encourage the reporting of qualitative results as if they were quantitatively produced and interpreted and highlights the advantage of conformity to the prevailing positivist perspective to gain publication in AMJ.

Yet AMJ editors have also called for researchers to “ensure that the research questions, data, and analysis are internally consistent ” (Bansal et al., 2018 , p. 1193) and to “Be authentic , detailed and clear in argumentation” (emphasis added) (Bansal et al., 2018 , p. 1193). These calls for consistency appear to be inconsistent with suggestions to present all qualitative research using a style that mimics quantitative, positivist research. Adopting the quantitative or positivist style for all qualitative reports may also confuse scholars, limit research quality, and hamper efforts to produce innovative, non-positivist research. This article provides six qualitative research designs to ensure a range of qualitative research publications are internally consistent in methods, logics, paradigmatic commitments, and writing styles. These designs provide alternatives to positivist mimicry in non-positivist scholarly texts.

Integrating Qualitative and Quantitative Research in New Ways

Qualitative research often omits consideration of the naturally occurring uses of numbers and statistics in everyday discourse. And quantitative researchers tend to ignore qualitative evidence such as stories and discourse. Yet knowledge production processes in society “rely on experts and laypeople and, in so doing, make use of both statistics and stories in their attempt to represent and understand social reality” (Ainsworth & Hardy, 2012 , p. 1649). Numbers and statistics are often used in stories to create legitimacy, and stories provide meaning to numbers (Gephart, 1988 ). Hence stories and statistics cannot be separated in processes of knowledge production (Ainsworth & Hardy, 2012 , p. 1697). The lack of attention to the role of quantification in everyday life means a huge domain of organizational discourse—all talk that uses numbers, quantities, and statistics—is largely unexplored in organizational research.

Qualitative research has, however, begun to study how words and numbers are mutually used for organizational storytelling (Ainsworth & Hardy, 2012 ; Gephart, 2016 ). This focus offers the opportunity to develop research designs to explore qualitative features and processes involved in quantitative phenomena such as financial crises (Gephart, 2016 ), to address how stories and numbers need to work together to create legitimate knowledge (Ainsworth & Hardy, 2012 ), and to show how statistics are used rhetorically to convince others of truths in organizational research (Gephart, 1988 ).

Ethnostatistics (Gephart, 1988 ; Gephart & Saylors, 2019 ) provides one example of how to integrate qualitative and quantitative research. Ethnostatistics examines how statistics are constructed and used by professionals. It explores how statistics are constructed in real settings, how violations of technical assumptions impact statistical outcomes, and how statistics are used rhetorically to convince others of the truth of research outcomes. Ethnostatistics has been used to reinterpret data from four celebrated network studies that themselves were reanalyzed (Kilduff & Oh, 2006 ). The ethnostatistical reanalyses revealed how ad hoc practices, including judgment calls and the imputation of new data into old data set for reanalysis, transformed the focus of network research from diffusion models to structural equivalence models.

Another innovative study uses a Bayesian ethnostatistical approach to understand how the pressure to produce sophisticated and increasingly complex theoretical narratives for causal models has impacted the quantitative knowledge generated in top journals (Saylors & Trafimow, 2020 ). The use of complex causal models has increased substantially over time due to a qualitative and untested belief that complex models are true. Yet statistically speaking, as the number of variables in a model increase, the likelihood the model is true rapidly decreases (Saylors & Trafimow, 2020 , p. 3).

The authors test the previously untested (qualitative) belief that complex causal models can be true. They found that “the joint probability of a six variable model is about 3.5%” (Saylors & Trafimow, 2020 , p. 1). They conclude that “much of the knowledge generated in top journals is likely false” hence “not reporting a (prior) belief in a complex model” should be relegated to the set of questionable research practices. This study shows how qualitative research that explores the lay theories and beliefs of statisticians and quantitative researchers can challenge and disrupt conventions in quantitative research, improve quantitative practices, and contribute qualitative foundations to quantitative research. Ethnostatistics thus opens the qualitative foundations of quantitative research to critical qualitative analyses.

The six qualitative research design processes discussed in this article are evident in scholarly research on organizations and management and provide distinct qualitative research designs and approaches to use. Qualitative research can provide research insights from several theoretical perspectives, using well-developed methods to produce scientific and scholarly insights into management and organizations. These approaches and designs can also inform management practice by creating actionable knowledge. The intended contribution of this article is to describe these well-developed methods, articulate key practices, and display core research designs. The hope is both to better equip researchers to do qualitative research, and to inspire them to do so.

Acknowledgments

The authors wish to acknowledge the assistance of Karen Lund at The University of Alberta for carefully preparing Figure 1 . Thanks also to Beverly Zubot for close reading of the manuscript and helpful suggestions.

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1. The fourth logic is retroduction. This refers to the process of building hypothetical models of structures and mechanisms that are assumed to produce empirical phenomena. It is the primary logic used in the critical realist approach to scientific research (Avenier & Thomas, 2015 ; Bhaskar, 1978 ). Retroduction requires the use of inductive or abductive strategies to discover the mechanisms that explain regularities (Blaikie, 2010 , p. 87). There is no evident logic for discovering mechanisms and this requires disciplined scientific thinking aided by creative imagination, intuition, and guesswork (Blaikie, 2010 ). Retroduction is likr deduction in asking “what” questions and differs from abduction because it produces explanations rather than understanding, causes rather than reasons, and hypothetical conceptual mechanisms rather than descriptions of behavioral processes as outcomes. Retroduction is becoming important in the field but has not as yet been extensively used in management and organization studies (for examples of uses, see Avenier & Thomas, 2015 ); hence, we do not address it at length in this article.

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Qualitative Analysis

A research tool for analyzing an organization's overall value based on non-quantifiable indicators

What is Qualitative Analysis?

Qualitative analysis is a research tool used in businesses in order to analyze an organization’s overall value based on non-quantifiable indicators. The non-quantifiable indicators can be information on items within an organization, such as their industry cycle , management expertise, responsiveness to inquiries, strength of business functions, labor relations, or even their visibility within media.

Qualitative analysis differs from quantitative analysis in terms of measurement. The former measures non-numeric information such as the examples used above, while the latter measures numerical data such as numbers on an income statement.

In most cases, both qualitative and quantitative analysis will be used together in order to extensively examine an organization’s trajectory and potential, both of which are incredibly important indicators used to determine investment opportunities.

Qualitative Aspects

Qualitative data comprises specific aspects that differ from other forms of data. For example, qualitative data is used to characterize objects or observations. Such observations include data that use your senses, such as sight, touch, and hearing.

Qualitative data does not refer to aspects that can be measured or numbered. For example, the numbers on a tax return or a balance sheet are not considered qualitative.

Qualitative observations and data can be incredibly helpful to businesses and investors due to the implications they can make. For example, if an organization were to determine that employee satisfaction is a crucial indicator that impacts productivity, it would improve the business tenfold.

Qualitative Analysis in Finance

Qualitative analysis is used in the financial industry to measure a company’s performance, help organizations make crucial decisions, and assist investors on whether or not to invest.

The most common use within finance, helping an investor make big decisions, is started by getting to know the management system extensively. Research analysts and investors do it by examining several qualitative variables, such as employee satisfaction , customer satisfaction, quality assurance, market recognition, and other precise aspects such as customer servicing and returns.

For the most part, examining the qualitative variables can be incredibly hard due to the inaccessibility of information. Many investors rely on news reports and company filings in order to gain a sense of the organization’s philosophy and how they serve their clients. In particular, investors analyze the management discussion and analysis (MD&A) section of an organization’s 10-k report, which is legally required to be published to shareholders.

Qualitative Business Analysis

Qualitative analysis is a highly prominent research tool used in business due to the vast implications that can be made on the statistical data. Researchers measure qualitative variables within an organization to examine a wide array of indicators, such as trajectory, proficiency, and satisfaction, all of which help investors decide on the company’s overall investment potential.

As for actual research, qualitative variables are much more complex to examine due to their non-numeric nature. To solve this, we attach numeric values to the qualitative data.

For example, let’s say ABC Company would like to analyze the satisfaction of their customers for their products. Measuring satisfaction is not numeric, but if we attribute numbers to each level of satisfaction, we can successfully examine the variable.

ABC Company would then ask their consumers to rate their satisfaction on a scale of five, which they would then be able to put into a statistical software . It would like something like the one below:

Qualitative Financial Analysis

Qualitative financial analysis is a research method in business that uses mathematics and statistical software in order to determine the value of specific financial items in a company.

From a base level, qualitative financial analysis is highly subjective. Investment analysts look for a variety of different factors in order to determine overall value.

The factors can include but are not limited to industry trends, management effectiveness, strength of a product line or brand, and consumer opinion. They are used in qualitative financial analysis to help an investor or business form an opinion about a company’s value and its stock.

Uses of Qualitative Analysis

Listed below are the many uses of qualitative analysis:

• Develop extensive consumer profiles
• Analyze business information that is not commonly examined
• Determine the impact of customer and employee satisfaction
• Better understand the trajectory of a business
• Help investors make more lucrative decisions
• Learn the importance of surveys and focus groups
• Determine if there is a market for your company’s products and services
• Determine the needs of the target market and audience
• More effectively understand management systems and how it impacts operations
• Gain a competitive advantage over other organizations and investors

More Resources

Thank you for reading CFI’s guide to Qualitative Analysis. To keep learning and advance your career, the following resources will be helpful:

• Competitive Advantage
• Focus Group
• Products and Services
• Types of SEC Filings
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What is Qualitative Research? Methods and Examples

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Qualitative research seeks to gain insights and understand people’s experiences and perspectives by studying social organizations and human behavior. Data in qualitative studies focuses on people’s beliefs and emotional responses. Qualitative data is especially helpful when a company wants to know how customers feel about a product or service, such as in user experience (UX) design or marketing . 

In this guide, we’ll go over:

Qualitative Research Definition

Qualitative research methods and examples, advantages and disadvantages of qualitative approaches, qualitative vs. quantitative research, showing qualitative research skills on resumes.

Researchers use qualitative approaches to “determine answers to research questions on human behavior and the cultural values that drive our thinking and behavior,” says Margaret J. King, director at The Center for Cultural Studies & Analysis in Philadelphia.

Data in qualitative research typically can’t be assessed mathematically — the data is not sets of numbers or quantifiable information. Rather, it’s collections of images, words, notes on behaviors, descriptions of emotions, and historical context. Data is collected through observations, interviews, surveys, focus groups, and secondary research. 

However, a qualitative study needs a “clear research question at its base,” notes King, and the research needs to be “observed, categorized, compared, and evaluated (along a scale or by a typology chart) by reference to a baseline in order to determine an outcome with value as new and reliable information.”

Who Uses Qualitative Research?

Researchers in social sciences and humanities often use qualitative research methods, especially in specific areas of study like anthropology, history, education, and sociology. 

Qualitative methods are also applicable in business, technology , and marketing spaces. For example, product managers use qualitative research to understand how target audiences respond to their products. They may use focus groups to gain insights from potential customers on product prototypes and improvements or surveys from existing customers to understand what changes users want to see. 

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Grounded Theory

Grounded theory is an inductive approach to theory development. In many forms of research, you begin with a hypothesis and then test it to see if you’re correct. In grounded theory, though, you go in without any assumptions and rely on the data you collect to form theories. You start with an open question about a phenomenon you are studying and collect and analyze data until you can form a fully-fledged theory from the information. 

Example: A company wants to improve its brand and marketing strategies. The company performs a grounded theory approach to solving this problem by conducting interviews and surveys with past, current, and prospective customers. The information gathered from these methods helps the company understand what type of branding and marketing their customer-base likes and dislikes, allowing the team to inductively craft a new brand and marketing strategy from the data. 

Action Research

Action research is one part study and one part problem-solving. Through action research, analysts investigate a problem or weakness and develop practical solutions. The process of action research is cyclical —- researchers assess solutions for efficiency and effectiveness and create further solutions to correct any issues found. 

Example: A manager notices her employees struggle to cooperate on group projects. She carefully reviews how team members interact with each other and asks them all to respond to a survey about communication. Through the survey and study, she finds that guidelines for group projects are unclear. After changing the guidelines, she reviews her team again to see if there are any changes to their behavior.  

>>MORE: Explore how action research helps consultants serve clients with Accenture’s Client Research and Problem Identification job simulation .

Phenomenological Research

Phenomenological research investigates a phenomenon in depth, looking at people’s experiences and understanding of the situation. This sort of study is primarily descriptive and seeks to broaden understanding around a specific incident and the people involved. Researchers in phenomenological studies must be careful to set aside any biases or assumptions because the information used should be entirely from the subjects themselves. 

Example : A researcher wants to better understand the lived experience of college students with jobs. The purpose of this research is to gain insights into the pressures of college students who balance studying and working at the same time. The researcher conducts a series of interviews with several college students, learning about their past and current situations. Through the first few interviews, the researcher builds a relationship with the students. Later discussions are more targeted, with questions prompting the students to discuss their emotions surrounding both work and school and the difficulties and benefits arising from their situation. The researcher then analyzes these interviews, and identifies shared themes to contextualize the experiences of the students. 

Ethnography

Ethnography is an immersive study of a particular culture or community. Through ethnographic research, analysts aim to learn about a group’s conventions, social dynamics, and cultural norms. Some researchers use active observation methods, finding ways to integrate themselves into the culture as much as possible. Others use passive observation, watching closely from the outside but not fully immersing themselves. 

Example: A company hires an external researcher to learn what their company’s culture is actually like. The researcher studies the social dynamics of the employees and may even look at how these employees interact with clients and with each other outside of the office. The goal is to deliver a comprehensive report of the company’s culture and the social dynamics of its employees. 

Case Studies

A case study is a type of in-depth analysis of a situation. Case studies can focus on an organization, belief system, event, person, or action. The goal of a case study is to understand the phenomenon and put it in a real-world context. Case studies are also commonly used in marketing and sales to highlight the benefits of a company’s products or services. 

Example: A business performs a case study of its competitors’ strategies. This case study aims to show why the company should adopt a specific business strategy. The study looks at each competitor’s business structure, marketing campaigns, product offerings, and historical growth trends. Then, using this data on other businesses, the researcher can theorize how that strategy would benefit their company. 

>>MORE: Learn how companies use case study interviews to assess candidates’ research and problem-solving skills. 

Qualitative research methods are great for generating new ideas. The exploratory nature of qualitative research means uncovering unexpected information, which often leads to new theories and further research topics. Additionally, qualitative findings feel meaningful. These studies focus on people, emotions, and societies and may feel closer to their communities than quantitative research that relies on more mathematical and logical data. 

However, qualitative research can be unreliable at times. It’s difficult to replicate qualitative studies since people’s opinions and emotions can change quickly. For example, a focus group has a lot of variables that can affect the outcome, and that same group, asked the same questions a year later, may have entirely different responses. The data collection can also be difficult and time-consuming with qualitative research. Ultimately, interviewing people, reviewing surveys, and understanding and explaining human emotions can be incredibly complex. 

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While qualitative research deals with data that isn’t easily manipulated by mathematics, quantitative research almost exclusively involves numbers and numerical data. Quantitative studies aim to find concrete details, like units of time, percentages, or statistics. 

Besides the types of data used, a core difference between quantitative and qualitative research is the idea of control and replication. 

“Qualitative is less subject to control (as in lab studies) and, therefore, less statistically measurable than quantitative approaches,” says King.

One person’s interview about a specific topic can have completely different responses than every other person’s interview since there are so many variables in qualitative research. On the other hand, quantitative studies can often be replicated. For instance, when testing the effects of a new medication, quantifiable data, like blood test results, can be repeated. Qualitative data, though, like how people feel about the medication, may differ from person to person and from moment to moment. 

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You can show your experience with qualitative research on your resume in your skills or work experience sections and your cover letter . 

In your skills section, you can list types of qualitative research you are skilled at, like conducting interviews, performing grounded theory research, or crafting case studies. 

You can highlight specific examples in the description of your past work or internship experiences. For example, you can talk about a time you used action research to solve a complex issue at your last job. 

Your cover letter is an excellent place to discuss in-depth qualitative research projects you’ve completed. For instance, say you spent a summer conducting ethnographic research or a whole semester running focus groups to get feedback on a product. You can talk about these experiences in your cover letter and note how these skills make you a great fit for the job. 

Grow your skills and explore your career options with Forage’s free job simulations . 

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Qualitative Research in Business and Management

• Michael D Myers - University of Auckland, New Zealand
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This accessible and expansive, yet remarkably concise textbook is designed to help readers with their research project. As well as guiding them through the key methods of collecting and analysing qualitative data, this book provides invaluable information on writing up their research and how to get published.

Now in its third edition,  Qualitative Research in Business and Management  has been fully updated to include a range of recent examples of aspects of qualitative research in action, and a new look at the methods and ethics of using social media data.

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Qualitative Research in Business and Management is an accessible and well-structured introduction in qualitative research. Myers clearly explains the main concepts and principles of qualitative research, illustrating them with recent examples from top journals. Being concise and comprehensive, I consider this the best textbook in the field.

Perfect for Dissertation support

Great book, well written

This is one of few books on qualitative research method in business. The coverage is extensive. It includes both the design and data analysis of qualitative research. Although the author is a scholar in information systems, he managed to include all the business and management sub-areas in the book. The explanation is also very easy to follow.

A good book to invite students to prepare for theses using qualitative methods. The book covers the essential in an abordable way.

a useful text aimed at Business and management students which will provide a useful source of advice and guidance as well as introducing the basics.

Well explained qualitative research concepts and the exercise sections are useful.

Currently this book is still in the university (building). Due to Covid 19 I was not able to collect it.

It is a clear and concise volume that summarises many of the issues my students face in conducting their qualitative research.

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Qualitative Research : Definition

Qualitative research is the naturalistic study of social meanings and processes, using interviews, observations, and the analysis of texts and images.  In contrast to quantitative researchers, whose statistical methods enable broad generalizations about populations (for example, comparisons of the percentages of U.S. demographic groups who vote in particular ways), qualitative researchers use in-depth studies of the social world to analyze how and why groups think and act in particular ways (for instance, case studies of the experiences that shape political views).   

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Qualitative Methods in Business Research

Qualitative Research in Organizations and Management

ISSN : 1746-5648

Article publication date: 13 March 2017

Ruel, S. (2017), "Qualitative Methods in Business Research", Qualitative Research in Organizations and Management , Vol. 12 No. 1, pp. 87-88. https://doi.org/10.1108/QROM-08-2016-1410

Emerald Publishing Limited

Copyright © 2017, Emerald Publishing Limited

Imagine for a moment that its 40 below 0 outside, the depth of winter is upon you, and you roll yourself up into the warmest blanket you can find to keep out the chill. This image – of being surrounded by this warm blanket – kept playing out in my mind as I read through the second edition of Qualitative Methods in Business Research by Paivi Eriksson and Anne Kovalainen. I fondly remember the first edition that was assigned to us in my first year as a doctoral student. When I started reading through the first edition, I thought that finally I could understand this journey I was on! The language in the first edition was clear, concise, and such a relief from the ontological and epistemological debates I had been exposed to. The second edition, thankfully, keeps this tradition alive: the book is attainable for its intended student audience and I might add for those that want a refresher in qualitative methodologies that the reader may have skipped over upon first reading.

There are five important changes within the structure and content of this second edition. The first two changes consist of renaming a few key chapters (chapter 4, “Research questions and literature review;” chapter 8, “Interviews and observations;” chapter 9 on “Digital data”), and the addition of new chapters on “Qualitative content analysis,” “Visual research,” and “Publishing.” The next change involves the addition of new and updated literature references (i.e. books and academic publications) to support the various chapters, and to instigate the student to do further independent study via the further reading section found at the end of each chapter. Finally, the two remaining changes involve more editorial issues such as restructuring problems and questions for the reader to practice their acquired knowledge and the tightening up of language for clarity. Within these editorial changes, there are now four parts to this edition (“The business of qualitative research,” “Working with qualitative data,” “Qualitative research approaches,” and “Writing, evaluating and publishing”) as opposed to initial three parts found in the first edition.

The new chapters on “Qualitative content analysis,” “Visual research,” and “Publishing” are very much welcome additions to this book. The “Qualitative content analysis” chapter was present in the first edition, but was lost in the “Electronic research” chapter. The “Visual research” chapter was, I found, an exciting addition as this method gains traction in studying businesses and their environment. Finally, the “Publishing” chapter was a surprise addition that was much needed. Many doctoral students question where and how to publish their research, some to make a difference within the business world and others to build their own academic pursuits. While this last chapter is brief, it allows for the beginning of a conversation on what avenue to follow (i.e. practitioner publications, conferences, book chapters, academic publications, etc.).

I identify in my academic work as a postfeminist poststructuralist. As controversial as this may sound, I must make this distinctive identification clear when I consider my expectations with respect to the “Feminist approach” chapter in this second edition. The authors point out right away that many textbooks do not identify feminism let alone as a method of study. While I was and continue to be ecstatic that these authors recognize this shortcoming within the business research literature, I really wanted to see some major updates to this chapter which unfortunately did not happen in this edition. Suggested improvements include considering introducing different types of feminism, and then suggesting matches of these types with appropriate methods. Too much focus was given to postmodernism as a feminist method, potentially confusing the audience into believing such avenues such as liberal feminism could be dealt with effectively say via a critical discourse analysis. Feminist studies span many different ontological states which necessitate a variety of potential approaches to bring forth feminist epistemologies, and thus different feminist approaches that can span an extensive continuum of possibilities. While I embrace this book as an introductory one to various qualitative methodologies, the authors have simplified the idea of feminism too much I believe.

On the whole, this is a wonderful warm blanket of a resource book for its intended audience. It provides a level of security to students in understanding the beginning of the conversation on a variety of qualitative methodologies. My first edition book is dog-eared, with many scribbles and tags throughout. I found myself doing the same thing with this second edition – writing down notes for myself, flipping corners of pages, etc. – and it is a welcome addition to my ever growing library of resource books that keep out the cold.

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Qualitative vs quantitative research.

13 min read You’ll use both quantitative and qualitative research methods to gather survey data. What are they exactly, and how can you best use them to gain the most accurate insights?

What is qualitative research?

Qualitative research  is all about  language, expression, body language and other forms of human communication . That covers words, meanings and understanding. Qualitative research is used to describe WHY. Why do people  feel  the way they do, why do they  act  in a certain way, what  opinions  do they have and what  motivates  them?

Qualitative data is used to understand phenomena – things that happen, situations that exist, and most importantly the meanings associated with them. It can help add a ‘why’ element to factual, objective data.

Qualitative research gives breadth, depth and context to questions, although its linguistic subtleties and subjectivity can mean that results are trickier to analyse than quantitative data.

This qualitative data is called  unstructured data by researchers. This is because it has not traditionally had the type of structure that can be processed by computers, until today. It has, until recently at least, been exclusively accessible to human brains. And although our brains are highly sophisticated, they have limited processing power. What can help analyse this structured data to assist computers and the human brain?

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What is quantitative research?

Quantitative data refers to numerical information. Quantitative research gathers information that can be counted, measured, or rated numerically – AKA quantitative data. Scores, measurements, financial records, temperature charts and receipts or ledgers are all examples of quantitative data.

Quantitative data is often structured data, because it follows a consistent, predictable pattern that computers and calculating devices are able to process with ease. Humans can process it too, although we are now able to pass it over to machines to process on our behalf. This is partly what has made quantitative data so important historically, and why quantitative data – sometimes called ‘hard data’ – has dominated over qualitative data in fields like business, finance and economics.

It’s easy to ‘crunch the numbers’ of quantitative data and produce results visually in graphs, tables and on data analysis dashboards. Thanks to today’s abundance and accessibility of processing power, combined with our ability to store huge amounts of information, quantitative data has fuelled the Big Data phenomenon, putting quantitative methods and vast amounts of quantitative data at our fingertips.

As we’ve indicated, quantitative and qualitative data are entirely different and mutually exclusive categories. Here are a few of the differences between them.

1. Data collection

Data collection methods for quantitative data and qualitative data vary, but there are also some places where they overlap.

2. Data analysis

Quantitative data suits statistical analysis techniques like linear regression, T-tests and ANOVA. These are quite easy to automate, and large quantities of quantitative data can be analyzed quickly.

Analyzing qualitative data needs a higher degree of human judgement, since unlike quantitative data, non numerical data of a subjective nature has certain characteristics that inferential statistics can’t perceive. Working at a human scale has historically meant that qualitative data is lower in volume – although it can be richer in insights.

3. Strengths and weaknesses

When weighing up qualitative vs quantitative research, it’s largely a matter of choosing the method appropriate to your research goals. If you’re in the position of having to choose one method over another, it’s worth knowing the strengths and limitations of each, so that you know what to expect from your results.

Qualitative vs quantitative – the role of research questions

How do you know whether you need qualitative or quantitative research techniques? By finding out what kind of data you’re going to be collecting.

You’ll do this as you develop your research question, one of the first steps to any research program. It’s a single sentence that sums up the purpose of your research, who you’re going to gather data from, and what results you’re looking for.

As you formulate your question, you’ll get a sense of the sort of answer you’re working towards, and whether it will be expressed in numerical data or qualitative data.

For example, your research question might be “How often does a poor customer experience cause shoppers to abandon their shopping carts?” – this is a quantitative topic, as you’re looking for numerical values.

Or it might be “What is the emotional impact of a poor customer experience on regular customers in our supermarket?” This is a qualitative topic, concerned with thoughts and feelings and answered in personal, subjective ways that vary between respondents.

Here’s how to evaluate your research question and decide which method to use:

• Qualitative research:

Use this if your goal is to  understand  something – experiences, problems, ideas.

For example, you may want to understand how poor experiences in a supermarket make your customers feel. You might carry out this research through focus groups or in depth interviews (IDI’s). For a larger scale research method you could start  by surveying supermarket loyalty card holders, asking open text questions, like “How would you describe your experience today?” or “What could be improved about your experience?” This research will provide context and understanding that quantitative research will not.

• Quantitative research:

Use this if your goal is to  test or confirm  a hypothesis, or to study cause and effect relationships. For example, you want to find out what percentage of your returning customers are happy with the customer experience at your store. You can collect data to answer this via a survey.

For example, you could recruit 1,000 loyalty card holders as participants, asking them, “On a scale of 1-5, how happy are you with our store?” You can then make simple mathematical calculations to find the average score. The larger sample size will help make sure your results aren’t skewed by anomalous data or outliers, so you can draw conclusions with confidence.

Qualitative and quantitative research combined?

Do you always have to choose between qualitative or quantitative data?

In some cases you can get the best of both worlds by combining both quantitative and qualitative data.You could use pre quantitative data to understand the landscape of your research. Here you can gain  insights around a topic  and propose a  hypothesis.  Then adopt a quantitative research method to test it out. Here you’ll discover where to focus your survey appropriately or to pre-test your survey, to ensure your questions are understood as you intended. Finally, using a round of qualitative research methods to bring your insights and story to life. This mixed methods approach is becoming increasingly popular with businesses who are looking for in depth insights.

For example, in the supermarket scenario we’ve described, you could start out with a qualitative data collection phase where you use focus groups and conduct interviews with customers. You might find suggestions in your qualitative data that customers would like to be able to buy children’s clothes in the store.

In response, the supermarket might pilot a children’s clothing range. Targeted  quantitative  research could then reveal whether or not those stores selling children’s clothes achieve higher  customer satisfaction  scores  and a  rise in profits  for clothing.

Together, qualitative and quantitative data, combined with statistical analysis, have provided important insights about customer experience, and have proven the effectiveness of a solution to business problems.

Qualitative vs quantitative question types

As we’ve noted, surveys are one of the data collection methods suitable for both quantitative and qualitative research. Depending on the types of questions you choose to include, you can generate qualitative and quantitative data. Here we have summarized some of the survey question types you can use for each purpose.

Qualitative data survey questions

There are fewer survey  question  options for collecting qualitative data, since they all essentially do the same thing – provide the respondent with space to enter information in their own words. Qualitative research is not typically done with surveys alone, and researchers may use a mix of qualitative methods. As well as a survey, they might conduct in depth interviews, use observational studies or hold focus groups.

Open text ‘Other’ box (can be used with multiple choice questions)

Text box (space for short written answer)

Essay box (space for longer, more detailed written answers)

Quantitative data survey questions

These questions will yield quantitative data – i.e. a numerical value.

Net Promoter Score (NPS)

Likert Scale

Radio buttons (respondents choose just one option)

Check boxes (respondents can choose multiple options)

Sliding scale

Star rating

Analysing data (quantitative or qualitative) using technology

We are currently at an exciting point in the history of qualitative analysis. Digital analysis and other methods that were formerly exclusively used for  quantitative data  are now used for interpreting non numerical data too.

Artificial intelligence programs can now be used to analyse open text, and turn qualitative data into structured and semi structured quantitative data that relates to qualitative data topics such as emotion and sentiment, opinion and experience.

Research that in the past would have meant qualitative researchers conducting time-intensive studies using analysis methods like thematic analysis can now be done in a very short space of time. This not only saves time and money, but opens up qualitative data analysis to a much wider range of businesses and organisations.

The most advanced tools can even be used for real-time statistical analysis, forecasting and prediction, making them a powerful asset for businesses.

Qualitative or quantitative – which is better for data analysis?

Historically, quantitative data was much easier to analyse than qualitative data. But as we’ve seen, modern technology is helping qualitative analysis to catch up, making it quicker and less labor-intensive than before.

That means the choice between qualitative and quantitative studies no longer needs to factor in ease of analysis, provided you have the right tools at your disposal. With an integrated platform like Qualtrics, which incorporates data collection, data cleaning, data coding and a powerful suite of analysis tools for both qualitative and quantitative data, you have a wide range of options at your fingertips.

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• What Is Qualitative Research? | Methods & Examples

What Is Qualitative Research? | Methods & Examples

Published on 4 April 2022 by Pritha Bhandari . Revised on 30 January 2023.

Qualitative research involves collecting and analysing non-numerical data (e.g., text, video, or audio) to understand concepts, opinions, or experiences. It can be used to gather in-depth insights into a problem or generate new ideas for research.

Qualitative research is the opposite of quantitative research , which involves collecting and analysing numerical data for statistical analysis.

Qualitative research is commonly used in the humanities and social sciences, in subjects such as anthropology, sociology, education, health sciences, and history.

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Table of contents

Approaches to qualitative research, qualitative research methods, qualitative data analysis, advantages of qualitative research, disadvantages of qualitative research, frequently asked questions about qualitative research.

Qualitative research is used to understand how people experience the world. While there are many approaches to qualitative research, they tend to be flexible and focus on retaining rich meaning when interpreting data.

Common approaches include grounded theory, ethnography, action research, phenomenological research, and narrative research. They share some similarities, but emphasise different aims and perspectives.

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Each of the research approaches involve using one or more data collection methods . These are some of the most common qualitative methods:

• Observations: recording what you have seen, heard, or encountered in detailed field notes.
• Interviews:  personally asking people questions in one-on-one conversations.
• Focus groups: asking questions and generating discussion among a group of people.
• Surveys : distributing questionnaires with open-ended questions.
• Secondary research: collecting existing data in the form of texts, images, audio or video recordings, etc.
• You take field notes with observations and reflect on your own experiences of the company culture.
• You distribute open-ended surveys to employees across all the company’s offices by email to find out if the culture varies across locations.
• You conduct in-depth interviews with employees in your office to learn about their experiences and perspectives in greater detail.

Qualitative researchers often consider themselves ‘instruments’ in research because all observations, interpretations and analyses are filtered through their own personal lens.

For this reason, when writing up your methodology for qualitative research, it’s important to reflect on your approach and to thoroughly explain the choices you made in collecting and analysing the data.

Qualitative data can take the form of texts, photos, videos and audio. For example, you might be working with interview transcripts, survey responses, fieldnotes, or recordings from natural settings.

Most types of qualitative data analysis share the same five steps:

• Prepare and organise your data. This may mean transcribing interviews or typing up fieldnotes.
• Review and explore your data. Examine the data for patterns or repeated ideas that emerge.
• Develop a data coding system. Based on your initial ideas, establish a set of codes that you can apply to categorise your data.
• Assign codes to the data. For example, in qualitative survey analysis, this may mean going through each participant’s responses and tagging them with codes in a spreadsheet. As you go through your data, you can create new codes to add to your system if necessary.
• Identify recurring themes. Link codes together into cohesive, overarching themes.

There are several specific approaches to analysing qualitative data. Although these methods share similar processes, they emphasise different concepts.

Qualitative research often tries to preserve the voice and perspective of participants and can be adjusted as new research questions arise. Qualitative research is good for:

• Flexibility

The data collection and analysis process can be adapted as new ideas or patterns emerge. They are not rigidly decided beforehand.

• Natural settings

Data collection occurs in real-world contexts or in naturalistic ways.

• Meaningful insights

Detailed descriptions of people’s experiences, feelings and perceptions can be used in designing, testing or improving systems or products.

• Generation of new ideas

Open-ended responses mean that researchers can uncover novel problems or opportunities that they wouldn’t have thought of otherwise.

Researchers must consider practical and theoretical limitations in analysing and interpreting their data. Qualitative research suffers from:

• Unreliability

The real-world setting often makes qualitative research unreliable because of uncontrolled factors that affect the data.

• Subjectivity

Due to the researcher’s primary role in analysing and interpreting data, qualitative research cannot be replicated . The researcher decides what is important and what is irrelevant in data analysis, so interpretations of the same data can vary greatly.

• Limited generalisability

Small samples are often used to gather detailed data about specific contexts. Despite rigorous analysis procedures, it is difficult to draw generalisable conclusions because the data may be biased and unrepresentative of the wider population .

• Labour-intensive

Although software can be used to manage and record large amounts of text, data analysis often has to be checked or performed manually.

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to test a hypothesis by systematically collecting and analysing data, while qualitative methods allow you to explore ideas and experiences in depth.

There are five common approaches to qualitative research :

• Grounded theory involves collecting data in order to develop new theories.
• Ethnography involves immersing yourself in a group or organisation to understand its culture.
• Narrative research involves interpreting stories to understand how people make sense of their experiences and perceptions.
• Phenomenological research involves investigating phenomena through people’s lived experiences.
• Action research links theory and practice in several cycles to drive innovative changes.

Data collection is the systematic process by which observations or measurements are gathered in research. It is used in many different contexts by academics, governments, businesses, and other organisations.

There are various approaches to qualitative data analysis , but they all share five steps in common:

• Prepare and organise your data.
• Review and explore your data.
• Develop a data coding system.
• Assign codes to the data.
• Identify recurring themes.

The specifics of each step depend on the focus of the analysis. Some common approaches include textual analysis , thematic analysis , and discourse analysis .

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Methodology

• Qualitative vs. Quantitative Research | Differences, Examples & Methods

Qualitative vs. Quantitative Research | Differences, Examples & Methods

Published on April 12, 2019 by Raimo Streefkerk . Revised on June 22, 2023.

When collecting and analyzing data, quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings. Both are important for gaining different kinds of knowledge.

Common quantitative methods include experiments, observations recorded as numbers, and surveys with closed-ended questions.

Quantitative research is at risk for research biases including information bias , omitted variable bias , sampling bias , or selection bias . Qualitative research Qualitative research is expressed in words . It is used to understand concepts, thoughts or experiences. This type of research enables you to gather in-depth insights on topics that are not well understood.

Common qualitative methods include interviews with open-ended questions, observations described in words, and literature reviews that explore concepts and theories.

Table of contents

The differences between quantitative and qualitative research, data collection methods, when to use qualitative vs. quantitative research, how to analyze qualitative and quantitative data, other interesting articles, frequently asked questions about qualitative and quantitative research.

Quantitative and qualitative research use different research methods to collect and analyze data, and they allow you to answer different kinds of research questions.

Quantitative and qualitative data can be collected using various methods. It is important to use a data collection method that will help answer your research question(s).

Many data collection methods can be either qualitative or quantitative. For example, in surveys, observational studies or case studies , your data can be represented as numbers (e.g., using rating scales or counting frequencies) or as words (e.g., with open-ended questions or descriptions of what you observe).

However, some methods are more commonly used in one type or the other.

Quantitative data collection methods

• Surveys :  List of closed or multiple choice questions that is distributed to a sample (online, in person, or over the phone).
• Experiments : Situation in which different types of variables are controlled and manipulated to establish cause-and-effect relationships.
• Observations : Observing subjects in a natural environment where variables can’t be controlled.

Qualitative data collection methods

• Interviews : Asking open-ended questions verbally to respondents.
• Focus groups : Discussion among a group of people about a topic to gather opinions that can be used for further research.
• Ethnography : Participating in a community or organization for an extended period of time to closely observe culture and behavior.
• Literature review : Survey of published works by other authors.

A rule of thumb for deciding whether to use qualitative or quantitative data is:

• Use quantitative research if you want to confirm or test something (a theory or hypothesis )
• Use qualitative research if you want to understand something (concepts, thoughts, experiences)

For most research topics you can choose a qualitative, quantitative or mixed methods approach . Which type you choose depends on, among other things, whether you’re taking an inductive vs. deductive research approach ; your research question(s) ; whether you’re doing experimental , correlational , or descriptive research ; and practical considerations such as time, money, availability of data, and access to respondents.

Quantitative research approach

You survey 300 students at your university and ask them questions such as: “on a scale from 1-5, how satisfied are your with your professors?”

You can perform statistical analysis on the data and draw conclusions such as: “on average students rated their professors 4.4”.

Qualitative research approach

You conduct in-depth interviews with 15 students and ask them open-ended questions such as: “How satisfied are you with your studies?”, “What is the most positive aspect of your study program?” and “What can be done to improve the study program?”

Based on the answers you get you can ask follow-up questions to clarify things. You transcribe all interviews using transcription software and try to find commonalities and patterns.

Mixed methods approach

You conduct interviews to find out how satisfied students are with their studies. Through open-ended questions you learn things you never thought about before and gain new insights. Later, you use a survey to test these insights on a larger scale.

It’s also possible to start with a survey to find out the overall trends, followed by interviews to better understand the reasons behind the trends.

Qualitative or quantitative data by itself can’t prove or demonstrate anything, but has to be analyzed to show its meaning in relation to the research questions. The method of analysis differs for each type of data.

Analyzing quantitative data

Quantitative data is based on numbers. Simple math or more advanced statistical analysis is used to discover commonalities or patterns in the data. The results are often reported in graphs and tables.

Applications such as Excel, SPSS, or R can be used to calculate things like:

• Average scores ( means )
• The number of times a particular answer was given
• The correlation or causation between two or more variables
• The reliability and validity of the results

Analyzing qualitative data

Qualitative data is more difficult to analyze than quantitative data. It consists of text, images or videos instead of numbers.

Some common approaches to analyzing qualitative data include:

• Qualitative content analysis : Tracking the occurrence, position and meaning of words or phrases
• Thematic analysis : Closely examining the data to identify the main themes and patterns
• Discourse analysis : Studying how communication works in social contexts

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Chi square goodness of fit test
• Degrees of freedom
• Null hypothesis
• Discourse analysis
• Control groups
• Mixed methods research
• Non-probability sampling
• Quantitative research
• Inclusion and exclusion criteria

Research bias

• Rosenthal effect
• Implicit bias
• Cognitive bias
• Selection bias
• Negativity bias
• Status quo bias

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

In mixed methods research , you use both qualitative and quantitative data collection and analysis methods to answer your research question .

The research methods you use depend on the type of data you need to answer your research question .

• If you want to measure something or test a hypothesis , use quantitative methods . If you want to explore ideas, thoughts and meanings, use qualitative methods .
• If you want to analyze a large amount of readily-available data, use secondary data. If you want data specific to your purposes with control over how it is generated, collect primary data.
• If you want to establish cause-and-effect relationships between variables , use experimental methods. If you want to understand the characteristics of a research subject, use descriptive methods.

Data collection is the systematic process by which observations or measurements are gathered in research. It is used in many different contexts by academics, governments, businesses, and other organizations.

There are various approaches to qualitative data analysis , but they all share five steps in common:

• Prepare and organize your data.
• Review and explore your data.
• Develop a data coding system.
• Assign codes to the data.
• Identify recurring themes.

The specifics of each step depend on the focus of the analysis. Some common approaches include textual analysis , thematic analysis , and discourse analysis .

A research project is an academic, scientific, or professional undertaking to answer a research question . Research projects can take many forms, such as qualitative or quantitative , descriptive , longitudinal , experimental , or correlational . What kind of research approach you choose will depend on your topic.

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Home » Qualitative Research – Methods, Analysis Types and Guide

Qualitative Research – Methods, Analysis Types and Guide

Table of Contents

Qualitative Research

Qualitative research is a type of research methodology that focuses on exploring and understanding people’s beliefs, attitudes, behaviors, and experiences through the collection and analysis of non-numerical data. It seeks to answer research questions through the examination of subjective data, such as interviews, focus groups, observations, and textual analysis.

Qualitative research aims to uncover the meaning and significance of social phenomena, and it typically involves a more flexible and iterative approach to data collection and analysis compared to quantitative research. Qualitative research is often used in fields such as sociology, anthropology, psychology, and education.

Qualitative Research Methods

Qualitative Research Methods are as follows:

One-to-One Interview

This method involves conducting an interview with a single participant to gain a detailed understanding of their experiences, attitudes, and beliefs. One-to-one interviews can be conducted in-person, over the phone, or through video conferencing. The interviewer typically uses open-ended questions to encourage the participant to share their thoughts and feelings. One-to-one interviews are useful for gaining detailed insights into individual experiences.

Focus Groups

This method involves bringing together a group of people to discuss a specific topic in a structured setting. The focus group is led by a moderator who guides the discussion and encourages participants to share their thoughts and opinions. Focus groups are useful for generating ideas and insights, exploring social norms and attitudes, and understanding group dynamics.

Ethnographic Studies

This method involves immersing oneself in a culture or community to gain a deep understanding of its norms, beliefs, and practices. Ethnographic studies typically involve long-term fieldwork and observation, as well as interviews and document analysis. Ethnographic studies are useful for understanding the cultural context of social phenomena and for gaining a holistic understanding of complex social processes.

Text Analysis

This method involves analyzing written or spoken language to identify patterns and themes. Text analysis can be quantitative or qualitative. Qualitative text analysis involves close reading and interpretation of texts to identify recurring themes, concepts, and patterns. Text analysis is useful for understanding media messages, public discourse, and cultural trends.

This method involves an in-depth examination of a single person, group, or event to gain an understanding of complex phenomena. Case studies typically involve a combination of data collection methods, such as interviews, observations, and document analysis, to provide a comprehensive understanding of the case. Case studies are useful for exploring unique or rare cases, and for generating hypotheses for further research.

Process of Observation

This method involves systematically observing and recording behaviors and interactions in natural settings. The observer may take notes, use audio or video recordings, or use other methods to document what they see. Process of observation is useful for understanding social interactions, cultural practices, and the context in which behaviors occur.

Record Keeping

This method involves keeping detailed records of observations, interviews, and other data collected during the research process. Record keeping is essential for ensuring the accuracy and reliability of the data, and for providing a basis for analysis and interpretation.

This method involves collecting data from a large sample of participants through a structured questionnaire. Surveys can be conducted in person, over the phone, through mail, or online. Surveys are useful for collecting data on attitudes, beliefs, and behaviors, and for identifying patterns and trends in a population.

Qualitative data analysis is a process of turning unstructured data into meaningful insights. It involves extracting and organizing information from sources like interviews, focus groups, and surveys. The goal is to understand people’s attitudes, behaviors, and motivations

Qualitative Research Analysis Methods

Qualitative Research analysis methods involve a systematic approach to interpreting and making sense of the data collected in qualitative research. Here are some common qualitative data analysis methods:

Thematic Analysis

This method involves identifying patterns or themes in the data that are relevant to the research question. The researcher reviews the data, identifies keywords or phrases, and groups them into categories or themes. Thematic analysis is useful for identifying patterns across multiple data sources and for generating new insights into the research topic.

Content Analysis

This method involves analyzing the content of written or spoken language to identify key themes or concepts. Content analysis can be quantitative or qualitative. Qualitative content analysis involves close reading and interpretation of texts to identify recurring themes, concepts, and patterns. Content analysis is useful for identifying patterns in media messages, public discourse, and cultural trends.

Discourse Analysis

This method involves analyzing language to understand how it constructs meaning and shapes social interactions. Discourse analysis can involve a variety of methods, such as conversation analysis, critical discourse analysis, and narrative analysis. Discourse analysis is useful for understanding how language shapes social interactions, cultural norms, and power relationships.

Grounded Theory Analysis

This method involves developing a theory or explanation based on the data collected. Grounded theory analysis starts with the data and uses an iterative process of coding and analysis to identify patterns and themes in the data. The theory or explanation that emerges is grounded in the data, rather than preconceived hypotheses. Grounded theory analysis is useful for understanding complex social phenomena and for generating new theoretical insights.

Narrative Analysis

This method involves analyzing the stories or narratives that participants share to gain insights into their experiences, attitudes, and beliefs. Narrative analysis can involve a variety of methods, such as structural analysis, thematic analysis, and discourse analysis. Narrative analysis is useful for understanding how individuals construct their identities, make sense of their experiences, and communicate their values and beliefs.

Phenomenological Analysis

This method involves analyzing how individuals make sense of their experiences and the meanings they attach to them. Phenomenological analysis typically involves in-depth interviews with participants to explore their experiences in detail. Phenomenological analysis is useful for understanding subjective experiences and for developing a rich understanding of human consciousness.

Comparative Analysis

This method involves comparing and contrasting data across different cases or groups to identify similarities and differences. Comparative analysis can be used to identify patterns or themes that are common across multiple cases, as well as to identify unique or distinctive features of individual cases. Comparative analysis is useful for understanding how social phenomena vary across different contexts and groups.

Applications of Qualitative Research

Qualitative research has many applications across different fields and industries. Here are some examples of how qualitative research is used:

• Market Research: Qualitative research is often used in market research to understand consumer attitudes, behaviors, and preferences. Researchers conduct focus groups and one-on-one interviews with consumers to gather insights into their experiences and perceptions of products and services.
• Health Care: Qualitative research is used in health care to explore patient experiences and perspectives on health and illness. Researchers conduct in-depth interviews with patients and their families to gather information on their experiences with different health care providers and treatments.
• Education: Qualitative research is used in education to understand student experiences and to develop effective teaching strategies. Researchers conduct classroom observations and interviews with students and teachers to gather insights into classroom dynamics and instructional practices.
• Social Work : Qualitative research is used in social work to explore social problems and to develop interventions to address them. Researchers conduct in-depth interviews with individuals and families to understand their experiences with poverty, discrimination, and other social problems.
• Anthropology : Qualitative research is used in anthropology to understand different cultures and societies. Researchers conduct ethnographic studies and observe and interview members of different cultural groups to gain insights into their beliefs, practices, and social structures.
• Psychology : Qualitative research is used in psychology to understand human behavior and mental processes. Researchers conduct in-depth interviews with individuals to explore their thoughts, feelings, and experiences.
• Public Policy : Qualitative research is used in public policy to explore public attitudes and to inform policy decisions. Researchers conduct focus groups and one-on-one interviews with members of the public to gather insights into their perspectives on different policy issues.

How to Conduct Qualitative Research

Here are some general steps for conducting qualitative research:

• Identify your research question: Qualitative research starts with a research question or set of questions that you want to explore. This question should be focused and specific, but also broad enough to allow for exploration and discovery.
• Select your research design: There are different types of qualitative research designs, including ethnography, case study, grounded theory, and phenomenology. You should select a design that aligns with your research question and that will allow you to gather the data you need to answer your research question.
• Recruit participants: Once you have your research question and design, you need to recruit participants. The number of participants you need will depend on your research design and the scope of your research. You can recruit participants through advertisements, social media, or through personal networks.
• Collect data: There are different methods for collecting qualitative data, including interviews, focus groups, observation, and document analysis. You should select the method or methods that align with your research design and that will allow you to gather the data you need to answer your research question.
• Analyze data: Once you have collected your data, you need to analyze it. This involves reviewing your data, identifying patterns and themes, and developing codes to organize your data. You can use different software programs to help you analyze your data, or you can do it manually.
• Interpret data: Once you have analyzed your data, you need to interpret it. This involves making sense of the patterns and themes you have identified, and developing insights and conclusions that answer your research question. You should be guided by your research question and use your data to support your conclusions.
• Communicate results: Once you have interpreted your data, you need to communicate your results. This can be done through academic papers, presentations, or reports. You should be clear and concise in your communication, and use examples and quotes from your data to support your findings.

Examples of Qualitative Research

Here are some real-time examples of qualitative research:

• Customer Feedback: A company may conduct qualitative research to understand the feedback and experiences of its customers. This may involve conducting focus groups or one-on-one interviews with customers to gather insights into their attitudes, behaviors, and preferences.
• Healthcare : A healthcare provider may conduct qualitative research to explore patient experiences and perspectives on health and illness. This may involve conducting in-depth interviews with patients and their families to gather information on their experiences with different health care providers and treatments.
• Education : An educational institution may conduct qualitative research to understand student experiences and to develop effective teaching strategies. This may involve conducting classroom observations and interviews with students and teachers to gather insights into classroom dynamics and instructional practices.
• Social Work: A social worker may conduct qualitative research to explore social problems and to develop interventions to address them. This may involve conducting in-depth interviews with individuals and families to understand their experiences with poverty, discrimination, and other social problems.
• Anthropology : An anthropologist may conduct qualitative research to understand different cultures and societies. This may involve conducting ethnographic studies and observing and interviewing members of different cultural groups to gain insights into their beliefs, practices, and social structures.
• Psychology : A psychologist may conduct qualitative research to understand human behavior and mental processes. This may involve conducting in-depth interviews with individuals to explore their thoughts, feelings, and experiences.
• Public Policy: A government agency or non-profit organization may conduct qualitative research to explore public attitudes and to inform policy decisions. This may involve conducting focus groups and one-on-one interviews with members of the public to gather insights into their perspectives on different policy issues.

Purpose of Qualitative Research

The purpose of qualitative research is to explore and understand the subjective experiences, behaviors, and perspectives of individuals or groups in a particular context. Unlike quantitative research, which focuses on numerical data and statistical analysis, qualitative research aims to provide in-depth, descriptive information that can help researchers develop insights and theories about complex social phenomena.

Qualitative research can serve multiple purposes, including:

• Exploring new or emerging phenomena : Qualitative research can be useful for exploring new or emerging phenomena, such as new technologies or social trends. This type of research can help researchers develop a deeper understanding of these phenomena and identify potential areas for further study.
• Understanding complex social phenomena : Qualitative research can be useful for exploring complex social phenomena, such as cultural beliefs, social norms, or political processes. This type of research can help researchers develop a more nuanced understanding of these phenomena and identify factors that may influence them.
• Generating new theories or hypotheses: Qualitative research can be useful for generating new theories or hypotheses about social phenomena. By gathering rich, detailed data about individuals’ experiences and perspectives, researchers can develop insights that may challenge existing theories or lead to new lines of inquiry.
• Providing context for quantitative data: Qualitative research can be useful for providing context for quantitative data. By gathering qualitative data alongside quantitative data, researchers can develop a more complete understanding of complex social phenomena and identify potential explanations for quantitative findings.

When to use Qualitative Research

Here are some situations where qualitative research may be appropriate:

• Exploring a new area: If little is known about a particular topic, qualitative research can help to identify key issues, generate hypotheses, and develop new theories.
• Understanding complex phenomena: Qualitative research can be used to investigate complex social, cultural, or organizational phenomena that are difficult to measure quantitatively.
• Investigating subjective experiences: Qualitative research is particularly useful for investigating the subjective experiences of individuals or groups, such as their attitudes, beliefs, values, or emotions.
• Conducting formative research: Qualitative research can be used in the early stages of a research project to develop research questions, identify potential research participants, and refine research methods.
• Evaluating interventions or programs: Qualitative research can be used to evaluate the effectiveness of interventions or programs by collecting data on participants’ experiences, attitudes, and behaviors.

Characteristics of Qualitative Research

Qualitative research is characterized by several key features, including:

• Focus on subjective experience: Qualitative research is concerned with understanding the subjective experiences, beliefs, and perspectives of individuals or groups in a particular context. Researchers aim to explore the meanings that people attach to their experiences and to understand the social and cultural factors that shape these meanings.
• Use of open-ended questions: Qualitative research relies on open-ended questions that allow participants to provide detailed, in-depth responses. Researchers seek to elicit rich, descriptive data that can provide insights into participants’ experiences and perspectives.
• Sampling-based on purpose and diversity: Qualitative research often involves purposive sampling, in which participants are selected based on specific criteria related to the research question. Researchers may also seek to include participants with diverse experiences and perspectives to capture a range of viewpoints.
• Data collection through multiple methods: Qualitative research typically involves the use of multiple data collection methods, such as in-depth interviews, focus groups, and observation. This allows researchers to gather rich, detailed data from multiple sources, which can provide a more complete picture of participants’ experiences and perspectives.
• Inductive data analysis: Qualitative research relies on inductive data analysis, in which researchers develop theories and insights based on the data rather than testing pre-existing hypotheses. Researchers use coding and thematic analysis to identify patterns and themes in the data and to develop theories and explanations based on these patterns.
• Emphasis on researcher reflexivity: Qualitative research recognizes the importance of the researcher’s role in shaping the research process and outcomes. Researchers are encouraged to reflect on their own biases and assumptions and to be transparent about their role in the research process.

Advantages of Qualitative Research

Qualitative research offers several advantages over other research methods, including:

• Depth and detail: Qualitative research allows researchers to gather rich, detailed data that provides a deeper understanding of complex social phenomena. Through in-depth interviews, focus groups, and observation, researchers can gather detailed information about participants’ experiences and perspectives that may be missed by other research methods.
• Flexibility : Qualitative research is a flexible approach that allows researchers to adapt their methods to the research question and context. Researchers can adjust their research methods in real-time to gather more information or explore unexpected findings.
• Contextual understanding: Qualitative research is well-suited to exploring the social and cultural context in which individuals or groups are situated. Researchers can gather information about cultural norms, social structures, and historical events that may influence participants’ experiences and perspectives.
• Participant perspective : Qualitative research prioritizes the perspective of participants, allowing researchers to explore subjective experiences and understand the meanings that participants attach to their experiences.
• Theory development: Qualitative research can contribute to the development of new theories and insights about complex social phenomena. By gathering rich, detailed data and using inductive data analysis, researchers can develop new theories and explanations that may challenge existing understandings.
• Validity : Qualitative research can offer high validity by using multiple data collection methods, purposive and diverse sampling, and researcher reflexivity. This can help ensure that findings are credible and trustworthy.

Limitations of Qualitative Research

Qualitative research also has some limitations, including:

• Subjectivity : Qualitative research relies on the subjective interpretation of researchers, which can introduce bias into the research process. The researcher’s perspective, beliefs, and experiences can influence the way data is collected, analyzed, and interpreted.
• Limited generalizability: Qualitative research typically involves small, purposive samples that may not be representative of larger populations. This limits the generalizability of findings to other contexts or populations.
• Time-consuming: Qualitative research can be a time-consuming process, requiring significant resources for data collection, analysis, and interpretation.
• Resource-intensive: Qualitative research may require more resources than other research methods, including specialized training for researchers, specialized software for data analysis, and transcription services.
• Limited reliability: Qualitative research may be less reliable than quantitative research, as it relies on the subjective interpretation of researchers. This can make it difficult to replicate findings or compare results across different studies.
• Ethics and confidentiality: Qualitative research involves collecting sensitive information from participants, which raises ethical concerns about confidentiality and informed consent. Researchers must take care to protect the privacy and confidentiality of participants and obtain informed consent.

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What Is Qualitative Analysis?

• How It Works

Qualitative Data

• In the Business Context
• Quantitative Analysis
• Qualitative Analysis FAQs
• Fundamental Analysis

Qualitative Analysis

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• Price-to-Earnings Ratio (P/E Ratio)
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In business and management, qualitative analysis uses subjective judgment to analyze a company's value or prospects based on non-quantifiable information, such as management expertise, industry cycles, strength of research and development, and labor relations.

Qualitative analysis contrasts with  quantitative analysis , which focuses on numbers found in reports such as balance sheets. The two techniques, however, will often be used together to examine a company's operations and evaluate its potential as an investment opportunity.

Key Takeaways

• Qualitative analysis uses subjective judgment based on "soft" or non-quantifiable data.
• Qualitative analysis deals with intangible and inexact information that can be difficult to collect and measure.
• Machines struggle to conduct qualitative analysis as intangibles can’t be defined by numeric values.
• Understanding people and company cultures are central to qualitative analysis.
• Looking at a company through the eyes of a customer and understanding its competitive advantage assists with qualitative analysis.

Investopedia / Paige McLaughlin

Understanding Qualitative Analysis

The distinction between qualitative and quantitative approaches is similar to the difference between human and artificial intelligence. Quantitative analysis uses exact inputs such as profit margins, debt ratios , earnings multiples, and the like. These can be plugged into a computerized model to yield an exact result, such as the fair value  of a stock or a forecast for earnings growth. Of course, for the time being, a human has to write the program that crunches these numbers, and that involves a fair degree of subjective judgment. Once they are programmed, though, computers can perform quantitative analysis in fractions of a second, while it might take even the most gifted and highly-trained humans minutes or hours.

Qualitative analysis, on the other hand, deals with intangible, inexact concerns that belong to the social and experiential realm rather than the mathematical one. This approach depends on the kind of intelligence that machines (currently) lack, since things like positive associations with a brand, management trustworthiness, customer satisfaction, competitive advantage , and cultural shifts are difficult, arguably impossible, to capture with numerical inputs. 

Many social scientists use qualitative analysis in their research, and it is especially prominent among anthropologists and sociologists.

Understanding People Through Qualitative Analysis

Qualitative analysis may sound almost like "listening to your gut," and indeed many qualitative analysts would argue that gut feelings have their place in the process. That does not mean, however, that it is not a rigorous approach. Indeed, it can consume much more time and energy than quantitative analysis.

People are central to qualitative analysis. An investor might start by getting to know a company's management , including their educational and professional backgrounds. One of the most important factors is their experience in the industry. More abstractly, do they have a record of hard work and prudent decision-making, or are they better at knowing—or being related to—the right people? Their reputations are also key: do their colleagues and peers respect them? Their relationships with business partners are also worth exploring since these can have a direct impact on operations.

Company Culture and Qualitative Analysis

The way employees view the company and its management is important. Are they satisfied and motivated, or do they resent their bosses? The rate of employee turnover can indicate employees' loyalty or lack thereof. What does workplace culture say about the company? Overly hierarchical offices promote intrigue and competition and sap productive energy; a sleepy, unmotivated environment can mean employees are mainly concerned with punching the clock. The ideal is a vibrant, creative culture that attracts top talent.

Gathering data for qualitative analysis can sometimes be difficult. Fortune 500 CEOs are not known for sitting down with retail investors for a chat or showing them around the corporate headquarters. In part, Warren Buffett can use qualitative analysis so effectively because people are willing to give him access to their time and information. The rest of us have to sift through news reports and companies' filings to get a sense of managers' records, strategies, and philosophies.

The management discussion and analysis (MD&A) section of a company's 10-K filing and quarterly earnings conference calls provide a window into strategies and communication styles. Clear, transparent communication and coherent strategies are useful. Buzzwords, evasiveness, and short-termism, not so much.

Qualitative data can also be collected in a number of other ways including interviews, panel groups, ethnography (participant observation), archival work, and document analysis. Qualitative data is often read carefully and coded thematically to identify themes, patterns, and trends.

Qualitative Analysis in the Business Context

Customers are the only group more crucial to a company's success than management and employees since they are the source of its revenue. Ironically, if a company places customers' interests before shareholders, it may be a better long-term investment. If feasible, it's a good idea to try being a customer. Say you're considering investing in an airline that has reined in costs, beat earnings estimates in three consecutive quarters, and plans to buy back shares . When you try to actually use the airline, however, you find the website bug-ridden, the customer service representatives cranky, the extra fees petty, and your fellow passengers resentful. The negative experience tells you that the company has a lack of priority for its customers and to be careful making an investment in the airline.

A company's business model and competitive advantage are vital components of qualitative analysis. What gives the firm an enduring leg up over its rivals? Has it invented a new technology that competitors will find hard to replicate, or that has intellectual property protection? Does it have a unique approach to solving a problem for its customers? Is its brand globally recognized—in a good way? Does its product have cultural resonance or an element of nostalgia? Will there still be a market for it in twenty years? If you can plausibly imagine another company stepping in and doing what this one does just a little bit better, then the barrier to entry may be too low. Why will an un-established company be the one to create or disrupt its chosen market, and why won't it then be replaced in turn?

Example of Qualitative Analysis in Business

The idea behind quantitative analysis is to measure things; the idea behind qualitative analysis is to understand them. The latter requires a holistic view and a fact-based overarching narrative. Context is key. For example, a CEO who dropped out of college would be a red flag in some cases, but Mark Zuckerberg and Steve Jobs are exceptions. Silicon Valley is, for better or worse, a different beast. A look at McDonald's Corp's ( MCD ) financials a few years ago would have told you nothing about a looming backlash against cheap, unhealthy food. On the other hand, a purely qualitative approach is vulnerable to distortion by blind spots and personal biases. Quantitative measures can act as a check on these tendencies.

Qualitative Analysis vs. Quantitative Analysis

Qualitative analysis relies on thick description and deep understanding of the subject being researched, obtained from in-depth interviews, observations, and/or close readings of text. This type of research typically looks at case studies and can be used to understand local phenomena.

Quantitative analysis instead relies on the statistical analyses of numerical data obtained from surveys, experiments, or administrative records. From this, inferences can be made and correlations between variables analyzed to understand more generalized phenomena.

What Are the Steps in Qualitative Analysis?

Although the exact steps may vary, most researchers and analysts undertaking qualitative analysis will follow these steps:

• Define your goals and objective
• Collect or obtain qualitative data
• Analyze the data to generate initial topic codes
• Identify patterns or themes in the codes
• Review and revise codes based on initial analysis
• Write up your findings

What Are the Methods of Qualitative Analysis?

Qualitative research encompasses a wide range of techniques and methodologies. Among the most common include:

• Ethnography (participant observation)
• Narrative or discourse analysis
• Focus groups
• Document/archival analysis

What Are Some Examples of Qualitative Data?

Qualitative data can take many forms. Common types include transcripts generated from one-on-one interviews, free text responses on surveys, narratives, quotations, text documents, images, or observations taken down in a notebook or research journal.

Where Is Qualitative Analysis Used?

Qualitative analysis can be applied to a wide range of research topics or practical settings. It is best used if you are interested in understanding human behavior from an informant or participant perspective to get a better understanding of what is going on in the social context around you.

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An Overview of Qualitative Research Methods

Direct Observation, Interviews, Participation, Immersion, Focus Groups

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Qualitative research is a type of social science research that collects and works with non-numerical data and that seeks to interpret meaning from these data that help understand social life through the study of targeted populations or places.

People often frame it in opposition to quantitative research , which uses numerical data to identify large-scale trends and employs statistical operations to determine causal and correlative relationships between variables.

Within sociology, qualitative research is typically focused on the micro-level of social interaction that composes everyday life, whereas quantitative research typically focuses on macro-level trends and phenomena.

Key Takeaways

Methods of qualitative research include:

• observation and immersion
• open-ended surveys
• focus groups
• content analysis of visual and textual materials
• oral history

Qualitative research has a long history in sociology and has been used within it for as long as the field has existed.

This type of research has long appealed to social scientists because it allows the researchers to investigate the meanings people attribute to their behavior, actions, and interactions with others.

While quantitative research is useful for identifying relationships between variables, like, for example, the connection between poverty and racial hate, it is qualitative research that can illuminate why this connection exists by going directly to the source—the people themselves.

Qualitative research is designed to reveal the meaning that informs the action or outcomes that are typically measured by quantitative research. So qualitative researchers investigate meanings, interpretations, symbols, and the processes and relations of social life.

What this type of research produces is descriptive data that the researcher must then interpret using rigorous and systematic methods of transcribing, coding, and analysis of trends and themes.

Because its focus is everyday life and people's experiences, qualitative research lends itself well to creating new theories using the inductive method , which can then be tested with further research.

Qualitative researchers use their own eyes, ears, and intelligence to collect in-depth perceptions and descriptions of targeted populations, places, and events.

Their findings are collected through a variety of methods, and often a researcher will use at least two or several of the following while conducting a qualitative study:

• Direct observation : With direct observation, a researcher studies people as they go about their daily lives without participating or interfering. This type of research is often unknown to those under study, and as such, must be conducted in public settings where people do not have a reasonable expectation of privacy. For example, a researcher might observe the ways in which strangers interact in public as they gather to watch a street performer.
• Open-ended surveys : While many surveys are designed to generate quantitative data, many are also designed with open-ended questions that allow for the generation and analysis of qualitative data. For example, a survey might be used to investigate not just which political candidates voters chose, but why they chose them, in their own words.
• Focus group : In a focus group, a researcher engages a small group of participants in a conversation designed to generate data relevant to the research question. Focus groups can contain anywhere from 5 to 15 participants. Social scientists often use them in studies that examine an event or trend that occurs within a specific community. They are common in market research, too.
• In-depth interviews : Researchers conduct in-depth interviews by speaking with participants in a one-on-one setting. Sometimes a researcher approaches the interview with a predetermined list of questions or topics for discussion but allows the conversation to evolve based on how the participant responds. Other times, the researcher has identified certain topics of interest but does not have a formal guide for the conversation, but allows the participant to guide it.
• Oral history : The oral history method is used to create a historical account of an event, group, or community, and typically involves a series of in-depth interviews conducted with one or multiple participants over an extended period.
• Participant observation : This method is similar to observation, however with this one, the researcher also participates in the action or events to not only observe others but to gain the first-hand experience in the setting.
• Ethnographic observation : Ethnographic observation is the most intensive and in-depth observational method. Originating in anthropology, with this method, a researcher fully immerses themselves into the research setting and lives among the participants as one of them for anywhere from months to years. By doing this, the researcher attempts to experience day-to-day existence from the viewpoints of those studied to develop in-depth and long-term accounts of the community, events, or trends under observation.
• Content analysis : This method is used by sociologists to analyze social life by interpreting words and images from documents, film, art, music, and other cultural products and media. The researchers look at how the words and images are used, and the context in which they are used to draw inferences about the underlying culture. Content analysis of digital material, especially that generated by social media users, has become a popular technique within the social sciences.

While much of the data generated by qualitative research is coded and analyzed using just the researcher's eyes and brain, the use of computer software to do these processes is increasingly popular within the social sciences.

Such software analysis works well when the data is too large for humans to handle, though the lack of a human interpreter is a common criticism of the use of computer software.

Pros and Cons

Qualitative research has both benefits and drawbacks.

On the plus side, it creates an in-depth understanding of the attitudes, behaviors, interactions, events, and social processes that comprise everyday life. In doing so, it helps social scientists understand how everyday life is influenced by society-wide things like social structure , social order , and all kinds of social forces.

This set of methods also has the benefit of being flexible and easily adaptable to changes in the research environment and can be conducted with minimal cost in many cases.

Among the downsides of qualitative research is that its scope is fairly limited so its findings are not always widely able to be generalized.

Researchers also have to use caution with these methods to ensure that they do not influence the data in ways that significantly change it and that they do not bring undue personal bias to their interpretation of the findings.

Fortunately, qualitative researchers receive rigorous training designed to eliminate or reduce these types of research bias.

• How to Conduct a Sociology Research Interview
• Definition of Idiographic and Nomothetic
• What Is Participant Observation Research?
• Pilot Study in Research
• Conducting Case Study Research in Sociology
• How to Understand Interpretive Sociology
• What Is Ethnography?
• Understanding Secondary Data and How to Use It in Research
• Social Surveys: Questionnaires, Interviews, and Telephone Polls
• Research in Essays and Reports
• Definition and Overview of Grounded Theory
• What Is Naturalistic Observation? Definition and Examples
• A Review of Software Tools for Quantitative Data Analysis
• Content Analysis: Method to Analyze Social Life Through Words, Images
• The Sociology of the Internet and Digital Sociology
• Immersion Definition: Cultural, Language, and Virtual

What is Qualitative in Qualitative Research

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• Published: 27 February 2019
• Volume 42 , pages 139–160, ( 2019 )

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What is qualitative research? If we look for a precise definition of qualitative research, and specifically for one that addresses its distinctive feature of being “qualitative,” the literature is meager. In this article we systematically search, identify and analyze a sample of 89 sources using or attempting to define the term “qualitative.” Then, drawing on ideas we find scattered across existing work, and based on Becker’s classic study of marijuana consumption, we formulate and illustrate a definition that tries to capture its core elements. We define qualitative research as an iterative process in which improved understanding to the scientific community is achieved by making new significant distinctions resulting from getting closer to the phenomenon studied. This formulation is developed as a tool to help improve research designs while stressing that a qualitative dimension is present in quantitative work as well. Additionally, it can facilitate teaching, communication between researchers, diminish the gap between qualitative and quantitative researchers, help to address critiques of qualitative methods, and be used as a standard of evaluation of qualitative research.

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If we assume that there is something called qualitative research, what exactly is this qualitative feature? And how could we evaluate qualitative research as good or not? Is it fundamentally different from quantitative research? In practice, most active qualitative researchers working with empirical material intuitively know what is involved in doing qualitative research, yet perhaps surprisingly, a clear definition addressing its key feature is still missing.

To address the question of what is qualitative we turn to the accounts of “qualitative research” in textbooks and also in empirical work. In his classic, explorative, interview study of deviance Howard Becker ( 1963 ) asks ‘How does one become a marijuana user?’ In contrast to pre-dispositional and psychological-individualistic theories of deviant behavior, Becker’s inherently social explanation contends that becoming a user of this substance is the result of a three-phase sequential learning process. First, potential users need to learn how to smoke it properly to produce the “correct” effects. If not, they are likely to stop experimenting with it. Second, they need to discover the effects associated with it; in other words, to get “high,” individuals not only have to experience what the drug does, but also to become aware that those sensations are related to using it. Third, they require learning to savor the feelings related to its consumption – to develop an acquired taste. Becker, who played music himself, gets close to the phenomenon by observing, taking part, and by talking to people consuming the drug: “half of the fifty interviews were conducted with musicians, the other half covered a wide range of people, including laborers, machinists, and people in the professions” (Becker 1963 :56).

Another central aspect derived through the common-to-all-research interplay between induction and deduction (Becker 2017 ), is that during the course of his research Becker adds scientifically meaningful new distinctions in the form of three phases—distinctions, or findings if you will, that strongly affect the course of his research: its focus, the material that he collects, and which eventually impact his findings. Each phase typically unfolds through social interaction, and often with input from experienced users in “a sequence of social experiences during which the person acquires a conception of the meaning of the behavior, and perceptions and judgments of objects and situations, all of which make the activity possible and desirable” (Becker 1963 :235). In this study the increased understanding of smoking dope is a result of a combination of the meaning of the actors, and the conceptual distinctions that Becker introduces based on the views expressed by his respondents. Understanding is the result of research and is due to an iterative process in which data, concepts and evidence are connected with one another (Becker 2017 ).

Indeed, there are many definitions of qualitative research, but if we look for a definition that addresses its distinctive feature of being “qualitative,” the literature across the broad field of social science is meager. The main reason behind this article lies in the paradox, which, to put it bluntly, is that researchers act as if they know what it is, but they cannot formulate a coherent definition. Sociologists and others will of course continue to conduct good studies that show the relevance and value of qualitative research addressing scientific and practical problems in society. However, our paper is grounded in the idea that providing a clear definition will help us improve the work that we do. Among researchers who practice qualitative research there is clearly much knowledge. We suggest that a definition makes this knowledge more explicit. If the first rationale for writing this paper refers to the “internal” aim of improving qualitative research, the second refers to the increased “external” pressure that especially many qualitative researchers feel; pressure that comes both from society as well as from other scientific approaches. There is a strong core in qualitative research, and leading researchers tend to agree on what it is and how it is done. Our critique is not directed at the practice of qualitative research, but we do claim that the type of systematic work we do has not yet been done, and that it is useful to improve the field and its status in relation to quantitative research.

The literature on the “internal” aim of improving, or at least clarifying qualitative research is large, and we do not claim to be the first to notice the vagueness of the term “qualitative” (Strauss and Corbin 1998 ). Also, others have noted that there is no single definition of it (Long and Godfrey 2004 :182), that there are many different views on qualitative research (Denzin and Lincoln 2003 :11; Jovanović 2011 :3), and that more generally, we need to define its meaning (Best 2004 :54). Strauss and Corbin ( 1998 ), for example, as well as Nelson et al. (1992:2 cited in Denzin and Lincoln 2003 :11), and Flick ( 2007 :ix–x), have recognized that the term is problematic: “Actually, the term ‘qualitative research’ is confusing because it can mean different things to different people” (Strauss and Corbin 1998 :10–11). Hammersley has discussed the possibility of addressing the problem, but states that “the task of providing an account of the distinctive features of qualitative research is far from straightforward” ( 2013 :2). This confusion, as he has recently further argued (Hammersley 2018 ), is also salient in relation to ethnography where different philosophical and methodological approaches lead to a lack of agreement about what it means.

Others (e.g. Hammersley 2018 ; Fine and Hancock 2017 ) have also identified the treat to qualitative research that comes from external forces, seen from the point of view of “qualitative research.” This threat can be further divided into that which comes from inside academia, such as the critique voiced by “quantitative research” and outside of academia, including, for example, New Public Management. Hammersley ( 2018 ), zooming in on one type of qualitative research, ethnography, has argued that it is under treat. Similarly to Fine ( 2003 ), and before him Gans ( 1999 ), he writes that ethnography’ has acquired a range of meanings, and comes in many different versions, these often reflecting sharply divergent epistemological orientations. And already more than twenty years ago while reviewing Denzin and Lincoln’ s Handbook of Qualitative Methods Fine argued:

While this increasing centrality [of qualitative research] might lead one to believe that consensual standards have developed, this belief would be misleading. As the methodology becomes more widely accepted, querulous challengers have raised fundamental questions that collectively have undercut the traditional models of how qualitative research is to be fashioned and presented (1995:417).

According to Hammersley, there are today “serious treats to the practice of ethnographic work, on almost any definition” ( 2018 :1). He lists five external treats: (1) that social research must be accountable and able to show its impact on society; (2) the current emphasis on “big data” and the emphasis on quantitative data and evidence; (3) the labor market pressure in academia that leaves less time for fieldwork (see also Fine and Hancock 2017 ); (4) problems of access to fields; and (5) the increased ethical scrutiny of projects, to which ethnography is particularly exposed. Hammersley discusses some more or less insufficient existing definitions of ethnography.

The current situation, as Hammersley and others note—and in relation not only to ethnography but also qualitative research in general, and as our empirical study shows—is not just unsatisfactory, it may even be harmful for the entire field of qualitative research, and does not help social science at large. We suggest that the lack of clarity of qualitative research is a real problem that must be addressed.

Towards a Definition of Qualitative Research

Seen in an historical light, what is today called qualitative, or sometimes ethnographic, interpretative research – or a number of other terms – has more or less always existed. At the time the founders of sociology – Simmel, Weber, Durkheim and, before them, Marx – were writing, and during the era of the Methodenstreit (“dispute about methods”) in which the German historical school emphasized scientific methods (cf. Swedberg 1990 ), we can at least speak of qualitative forerunners.

Perhaps the most extended discussion of what later became known as qualitative methods in a classic work is Bronisław Malinowski’s ( 1922 ) Argonauts in the Western Pacific , although even this study does not explicitly address the meaning of “qualitative.” In Weber’s ([1921–-22] 1978) work we find a tension between scientific explanations that are based on observation and quantification and interpretative research (see also Lazarsfeld and Barton 1982 ).

If we look through major sociology journals like the American Sociological Review , American Journal of Sociology , or Social Forces we will not find the term qualitative sociology before the 1970s. And certainly before then much of what we consider qualitative classics in sociology, like Becker’ study ( 1963 ), had already been produced. Indeed, the Chicago School often combined qualitative and quantitative data within the same study (Fine 1995 ). Our point being that before a disciplinary self-awareness the term quantitative preceded qualitative, and the articulation of the former was a political move to claim scientific status (Denzin and Lincoln 2005 ). In the US the World War II seem to have sparked a critique of sociological work, including “qualitative work,” that did not follow the scientific canon (Rawls 2018 ), which was underpinned by a scientifically oriented and value free philosophy of science. As a result the attempts and practice of integrating qualitative and quantitative sociology at Chicago lost ground to sociology that was more oriented to surveys and quantitative work at Columbia under Merton-Lazarsfeld. The quantitative tradition was also able to present textbooks (Lundberg 1951 ) that facilitated the use this approach and its “methods.” The practices of the qualitative tradition, by and large, remained tacit or was part of the mentoring transferred from the renowned masters to their students.

This glimpse into history leads us back to the lack of a coherent account condensed in a definition of qualitative research. Many of the attempts to define the term do not meet the requirements of a proper definition: A definition should be clear, avoid tautology, demarcate its domain in relation to the environment, and ideally only use words in its definiens that themselves are not in need of definition (Hempel 1966 ). A definition can enhance precision and thus clarity by identifying the core of the phenomenon. Preferably, a definition should be short. The typical definition we have found, however, is an ostensive definition, which indicates what qualitative research is about without informing us about what it actually is :

Qualitative research is multimethod in focus, involving an interpretative, naturalistic approach to its subject matter. This means that qualitative researchers study things in their natural settings, attempting to make sense of, or interpret, phenomena in terms of the meanings people bring to them. Qualitative research involves the studied use and collection of a variety of empirical materials – case study, personal experience, introspective, life story, interview, observational, historical, interactional, and visual texts – that describe routine and problematic moments and meanings in individuals’ lives. (Denzin and Lincoln 2005 :2)

Flick claims that the label “qualitative research” is indeed used as an umbrella for a number of approaches ( 2007 :2–4; 2002 :6), and it is not difficult to identify research fitting this designation. Moreover, whatever it is, it has grown dramatically over the past five decades. In addition, courses have been developed, methods have flourished, arguments about its future have been advanced (for example, Denzin and Lincoln 1994) and criticized (for example, Snow and Morrill 1995 ), and dedicated journals and books have mushroomed. Most social scientists have a clear idea of research and how it differs from journalism, politics and other activities. But the question of what is qualitative in qualitative research is either eluded or eschewed.

We maintain that this lacuna hinders systematic knowledge production based on qualitative research. Paul Lazarsfeld noted the lack of “codification” as early as 1955 when he reviewed 100 qualitative studies in order to offer a codification of the practices (Lazarsfeld and Barton 1982 :239). Since then many texts on “qualitative research” and its methods have been published, including recent attempts (Goertz and Mahoney 2012 ) similar to Lazarsfeld’s. These studies have tried to extract what is qualitative by looking at the large number of empirical “qualitative” studies. Our novel strategy complements these endeavors by taking another approach and looking at the attempts to codify these practices in the form of a definition, as well as to a minor extent take Becker’s study as an exemplar of what qualitative researchers actually do, and what the characteristic of being ‘qualitative’ denotes and implies. We claim that qualitative researchers, if there is such a thing as “qualitative research,” should be able to codify their practices in a condensed, yet general way expressed in language.

Lingering problems of “generalizability” and “how many cases do I need” (Small 2009 ) are blocking advancement – in this line of work qualitative approaches are said to differ considerably from quantitative ones, while some of the former unsuccessfully mimic principles related to the latter (Small 2009 ). Additionally, quantitative researchers sometimes unfairly criticize the first based on their own quality criteria. Scholars like Goertz and Mahoney ( 2012 ) have successfully focused on the different norms and practices beyond what they argue are essentially two different cultures: those working with either qualitative or quantitative methods. Instead, similarly to Becker ( 2017 ) who has recently questioned the usefulness of the distinction between qualitative and quantitative research, we focus on similarities.

The current situation also impedes both students and researchers in focusing their studies and understanding each other’s work (Lazarsfeld and Barton 1982 :239). A third consequence is providing an opening for critiques by scholars operating within different traditions (Valsiner 2000 :101). A fourth issue is that the “implicit use of methods in qualitative research makes the field far less standardized than the quantitative paradigm” (Goertz and Mahoney 2012 :9). Relatedly, the National Science Foundation in the US organized two workshops in 2004 and 2005 to address the scientific foundations of qualitative research involving strategies to improve it and to develop standards of evaluation in qualitative research. However, a specific focus on its distinguishing feature of being “qualitative” while being implicitly acknowledged, was discussed only briefly (for example, Best 2004 ).

In 2014 a theme issue was published in this journal on “Methods, Materials, and Meanings: Designing Cultural Analysis,” discussing central issues in (cultural) qualitative research (Berezin 2014 ; Biernacki 2014 ; Glaeser 2014 ; Lamont and Swidler 2014 ; Spillman 2014). We agree with many of the arguments put forward, such as the risk of methodological tribalism, and that we should not waste energy on debating methods separated from research questions. Nonetheless, a clarification of the relation to what is called “quantitative research” is of outmost importance to avoid misunderstandings and misguided debates between “qualitative” and “quantitative” researchers. Our strategy means that researchers, “qualitative” or “quantitative” they may be, in their actual practice may combine qualitative work and quantitative work.

In this article we accomplish three tasks. First, we systematically survey the literature for meanings of qualitative research by looking at how researchers have defined it. Drawing upon existing knowledge we find that the different meanings and ideas of qualitative research are not yet coherently integrated into one satisfactory definition. Next, we advance our contribution by offering a definition of qualitative research and illustrate its meaning and use partially by expanding on the brief example introduced earlier related to Becker’s work ( 1963 ). We offer a systematic analysis of central themes of what researchers consider to be the core of “qualitative,” regardless of style of work. These themes – which we summarize in terms of four keywords: distinction, process, closeness, improved understanding – constitute part of our literature review, in which each one appears, sometimes with others, but never all in the same definition. They serve as the foundation of our contribution. Our categories are overlapping. Their use is primarily to organize the large amount of definitions we have identified and analyzed, and not necessarily to draw a clear distinction between them. Finally, we continue the elaboration discussed above on the advantages of a clear definition of qualitative research.

In a hermeneutic fashion we propose that there is something meaningful that deserves to be labelled “qualitative research” (Gadamer 1990 ). To approach the question “What is qualitative in qualitative research?” we have surveyed the literature. In conducting our survey we first traced the word’s etymology in dictionaries, encyclopedias, handbooks of the social sciences and of methods and textbooks, mainly in English, which is common to methodology courses. It should be noted that we have zoomed in on sociology and its literature. This discipline has been the site of the largest debate and development of methods that can be called “qualitative,” which suggests that this field should be examined in great detail.

In an ideal situation we should expect that one good definition, or at least some common ideas, would have emerged over the years. This common core of qualitative research should be so accepted that it would appear in at least some textbooks. Since this is not what we found, we decided to pursue an inductive approach to capture maximal variation in the field of qualitative research; we searched in a selection of handbooks, textbooks, book chapters, and books, to which we added the analysis of journal articles. Our sample comprises a total of 89 references.

In practice we focused on the discipline that has had a clear discussion of methods, namely sociology. We also conducted a broad search in the JSTOR database to identify scholarly sociology articles published between 1998 and 2017 in English with a focus on defining or explaining qualitative research. We specifically zoom in on this time frame because we would have expect that this more mature period would have produced clear discussions on the meaning of qualitative research. To find these articles we combined a number of keywords to search the content and/or the title: qualitative (which was always included), definition, empirical, research, methodology, studies, fieldwork, interview and observation .

As a second phase of our research we searched within nine major sociological journals ( American Journal of Sociology , Sociological Theory , American Sociological Review , Contemporary Sociology , Sociological Forum , Sociological Theory , Qualitative Research , Qualitative Sociology and Qualitative Sociology Review ) for articles also published during the past 19 years (1998–2017) that had the term “qualitative” in the title and attempted to define qualitative research.

Lastly we picked two additional journals, Qualitative Research and Qualitative Sociology , in which we could expect to find texts addressing the notion of “qualitative.” From Qualitative Research we chose Volume 14, Issue 6, December 2014, and from Qualitative Sociology we chose Volume 36, Issue 2, June 2017. Within each of these we selected the first article; then we picked the second article of three prior issues. Again we went back another three issues and investigated article number three. Finally we went back another three issues and perused article number four. This selection criteria was used to get a manageable sample for the analysis.

The coding process of the 89 references we gathered in our selected review began soon after the first round of material was gathered, and we reduced the complexity created by our maximum variation sampling (Snow and Anderson 1993 :22) to four different categories within which questions on the nature and properties of qualitative research were discussed. We call them: Qualitative and Quantitative Research, Qualitative Research, Fieldwork, and Grounded Theory. This – which may appear as an illogical grouping – merely reflects the “context” in which the matter of “qualitative” is discussed. If the selection process of the material – books and articles – was informed by pre-knowledge, we used an inductive strategy to code the material. When studying our material, we identified four central notions related to “qualitative” that appear in various combinations in the literature which indicate what is the core of qualitative research. We have labeled them: “distinctions”, “process,” “closeness,” and “improved understanding.” During the research process the categories and notions were improved, refined, changed, and reordered. The coding ended when a sense of saturation in the material arose. In the presentation below all quotations and references come from our empirical material of texts on qualitative research.

Analysis – What is Qualitative Research?

In this section we describe the four categories we identified in the coding, how they differently discuss qualitative research, as well as their overall content. Some salient quotations are selected to represent the type of text sorted under each of the four categories. What we present are examples from the literature.

Qualitative and Quantitative

This analytic category comprises quotations comparing qualitative and quantitative research, a distinction that is frequently used (Brown 2010 :231); in effect this is a conceptual pair that structures the discussion and that may be associated with opposing interests. While the general goal of quantitative and qualitative research is the same – to understand the world better – their methodologies and focus in certain respects differ substantially (Becker 1966 :55). Quantity refers to that property of something that can be determined by measurement. In a dictionary of Statistics and Methodology we find that “(a) When referring to *variables, ‘qualitative’ is another term for *categorical or *nominal. (b) When speaking of kinds of research, ‘qualitative’ refers to studies of subjects that are hard to quantify, such as art history. Qualitative research tends to be a residual category for almost any kind of non-quantitative research” (Stiles 1998:183). But it should be obvious that one could employ a quantitative approach when studying, for example, art history.

The same dictionary states that quantitative is “said of variables or research that can be handled numerically, usually (too sharply) contrasted with *qualitative variables and research” (Stiles 1998:184). From a qualitative perspective “quantitative research” is about numbers and counting, and from a quantitative perspective qualitative research is everything that is not about numbers. But this does not say much about what is “qualitative.” If we turn to encyclopedias we find that in the 1932 edition of the Encyclopedia of the Social Sciences there is no mention of “qualitative.” In the Encyclopedia from 1968 we can read:

Qualitative Analysis. For methods of obtaining, analyzing, and describing data, see [the various entries:] CONTENT ANALYSIS; COUNTED DATA; EVALUATION RESEARCH, FIELD WORK; GRAPHIC PRESENTATION; HISTORIOGRAPHY, especially the article on THE RHETORIC OF HISTORY; INTERVIEWING; OBSERVATION; PERSONALITY MEASUREMENT; PROJECTIVE METHODS; PSYCHOANALYSIS, article on EXPERIMENTAL METHODS; SURVEY ANALYSIS, TABULAR PRESENTATION; TYPOLOGIES. (Vol. 13:225)

Some, like Alford, divide researchers into methodologists or, in his words, “quantitative and qualitative specialists” (Alford 1998 :12). Qualitative research uses a variety of methods, such as intensive interviews or in-depth analysis of historical materials, and it is concerned with a comprehensive account of some event or unit (King et al. 1994 :4). Like quantitative research it can be utilized to study a variety of issues, but it tends to focus on meanings and motivations that underlie cultural symbols, personal experiences, phenomena and detailed understanding of processes in the social world. In short, qualitative research centers on understanding processes, experiences, and the meanings people assign to things (Kalof et al. 2008 :79).

Others simply say that qualitative methods are inherently unscientific (Jovanović 2011 :19). Hood, for instance, argues that words are intrinsically less precise than numbers, and that they are therefore more prone to subjective analysis, leading to biased results (Hood 2006 :219). Qualitative methodologies have raised concerns over the limitations of quantitative templates (Brady et al. 2004 :4). Scholars such as King et al. ( 1994 ), for instance, argue that non-statistical research can produce more reliable results if researchers pay attention to the rules of scientific inference commonly stated in quantitative research. Also, researchers such as Becker ( 1966 :59; 1970 :42–43) have asserted that, if conducted properly, qualitative research and in particular ethnographic field methods, can lead to more accurate results than quantitative studies, in particular, survey research and laboratory experiments.

Some researchers, such as Kalof, Dan, and Dietz ( 2008 :79) claim that the boundaries between the two approaches are becoming blurred, and Small ( 2009 ) argues that currently much qualitative research (especially in North America) tries unsuccessfully and unnecessarily to emulate quantitative standards. For others, qualitative research tends to be more humanistic and discursive (King et al. 1994 :4). Ragin ( 1994 ), and similarly also Becker, ( 1996 :53), Marchel and Owens ( 2007 :303) think that the main distinction between the two styles is overstated and does not rest on the simple dichotomy of “numbers versus words” (Ragin 1994 :xii). Some claim that quantitative data can be utilized to discover associations, but in order to unveil cause and effect a complex research design involving the use of qualitative approaches needs to be devised (Gilbert 2009 :35). Consequently, qualitative data are useful for understanding the nuances lying beyond those processes as they unfold (Gilbert 2009 :35). Others contend that qualitative research is particularly well suited both to identify causality and to uncover fine descriptive distinctions (Fine and Hallett 2014 ; Lichterman and Isaac Reed 2014 ; Katz 2015 ).

There are other ways to separate these two traditions, including normative statements about what qualitative research should be (that is, better or worse than quantitative approaches, concerned with scientific approaches to societal change or vice versa; Snow and Morrill 1995 ; Denzin and Lincoln 2005 ), or whether it should develop falsifiable statements; Best 2004 ).

We propose that quantitative research is largely concerned with pre-determined variables (Small 2008 ); the analysis concerns the relations between variables. These categories are primarily not questioned in the study, only their frequency or degree, or the correlations between them (cf. Franzosi 2016 ). If a researcher studies wage differences between women and men, he or she works with given categories: x number of men are compared with y number of women, with a certain wage attributed to each person. The idea is not to move beyond the given categories of wage, men and women; they are the starting point as well as the end point, and undergo no “qualitative change.” Qualitative research, in contrast, investigates relations between categories that are themselves subject to change in the research process. Returning to Becker’s study ( 1963 ), we see that he questioned pre-dispositional theories of deviant behavior working with pre-determined variables such as an individual’s combination of personal qualities or emotional problems. His take, in contrast, was to understand marijuana consumption by developing “variables” as part of the investigation. Thereby he presented new variables, or as we would say today, theoretical concepts, but which are grounded in the empirical material.

Qualitative Research

This category contains quotations that refer to descriptions of qualitative research without making comparisons with quantitative research. Researchers such as Denzin and Lincoln, who have written a series of influential handbooks on qualitative methods (1994; Denzin and Lincoln 2003 ; 2005 ), citing Nelson et al. (1992:4), argue that because qualitative research is “interdisciplinary, transdisciplinary, and sometimes counterdisciplinary” it is difficult to derive one single definition of it (Jovanović 2011 :3). According to them, in fact, “the field” is “many things at the same time,” involving contradictions, tensions over its focus, methods, and how to derive interpretations and findings ( 2003 : 11). Similarly, others, such as Flick ( 2007 :ix–x) contend that agreeing on an accepted definition has increasingly become problematic, and that qualitative research has possibly matured different identities. However, Best holds that “the proliferation of many sorts of activities under the label of qualitative sociology threatens to confuse our discussions” ( 2004 :54). Atkinson’s position is more definite: “the current state of qualitative research and research methods is confused” ( 2005 :3–4).

Qualitative research is about interpretation (Blumer 1969 ; Strauss and Corbin 1998 ; Denzin and Lincoln 2003 ), or Verstehen [understanding] (Frankfort-Nachmias and Nachmias 1996 ). It is “multi-method,” involving the collection and use of a variety of empirical materials (Denzin and Lincoln 1998; Silverman 2013 ) and approaches (Silverman 2005 ; Flick 2007 ). It focuses not only on the objective nature of behavior but also on its subjective meanings: individuals’ own accounts of their attitudes, motivations, behavior (McIntyre 2005 :127; Creswell 2009 ), events and situations (Bryman 1989) – what people say and do in specific places and institutions (Goodwin and Horowitz 2002 :35–36) in social and temporal contexts (Morrill and Fine 1997). For this reason, following Weber ([1921-22] 1978), it can be described as an interpretative science (McIntyre 2005 :127). But could quantitative research also be concerned with these questions? Also, as pointed out below, does all qualitative research focus on subjective meaning, as some scholars suggest?

Others also distinguish qualitative research by claiming that it collects data using a naturalistic approach (Denzin and Lincoln 2005 :2; Creswell 2009 ), focusing on the meaning actors ascribe to their actions. But again, does all qualitative research need to be collected in situ? And does qualitative research have to be inherently concerned with meaning? Flick ( 2007 ), referring to Denzin and Lincoln ( 2005 ), mentions conversation analysis as an example of qualitative research that is not concerned with the meanings people bring to a situation, but rather with the formal organization of talk. Still others, such as Ragin ( 1994 :85), note that qualitative research is often (especially early on in the project, we would add) less structured than other kinds of social research – a characteristic connected to its flexibility and that can lead both to potentially better, but also worse results. But is this not a feature of this type of research, rather than a defining description of its essence? Wouldn’t this comment also apply, albeit to varying degrees, to quantitative research?

In addition, Strauss ( 2003 ), along with others, such as Alvesson and Kärreman ( 2011 :10–76), argue that qualitative researchers struggle to capture and represent complex phenomena partially because they tend to collect a large amount of data. While his analysis is correct at some points – “It is necessary to do detailed, intensive, microscopic examination of the data in order to bring out the amazing complexity of what lies in, behind, and beyond those data” (Strauss 2003 :10) – much of his analysis concerns the supposed focus of qualitative research and its challenges, rather than exactly what it is about. But even in this instance we would make a weak case arguing that these are strictly the defining features of qualitative research. Some researchers seem to focus on the approach or the methods used, or even on the way material is analyzed. Several researchers stress the naturalistic assumption of investigating the world, suggesting that meaning and interpretation appear to be a core matter of qualitative research.

We can also see that in this category there is no consensus about specific qualitative methods nor about qualitative data. Many emphasize interpretation, but quantitative research, too, involves interpretation; the results of a regression analysis, for example, certainly have to be interpreted, and the form of meta-analysis that factor analysis provides indeed requires interpretation However, there is no interpretation of quantitative raw data, i.e., numbers in tables. One common thread is that qualitative researchers have to get to grips with their data in order to understand what is being studied in great detail, irrespective of the type of empirical material that is being analyzed. This observation is connected to the fact that qualitative researchers routinely make several adjustments of focus and research design as their studies progress, in many cases until the very end of the project (Kalof et al. 2008 ). If you, like Becker, do not start out with a detailed theory, adjustments such as the emergence and refinement of research questions will occur during the research process. We have thus found a number of useful reflections about qualitative research scattered across different sources, but none of them effectively describe the defining characteristics of this approach.

Although qualitative research does not appear to be defined in terms of a specific method, it is certainly common that fieldwork, i.e., research that entails that the researcher spends considerable time in the field that is studied and use the knowledge gained as data, is seen as emblematic of or even identical to qualitative research. But because we understand that fieldwork tends to focus primarily on the collection and analysis of qualitative data, we expected to find within it discussions on the meaning of “qualitative.” But, again, this was not the case.

Instead, we found material on the history of this approach (for example, Frankfort-Nachmias and Nachmias 1996 ; Atkinson et al. 2001), including how it has changed; for example, by adopting a more self-reflexive practice (Heyl 2001), as well as the different nomenclature that has been adopted, such as fieldwork, ethnography, qualitative research, naturalistic research, participant observation and so on (for example, Lofland et al. 2006 ; Gans 1999 ).

We retrieved definitions of ethnography, such as “the study of people acting in the natural courses of their daily lives,” involving a “resocialization of the researcher” (Emerson 1988 :1) through intense immersion in others’ social worlds (see also examples in Hammersley 2018 ). This may be accomplished by direct observation and also participation (Neuman 2007 :276), although others, such as Denzin ( 1970 :185), have long recognized other types of observation, including non-participant (“fly on the wall”). In this category we have also isolated claims and opposing views, arguing that this type of research is distinguished primarily by where it is conducted (natural settings) (Hughes 1971:496), and how it is carried out (a variety of methods are applied) or, for some most importantly, by involving an active, empathetic immersion in those being studied (Emerson 1988 :2). We also retrieved descriptions of the goals it attends in relation to how it is taught (understanding subjective meanings of the people studied, primarily develop theory, or contribute to social change) (see for example, Corte and Irwin 2017 ; Frankfort-Nachmias and Nachmias 1996 :281; Trier-Bieniek 2012 :639) by collecting the richest possible data (Lofland et al. 2006 ) to derive “thick descriptions” (Geertz 1973 ), and/or to aim at theoretical statements of general scope and applicability (for example, Emerson 1988 ; Fine 2003 ). We have identified guidelines on how to evaluate it (for example Becker 1996 ; Lamont 2004 ) and have retrieved instructions on how it should be conducted (for example, Lofland et al. 2006 ). For instance, analysis should take place while the data gathering unfolds (Emerson 1988 ; Hammersley and Atkinson 2007 ; Lofland et al. 2006 ), observations should be of long duration (Becker 1970 :54; Goffman 1989 ), and data should be of high quantity (Becker 1970 :52–53), as well as other questionable distinctions between fieldwork and other methods:

Field studies differ from other methods of research in that the researcher performs the task of selecting topics, decides what questions to ask, and forges interest in the course of the research itself . This is in sharp contrast to many ‘theory-driven’ and ‘hypothesis-testing’ methods. (Lofland and Lofland 1995 :5)

But could not, for example, a strictly interview-based study be carried out with the same amount of flexibility, such as sequential interviewing (for example, Small 2009 )? Once again, are quantitative approaches really as inflexible as some qualitative researchers think? Moreover, this category stresses the role of the actors’ meaning, which requires knowledge and close interaction with people, their practices and their lifeworld.

It is clear that field studies – which are seen by some as the “gold standard” of qualitative research – are nonetheless only one way of doing qualitative research. There are other methods, but it is not clear why some are more qualitative than others, or why they are better or worse. Fieldwork is characterized by interaction with the field (the material) and understanding of the phenomenon that is being studied. In Becker’s case, he had general experience from fields in which marihuana was used, based on which he did interviews with actual users in several fields.

Grounded Theory

Another major category we identified in our sample is Grounded Theory. We found descriptions of it most clearly in Glaser and Strauss’ ([1967] 2010 ) original articulation, Strauss and Corbin ( 1998 ) and Charmaz ( 2006 ), as well as many other accounts of what it is for: generating and testing theory (Strauss 2003 :xi). We identified explanations of how this task can be accomplished – such as through two main procedures: constant comparison and theoretical sampling (Emerson 1998:96), and how using it has helped researchers to “think differently” (for example, Strauss and Corbin 1998 :1). We also read descriptions of its main traits, what it entails and fosters – for instance, an exceptional flexibility, an inductive approach (Strauss and Corbin 1998 :31–33; 1990; Esterberg 2002 :7), an ability to step back and critically analyze situations, recognize tendencies towards bias, think abstractly and be open to criticism, enhance sensitivity towards the words and actions of respondents, and develop a sense of absorption and devotion to the research process (Strauss and Corbin 1998 :5–6). Accordingly, we identified discussions of the value of triangulating different methods (both using and not using grounded theory), including quantitative ones, and theories to achieve theoretical development (most comprehensively in Denzin 1970 ; Strauss and Corbin 1998 ; Timmermans and Tavory 2012 ). We have also located arguments about how its practice helps to systematize data collection, analysis and presentation of results (Glaser and Strauss [1967] 2010 :16).

Grounded theory offers a systematic approach which requires researchers to get close to the field; closeness is a requirement of identifying questions and developing new concepts or making further distinctions with regard to old concepts. In contrast to other qualitative approaches, grounded theory emphasizes the detailed coding process, and the numerous fine-tuned distinctions that the researcher makes during the process. Within this category, too, we could not find a satisfying discussion of the meaning of qualitative research.

Defining Qualitative Research

In sum, our analysis shows that some notions reappear in the discussion of qualitative research, such as understanding, interpretation, “getting close” and making distinctions. These notions capture aspects of what we think is “qualitative.” However, a comprehensive definition that is useful and that can further develop the field is lacking, and not even a clear picture of its essential elements appears. In other words no definition emerges from our data, and in our research process we have moved back and forth between our empirical data and the attempt to present a definition. Our concrete strategy, as stated above, is to relate qualitative and quantitative research, or more specifically, qualitative and quantitative work. We use an ideal-typical notion of quantitative research which relies on taken for granted and numbered variables. This means that the data consists of variables on different scales, such as ordinal, but frequently ratio and absolute scales, and the representation of the numbers to the variables, i.e. the justification of the assignment of numbers to object or phenomenon, are not questioned, though the validity may be questioned. In this section we return to the notion of quality and try to clarify it while presenting our contribution.

Broadly, research refers to the activity performed by people trained to obtain knowledge through systematic procedures. Notions such as “objectivity” and “reflexivity,” “systematic,” “theory,” “evidence” and “openness” are here taken for granted in any type of research. Next, building on our empirical analysis we explain the four notions that we have identified as central to qualitative work: distinctions, process, closeness, and improved understanding. In discussing them, ultimately in relation to one another, we make their meaning even more precise. Our idea, in short, is that only when these ideas that we present separately for analytic purposes are brought together can we speak of qualitative research.

Distinctions

We believe that the possibility of making new distinctions is one the defining characteristics of qualitative research. It clearly sets it apart from quantitative analysis which works with taken-for-granted variables, albeit as mentioned, meta-analyses, for example, factor analysis may result in new variables. “Quality” refers essentially to distinctions, as already pointed out by Aristotle. He discusses the term “qualitative” commenting: “By a quality I mean that in virtue of which things are said to be qualified somehow” (Aristotle 1984:14). Quality is about what something is or has, which means that the distinction from its environment is crucial. We see qualitative research as a process in which significant new distinctions are made to the scholarly community; to make distinctions is a key aspect of obtaining new knowledge; a point, as we will see, that also has implications for “quantitative research.” The notion of being “significant” is paramount. New distinctions by themselves are not enough; just adding concepts only increases complexity without furthering our knowledge. The significance of new distinctions is judged against the communal knowledge of the research community. To enable this discussion and judgements central elements of rational discussion are required (cf. Habermas [1981] 1987 ; Davidsson [ 1988 ] 2001) to identify what is new and relevant scientific knowledge. Relatedly, Ragin alludes to the idea of new and useful knowledge at a more concrete level: “Qualitative methods are appropriate for in-depth examination of cases because they aid the identification of key features of cases. Most qualitative methods enhance data” (1994:79). When Becker ( 1963 ) studied deviant behavior and investigated how people became marihuana smokers, he made distinctions between the ways in which people learned how to smoke. This is a classic example of how the strategy of “getting close” to the material, for example the text, people or pictures that are subject to analysis, may enable researchers to obtain deeper insight and new knowledge by making distinctions – in this instance on the initial notion of learning how to smoke. Others have stressed the making of distinctions in relation to coding or theorizing. Emerson et al. ( 1995 ), for example, hold that “qualitative coding is a way of opening up avenues of inquiry,” meaning that the researcher identifies and develops concepts and analytic insights through close examination of and reflection on data (Emerson et al. 1995 :151). Goodwin and Horowitz highlight making distinctions in relation to theory-building writing: “Close engagement with their cases typically requires qualitative researchers to adapt existing theories or to make new conceptual distinctions or theoretical arguments to accommodate new data” ( 2002 : 37). In the ideal-typical quantitative research only existing and so to speak, given, variables would be used. If this is the case no new distinction are made. But, would not also many “quantitative” researchers make new distinctions?

Process does not merely suggest that research takes time. It mainly implies that qualitative new knowledge results from a process that involves several phases, and above all iteration. Qualitative research is about oscillation between theory and evidence, analysis and generating material, between first- and second -order constructs (Schütz 1962 :59), between getting in contact with something, finding sources, becoming deeply familiar with a topic, and then distilling and communicating some of its essential features. The main point is that the categories that the researcher uses, and perhaps takes for granted at the beginning of the research process, usually undergo qualitative changes resulting from what is found. Becker describes how he tested hypotheses and let the jargon of the users develop into theoretical concepts. This happens over time while the study is being conducted, exemplifying what we mean by process.

In the research process, a pilot-study may be used to get a first glance of, for example, the field, how to approach it, and what methods can be used, after which the method and theory are chosen or refined before the main study begins. Thus, the empirical material is often central from the start of the project and frequently leads to adjustments by the researcher. Likewise, during the main study categories are not fixed; the empirical material is seen in light of the theory used, but it is also given the opportunity to kick back, thereby resisting attempts to apply theoretical straightjackets (Becker 1970 :43). In this process, coding and analysis are interwoven, and thus are often important steps for getting closer to the phenomenon and deciding what to focus on next. Becker began his research by interviewing musicians close to him, then asking them to refer him to other musicians, and later on doubling his original sample of about 25 to include individuals in other professions (Becker 1973:46). Additionally, he made use of some participant observation, documents, and interviews with opiate users made available to him by colleagues. As his inductive theory of deviance evolved, Becker expanded his sample in order to fine tune it, and test the accuracy and generality of his hypotheses. In addition, he introduced a negative case and discussed the null hypothesis ( 1963 :44). His phasic career model is thus based on a research design that embraces processual work. Typically, process means to move between “theory” and “material” but also to deal with negative cases, and Becker ( 1998 ) describes how discovering these negative cases impacted his research design and ultimately its findings.

Obviously, all research is process-oriented to some degree. The point is that the ideal-typical quantitative process does not imply change of the data, and iteration between data, evidence, hypotheses, empirical work, and theory. The data, quantified variables, are, in most cases fixed. Merging of data, which of course can be done in a quantitative research process, does not mean new data. New hypotheses are frequently tested, but the “raw data is often the “the same.” Obviously, over time new datasets are made available and put into use.

Another characteristic that is emphasized in our sample is that qualitative researchers – and in particular ethnographers – can, or as Goffman put it, ought to ( 1989 ), get closer to the phenomenon being studied and their data than quantitative researchers (for example, Silverman 2009 :85). Put differently, essentially because of their methods qualitative researchers get into direct close contact with those being investigated and/or the material, such as texts, being analyzed. Becker started out his interview study, as we noted, by talking to those he knew in the field of music to get closer to the phenomenon he was studying. By conducting interviews he got even closer. Had he done more observations, he would undoubtedly have got even closer to the field.

Additionally, ethnographers’ design enables researchers to follow the field over time, and the research they do is almost by definition longitudinal, though the time in the field is studied obviously differs between studies. The general characteristic of closeness over time maximizes the chances of unexpected events, new data (related, for example, to archival research as additional sources, and for ethnography for situations not necessarily previously thought of as instrumental – what Mannay and Morgan ( 2015 ) term the “waiting field”), serendipity (Merton and Barber 2004 ; Åkerström 2013 ), and possibly reactivity, as well as the opportunity to observe disrupted patterns that translate into exemplars of negative cases. Two classic examples of this are Becker’s finding of what medical students call “crocks” (Becker et al. 1961 :317), and Geertz’s ( 1973 ) study of “deep play” in Balinese society.

By getting and staying so close to their data – be it pictures, text or humans interacting (Becker was himself a musician) – for a long time, as the research progressively focuses, qualitative researchers are prompted to continually test their hunches, presuppositions and hypotheses. They test them against a reality that often (but certainly not always), and practically, as well as metaphorically, talks back, whether by validating them, or disqualifying their premises – correctly, as well as incorrectly (Fine 2003 ; Becker 1970 ). This testing nonetheless often leads to new directions for the research. Becker, for example, says that he was initially reading psychological theories, but when facing the data he develops a theory that looks at, you may say, everything but psychological dispositions to explain the use of marihuana. Especially researchers involved with ethnographic methods have a fairly unique opportunity to dig up and then test (in a circular, continuous and temporal way) new research questions and findings as the research progresses, and thereby to derive previously unimagined and uncharted distinctions by getting closer to the phenomenon under study.

Let us stress that getting close is by no means restricted to ethnography. The notion of hermeneutic circle and hermeneutics as a general way of understanding implies that we must get close to the details in order to get the big picture. This also means that qualitative researchers can literally also make use of details of pictures as evidence (cf. Harper 2002). Thus, researchers may get closer both when generating the material or when analyzing it.

Quantitative research, we maintain, in the ideal-typical representation cannot get closer to the data. The data is essentially numbers in tables making up the variables (Franzosi 2016 :138). The data may originally have been “qualitative,” but once reduced to numbers there can only be a type of “hermeneutics” about what the number may stand for. The numbers themselves, however, are non-ambiguous. Thus, in quantitative research, interpretation, if done, is not about the data itself—the numbers—but what the numbers stand for. It follows that the interpretation is essentially done in a more “speculative” mode without direct empirical evidence (cf. Becker 2017 ).

Improved Understanding

While distinction, process and getting closer refer to the qualitative work of the researcher, improved understanding refers to its conditions and outcome of this work. Understanding cuts deeper than explanation, which to some may mean a causally verified correlation between variables. The notion of explanation presupposes the notion of understanding since explanation does not include an idea of how knowledge is gained (Manicas 2006 : 15). Understanding, we argue, is the core concept of what we call the outcome of the process when research has made use of all the other elements that were integrated in the research. Understanding, then, has a special status in qualitative research since it refers both to the conditions of knowledge and the outcome of the process. Understanding can to some extent be seen as the condition of explanation and occurs in a process of interpretation, which naturally refers to meaning (Gadamer 1990 ). It is fundamentally connected to knowing, and to the knowing of how to do things (Heidegger [1927] 2001 ). Conceptually the term hermeneutics is used to account for this process. Heidegger ties hermeneutics to human being and not possible to separate from the understanding of being ( 1988 ). Here we use it in a broader sense, and more connected to method in general (cf. Seiffert 1992 ). The abovementioned aspects – for example, “objectivity” and “reflexivity” – of the approach are conditions of scientific understanding. Understanding is the result of a circular process and means that the parts are understood in light of the whole, and vice versa. Understanding presupposes pre-understanding, or in other words, some knowledge of the phenomenon studied. The pre-understanding, even in the form of prejudices, are in qualitative research process, which we see as iterative, questioned, which gradually or suddenly change due to the iteration of data, evidence and concepts. However, qualitative research generates understanding in the iterative process when the researcher gets closer to the data, e.g., by going back and forth between field and analysis in a process that generates new data that changes the evidence, and, ultimately, the findings. Questioning, to ask questions, and put what one assumes—prejudices and presumption—in question, is central to understand something (Heidegger [1927] 2001 ; Gadamer 1990 :368–384). We propose that this iterative process in which the process of understanding occurs is characteristic of qualitative research.

Improved understanding means that we obtain scientific knowledge of something that we as a scholarly community did not know before, or that we get to know something better. It means that we understand more about how parts are related to one another, and to other things we already understand (see also Fine and Hallett 2014 ). Understanding is an important condition for qualitative research. It is not enough to identify correlations, make distinctions, and work in a process in which one gets close to the field or phenomena. Understanding is accomplished when the elements are integrated in an iterative process.

It is, moreover, possible to understand many things, and researchers, just like children, may come to understand new things every day as they engage with the world. This subjective condition of understanding – namely, that a person gains a better understanding of something –is easily met. To be qualified as “scientific,” the understanding must be general and useful to many; it must be public. But even this generally accessible understanding is not enough in order to speak of “scientific understanding.” Though we as a collective can increase understanding of everything in virtually all potential directions as a result also of qualitative work, we refrain from this “objective” way of understanding, which has no means of discriminating between what we gain in understanding. Scientific understanding means that it is deemed relevant from the scientific horizon (compare Schütz 1962 : 35–38, 46, 63), and that it rests on the pre-understanding that the scientists have and must have in order to understand. In other words, the understanding gained must be deemed useful by other researchers, so that they can build on it. We thus see understanding from a pragmatic, rather than a subjective or objective perspective. Improved understanding is related to the question(s) at hand. Understanding, in order to represent an improvement, must be an improvement in relation to the existing body of knowledge of the scientific community (James [ 1907 ] 1955). Scientific understanding is, by definition, collective, as expressed in Weber’s famous note on objectivity, namely that scientific work aims at truths “which … can claim, even for a Chinese, the validity appropriate to an empirical analysis” ([1904] 1949 :59). By qualifying “improved understanding” we argue that it is a general defining characteristic of qualitative research. Becker‘s ( 1966 ) study and other research of deviant behavior increased our understanding of the social learning processes of how individuals start a behavior. And it also added new knowledge about the labeling of deviant behavior as a social process. Few studies, of course, make the same large contribution as Becker’s, but are nonetheless qualitative research.

Understanding in the phenomenological sense, which is a hallmark of qualitative research, we argue, requires meaning and this meaning is derived from the context, and above all the data being analyzed. The ideal-typical quantitative research operates with given variables with different numbers. This type of material is not enough to establish meaning at the level that truly justifies understanding. In other words, many social science explanations offer ideas about correlations or even causal relations, but this does not mean that the meaning at the level of the data analyzed, is understood. This leads us to say that there are indeed many explanations that meet the criteria of understanding, for example the explanation of how one becomes a marihuana smoker presented by Becker. However, we may also understand a phenomenon without explaining it, and we may have potential explanations, or better correlations, that are not really understood.

We may speak more generally of quantitative research and its data to clarify what we see as an important distinction. The “raw data” that quantitative research—as an idealtypical activity, refers to is not available for further analysis; the numbers, once created, are not to be questioned (Franzosi 2016 : 138). If the researcher is to do “more” or “change” something, this will be done by conjectures based on theoretical knowledge or based on the researcher’s lifeworld. Both qualitative and quantitative research is based on the lifeworld, and all researchers use prejudices and pre-understanding in the research process. This idea is present in the works of Heidegger ( 2001 ) and Heisenberg (cited in Franzosi 2010 :619). Qualitative research, as we argued, involves the interaction and questioning of concepts (theory), data, and evidence.

Ragin ( 2004 :22) points out that “a good definition of qualitative research should be inclusive and should emphasize its key strengths and features, not what it lacks (for example, the use of sophisticated quantitative techniques).” We define qualitative research as an iterative process in which improved understanding to the scientific community is achieved by making new significant distinctions resulting from getting closer to the phenomenon studied. Qualitative research, as defined here, is consequently a combination of two criteria: (i) how to do things –namely, generating and analyzing empirical material, in an iterative process in which one gets closer by making distinctions, and (ii) the outcome –improved understanding novel to the scholarly community. Is our definition applicable to our own study? In this study we have closely read the empirical material that we generated, and the novel distinction of the notion “qualitative research” is the outcome of an iterative process in which both deduction and induction were involved, in which we identified the categories that we analyzed. We thus claim to meet the first criteria, “how to do things.” The second criteria cannot be judged but in a partial way by us, namely that the “outcome” —in concrete form the definition-improves our understanding to others in the scientific community.

We have defined qualitative research, or qualitative scientific work, in relation to quantitative scientific work. Given this definition, qualitative research is about questioning the pre-given (taken for granted) variables, but it is thus also about making new distinctions of any type of phenomenon, for example, by coining new concepts, including the identification of new variables. This process, as we have discussed, is carried out in relation to empirical material, previous research, and thus in relation to theory. Theory and previous research cannot be escaped or bracketed. According to hermeneutic principles all scientific work is grounded in the lifeworld, and as social scientists we can thus never fully bracket our pre-understanding.

We have proposed that quantitative research, as an idealtype, is concerned with pre-determined variables (Small 2008 ). Variables are epistemically fixed, but can vary in terms of dimensions, such as frequency or number. Age is an example; as a variable it can take on different numbers. In relation to quantitative research, qualitative research does not reduce its material to number and variables. If this is done the process of comes to a halt, the researcher gets more distanced from her data, and it makes it no longer possible to make new distinctions that increase our understanding. We have above discussed the components of our definition in relation to quantitative research. Our conclusion is that in the research that is called quantitative there are frequent and necessary qualitative elements.

Further, comparative empirical research on researchers primarily working with ”quantitative” approaches and those working with ”qualitative” approaches, we propose, would perhaps show that there are many similarities in practices of these two approaches. This is not to deny dissimilarities, or the different epistemic and ontic presuppositions that may be more or less strongly associated with the two different strands (see Goertz and Mahoney 2012 ). Our point is nonetheless that prejudices and preconceptions about researchers are unproductive, and that as other researchers have argued, differences may be exaggerated (e.g., Becker 1996 : 53, 2017 ; Marchel and Owens 2007 :303; Ragin 1994 ), and that a qualitative dimension is present in both kinds of work.

Several things follow from our findings. The most important result is the relation to quantitative research. In our analysis we have separated qualitative research from quantitative research. The point is not to label individual researchers, methods, projects, or works as either “quantitative” or “qualitative.” By analyzing, i.e., taking apart, the notions of quantitative and qualitative, we hope to have shown the elements of qualitative research. Our definition captures the elements, and how they, when combined in practice, generate understanding. As many of the quotations we have used suggest, one conclusion of our study holds that qualitative approaches are not inherently connected with a specific method. Put differently, none of the methods that are frequently labelled “qualitative,” such as interviews or participant observation, are inherently “qualitative.” What matters, given our definition, is whether one works qualitatively or quantitatively in the research process, until the results are produced. Consequently, our analysis also suggests that those researchers working with what in the literature and in jargon is often called “quantitative research” are almost bound to make use of what we have identified as qualitative elements in any research project. Our findings also suggest that many” quantitative” researchers, at least to some extent, are engaged with qualitative work, such as when research questions are developed, variables are constructed and combined, and hypotheses are formulated. Furthermore, a research project may hover between “qualitative” and “quantitative” or start out as “qualitative” and later move into a “quantitative” (a distinct strategy that is not similar to “mixed methods” or just simply combining induction and deduction). More generally speaking, the categories of “qualitative” and “quantitative,” unfortunately, often cover up practices, and it may lead to “camps” of researchers opposing one another. For example, regardless of the researcher is primarily oriented to “quantitative” or “qualitative” research, the role of theory is neglected (cf. Swedberg 2017 ). Our results open up for an interaction not characterized by differences, but by different emphasis, and similarities.

Let us take two examples to briefly indicate how qualitative elements can fruitfully be combined with quantitative. Franzosi ( 2010 ) has discussed the relations between quantitative and qualitative approaches, and more specifically the relation between words and numbers. He analyzes texts and argues that scientific meaning cannot be reduced to numbers. Put differently, the meaning of the numbers is to be understood by what is taken for granted, and what is part of the lifeworld (Schütz 1962 ). Franzosi shows how one can go about using qualitative and quantitative methods and data to address scientific questions analyzing violence in Italy at the time when fascism was rising (1919–1922). Aspers ( 2006 ) studied the meaning of fashion photographers. He uses an empirical phenomenological approach, and establishes meaning at the level of actors. In a second step this meaning, and the different ideal-typical photographers constructed as a result of participant observation and interviews, are tested using quantitative data from a database; in the first phase to verify the different ideal-types, in the second phase to use these types to establish new knowledge about the types. In both of these cases—and more examples can be found—authors move from qualitative data and try to keep the meaning established when using the quantitative data.

A second main result of our study is that a definition, and we provided one, offers a way for research to clarify, and even evaluate, what is done. Hence, our definition can guide researchers and students, informing them on how to think about concrete research problems they face, and to show what it means to get closer in a process in which new distinctions are made. The definition can also be used to evaluate the results, given that it is a standard of evaluation (cf. Hammersley 2007 ), to see whether new distinctions are made and whether this improves our understanding of what is researched, in addition to the evaluation of how the research was conducted. By making what is qualitative research explicit it becomes easier to communicate findings, and it is thereby much harder to fly under the radar with substandard research since there are standards of evaluation which make it easier to separate “good” from “not so good” qualitative research.

To conclude, our analysis, which ends with a definition of qualitative research can thus both address the “internal” issues of what is qualitative research, and the “external” critiques that make it harder to do qualitative research, to which both pressure from quantitative methods and general changes in society contribute.

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Acknowledgements

Financial Support for this research is given by the European Research Council, CEV (263699). The authors are grateful to Susann Krieglsteiner for assistance in collecting the data. The paper has benefitted from the many useful comments by the three reviewers and the editor, comments by members of the Uppsala Laboratory of Economic Sociology, as well as Jukka Gronow, Sebastian Kohl, Marcin Serafin, Richard Swedberg, Anders Vassenden and Turid Rødne.

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Aspers, P., Corte, U. What is Qualitative in Qualitative Research. Qual Sociol 42 , 139–160 (2019). https://doi.org/10.1007/s11133-019-9413-7

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What is qualitative research? Definition and meaning

Qualitative research is a mainly exploratory type of scientific research used to understand people’s beliefs, experiences, behavior, attitudes and interactions. Unlike quantitative research, qualitative research generates non-numerical data.

Simply put, qualitative research focuses on the “why” of a phenomena rather than the “what”. Theories of the “why” are devised using systems of inquiry.

Common methods of qualitative research include interviews, focus groups (group discussions), and observations.

Qualtitive research was first used in psychological studies as researchers found it too tedious to evaluate human behavior with numbers. Since then it has become a form of research commonly used in other research fields.  

According to the University of Utah College of Nursing, qualitative   methods “allow the researcher to study selected issues in depth and detail without being constrained by pre-determined categories of analysis.”

There are five main methods of qualitative research:

1. Ethnography – researchers completely immerse themselves in the environment first-hand. Ethnography involves hands-on, on-the-scene learning. This method is relevant wherever people are relevant. According to Encyclopaedia Britannica , “Contemporary ethnography is based almost entirely on fieldwork and requires the complete immersion of the anthropologist in the culture and everyday life of the people who are the subject of his study.”

2. Narrative –  the use of field texts, such as stories, journals, interviews, photos and life experience. Narrative knowledge is created through the stories of lived experience and sense-making. It offers valuable insight into the complexity of human lives, cultures, and behaviors, according to the UK National Centre for Research Methods.

3. Phenomenological –  A method used to describe how humans experience a certain phenomenon. The Center for Innovation in Research and Teaching says a phenomenological study “attempts to set aside biases and preconceived assumptions about human experiences, feelings, and responses to a particular situation.”

4. Grounded Theory –  an inductive methodology developed by Glaser and Strauss in the 1960s. Grounded theory may be defined as ‘the discovery of theory from data systematically obtained from social research’. Researchers gather data from interviews or existing documents to create a theory about a certain event. Axial coding, the process of relating categories and concepts to each other through inductive and deductive thinking, is used to help build the theory.

5. Case Study – a research method in which the subject of study (the case) is examined in-depth. Case studies can involve both qualitative and quantitative research methods. Data is collected through interviews, documents, reports, observations.

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• Introduction

Qualitative research is a type of research that explores and provides deeper insights into real-world problems. [1] Instead of collecting numerical data points or intervening or introducing treatments just like in quantitative research, qualitative research helps generate hypothenar to further investigate and understand quantitative data. Qualitative research gathers participants' experiences, perceptions, and behavior. It answers the hows and whys instead of how many or how much. It could be structured as a standalone study, purely relying on qualitative data, or part of mixed-methods research that combines qualitative and quantitative data. This review introduces the readers to some basic concepts, definitions, terminology, and applications of qualitative research.

Qualitative research, at its core, asks open-ended questions whose answers are not easily put into numbers, such as "how" and "why." [2] Due to the open-ended nature of the research questions, qualitative research design is often not linear like quantitative design. [2] One of the strengths of qualitative research is its ability to explain processes and patterns of human behavior that can be difficult to quantify. [3] Phenomena such as experiences, attitudes, and behaviors can be complex to capture accurately and quantitatively. In contrast, a qualitative approach allows participants themselves to explain how, why, or what they were thinking, feeling, and experiencing at a particular time or during an event of interest. Quantifying qualitative data certainly is possible, but at its core, qualitative data is looking for themes and patterns that can be difficult to quantify, and it is essential to ensure that the context and narrative of qualitative work are not lost by trying to quantify something that is not meant to be quantified.

However, while qualitative research is sometimes placed in opposition to quantitative research, where they are necessarily opposites and therefore "compete" against each other and the philosophical paradigms associated with each other, qualitative and quantitative work are neither necessarily opposites, nor are they incompatible. [4] While qualitative and quantitative approaches are different, they are not necessarily opposites and certainly not mutually exclusive. For instance, qualitative research can help expand and deepen understanding of data or results obtained from quantitative analysis. For example, say a quantitative analysis has determined a correlation between length of stay and level of patient satisfaction, but why does this correlation exist? This dual-focus scenario shows one way in which qualitative and quantitative research could be integrated.

Qualitative Research Approaches

Ethnography

Ethnography as a research design originates in social and cultural anthropology and involves the researcher being directly immersed in the participant’s environment. [2] Through this immersion, the ethnographer can use a variety of data collection techniques to produce a comprehensive account of the social phenomena that occurred during the research period. [2] That is to say, the researcher’s aim with ethnography is to immerse themselves into the research population and come out of it with accounts of actions, behaviors, events, etc, through the eyes of someone involved in the population. Direct involvement of the researcher with the target population is one benefit of ethnographic research because it can then be possible to find data that is otherwise very difficult to extract and record.

Grounded theory

Grounded Theory is the "generation of a theoretical model through the experience of observing a study population and developing a comparative analysis of their speech and behavior." [5] Unlike quantitative research, which is deductive and tests or verifies an existing theory, grounded theory research is inductive and, therefore, lends itself to research aimed at social interactions or experiences. [3] [2] In essence, Grounded Theory’s goal is to explain how and why an event occurs or how and why people might behave a certain way. Through observing the population, a researcher using the Grounded Theory approach can then develop a theory to explain the phenomena of interest.

Phenomenology

Phenomenology is the "study of the meaning of phenomena or the study of the particular.” [5] At first glance, it might seem that Grounded Theory and Phenomenology are pretty similar, but the differences can be seen upon careful examination. At its core, phenomenology looks to investigate experiences from the individual's perspective. [2] Phenomenology is essentially looking into the "lived experiences" of the participants and aims to examine how and why participants behaved a certain way from their perspective. Herein lies one of the main differences between Grounded Theory and Phenomenology. Grounded Theory aims to develop a theory for social phenomena through an examination of various data sources. In contrast, Phenomenology focuses on describing and explaining an event or phenomenon from the perspective of those who have experienced it.

Narrative research

One of qualitative research’s strengths lies in its ability to tell a story, often from the perspective of those directly involved in it. Reporting on qualitative research involves including details and descriptions of the setting involved and quotes from participants. This detail is called a "thick" or "rich" description and is a strength of qualitative research. Narrative research is rife with the possibilities of "thick" description as this approach weaves together a sequence of events, usually from just one or two individuals, hoping to create a cohesive story or narrative. [2] While it might seem like a waste of time to focus on such a specific, individual level, understanding one or two people’s narratives for an event or phenomenon can help to inform researchers about the influences that helped shape that narrative. The tension or conflict of differing narratives can be "opportunities for innovation." [2]

Research Paradigm

Research paradigms are the assumptions, norms, and standards underpinning different research approaches. Essentially, research paradigms are the "worldviews" that inform research. [4] It is valuable for qualitative and quantitative researchers to understand what paradigm they are working within because understanding the theoretical basis of research paradigms allows researchers to understand the strengths and weaknesses of the approach being used and adjust accordingly. Different paradigms have different ontologies and epistemologies. Ontology is defined as the "assumptions about the nature of reality,” whereas epistemology is defined as the "assumptions about the nature of knowledge" that inform researchers' work. [2] It is essential to understand the ontological and epistemological foundations of the research paradigm researchers are working within to allow for a complete understanding of the approach being used and the assumptions that underpin the approach as a whole. Further, researchers must understand their own ontological and epistemological assumptions about the world in general because their assumptions about the world will necessarily impact how they interact with research. A discussion of the research paradigm is not complete without describing positivist, postpositivist, and constructivist philosophies.

Positivist versus postpositivist

To further understand qualitative research, we must discuss positivist and postpositivist frameworks. Positivism is a philosophy that the scientific method can and should be applied to social and natural sciences. [4] Essentially, positivist thinking insists that the social sciences should use natural science methods in their research. It stems from positivist ontology, that there is an objective reality that exists that is wholly independent of our perception of the world as individuals. Quantitative research is rooted in positivist philosophy, which can be seen in the value it places on concepts such as causality, generalizability, and replicability.

Conversely, postpositivists argue that social reality can never be one hundred percent explained, but could be approximated. [4] Indeed, qualitative researchers have been insisting that there are “fundamental limits to the extent to which the methods and procedures of the natural sciences could be applied to the social world,” and therefore, postpositivist philosophy is often associated with qualitative research. [4] An example of positivist versus postpositivist values in research might be that positivist philosophies value hypothesis-testing, whereas postpositivist philosophies value the ability to formulate a substantive theory.

Constructivist

Constructivism is a subcategory of postpositivism. Most researchers invested in postpositivist research are also constructivist, meaning they think there is no objective external reality that exists but instead that reality is constructed. Constructivism is a theoretical lens that emphasizes the dynamic nature of our world. "Constructivism contends that individuals' views are directly influenced by their experiences, and it is these individual experiences and views that shape their perspective of reality.” [6]  constructivist thought focuses on how "reality" is not a fixed certainty and how experiences, interactions, and backgrounds give people a unique view of the world. Constructivism contends, unlike positivist views, that there is not necessarily an "objective"reality we all experience. This is the ‘relativist’ ontological view that reality and our world are dynamic and socially constructed. Therefore, qualitative scientific knowledge can be inductive as well as deductive.” [4]

So why is it important to understand the differences in assumptions that different philosophies and approaches to research have? Fundamentally, the assumptions underpinning the research tools a researcher selects provide an overall base for the assumptions the rest of the research will have. It can even change the role of the researchers. [2] For example, is the researcher an "objective" observer, such as in positivist quantitative work? Or is the researcher an active participant in the research, as in postpositivist qualitative work? Understanding the philosophical base of the study undertaken allows researchers to fully understand the implications of their work and their role within the research and reflect on their positionality and bias as it pertains to the research they are conducting.

Data Sampling 

The better the sample represents the intended study population, the more likely the researcher is to encompass the varying factors. The following are examples of participant sampling and selection: [7]

• Purposive sampling- selection based on the researcher’s rationale for being the most informative.
• Criterion sampling selection based on pre-identified factors.
• Convenience sampling- selection based on availability.
• Snowball sampling- the selection is by referral from other participants or people who know potential participants.
• Extreme case sampling- targeted selection of rare cases.
• Typical case sampling selection based on regular or average participants. 

Data Collection and Analysis

Qualitative research uses several techniques, including interviews, focus groups, and observation. [1] [2] [3] Interviews may be unstructured, with open-ended questions on a topic, and the interviewer adapts to the responses. Structured interviews have a predetermined number of questions that every participant is asked. It is usually one-on-one and appropriate for sensitive topics or topics needing an in-depth exploration. Focus groups are often held with 8-12 target participants and are used when group dynamics and collective views on a topic are desired. Researchers can be participant-observers to share the experiences of the subject or non-participants or detached observers.

While quantitative research design prescribes a controlled environment for data collection, qualitative data collection may be in a central location or the participants' environment, depending on the study goals and design. Qualitative research could amount to a large amount of data. Data is transcribed, which may then be coded manually or using computer-assisted qualitative data analysis software or CAQDAS such as ATLAS.ti or NVivo. [8] [9] [10]

After the coding process, qualitative research results could be in various formats. It could be a synthesis and interpretation presented with excerpts from the data. [11] Results could also be in the form of themes and theory or model development.

Dissemination

The healthcare team can use two reporting standards to standardize and facilitate the dissemination of qualitative research outcomes. The Consolidated Criteria for Reporting Qualitative Research or COREQ is a 32-item checklist for interviews and focus groups. [12] The Standards for Reporting Qualitative Research (SRQR) is a checklist covering a more comprehensive range of qualitative research. [13]

Applications

Many times, a research question will start with qualitative research. The qualitative research will help generate the research hypothesis, which can be tested with quantitative methods. After the data is collected and analyzed with quantitative methods, a set of qualitative methods can be used to dive deeper into the data to better understand what the numbers truly mean and their implications. The qualitative techniques can then help clarify the quantitative data and also help refine the hypothesis for future research. Furthermore, with qualitative research, researchers can explore poorly studied subjects with quantitative methods. These include opinions, individual actions, and social science research.

An excellent qualitative study design starts with a goal or objective. This should be clearly defined or stated. The target population needs to be specified. A method for obtaining information from the study population must be carefully detailed to ensure no omissions of part of the target population. A proper collection method should be selected that will help obtain the desired information without overly limiting the collected data because, often, the information sought is not well categorized or obtained. Finally, the design should ensure adequate methods for analyzing the data. An example may help better clarify some of the various aspects of qualitative research.

A researcher wants to decrease the number of teenagers who smoke in their community. The researcher could begin by asking current teen smokers why they started smoking through structured or unstructured interviews (qualitative research). The researcher can also get together a group of current teenage smokers and conduct a focus group to help brainstorm factors that may have prevented them from starting to smoke (qualitative research).

In this example, the researcher has used qualitative research methods (interviews and focus groups) to generate a list of ideas of why teens start to smoke and factors that may have prevented them from starting to smoke. Next, the researcher compiles this data. The research found that, hypothetically, peer pressure, health issues, cost, being considered "cool," and rebellious behavior all might increase or decrease the likelihood of teens starting to smoke.

The researcher creates a survey asking teen participants to rank how important each of the above factors is in either starting smoking (for current smokers) or not smoking (for current nonsmokers). This survey provides specific numbers (ranked importance of each factor) and is thus a quantitative research tool.

The researcher can use the survey results to focus efforts on the one or two highest-ranked factors. Let us say the researcher found that health was the primary factor that keeps teens from starting to smoke, and peer pressure was the primary factor that contributed to teens starting smoking. The researcher can go back to qualitative research methods to dive deeper into these for more information. The researcher wants to focus on keeping teens from starting to smoke, so they focus on the peer pressure aspect.

The researcher can conduct interviews and focus groups (qualitative research) about what types and forms of peer pressure are commonly encountered, where the peer pressure comes from, and where smoking starts. The researcher hypothetically finds that peer pressure often occurs after school at the local teen hangouts, mostly in the local park. The researcher also hypothetically finds that peer pressure comes from older, current smokers who provide the cigarettes.

The researcher could further explore this observation made at the local teen hangouts (qualitative research) and take notes regarding who is smoking, who is not, and what observable factors are at play for peer pressure to smoke. The researcher finds a local park where many local teenagers hang out and sees that the smokers tend to hang out in a shady, overgrown area of the park. The researcher notes that smoking teenagers buy their cigarettes from a local convenience store adjacent to the park, where the clerk does not check identification before selling cigarettes. These observations fall under qualitative research.

If the researcher returns to the park and counts how many individuals smoke in each region, this numerical data would be quantitative research. Based on the researcher's efforts thus far, they conclude that local teen smoking and teenagers who start to smoke may decrease if there are fewer overgrown areas of the park and the local convenience store does not sell cigarettes to underage individuals.

The researcher could try to have the parks department reassess the shady areas to make them less conducive to smokers or identify how to limit the sales of cigarettes to underage individuals by the convenience store. The researcher would then cycle back to qualitative methods of asking at-risk populations their perceptions of the changes and what factors are still at play, and quantitative research that includes teen smoking rates in the community and the incidence of new teen smokers, among others. [14] [15]

Qualitative research functions as a standalone research design or combined with quantitative research to enhance our understanding of the world. Qualitative research uses techniques including structured and unstructured interviews, focus groups, and participant observation not only to help generate hypotheses that can be more rigorously tested with quantitative research but also to help researchers delve deeper into the quantitative research numbers, understand what they mean, and understand what the implications are. Qualitative research allows researchers to understand what is going on, especially when things are not easily categorized. [16]

• Issues of Concern

As discussed in the sections above, quantitative and qualitative work differ in many ways, including the evaluation criteria. There are four well-established criteria for evaluating quantitative data: internal validity, external validity, reliability, and objectivity. Credibility, transferability, dependability, and confirmability are the correlating concepts in qualitative research. [4] [11] The corresponding quantitative and qualitative concepts can be seen below, with the quantitative concept on the left and the qualitative concept on the right:

• Internal validity: Credibility
• External validity: Transferability
• Reliability: Dependability
• Objectivity: Confirmability

In conducting qualitative research, ensuring these concepts are satisfied and well thought out can mitigate potential issues from arising. For example, just as a researcher will ensure that their quantitative study is internally valid, qualitative researchers should ensure that their work has credibility. 

Indicators such as triangulation and peer examination can help evaluate the credibility of qualitative work.

• Triangulation: Triangulation involves using multiple data collection methods to increase the likelihood of getting a reliable and accurate result. In our above magic example, the result would be more reliable if we interviewed the magician, backstage hand, and the person who "vanished." In qualitative research, triangulation can include telephone surveys, in-person surveys, focus groups, and interviews and surveying an adequate cross-section of the target demographic.
• Peer examination: A peer can review results to ensure the data is consistent with the findings.

A "thick" or "rich" description can be used to evaluate the transferability of qualitative research, whereas an indicator such as an audit trail might help evaluate the dependability and confirmability.

• Thick or rich description:  This is a detailed and thorough description of details, the setting, and quotes from participants in the research. [5] Thick descriptions will include a detailed explanation of how the study was conducted. Thick descriptions are detailed enough to allow readers to draw conclusions and interpret the data, which can help with transferability and replicability.
• Audit trail: An audit trail provides a documented set of steps of how the participants were selected and the data was collected. The original information records should also be kept (eg, surveys, notes, recordings).

One issue of concern that qualitative researchers should consider is observation bias. Here are a few examples:

• Hawthorne effect: The effect is the change in participant behavior when they know they are being observed. Suppose a researcher wanted to identify factors that contribute to employee theft and tell the employees they will watch them to see what factors affect employee theft. In that case, one would suspect employee behavior would change when they know they are being protected.
• Observer-expectancy effect: Some participants change their behavior or responses to satisfy the researcher's desired effect. This happens unconsciously for the participant, so it is essential to eliminate or limit the transmission of the researcher's views.
• Artificial scenario effect: Some qualitative research occurs in contrived scenarios with preset goals. In such situations, the information may not be accurate because of the artificial nature of the scenario. The preset goals may limit the qualitative information obtained.
• Clinical Significance

Qualitative or quantitative research helps healthcare providers understand patients and the impact and challenges of the care they deliver. Qualitative research provides an opportunity to generate and refine hypotheses and delve deeper into the data generated by quantitative research. Qualitative research is not an island apart from quantitative research but an integral part of research methods to understand the world around us. [17]

• Enhancing Healthcare Team Outcomes

Qualitative research is essential for all healthcare team members as all are affected by qualitative research. Qualitative research may help develop a theory or a model for health research that can be further explored by quantitative research. Much of the qualitative research data acquisition is completed by numerous team members, including social workers, scientists, nurses, etc. Within each area of the medical field, there is copious ongoing qualitative research, including physician-patient interactions, nursing-patient interactions, patient-environment interactions, healthcare team function, patient information delivery, etc. 

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Disclosure: Steven Tenny declares no relevant financial relationships with ineligible companies.

Disclosure: Janelle Brannan declares no relevant financial relationships with ineligible companies.

Disclosure: Grace Brannan declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

• Cite this Page Tenny S, Brannan JM, Brannan GD. Qualitative Study. [Updated 2022 Sep 18]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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7 Benefits of qualitative market research (and how to overcome the challenges)

1. create data-driven marketing and brand campaigns, 2. support and streamline product development, 3. qualitative research is flexible and easy to adapt, 4. stay on top of trends, 5. understand nuanced customer experiences, 6. increased depth of consumer knowledge, 7. reduced customer churn, the challenges of qualitative market research, power your product development with qualitative market research.

Get new ideas.

Challenge outdated assumptions.

Create narratives that hit home.

Design products that users can’t live without.

These are all reasons to do qualitative research…

The benefits of a qualitative study of your target market are endless, but we’ve gathered the 7 best ones.

Because qualitative research can — and should — be used for so many scenarios. From discovering unexpected insights to validating what you think you know about your customers. It’s essential for everything from refining your product and services based on direct feedback to ensuring your marketing messages hit the mark.

Whether you’re exploring new markets, enhancing customer experience, or simply aiming to connect more deeply with your audience, qualitative research opens up a world of possibilities for informed decision-making and strategic innovation. Let’s look at the advantages that you get from doing qualitative research the right way.

Some brands just seem to get their audience, and that’s not just because they’ve hired a team of ”people-persons”. In fact, it’s probably a lot more data-driven than you might think from just looking at their campaigns. What you see there is qualitative research at work, leading brands to decisions that are grounded in their customers’ real feelings and needs.

By integrating these insights, they find the right words, the most relatable stories, and the most engaging content, all based on what their audience truly cares about.

Moreover, every decision, from the tone of voice in an email to the theme of a major campaign, is backed by solid data from their qualitative analysis.

Using qualitative data like this aligns the brand’s actions with consumer expectations, creating experiences that feel tailor-made. That’s when brands become fluent in their audience’s language, and a real conversation can be had.

Great product development isn’t developers saying ”hey, look at what we can do!”‘ but about them saying to users: ”hey, look at what YOU can finally do!”. It’s about empowering consumers and that starts with having a deep understanding of how they interact with your product.

And qualitative data helps them do exactly that.

When analytics show where users get stuck, the data collection from qualitative research shows why —and how to help them move forward. Using that combination of quantitative and qualitative research will enable you to create user-friendly and market-ready products far quicker and more efficiently than with guesswork.

There are so many ways to uncover the ‘why’ behind the what, the qualitative data behind the numbers. That’s one of the many beauties of qualitative research methods: you can adapt it to specific situations.

If you want to zoom in, get some customers to sit down one-on-one with you. If you want to uncover sentiments or trends in a larger group, you can send out video surveys. And if you want dynamic, creative discussions, you use focus groups.

You can combine methods to collect data of different formats and test whether your findings from one match with the other. This versatility in gathering data is great for really getting to know the nuances that live within your target audience.

Get reliable qual insights from Attest

Get inspo from target customers and enrich your quant research with Video Responses from Attest, delivered fast!

If you want to know what’s going to be trending soon, all you need to do is listen. With the right qualitative market research methods you can catch sentiments that turn into trends before your competitors do.

Luckily, qualitative research, with its smaller sample sizes, means you can gather and analyze consumer opinions pretty quickly. This speed combined with the reassurance from quantitative research lets you identify emerging trends before they’re already cringe.

But it’s not just about being fast — it’s about being right. That’s exactly what qualitative research lets you be.

Sure, numerical data can also quickly show you trends — peaks or drops in any graph highlight that something is going on. But without knowing exactly what, taking action is a big risk that you shouldn’t be taking.

On paper, customers might seem very similar, all fitting the description of your ”ideal target customer”. But one might give you 10/10, while another might leave quietly after a free trial.

People are nuanced, and anything can influence their experience with your product or service. Qualitative research allows you to discover those nuances.

With qualitative research, you find out that people say that newsletters past 6PM are ”annoying”, or that they’re not reading anything attentively past that time.

And that’s just scratching the surface of just how deep qualitative research methods can go.

Knowing what your target customers are thinking and feeling will increase your empathy for them and allow you to make more tailored decisions that truly suit their needs.

Quantitative research methods don’t allow for ”yes, but..”.

You might think you’re getting to know your customers through a quantitative research study, but you’re only getting to know them within the limits of the framework that you yourself built for this research.

With qualitative research, you can step outside of that and give your audience the freedom to tell you new, surprising things about themselves.

It places you right in the middle of their natural environments, whether that’s through ethnographic studies, diary entries, or in-depth interviews. This context enriches your understanding, making the data collected far more meaningful and actionable.

So, let’s sum it up. What happens when you take the time to listen to someone, actively try to cater to their needs and even get to learn the unspoken truths about them through observation or reading between the lines?

Exactly: people will want to stay close to people and brands who make them feel heard and understood.

By deeply understanding their needs, preferences, and the nuances of their experiences with your brand — and acting on this knowledge — you set the stage for increased customer loyalty and reduced churn.

And it’s not ‘just’ some form of emotional attachment, it also simply boils down to something practical: When your products and services are sculpted with the rich insights gained from qualitative research, they align more closely with what your customers actually want and need — so why would they leave?

We couldn’t call ourselves lovers of research and not provide some balance to this list.

Of course conducting qualitative research isn’t just big benefits and amazing insights. Here are some challenges you’ll face through your qualitative market research, and how to overcome them:

• Bias and subjectivity can sneak in . When you’re dealing with open-ended responses, it’s easy to read too much into them based on your own perspectives and assumptions. Mix up your research team to bring different viewpoints to the table and use structured ways to look at the data. Tools that help with data analysis can also keep things more objective.
• Getting the right people to talk to can be tough . Finding participants that perfectly match your target audience is easier said than done, and that doesn’t even include convincing them to participate. Use a tool that takes care of this for you, so you can focus on the questions and answers.
• Qualitative research often involves fewer participants. This might leave you wondering if what you’re hearing reflects the bigger picture. Blend in some quantitative data to round out the picture. Platforms like Attest make it easy to combine both qualitative and quantitative insights.
• So much data, so little time . Sifting through all the feedback can feel overwhelming. Not just because of the amounts, but also because you’re not sure whether you’re processing it right. Luckily, there are qualitative data analysis tools out there that can help you sort, organize, and make sense of all the information.

We’re not saying Attest is the answer to everything, but it is for a lot of issues. Check out our rundown of how different market research tools work to see whether or not we are right for each other.  

How to ace a new client pitch with qual

Qual research helped retail experience agency Barrows understand glasses wearers’ pain points and wow a prospective client. Read on for the full case study.

It’s clear that qualitative market research is the best way to hit the jackpot, particularly for product development and data-driven decision-making.

Getting genuine, unscripted insights can steer your product development in directions you might not have considered before.

And the ultimate market research toolkit will include insights from both qualitative and quantitative research. Blending the two will make sure you have a comprehensive understanding of your target customers.

What is qualitative market research?

Qualitative market research is about understanding your customers’ perspectives through their own words. Qualitative research methods involve collecting non-numerical data like opinions, experiences, and motivations through methods such as videos, interviews and focus groups. This approach helps you grasp the why behind customer behaviors.

Through methods like interviews, focus groups, and observation, you get to hear the stories, understand the emotions, and uncover the motivations that drive consumer behavior. It’s a way to collect valuable, in-depth insights that numerical data (quantitative research) and other research methods can’t provide, helping you grasp not just what your customers are doing but why they’re doing it.

Why is qualitative market research important?

Qualitative marketing research is crucial because it offers insights into your customers’ minds that you can’t get from numbers alone. It’s crucial because it gives you a clearer picture of consumer behavior, beyond what can be measured in surveys or captured in quantitative data.

Understanding the nuances of how people feel about your product, brand, or service allows for more tailored and effective decision-making. Whether you’re refining your marketing messages or developing new products, conducting qualitative market research helps your strategies resonate deeply with your target audience.

What are the benefits of qualitative market research?

Qualitative research shines when it comes to uncovering the rich, complex fabric of consumer opinions and experiences. It’s a powerhouse for generating valuable insights that inform data-driven marketing and brand campaigns.

By engaging directly with consumers, you gain a nuanced understanding of their needs and preferences, which is gold for guiding product development and enhancing user experiences. Additionally, this approach’s flexibility makes it easier to adapt to market changes, stay ahead of trends, and identify unmet needs that can spark innovation.

Moreover, it can significantly reduce customer churn by ensuring your offerings align closely with what your customers truly value.

What challenges do market researchers face with qualitative methods, and how can they be overcome?

One of the biggest challenges is ensuring the reliability and objectivity of the data collected, as personal biases from both researchers and participants can skew results.

Overcoming this requires a careful research design, a clear and structured research process, and, when possible, triangulation of data from multiple sources to validate findings. Another challenge is the time and resources required for data collection and analysis, which can be mitigated by using technology like online focus groups or qualitative analysis software.

These tools not only streamline the research process but also expand the reach of your research, allowing you to conduct studies across diverse demographics and geographical locations more efficiently.

What are some common methods of conducting qualitative market research?

Qualitative market research can take many forms, from one-on-one interviews that offer deep dives into individual consumer experiences to video interviews and focus groups that provide a broad spectrum of opinions and dynamics.

Other methods include ethnographic research, where researchers observe consumers in their natural environments, and content analysis, where the focus is on analyzing communication patterns and content. Each method serves different research objectives, from developing new products to understanding consumer behavior and gathering data that informs every aspect of your marketing efforts.

Customer Research Manager 

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With regard to the information collection: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] .

On May 23, 2022, FDA issued a proposed rule to amend requirements concerning CGMP, postmarketing safety reporting, and labeling that apply to certain medical gases, and to establish regulations regarding certification of designated medical gases ( 87 FR 31302 ). This rule satisfies the requirement in section 756 of the Consolidated Appropriations Act, 2017 ( Pub. L. 115-31 ) that FDA issue final regulations revising the Federal drug regulations with respect to medical gases by July 15, 2017.

By tailoring certain labeling, CGMP, certification, and postmarketing safety reporting requirements more narrowly to medical gases, FDA intends to better address the unique characteristics of medical gases. Specifically, the final rule is intended to provide clarity and consistency regarding how information is presented in the labeling of certain medical gases, as well as to ensure important safety information is included. The CGMP requirements in this final rule are intended to reflect appropriate requirements for the manufacturing, processing, packing, and holding of such products. The certification requirements in this final rule implement and clarify the certification process for designated medical gases described in section 576 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ( 21 U.S.C. 360ddd-1 ). Lastly, the new postmarketing safety reporting regulations for designated medical gases address human and animal use and better reflect the development, manufacturing, and distribution of designated medical gases. Independently and collectively, FDA anticipates that these four categories of regulatory changes will promote greater efficiency in the regulation of medical gases while helping to ensure that they adhere to all applicable safety and quality standards.

Following consideration of comments received and further internal deliberation, we are finalizing this rule as described in this document.

We received fewer than 25 comments on the proposed rule. The most detailed comments were from industry trade associations and consultants. The other comments were from individuals. Comments addressed many of the labeling, CGMP, certification, and safety reporting provisions, as well as general considerations, including general support, definitions, timing of the rule, and the effective date.

The remainder of this subsection includes a brief description of the four major provisions of this rule.

This rule includes several changes to FDA's drug labeling regulations, including the addition of certain operations required to produce a medical gas to the list of operations that are performed by its manufacturer. We are revising the requirements for stating the ingredients in the labeling of a designated medical gas or medically appropriate combination of designated medical gases (referred to hereafter in this preamble as “medically appropriate combination”). [ 1 ] We also specify Start Printed Page 51739 requirements for the declaration of net quantity of contents in the labeling of designated medical gases and medically appropriate combinations.

We are requiring that all designated medical gases—whether certified for human use, animal use, or both—and medically appropriate combinations bear labeling that is in a standardized format.

FDA is revising the requirements for warning statements for certain medical gases including that the labeling of medical air and carbon monoxide bear certain warning statements. We are including different labeling requirements for final use containers and bulk or transport containers. We also are requiring a new oxygen warning statement and graphic warning symbol to alert users of the risks of smoking, vaping, and open flames near an oxygen container.

FDA is revising the medical gas container labeling regulations to clarify that the owner of a designated medical gas container or a container of a medically appropriate combination can be mentioned on the container to facilitate return of the container to the owner, and to ensure that product quality issues are directed to the appropriate entity. This rule also includes clarifying revisions to the definition of “portable cryogenic medical gas container” for purposes of FDA's labeling regulations.

FDA is issuing new CGMP regulations specific to medical gases. These regulations include many of the same categories of provisions as the general drug CGMP regulations but reflect differences in how medical gases are manufactured, processed, packed, and held. These regulations represent the minimum CGMP for medical gases. Of note, we include different cleaning requirements for medical gases because these gases are generally manufactured in a sealed, closed system, and because cleaning at inappropriate times can introduce contaminants.

FDA is including requirements for medical gas containers and closures that are similar to the general drug CGMP regulations, with an additional requirement that portable cryogenic medical gas containers and small cryogenic gas containers for use by individual patients have a working gauge to assist the user in determining whether the container contains an adequate supply of medical gas for continued use (minor revisions were made to the version of this provision in the proposed rule). This will help users determine when a container must be refilled or replaced and when a leaking or venting container is empty. We are not including time limitations on production because medical gases are generally not expected to expire or degrade. Additionally, unlike the salvaging requirements under the general drug CGMP regulations, medical gases that have been stored improperly may be salvaged unless their containers have been subjected to adverse conditions that negatively impact the identity, strength, quality, or purity of the product or the integrity of the product's container closure.

FDA is issuing new regulations regarding the certification process for designated medical gases that are intended to codify the certification process and provide additional clarity where necessary. These requirements govern the process for applicants to file a certification request and supplements as well as the contents of such a request. The regulations also set forth requirements concerning the transfer of ownership of a certification from one entity to another.

We are requiring the submission of a streamlined annual report, to include certain required contents and submission timing. Changes to the proposed rule include requiring submission on a calendar year basis, rather than based on the anniversary of the date the certification request was deemed granted, and clarifying revisions to the list of facilities to be included in the annual report.

These regulations set forth requirements that are similar to the recommendations described in the November 2015 draft guidance for industry “Certification Process for Designated Medical Gases” (November 25, 2015, 80 FR 73771 ) (Ref. 1).

FDA is issuing new postmarketing quality and safety reporting requirements for designated medical gases.

We are including requirements for submitting field alert reports (FARs), including revised submission timelines to allow applicants time to compile sufficient information to complete their FAR.

We are including adverse event reporting requirements related to the use of designated medical gases in humans and animals. For designated medical gases that are certified for human use and deemed to have in effect an approved application under section 505 of the FD&C Act ( 21 U.S.C. 355 ), we are requiring that applicants and nonapplicants report serious adverse events within 15 calendar days from when the applicant or nonapplicant has met certain reporting criteria and acquired certain minimum data.

We are issuing requirements for the contents and format of submissions, including an electronic submission requirement, the process for requesting a waiver of the electronic submission requirement, recordkeeping requirements, written procedures requirements, and patient privacy provisions.

For designated medical gases that are certified for animal use and deemed to have in effect an approved application under section 512 of the FD&C Act ( 21 U.S.C. 360b ), we are requiring that applicants and nonapplicants submit serious adverse event reports to FDA within 15 calendar days from when the applicant or nonapplicant has met certain reporting criteria and that recordkeeping requirements related to adverse events are maintained.

Sections 501, 502, 505, 512, 575, 576, and 704 of the FD&C Act ( 21 U.S.C. 351 , 352 , 355 , 360b , 360ddd , 360ddd-1 , and 374 ), in conjunction with our general rulemaking authority in section 701(a) of the FD&C Act ( 21 U.S.C. 371(a) ), serve as our principal legal authority for this final rule.

This final rule establishes CGMP regulations specific to medical gases. These regulations include many of the same categories of requirements as the general drug product CGMP regulations but are tailored to reflect differences in how medical gases are manufactured, packaged, labeled, stored, and distributed. We quantify benefits to industry from removing CGMP requirements that would not apply to medical gases, such as removing certain building and facility requirements, including more limited equipment maintenance and cleaning requirements, and codifying some existing practices, which may streamline inspections. Additional benefits will include a potentially small reduction in fires from Start Printed Page 51740 graphic warning labels on oxygen containers, and clarification that adverse events generally are not required to be submitted for reports of the death of a patient or animal who was administered oxygen, nor when fires associated with the administration of oxygen occur but do not include an adverse event experienced by the patient or animal.

We quantify costs to industry from new labeling requirements, regulatory clarification leading to firms becoming compliant with existing requirements, and added CGMP requirements including a requirement for portable cryogenic containers to have a working gauge. Additional costs will include maintaining resumes for consultants, and potential cost of relabeling medical air containers. We estimate that the annualized benefits over 10 years will range from $0.00 million to $7.02 million at a 7 percent discount rate, with a primary estimate of $3.51 million, and from $0.00 million to $7.43 million at a 3 percent discount rate, with a primary estimate of $3.72 million. The annualized costs will range from $1.52 million to $5.30 million at a 7 percent discount rate, with a primary estimate of $3.24 million, and from $1.36 million to $5.11 million at a 3 percent discount rate, with a primary estimate of $3.07 million.

Medical gases have historically been manufactured, labeled, and distributed in a manner different than most other drugs. Under section 576 of the FD&C Act, the process for obtaining marketing authorization for a designated medical gas also differs from the process for obtaining marketing authorization for other human and animal drugs. Moreover, because of these differences, FDA believes that the likelihood of identifying new safety issues for medical gases is low. Thus, some existing regulations are not well-tailored to addressing designated medical gases and other medical gases. FDA undertook this rulemaking to address these differences, and to decrease regulatory burden where appropriate. On May 23, 2022, FDA issued a proposed rule to amend requirements concerning CGMP, postmarketing safety reporting, and labeling that apply to certain medical gases, and to establish regulations regarding certification of designated medical gases.

Although we believe that these four categories of regulatory changes will best help to address the unique characteristics of medical gases when implemented collectively, each provision independently improves the clarity of the regulations and requirements applicable to medical gases. In the event of a stay or invalidation of any major provision(s), those that remain in effect would continue to function sensibly  [ 2 ] to advance the statutory requirements applicable to medical gases and provide useful, clear standards for firms to meet their existing statutory obligations. For example, invalidation of the major provisions related to certification of a designated medical gas would have no effect on those addressing CGMP for medical gases. Likewise, in the absence of new provisions specific to postmarketing safety reporting for medical gases, each of the other major provisions would continue to contribute to greater clarity and efficiency for the medical gas industry, while helping to maintain a high standard of safety and quality. Finally, because medical gases have historically been regulated as drugs rather than as a specialized subset thereof, were any major provision in this regulation invalidated, medical gases would continue to be regulated under the existing general regulatory regime corresponding to that provision ( e.g., if medical gas CGMP requirements are invalidated, medical gases would remain subject to the general drug CGMP requirements in parts 210 and 211 ( 21 CFR parts 210 and 211 )). Therefore, it is FDA's intent to preserve each of the rule's four major provisions to the fullest possible extent, to help address the unique aspects of medical gases that set them apart from most other drugs.

We received fewer than 25 comments on the proposed rule. The most detailed comments were from industry trade associations and consultants. The other comments were from individuals. Comments covered many aspects of the proposed rule, including:

• General considerations, including general support, definitions, timing of the rule, and the effective date;
• Labeling requirements, including labeling statements and the applicability of labeling provisions to different types of containers; Start Printed Page 51741
• CGMP requirements, including buildings and facilities, equipment, control of incoming products, packaging and labeling control, holding and distribution, laboratory controls, records, and returned medical gases;
• Certification requirements, including annual reporting, withdrawal, and the applicability of current requirements in part 314 ( 21 CFR part 314 ); and
• Postmarketing quality and safety reporting requirements, including submitting FARs, reporting of individual case safety reports (ICSRs) related to human use, and reporting of adverse events related to animal use.

We are issuing this final rule under sections 501, 502, 505, 512, 575, 576, 701, and 704 of the FD&C Act. Medical gases are generally regulated as prescription drugs under sections 201(g)(1) and 503(b)(1) of the FD&C Act ( 21 U.S.C. 321(g)(1) and 353(b)(1) ) (although oxygen may be provided without a prescription for certain uses specified at section 576(b)(2) of the FD&C Act).

Section 501 of the FD&C Act describes the circumstances under which a drug is deemed to be adulterated. Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice. For purposes of section 501(a)(2)(B), “current good manufacturing practice” includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

Section 502 of the FD&C Act describes the circumstances under which a drug is deemed to be misbranded. Under section 502(f) of the FD&C Act, a drug is deemed to be misbranded unless its labeling bears adequate directions for use and such adequate warnings against use where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration, in such manner and form, as are necessary for the protection of users. Under section 704 of the FD&C Act, FDA is authorized to inspect, among other things, records in any establishment in which prescription drugs or nonprescription drugs intended for human use are manufactured, processed, packed, or held bearing on whether such products are in violation of the FD&C Act.

Section 576 of the FD&C Act describes the certification process for designated medical gases (as defined in section 575 of the FD&C Act) and the effect of certification, the applicability of FDA's prescription requirements, and certain labeling requirements. Under section 576(a)(3)(A)(i) of the FD&C Act, a certified designated medical gas is subject to all applicable postapproval requirements. Under section 505(k) of the FD&C Act, FDA has the authority to establish certain postmarketing safety reporting regulations for human drugs to enable FDA to determine or facilitate a determination as to whether there are or may be grounds to invoke section 505(e) of the FD&C Act, which concerns the withdrawal or suspension of approval of a new drug application (NDA) or abbreviated new drug application (ANDA). Section 512(l) of the FD&C Act authorizes FDA to establish postmarketing safety reporting regulations for new animal drugs to enable FDA to determine or facilitate a determination as to whether there are or may be grounds to withdraw approval of an application pursuant to section 512(e) or 512(m)(4) of the FD&C Act.

Thus, sections 501, 502, 505, 512, 575, 576, and 704 of the FD&C Act, in conjunction with our general authority in section 701(a) of the FD&C Act to issue regulations for the efficient enforcement of the FD&C Act, serve as our principal legal authority for this final rule.

We received fewer than 25 comment letters on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. We received comments from individuals, trade organizations, and industry consultants.

We describe and respond to the comments in sections V.B. through V.G. of this document. We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.

Additionally, on its own initiative, FDA is making minor technical and grammatical changes to the rule to improve clarity.

(Comment 1) Some comments make general remarks supporting the proposed rule without focusing on a particular proposed provision. One comment also notes that the COVID-19 pandemic highlighted the need for updated medical gas regulations.

(Response 1) We appreciate these comments of support and agree that this rulemaking is needed.

(Comment 2) One comment encourages FDA to publish this rule widely to ensure that all affected entities access it.

(Response 2) FDA is publishing this final rule publicly consistent with requirements under the Administrative Procedure Act and Agency practice. We believe this sufficiently addresses the need to make regulatory changes widely accessible to the public.

(Comment 3) One comment discusses when to publish the final rule, urging FDA to issue the final rule swiftly.

(Response 3) FDA acknowledges the public interest in finalizing this rule promptly. The Agency works within its defined processes to draft, clear, and issue regulations. During the rulemaking process, FDA published in the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) its estimated timeline for completion of the final rule.

FDA proposed changes to part 4, subpart A ( 21 CFR part 4, subpart A ) to reflect the new CGMP requirements for medical gases proposed in part 213 ( 21 CFR part 213 ). FDA proposed definitions of “medical gas” and “medical gas CGMPs” in § 4.2, and conforming changes to account for combination products that contain a medical gas in § 4.3. FDA also proposed in § 4.4 conforming changes to account for combination products that contain a medical gas, as well as a list of CGMP provisions from part 213 that must be satisfied if the CGMP operating system for a combination product containing a medical gas has been shown to comply with the device quality system regulations. We received one comment on these provisions, which we discuss below.

(Comment 4) One comment notes that some manufacturers of designated medical gases will not know whether their product will ultimately be used as Start Printed Page 51742 a drug constituent part of a combination product. As such, the comment asks whether such designated medical gases are subject to the CGMP regulations in part 4.

(Response 4) In the example in the comment, if the entities are manufacturing only the gas, they would not be subject to the CGMP regulations in part 4, which only apply to combination product manufacturers (§ 4.1). Such original manufacturers of designated medical gases only have to comply with part 213. However, for example, a third party manufacturing a combination product that includes such a designated medical gas would be subject to these part 4 CGMP requirements.

FDA proposed to revise § 16.1(b)(2) ( 21 CFR 16.1(b)(2) ) to broaden the scope of regulatory hearings to include hearings relating to revocation of a grant of a certification for a designated medical gas. We did not receive comments on the proposed revision and are finalizing the provision as proposed with minor technical changes made on our own initiative.

(Comment 5) One comment makes general remarks supporting the proposed revisions to the labeling regulations in part 201 ( 21 CFR part 201 ) without focusing on a particular proposed provision.

(Response 5) We appreciate this comment of support.

FDA proposed revisions to the “manufacturer” definition in § 201.1(b), adding proposed paragraph (11) to address medical gas manufacturing activities for purposes of part 201 and section 502(a) and (b)(1) of the FD&C Act. We proposed to specify that, with respect to a medical gas, the manufacturer is the person fabricating the gas by chemical reaction, physical separation, compression of atmospheric air, purification ( e.g., reprocessing an industrial gas into a medical gas), by combining two or more distinct medical gases, or by other process.

(Comment 6) One comment recommends that FDA remove the catchall “other processes” and include filling a medical gas container in the list of manufacturing operations. The comment expresses that this change would capture operations performed post-fabrication.

(Response 6) FDA does not agree with this recommendation. The operations listed in § 201.1(b)(11) focus on methods of “fabricating the gas,” rather than downstream processes. While certain downstream processes will be subject to the CGMP requirements in part 213 when in effect, the purpose of § 201.1(b) is to capture the primary activities conducted to initially produce a drug product.

Although FDA did not propose revisions to § 201.100, the Agency received comments proposing revisions to the current text.

(Comment 7) One comment proposes a new § 201.100(a)(1)(iv) to specify that a designated medical gas used to clean or purge medical gas containers, including medical gas pipelines, is exempt from the requirement in section 502(f)(1) of the FD&C Act that its labeling bear adequate directions for use. The comment adds that this would allow individuals to obtain designated medical gases for such use (for example, nitrogen for purging medical pipelines).

(Response 7) FDA does not agree with this comment. Revisions to § 201.100(a)(1) are not necessary because gases used for the purposes described in the comment do not meet the definition of a drug under section 201(g)(1) of the FD&C Act. Therefore FDA's drug labeling requirements, including the requirement to bear adequate directions for use, would not apply to a gas intended only for these uses.

(Comment 8) One comment proposes revisions to § 201.100(b) exempting designated medical gases in compliance with § 201.161 from the labeling requirements in § 201.100(b) because § 201.161 as revised by this rulemaking includes specific requirements for designated medical gas labeling.

(Response 8) FDA does not believe these revisions are needed. The purpose of § 201.100 is to exempt prescription drugs from the requirements in section 502(f)(1) of the FD&C Act if certain requirements are met. For designated medical gases, section 576(a)(3)(A)(ii) of the FD&C Act already addresses this requirement by stating that, for such gases, the requirements of sections 503(b)(4) and 502(f) of the FD&C Act are deemed to have been met for a designated medical gas if the labeling on its final use container bears the information required by section 503(b)(4), a warning statement concerning the use of the medical gas (as determined by the Secretary by regulation), and appropriate directions and warnings concerning storage and handling.

The revisions to § 201.161 in this rulemaking further satisfy this requirement, as sections 503(b)(4) and 502(f) of the FD&C Act are deemed to have been met for a designated medical gas if the final use container bears the information required in § 201.161(a).

FDA proposed several changes to the medical gas labeling requirements in § 201.161. We proposed moving the warning statement requirements for oxygen in § 201.161(a)(1)(i) to § 201.161(a)(1), without proposing any changes to the requirements. We also proposed moving the warning statement requirements for nitrogen, carbon dioxide, helium, nitrous oxide, and medically appropriate combinations of oxygen, nitrogen, carbon dioxide, helium, and nitrous oxide in § 201.161(a)(1)(ii) to § 201.161(a)(2) and proposed expanding their scope to all designated medical gases other than oxygen as well as medically appropriate combinations of any medical gases. We also proposed adding a requirement that the final use container bears the symbol “Rx only.” In proposed § 201.161(a)(3), we proposed requiring that the final use container bears appropriate directions and warnings concerning storage and handling.

In proposed § 201.161(b), we proposed requirements that a designated medical gas or medically appropriate combination of designated medical gases in a bulk or transport container be identified with the name of the product contained therein and accompanied by documentation identifying the product as meeting applicable compendial standards.

Lastly, proposed § 201.161(c) included several definitions. We received no comments on the proposed definitions of “designated medical gas” (proposed § 201.161(c)(1)) or “bulk or transport container” (proposed § 201.161(c)(3)) and are finalizing these definitions as proposed with minor technical changes made on our own initiative. We proposed to define “final use container” as a container that is for direct use or access by a patient or healthcare provider to administer a designated medical gas or medically appropriate combination of designated medical gases, not including bulk or transport containers or containers that are described in §  868.5655 ( 21 CFR 868.5655 ).

We respond to the comments on proposed § 201.161 in the following paragraphs. Start Printed Page 51743

(Comment 9) One comment recommends that the oxygen warning statement in proposed § 201.161(a)(1)(i) include additional instances in which oxygen may be provided without a prescription aside from depressurization or environmental oxygen deficiency, or emergency resuscitation. As an example of such an additional use, the comment suggests the emergency use of oxygen for hyperbaric oxygen therapy for decompression sickness.

(Response 9) FDA disagrees. The uses described in § 201.161(a)(1)(i) of the proposed rule are consistent with the circumstances described in section 576(b)(2)(A) of the FD&C Act under which oxygen may be provided without a prescription. FDA does not believe it would be appropriate to include additional uses in this provision.

(Comment 10) Regarding FDA's proposed requirement in § 201.161(a)(1)(ii) that final use containers bear a “No Smoking” and “No Vaping” warning statement and a graphic symbol conveying that smoking, vaping, and open flames near oxygen are dangerous, one comment notes that industry may need time to develop graphic symbols and text.

(Response 10) FDA recognizes the concerns expressed in this comment, and we note, as stated in section VI of this document, that firms will have 18 months to develop the required warning statement and graphic symbol. The Agency is happy to discuss the matter further with industry as firms develop graphics to address this requirement.

(Comment 11) One comment proposes adding a new § 201.161(a)(1)(iii) to state that, if oxygen is provided as a designated medical gas in the form of a cryogenic liquid in a cryogenic final use container meeting the definition of a device, the warning statements in § 201.161 are not required. The comment conditions this on the device label providing adequate directions for use in accordance with the device approval. The comment notes that this would reflect the current labeling appearing on home oxygen units.

(Response 11) FDA does not agree that this revision is needed. The definition of “final use container” in § 201.161(c)(2) already makes clear that the term does not include containers meeting the definition of a medical device and classified under § 868.5655. As devices, these containers have separate labeling requirements. Therefore, further clarification in § 201.161 is not necessary.

(Comment 12) In response to FDA's request for feedback regarding the inclusion in § 201.161(a)(2) of medical air in the proposed labeling requirements for designated medical gases other than oxygen and medically appropriate combinations of designated medical gases, one comment responds that they do not oppose this.

(Response 12) FDA appreciates the feedback on this request.

(Comment 13) One comment requests that FDA add language to § 201.161(a)(2) explaining that the required statements in § 201.161 are not required for cryogenic nitrogen in an open top dewar. The comment notes that certain uses of cryogenic nitrogen, such as dermatological use, are device uses rather than drug uses.

(Response 13) While FDA agrees that cryogenic nitrogen being used for certain dermatological purposes is a device use, and therefore not subject to § 201.161, the Agency declines to add the requested language. As revised by this rule, § 201.161(a) states that section 503(b)(4) of the FD&C Act, which only applies to drugs, is deemed to have been met if a designated medical gas is in compliance with § 201.161(a). Therefore, it is clear that the requirements in § 201.161 only apply to medical gases that are drugs, and that if a gas is a device, it is subject to applicable device labeling requirements. This position is consistent with FDA's draft guidance for industry entitled “Certification Process for Designated Medical Gases”  [ 3 ] (Ref. 1).

(Comment 14) One comment requests that FDA revise § 201.161(b) to require that a designated medical gas or medically appropriate combination of designated medical gases in a bulk or transport container must be “provided with” documentation identifying the product as meeting applicable compendial standards, rather than “accompanied by” such documentation. This comment is intended to allow for current industry practices of electronic delivery of such documentation.

(Response 14) FDA believes that this change is unnecessary. Information promptly transmitted electronically would be considered to accompany a drug. Therefore, revisions are not necessary to address the concern expressed in this comment.

(Comment 15) One comment recommends that the definition of “final use container” in § 201.161(c)(2) be revised to mean a container that is “labeled” for direct use, rather than a container that is “for” direct use. The comment notes that the proposed definition of “bulk or transport container” includes cylinders that are connected to a medical gas supply system, such as a hospital's oxygen system. However, the comment asserts that cylinder banks may contain individual labeled cylinders.

(Response 15) FDA disagrees with the proposed revision. First, specifying that a container is a final use container if it is “labeled” for direct use would be circular, and a firm could avoid being regulated as a final use container simply by not labeling its containers accordingly. Second, FDA believes that the purpose of the container should determine the appropriate labeling. If the container is intended to be used as a final use container, it must be labeled in compliance with § 201.161(a), and if a container is intended to be used as a bulk or transport container, it must be labeled in compliance with § 201.161(b).

FDA proposed changes to § 201.328(a)(1) to reference § 213.94(e)(3) instead of § 211.94(e)(2). We also proposed to add § 201.328(d) to clarify that a container filled with a designated medical gas or medically appropriate combination of designated medical gases may bear a statement identifying the name of the owner of the container or the address to which the container should be returned after use, noting that this statement may appear on a separate sticker or decal. We further proposed that if the owner of the container is not the manufacturer, packer, or distributor of the designated medical gas or medically appropriate combination of designated medical gases, that shall be clearly stated on the container. Proposed § 201.328(d) further notes that the addition of such statement shall not cause the owner of the cylinder to be a “relabeler” for purposes of FDA's registration and listing requirements.

(Comment 16) Although FDA did not propose changes to the definition of “portable cryogenic medical gas container” in § 201.328(a), one comment did suggest changes. This provision refers to a container that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, health care entity, nursing home, other facility, or home health care setting, or is a base unit used to fill small cryogenic gas containers for use by individual patients. The term does not include cryogenic containers that are not designed to be connected to a medical gas supply system, including portable liquid oxygen units as defined in § 868.5655. First, the comment requests to remove the term “base unit” Start Printed Page 51744 because the term is commonly used to refer to the device maintained at a patient's home that is filled with oxygen. The comment notes that these containers are not typically moved. Second, the comment suggests removing “small” before “cryogenic gas containers” in the exclusionary language, as well as including language clarifying that cryogenic gas containers utilize proprietary connections. Third, the comment suggests removing from the exclusionary language the reference to devices defined in § 868.5655.

(Response 16) FDA agrees that the term “base unit” should be removed from the definition. Because there may be confusion over what a “base unit” includes, we believe it is more appropriate to focus on the purpose of the container. As such, we are revising the definition to include, among other things, a container that “is used to fill small cryogenic gas containers for use by individual patients.”

However, we disagree with the other requested changes. Because portable cryogenic medical gas containers can be in patients' homes, we believe that it is critical that they include proper labeling. Removing “small” before “cryogenic gas containers” would unnecessarily expand the exclusionary language and limit the scope of products subject to the labeling requirements described in part 201. We also do not believe adding the qualifier that cryogenic gas containers utilize proprietary connections to the exclusionary language is appropriate, as it is not clear why the exclusion should depend on the type of connections used. We also note that these requested revisions are not consistent with similar revisions proposed for § 213.94(e)(1) (concerning requirements for medical gas containers and closures) (see response 30).

We do not believe it is appropriate to remove the reference to § 868.5655 from the exclusionary language. It is unclear why the comment suggests removing this language while also noting that base units are considered devices; if the reference to § 868.5655 were removed from the exclusionary language, the definition might arguably be read to consider such devices to be portable cryogenic medical gas containers subject to the wraparound labeling requirement. This distinction between containers that are devices, and those that are not, is important, and FDA believes that the definition as revised makes clear which containers are devices subject to applicable device requirements, and which are portable cryogenic medical gas containers subject to applicable drug requirements.

Lastly, we are revising “does not include” to “exclude,” consistent with the revisions discussed in response 31 below. As finalized, the term “portable cryogenic medical gas containers” excludes cryogenic containers that are not designed to be connected to a medical gas supply system.

(Comment 17) One comment requests that § 201.328(d) be revised to clarify that, if information identifying the name of the owner of the container or the address to which the container should be returned after use appears on a separate sticker or decal, such sticker or decal should not cover up other language on the label.

(Response 17) FDA appreciates the concern that labeling information should be clearly displayed and not covered up, but the Agency does not believe the proposed revisions are necessary because other provisions address this issue. In particular, section 502(c) of the FD&C Act states that a drug shall be misbranded if any word, statement, or other information required by or under authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Additionally, § 201.15(a)(6) of FDA's labeling regulations makes clear that “obscuring designs or vignettes” may cause required information to lack the prominence and conspicuousness required by section 502(c) of the FD&C Act.

FDA proposed conforming edits to the general provisions concerning drug CGMP requirements in part 210 to reflect the proposed establishment of medical gas CGMP requirements in part 213. We did not receive comments on the proposed revisions and are finalizing the provisions as proposed with minor technical changes made on our own initiative.

FDA proposed conforming edits to the drug CGMP requirements in part 211 to reflect that medical gases would no longer be subject to this part. We did not receive comments on the proposed revisions and are finalizing the provisions as proposed.

(Comment 18) Some comments make general remarks supporting the proposed CGMP regulations without focusing on a particular proposed provision.

(Response 18) We appreciate these comments of support.

FDA proposed definitions of several terms used in part 213. We received comments on several of those proposed definitions, as discussed below. We are finalizing as proposed (with minor technical and grammatical changes made on our own initiative) those definitions for which we received no comments.

We proposed to define “acceptance criteria” as the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).

(Comment 19) One comment requests that the “acceptance criteria” definition in proposed § 213.3(b)(1) be consistent not only with the acceptance criteria definition in part 210, but also the corresponding definitions in other regulations and guidance. For example, the comment notes that the “acceptance criteria” definition in part 212 ( 21 CFR part 212 ) concerning positron emission tomography (PET) drugs differs from the proposed definition for medical gases.

(Response 19) FDA does not believe that revisions are necessary. The proposed “acceptance criteria” definition in § 213.3(b)(1) is identical to the current “acceptance criteria” definition in § 210.3(b)(20), and FDA further believes that it is generally consistent with the “acceptance criteria” definition in § 212.1. In any case, PET drugs are outside the scope of this rulemaking, as FDA did not propose any revisions to part 212 in the proposed rule.

We proposed to define “batch” as a specific quantity of a medical gas or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

(Comment 20) One comment suggests that batches, as defined in proposed § 213.3(b)(2), and lot numbers, as defined in § 213.3(b)(10), be defined per day. The comment argues that this Start Printed Page 51745 would provide sufficient information for downstream tracking and reporting.

(Response 20) FDA disagrees. As discussed in the proposed rule, we believe the proposed “batch” definition allows for significant flexibility in defining a batch to address considerations raised by different types of firms and different manufacturing, processing, packing, and holding activities ( 87 FR 31302 at 31310). We do not believe the term should restrict batches to a quantity produced in a single day. As such, we also do not believe that any revisions to the definition in § 213.3(b)(10) for “lot number, control number, or batch number” are necessary.

We proposed to define “commingling or commingled” as the act of combining one lot of designated medical gas or component with another lot or lots of the same designated medical gas or component.

(Comment 21) One comment concurs with the definition of “commingling or commingled” in proposed § 213.3(b)(3), but notes that, in the event lots are combined, firms should maintain tracking information at the container level to record which lots are included in the combined product and when they were added.

(Response 21) We believe that the tracking requirements established in this final rule sufficiently address any risks associated with the receipt of gases from multiple suppliers. Specifically, § 213.82 contains requirements for the receipt of incoming designated medical gases, including that either a signed certificate of analysis (COA) must accompany the gas or that the receiving firm must conduct full compendial testing (all tests necessary to ensure compliance with an official compendium), and that an identity test must be performed (see response 26 below for more information regarding revisions to § 213.82). Additionally, § 213.101(b) requires that in-process and final product containers of components and incoming designated medical gases shall identify the name of the component or designated medical gas or the name and percentage of each component or designated medical gas if they contain multiple components or designated medical gases, and the unique lot number assigned.

We proposed to define “original manufacturer” as the person or entity that initially produces a designated medical gas by chemical reaction, physical separation, compression of atmospheric air, purification ( e.g., re-processing an industrial gas into a medical gas), or other means.

(Comment 22) One comment suggests that the “original manufacturer” definition in § 213.3(b)(13) be revised to exclude processing agents such as nitrogen used in bottle purging and product overlay because these gases are not a part of the drug product and are not considered medical gases.

(Response 22) FDA does not believe that revisions are necessary to address this concern. We agree that gases used in the production of drugs that are not medical gases are not subject to part 213. Such gases may be subject to part 211 if the drug product is subject to those regulations depending on the use of the gas, but that is outside the scope of this rulemaking. We also note that, as discussed below in response 45, we do not believe it is necessary for the definition to include “or entity” because the word “person” captures all relevant entities. As such, we have revised the definition to remove “or entity.”

(Comment 23) One comment proposes adding a definition of “subsequent manufacturer” in § 213.3(b) to resolve regulatory uncertainty that may exist without distinguishing between subsequent manufacturers and original manufacturers.

(Response 23) FDA does not believe that this definition is necessary. We understand “subsequent manufacturer” to refer to a person that performs manufacturing operations after the initial production of a designated medical gas, such as transfilling and curbside filling. We agree that subsequent manufacturers that are not engaged in the activities described in § 213.3(b)(13) are not original manufacturers. However, the proposed rule preamble clarified what kinds of entities would not be considered an original manufacturer ( 87 FR 31302 at 31311). If a provision does not specify that it applies only to original manufacturers, then subsequent manufacturers subject to part 213 would need to comply as applicable. Moreover, part 213 does not use the term “subsequent manufacturer,” and the comment's proposed revisions would only use the term in the definition section.

FDA proposed to establish requirements for the design and construction features of buildings and facilities for the manufacture, processing, packing, or holding of medical gases (proposed § 213.42). We received one comment on these provisions, which we discuss below.

(Comment 24) One comment asks for clarification regarding what FDA considers to be “adequate space” in proposed § 213.42(a), which would require that buildings and facilities used in the manufacture, processing, packing, or holding of a medical gas be of adequate design, including adequate space, for the orderly placement of equipment and materials to prevent mix-ups and allow for adequate cleaning, maintenance, and proper operations. The comment asserts that the term is ambiguous and proper equipment, operations, and labeling should allow firms to mitigate the risk of mix-ups.

(Response 24) The use of the term “adequate space” is intended to allow for flexibility in designing a manufacturing facility that prevents mix-ups and allows for adequate cleaning, maintenance, and proper operations. We agree that there are not necessarily size restrictions and that using proper equipment and processes are key to ensuring that the space is appropriate for the operations. We do not believe that revisions to § 213.42(a) are necessary.

FDA proposed to establish several requirements concerning equipment used in the manufacture, processing, packing, or holding of medical gases (proposed §§ 213.63, 213.65, 213.67, and 213.68). We received no comments on proposed §§ 213.63, 213.65, and 213.67 and are finalizing them as proposed with a minor technical change made on our own initiative. We received comment only on proposed § 213.68(a), which specified that automatic, mechanical, and electronic equipment used in the manufacture of medical gases shall be routinely calibrated, inspected, and checked according to a written program designed to ensure proper performance, and that written procedures and records of calibration, inspections, and checks shall be maintained.

(Comment 25) One comment suggests that proposed § 213.68(a) be revised to include a minimum frequency for calibration, inspection, and checking of automatic, mechanical, and electronic equipment.

(Response 25) FDA does not believe it is necessary to include specific frequency requirements for such calibration, inspection, and checking of equipment. This is also consistent with § 211.68(a) and affords flexibility to Start Printed Page 51746 firms to take steps that will ensure proper performance based on the operations conducted and equipment used.

FDA proposed to establish several requirements concerning the control of incoming designated medical gas, components, and medical gas containers and closures (proposed §§ 213.80, 213.82, 213.84, 213.89, and 213.94). We received no comments on proposed §§ 213.80 and 213.89 and are finalizing them as proposed. We respond to the comments on proposed §§ 213.82, 213.84, and 213.94 below.

FDA proposed that, upon receipt of an incoming designated medical gas, the firm shall verify and record that a signed certificate of analysis from the supplier accompanies each different designated medical gas in a shipment, including the supplier's name; name of the incoming designated medical gas; lot number or other unique identification number; actual analytical result obtained for strength, as well as the results of other tests performed; identification of the test method(s) used for analysis; NDA or new animal drug application (NADA) number of the incoming designated medical gas; and the supplier representative's signature and the date of signature (proposed § 213.82(a)(1)). If the incoming designated medical gas is obtained from a supplier other than the original manufacturer, FDA proposed requiring the shipment to include complete information from the original manufacturer's COA, and that the firm establish and maintain a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures (proposed § 213.82(a)(2)). Lastly, FDA proposed requiring that an identity test be performed upon receipt (proposed § 213.82(b)).

(Comment 26) One comment asks that § 213.82(a)(1) be revised to allow receiving firms to conduct full compendial testing on the commingled product as an alternative to verifying that a COA accompanies the shipment. The comment maintains that this is consistent with industry practice.

(Response 26) FDA generally agrees with this comment. The Agency believes that both proposed approaches are appropriate for ensuring that each shipment of each incoming designated medical gas is verified as meeting relevant standards and is appropriate for use. However, FDA does not believe it is appropriate to specify that the full compendial testing be of the commingled product because testing of the gas before it is commingled would also confirm that it meets compendial standards. Further, § 213.82(a)(2) requires that, for incoming designated medical gas from a supplier other than the original manufacturer, each shipment shall also include complete information from the original manufacturer's COA. We are revising § 213.82(a)(1) accordingly to state that, upon receipt of each shipment of each incoming designated medical gas, the firm shall either perform full compendial testing on the gas and record the results, or verify and record that a signed COA from the supplier accompanies each different designated medical gas in a shipment.

(Comment 27) One comment requests that, instead of requiring that “a signed certificate of analysis from the supplier accompanies each different designated medical gas,” § 213.82(a)(1) should state that “a signed document from the supplier is provided for each different designated medical gas . . . .” The comment suggests additional edits, including that the document must identify the product as meeting compendial standards, that a COA may be used to satisfy these requirements, and that only if a COA is used would paragraphs (a)(1)(i) through (vii) apply.

(Response 27) FDA does not agree that the term “certificate of analysis” should be replaced with the term “document.” First, by retaining the term “certificate of analysis” after using the more general term “document,” the suggested revisions would create ambiguity concerning what requirements would apply to a “document” that is not a COA. Second, our intent is that the entity providing this documentation certify the information accompanying the shipment. Therefore, “document” is less clear than the term “certificate of analysis.” We similarly disagree with including a statement that a COA may be used to satisfy these requirements because FDA is already using that term to refer to the applicable documentation.

FDA disagrees with revising “accompanies” to read “is provided for.” In general, we believe the terms can be read similarly, and FDA generally intends to interpret “accompany” broadly enough to include prompt electronic transmission, as discussed above in response 14.

FDA does not agree that it is necessary to add that the COA identifies the product as meeting applicable compendial standards. This is already covered by § 213.82(a)(1)(ii), (iv), and (vii), which require that the COA identify the name of the designated medical gas, its analytical test results, and a signature from the supplier's representative. For example, a supplier of Oxygen, USP (United States Pharmacopeia) would be certifying that the gas meets compendial standards for Oxygen, USP by identifying the gas by its compendial name and including test results demonstrating that the gas meets applicable standards.

(Comment 28) One comment asks that FDA delete proposed § 213.82(a)(1)(vi) because the inclusion of NDA or NADA information does not provide support for the quality or traceability of the product in addition to the other information provided. The comment maintains that NDA or NADA information may not be accurate in the case of commingled or combined gases, or gases from subsequent manufacturers.

(Response 28) FDA disagrees with the requested deletion. The Agency's intent in § 213.82 is to ensure that adequate information accompanies incoming designated medical gases shipped from original manufacturers to downstream entities, not combined or commingled gases from one subsequent manufacturer to another. However, we recognize that there may be confusion regarding the proposed definition of “incoming designated medical gas.” Therefore, we are revising that definition in § 213.3(b)(8) to state that an “incoming designated medical gas” is a designated medical gas received from one source that, after receipt, is commingled with the same gas from another source, used in a medically appropriate combination of designated medical gases or in the production of another medical gas, or further distributed.

FDA proposed requirements for testing and approval or rejection of components, containers, and closures. Proposed § 213.84(a) included requirements either to examine components, containers, and closures prior to manufacturing or filling, or ensure that a statement of verification is provided from the supplier, provided that the firm establishes and maintains a program to ensure the reliability of the supplier's capabilities. Under proposed § 213.84(b), firms shall take appropriate actions to protect against container and closure leaks, including performing leak Start Printed Page 51747 tests on containers and closures at the time of fill and after fill but prior to release. Under proposed § 213.84(c), each component shall be sampled, tested, and approved or rejected as appropriate prior to use, either by performing testing for conformance with written specifications or by an identity test on the component accompanied by an acceptable COA from the supplier, provided that the firm establishes and maintains a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures.

(Comment 29) FDA specifically sought comments on the proposed requirement in § 213.84(b) that firms take appropriate actions to protect against container and closure leaks, including performing leak tests on containers and closures at the time of fill and after fill but prior to release. One comment maintains that FDA's proposed requirements would be sufficient. However, one comment asserts that leak testing upon pickup of a container would not be appropriate, both because of staffing and due to the varied timing at which the container is returned.

(Response 29) FDA appreciates this feedback and agrees that, unless an establishment is in receipt of a complaint or complaints of leaking or empty containers, the proposed language and associated testing described in § 213.84(b) is sufficient. Regarding the comment concerning leak testing upon pickup, FDA did not propose to require such testing, but rather noted in the preamble to the proposed rule that such testing may be needed to further protect against container and closure leaks to provide sufficient assurance of the durability of the container closure system throughout its period of use ( 87 FR 31302 at 31314). FDA does not believe that such testing will always be necessary, and other testing (or no additional testing) could be appropriate depending on the manufacturer's circumstances.

However, we continue to believe that leaking and empty container complaints is a serious concern, in light of the numerous instances of leaking and empty containers described in the proposed rule ( 87 FR 31302 at 31314) (see also Ref. 2). In several instances, firms did not appropriately evaluate the complaints in that the investigation conducted was inadequate, even when similar complaints were received, lacking steps such as evaluating the durability and suitability of containers and closures to identify a root cause. Therefore, we are adding to the complaint files provision at § 213.198(a) a requirement that all complaints involving leaking containers or closures be reviewed, evaluated, and investigated in accordance with § 213.192.

The level of effort, formality, and documentation of the investigation of complaints should be commensurate with the level of risk. For complaints of leaking and empty containers, an appropriate investigation should include a review of production and testing procedures and records, and will often include additional testing and actions, such as use of more sensitive leak testing methods and use of mechanisms that allow for identification of containers that are the subject of a complaint. Based on the result of the investigation, the firm must take appropriate corrective action under § 213.192 ( e.g., additional leak testing, removal of container or closure from circulation, addition of periodic leak testing to support container and closure durability). When there are no complaints of leaking or empty containers, we do not anticipate the need for additional leak testing. But in the event a firm becomes aware of repeated or trending leaks or empty containers, or other information indicating a production issue or container or closure issue that may result in leaking or empty containers, it is important that root causes are identified and corrective actions are taken that result in product and process improvements to ensure that the container closure system operates correctly, and that the gas will be available to the patient when needed.

FDA proposed that medical gas containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the gas beyond the official or established requirements (proposed § 213.94(a)). We also proposed to require that container closure systems provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the gas (proposed § 213.94(b)). Under proposed § 213.94(c), medical gas containers and closures shall be clean to assure that they are suitable for their intended use. Additionally, we proposed that standards or specifications, testing methods, and where indicated, cleaning methods shall be written and followed (proposed § 213.94(d)).

Proposed § 213.94(e) included revisions to the requirements in § 211.94(e), including new proposed requirements. Under proposed § 213.94(e)(1), portable cryogenic medical gas containers that are not manufactured with permanent gas use outlet connections ( e.g., those that have been silver-brazed) must have gas-specific use outlet connections that are attached to the valve body so that they cannot be readily removed or replaced (without making the valve inoperable and preventing the container's use) except by the manufacturer. FDA proposed to define “manufacturer” for purposes of §  213.94(e)(1) to include any individual or firm that fills high-pressure medical gas cylinders or cryogenic medical gas containers. FDA proposed to define “portable cryogenic medical gas container” for purposes of §  213.94(e)(1) as one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, healthcare entity, nursing home, other facility, or home healthcare setting, or is a base unit used to fill small cryogenic gas containers for use by individual patients. The term would not include cryogenic containers that are not designed to be connected to a medical gas supply system, e.g., tank trucks, trailers, rail cars, or small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined in §  868.5655).

Under proposed § 213.94(e)(2), portable cryogenic medical gas containers as defined in proposed §  213.94(e)(1) as well as small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined in §  868.5655) must have a working gauge sufficient to indicate whether the container has an adequate supply of medical gas for continued use.

Finally, proposed § 213.94(e)(3) required that the labeling specified at § 201.328(a) be affixed to the container in a manner that does not interfere with other labeling, and each label as well as materials used for coloring medical gas containers must be reasonably resistant to fading, durable when exposed to atmospheric conditions, and not readily soluble in water.

(Comment 30) Regarding the proposed requirements for gas-specific use outlet connections in § 213.94(e)(1), one comment recommends adding “home healthcare” before “base unit” in the definition of “portable cryogenic medical gas container.” The comment intends for this to clarify the term “base unit” and to achieve consistency with current safe practices.

(Response 30) FDA does not agree. As discussed above in response 16, although the proposed language for the Start Printed Page 51748 definition of “portable cryogenic medical gas container” in § 213.94(e)(1) is identical to the current definition in §§ 201.328(a) and 211.94(e)(1), different revisions were proposed for §§ 201.328(a) and 213.94(e)(1). Rather than adding “home healthcare” before “base unit,” FDA believes that it is most appropriate to remove “base unit” to focus on the purpose of the container.

(Comment 31) One comment recommends that the exclusionary language in the last sentence in § 213.94(e)(1) be revised such that “does not include” would be revised to “exclude” and that “not” would be removed before “designed.” The comment's requested revisions would read “[t]he term excludes cryogenic containers that are designed to be connected to a medical gas supply system . . . .” The comment asserts that these changes would remove the double negative and provide clarity.

(Response 31) FDA agrees that revising “does not include” to “exclude” is clearer and has made that change in the final rule. However, FDA does not agree with removing “not” before “designed,” as that revision would change the meaning of the sentence. The first revision is sufficient to remove the double negative. We are also making this change in § 201.328(a). As finalized, the term “portable cryogenic medical gas container” excludes cryogenic containers that are not designed to be connected to a medical gas supply system.

(Comment 32) Multiple comments discuss the proposed requirement in § 213.94(e)(2) that portable cryogenic medical gas containers and small cryogenic gas containers for use by individual patients have a working gauge sufficient to indicate whether the container contains an adequate supply of medical gas for continued use. One comment expresses general support but maintains that the gauge should be subject to the testing provisions for components in § 213.84(c). Another comment suggests deleting the phrase “sufficient to indicate whether the container contains an adequate supply of medical gas for continued use” because patient use is subjective and determined on an individual basis. Instead, the comment requests that the gauge should indicate container pressure or the amount of liquid in the container.

(Response 32) We appreciate the comment of support and agree that the gauge would be subject to the testing provisions for components, as the gauge is part of the container closure system. Regarding the comment recommending that we revise proposed § 213.94(e)(2), FDA would like to clarify that the intent of this language is to ensure that the gauge allows the user to understand how much of the medical gas remains in the tank. We recognize that it is not possible for a gauge to display patient-specific information. To help clarify this we are revising the codified to read, in pertinent part, that portable cryogenic medical gas containers and small cryogenic gas containers for use by individual patients have a working gauge sufficient to assist the user in determining whether the container contains an adequate supply of medical gas for continued use. We agree with the comment that a gauge capable of displaying container pressure or liquid level would satisfy this requirement.

FDA proposed to establish several requirements concerning production and process controls for medical gases (proposed §§ 213.100, 213.101, and 213.110). We received no comments on the proposed provisions and are finalizing them as proposed.

FDA proposed to establish several requirements concerning packaging and labeling controls for medical gases (proposed §§ 213.122, 213.125, and 213.130). We received no comments on proposed §§ 213.122 and 213.130 and are finalizing them as proposed.

In proposed § 213.125(a), we proposed that labeling and packaging operations must be controlled to prevent labeling and product mix-ups, and that procedures shall be written and followed describing in sufficient detail the control procedures employed for the issuance of labeling. In proposed § 213.125(b), we proposed requiring that procedures be used to reconcile the quantities of labeling issued, used, and returned, and that procedures require evaluation of discrepancies when such discrepancies are outside narrow preset limits based on historical operating data (FDA proposed that labeling reconciliation be waived for cut or roll labeling if a 100-percent examination is performed in accordance with § 213.122(f)(2), and for 360° wraparound labels on portable cryogenic medical gas containers). Proposed § 213.125(c) states that all excess lot number stickers or decals bearing lot or control numbers shall be discarded. Lastly, proposed § 213.125(d) exempted bulk or transport containers from § 213.125. We respond to the comments on proposed § 213.125 below.

(Comment 33) Regarding proposed § 213.125(c), one comment requests clarification regarding what constitutes excess lot number stickers or decals. The comment asserts that, if the intent is for a container to only have one label, the wear and tear of medical gas labels may justify multiple labels including the same content.

(Response 33) FDA's intent in proposed § 213.125(c) is to address the risks of excess labeling materials that are unused. FDA does not object to including lot number information in more than one location on the container closure. Rather, our concern is that extra stickers will be inadvertently used for another batch, which would lead to mix-ups. We believe the provision as drafted addresses this concern and do not believe that changes are needed.

FDA proposed to establish warehousing and distribution procedure requirements. Specifically, FDA proposed that written procedures be established and followed describing the distribution of medical gases, including a system by which the distribution of each lot can be readily determined to facilitate its recall (proposed § 213.150(a)). Additionally, FDA proposed that written procedures be established and followed describing the warehousing of medical gases, including quarantine before release by the quality unit (proposed § 213.150(b)).

(Comment 34) Although not directed at a specific provision, one comment discusses the transfilling process and the information that should be tracked. The comment maintains that transfillers should record which lots of medical gas were added as well as the date. The comment further asserts that once transfilling occurs, this information can no longer be tracked.

(Response 34) FDA does not believe that changes are needed to address this issue. Although tracking this information upon adding gas to a transfilling container may enhance traceability to some degree, FDA expects that the benefits would be minimal while the added burden of tracking this information would be significant. Moreover, it would be unclear in the long term what lots are in the cylinder because the gases from multiple batches would commingle and the transfiller would not be able to determine when a lot is no longer present in the container. Therefore, the list of lots could become quite long and unmanageable over time. Start Printed Page 51749

FDA proposed to establish several laboratory control requirements (proposed §§ 213.160, 213.165, and 213.166). We received no comments on proposed §§ 213.160 and 213.166 and are finalizing them as proposed.

FDA proposed testing and release requirements in § 213.165. Under proposed § 213.165(a), for each batch of medical gas, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the gas, including the identity and strength, prior to release. Additionally, FDA proposed that any sampling and testing plans shall be described in written procedures that shall be followed, including the method of sampling, the number of units per batch to be tested, and acceptance criteria (proposed § 213.165(b)). Under proposed § 213.165(c), the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented, and such validation and documentation may be accomplished in accordance with §  213.194(a)(2). Also under proposed § 213.165(c), the suitability of all testing methods shall be verified under actual conditions of use. Proposed § 213.165(d) would require rejection of medical gases that fail to meet established standards or specifications and any other relevant quality criteria. This proposal is generally consistent with the requirements described in § 211.165(f), but FDA did not propose to include in § 213.165(d) the provision stating that reprocessing may be performed or the requirements for using reprocessed material because the Agency is not aware of reprocessing that occurs for medical gases. FDA solicited comment on this issue, including any example scenarios in which medical gases are reprocessed. Finally, proposed § 213.165(e) would exempt from this section filling of designated medical gases and medically appropriate combinations of medical gases via liquid to liquid into a container at a delivery site.

(Comment 35) Regarding § 213.165(d)'s proposed requirement to reject medical gases that fail to meet established standards or specifications, one comment notes that they are not aware of any reprocessing of medical gases.

(Response 35) FDA appreciates the additional information. In light of the response received, we do not believe revisions to § 213.165(d) are necessary.

FDA proposed to establish records requirements (proposed §§ 213.180, 213.182, 213.184, 213.186, 213.189, 213.192, 213.194, 213.196, and 213.198). We received no comments on proposed §§ 213.180, 213.184, 213.186, 213.192, 213.194, and 213.198 and are finalizing them as proposed with minor technical and grammatical changes made on our own initiative. We respond to the comments on proposed §§ 213.182, 213.189, and 213.196 below.

We proposed that a written record of major equipment cleaning, maintenance (except routine maintenance), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed (proposed § 213.182). If equipment is dedicated to manufacture of one product, then individual equipment logs would not be required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, we proposed that the records of cleaning, maintenance, and use shall be part of the batch record. We proposed that the persons performing and double-checking the cleaning and maintenance (or, if using automated equipment under §  213.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Lastly, we proposed that entries in the log shall be in chronological order.

(Comment 36) One comment suggests revising § 213.182 to state that cleaning and maintenance is performed on a periodic basis or when there is suspected contamination and is not associated with a batch or lot process. The comment further requests that this provision state that equipment cleaning and non-routine maintenance is documented on separate cleaning or maintenance records. While the comment agrees that keeping a record of maintenance performed on production equipment is necessary, the comment maintains that, because these gases are manufactured and filled in a closed, pressurized system, equipment should not be cleaned between batches and lots. Otherwise, the comment asserts, contaminants could be introduced. Additionally, the comment states that the requirement to keep a use log of production equipment is not needed because this information is included on batch production records and would only increase manufacturers' burden.

(Response 36) FDA disagrees with this comment. The comment's suggested revisions go beyond recordkeeping requirements. The underlying cleaning and maintenance requirements are already addressed in §§ 213.42(c) and 213.67. Additionally, FDA does not believe that this provision as originally proposed suggests or requires cleaning at inappropriate times.

We also do not believe that the proposed requirements in § 213.182 are overly burdensome. Because the requirements in § 213.182 are intended to support good recordkeeping practices, such as the ability to locate records related to the equipment used in medical gas production (without needing to review one or more batch records), we decline to make the suggested revisions.

We proposed to require that batch production and control records be prepared for each batch of medical gas produced (proposed § 213.189(a)). We further proposed in § 213.189(b) that these records shall include documentation that each significant step in the manufacture, processing, packing, or holding of the medical gas produced was accomplished, including dates and times of each significant step, including in-process and laboratory tests as applicable; a description of the container for the medical gas, including the number and size of the containers filled as applicable; specific identification of each component and its source or in-process material used as applicable; measures of components used in the course of processing as applicable; testing results, including any in-process test results and finished product test results; dated signature or initials of the persons performing and directly supervising or checking each significant event in the operation; inspection of the packaging and labeling area before and after use; complete labeling control records, including specimens or copies of all labeling used and label application and reconciliation records as appropriate; and any investigation made according to §  213.192.

(Comment 37) One comment requests that the Agency revise § 213.189(b)(1) by deleting the words “and times” from the provision requiring that batch production and control records include “[d]ates and times of each significant step, including in-process and laboratory tests as applicable.” The Start Printed Page 51750 comment asserts that recording the time of production would not improve medical gas safety in light of the manufacturing processes used for medical gases.

(Response 37) FDA agrees with this comment. The Agency also notes that, considering the long, continuous production processes associated with many of these gases (for example, air separation used to produce oxygen and nitrogen), recording time as part of a firm's batch production and control records may be challenging. Therefore, the Agency is revising § 213.189(b)(1) to delete the reference to the time of significant steps. The finalized language requires that batch production records include the dates of each significant step, including in-process and laboratory tests as applicable.

(Comment 38) One comment asks that we delete § 213.189(b)(8), which would require batch production and control records to include complete labeling control records, including specimens or copies of all labeling used and label application and reconciliation records as appropriate. The comment maintains that the inclusion of labeling information would not provide added safety assurance, as would be the case for other drugs. Additionally, the comment notes that labels are reused, and industry performs a 100 percent inspection of cylinder labels during production.

(Response 38) We decline to delete § 213.189(b)(8). As discussed in the preamble to the proposed rule, because labeling does not always need to be applied due to the reuse of labels, documentation of these labeling control activities is important to help prevent mix-ups and the incorrect application of labeling ( 87 FR 31302 at 31319). Moreover, the inclusion of labeling control records can help facilitate investigations of complaints and other post-market activities. Due to the industry practice of the reuse of the labels, it is possible that no labels are applied during the manufacturing of a batch. In these instances, a copy of the label or a reproduction of the label is reasonable to include as part of the labeling control activities.

We proposed in § 213.196 to require that distribution records contain the name of the product, lot or batch number, name and address of the consignee, and date and quantity shipped, and that, for medical air and medically appropriate combinations of designated medical gases, the distribution record include the percentage of each gas.

(Comment 39) Multiple comments discuss the proposed requirement to include lot or batch number information in distribution records in § 213.196. One comment expresses concern that the exemption in § 211.196 (stating that compressed medical gas products do not need to include lot or control numbers in distribution records) would limit the ability to track a safety event. Another comment requests that “lot or batch number” be removed from § 213.196 to be consistent with the current requirements in § 211.196.

(Response 39) FDA declines to revise § 213.196. Regarding the concern about handling safety events, FDA proposed deletion of the exemption in § 211.196 for compressed medical gas products specifically because § 213.196 would fully address this requirement for medical gases. Regarding the proposed revision to § 213.196 to remove “lot or batch number,” FDA continues to believe that including the lot or batch number is essential to properly tracking and tracing product in the event a safety issue is discovered (see proposed rule discussion, 87 FR 31302 at 31320).

(Comment 40) One comment requests that FDA revise § 213.196 to explain that distribution records shall contain the required information (the name of the product, lot or batch number, name and address of the consignee, and date and quantity shipped) “to facilitate a recall if needed.” The comment asserts this would help achieve FDA's objective of improved traceability.

(Response 40) FDA does not agree. Because distribution records can serve many purposes aside from facilitating a recall, the suggested revision would unduly narrow the provision. As proposed (and finalized), § 213.196 can help a firm facilitate a recall and address other safety concerns that arise.

(Comment 41) One comment maintains that distribution records for medical air should not be required to include the percentage of each gas. The comment contends that, because the compendial standard for medical air specifies the range for the quantity of oxygen in nitrogen, including the specific percentage of oxygen for a shipment would not provide a benefit.

(Response 41) FDA agrees. Because medical air must be shown to meet compendial standards in order to be released, it is not necessary to state the amount of oxygen within the allowable range in the distribution records. Therefore, we have deleted “medical air and” from the second sentence of § 213.196 such that the requirement that the distribution record include the percentage of each gas only applies to medically appropriate combinations of designated medical gases.

FDA proposed to establish requirements for returned and salvaged medical gases (proposed §§ 213.204 and 213.208). We received no comments on proposed § 213.208 and are finalizing it as proposed with a minor grammatical change made on our own initiative.

FDA proposed in § 213.204 to require that returned medical gases be identified as such and held, and that, if the conditions under which the returned gases have been held, stored, or shipped before or during their return, or if the condition of the gas, its container, carton, or labeling, as a result of storage or shipping, cast doubt on its safety, identity, strength, quality, or purity, the returned medical gas shall be destroyed unless examination, testing, or other investigations prove the gas meets appropriate standards of safety, identity, strength, quality, or purity. Moreover, FDA proposed to require that firms maintain certain records of returned medical gases, and if the reason for a medical gas being returned implicates associated batches, an appropriate investigation pursuant to proposed §  213.192 shall be conducted. Procedures for holding, testing, and use of returned medical gases would need to be in writing and followed. FDA proposed that §  213.204 would not apply to the routine refilling of cryogenic medical gas containers in the normal course of business unless the container was returned for a quality issue.

(Comment 42) One comment requests that FDA exempt containers that assure the quality of the residual product prior to refill from the returned medical gases requirements in proposed § 213.204. The comment maintains that certain cylinders have residual pressure valves that prevent backflow.

(Response 42) FDA does not believe this change is necessary to address the comment's concern. As noted in the proposed rule, § 213.204 would apply to situations in which a distributed medical gas is sent back to a firm due to a quality issue ( 87 FR 31302 at 31321). Proposed § 213.204 included an exception for the routine refilling of cryogenic medical gas containers in the normal course of business because we understand that small amounts of gas are expected to remain in a returned container that will be reused (Id.). In the event a cylinder with a residual pressure valve is returned in the normal course of business for refilling and Start Printed Page 51751 redistribution, the requirements in § 213.204 would not apply. We note, however, that such valves could nonetheless fail, and if, for any reason, a cylinder with such a valve were returned and any of the conditions in the second sentence of § 213.204 are present, then the returned gas must be destroyed unless examination, testing, or other investigations prove the gas meets appropriate standards of safety, identity, strength, quality, or purity.

We proposed a new part 230 ( 21 CFR part 230 ) to include requirements concerning the certification of designated medical gases and postmarketing safety reporting.

(Comment 43) Some comments make general remarks supporting the proposed certification and safety reporting regulations without focusing on a particular proposed provision.

(Response 43) We appreciate these comments of support.

FDA proposed definitions of several terms used in part 230. We received comments on several of those proposed definitions, as discussed below. We are finalizing as proposed those definitions for which we received no comments with minor technical changes made on our own initiative.

We proposed to define “applicant” as any person or entity who submits a certification request for a designated medical gas under part 230, including a supplement, and any person or entity who owns a granted certification for a designated medical gas under part 230 (proposed § 230.3(b)(2)).

(Comment 44) One comment asks that we add language to clarify that the applicant is a person or entity who submits a certification request “as an original manufacturer” as defined in the medical gas CGMP regulations at § 213.3(b)(13). The comment asserts that this would be consistent with parts 201 and 213 and account for applicants that are both original manufacturers and subsequent manufacturers.

(Response 44) FDA does not agree with these requested revisions. Consistent with section 576(a)(1) of the FD&C Act, § 230.50(a)(1) of the designated medical gas certification regulations makes clear that any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce is the entity that shall file a certification request. We agree that subsequent manufacturers are not required to submit certification requests, but revising the “applicant” definition is unnecessary because the applicant is any person or entity who submits a certification request. If a subsequent manufacturer erroneously submitted a certification request, FDA may determine that the request was unnecessary and not grant it, but the subsequent manufacturer would still be considered the applicant for purposes of all interactions with the Agency related to the certification request. Moreover, as stated in response 45, FDA does believe it is appropriate to remove “or entity” from the definition of “applicant,” as the word “person” captures all relevant entities.

We proposed to define “nonapplicant” as any person other than the applicant whose name appears on the label of a designated medical gas container as a manufacturer, packer, or distributor (proposed § 230.3(b)(9)).

(Comment 45) One comment suggests revisions to the proposed “nonapplicant” definition in § 230.3(b)(9) for consistency across the regulations applicable to designated medical gases. First, the comment asks that the definition be revised to include any person or entity, rather than just any person, meeting the criteria in the definition. This suggested revision is intended to be consistent with the “applicant” definition in § 230.3(b)(2). Second, the comment asks that the definition be revised to refer to entities that appear on the label of a designated medical gas container as a subsequent manufacturer or distributor, rather than as a manufacturer, packer, or distributor. The comment asserts that these revisions are intended to account for nonapplicants that are also original manufacturers. The comment maintains that removal of the term “packer” would be consistent with industry terminology.

(Response 45) We do not believe that changes are necessary to the “nonapplicant” definition. First, FDA routinely uses the word “person” to include entities and organizations that are not individuals. The term “person” as defined in section 201(e) of the FD&C Act includes an individual, partnership, corporation, and association. Additionally, the definition of “applicant” in § 314.3 “is any person who submits an NDA . . . or ANDA . . . .” As discussed in response 44 above, FDA also concludes it is not necessary to include “or entity” in the definition of “applicant” in § 230.3(b)(2). Section 230.50(b)(1) has also been revised to refer to “person” and not “entity.”

Second, we do not agree with the use of the term “subsequent manufacturer” or the removal of the term “packer.” If an entity is an original manufacturer of a designated medical gas, FDA expects that it would be the applicant as opposed to a nonapplicant. Nonetheless, for a given designated medical gas, whether a firm is the applicant or a nonapplicant will depend on the activities performed for that product. We also note that the terminology used in the proposed definition is consistent with existing § 314.80(c)(1)(iii). While the medical gas industry may not ordinarily use the term “packing” to refer to its operations, the activities that subsequent manufacturers perform (such as transfilling, mixing, or filling at a delivery site) are expected to fall within the term “manufacturer, packer, or distributor.”

FDA proposed requirements for all types of certification submissions (proposed § 230.50). We received no comments on the proposed requirements and are finalizing them as proposed with minor technical edits made on our own initiative for clarity.

FDA proposed requirements regarding withdrawal of a certification request prior to it being deemed granted (proposed § 230.65). We received no comments on the proposed requirements and are finalizing them as proposed.

FDA proposed requirements regarding supplements and other changes to a granted certification (proposed § 230.70). We received no comments on the proposed requirements and are finalizing them as proposed.

FDA proposed requirements regarding the change in ownership of a granted certification (proposed § 230.72). We received no comments on the proposed requirements and are finalizing them as proposed. Start Printed Page 51752

FDA proposed to establish annual report requirements in proposed § 230.80. First, FDA proposed that applicants must submit an annual report each year within 60 calendar days of the anniversary of the date the certification was granted, and that the annual report form must be signed and completed and submitted in an electronic format that FDA can process, review, and archive, or in hard copy by submitting two paper copies to CDER's Central Document Room (proposed § 213.80(a)). Under proposed § 213.80(b), the annual report would contain, for the prior 12 months, a brief summary of significant new information that might affect the safety, effectiveness, or labeling of the designated medical gas, including any actions the applicant has taken or intends to take as a result of this new information; information about the quantity of the designated medical gas distributed by the applicant, including the National Drug Code (NDC) numbers and quantities distributed for domestic use and the quantities distributed for foreign use; any changes to the applicant's name or contact information; and a list of current facilities, as well as a list of facilities that are no longer in use.

(Comment 46) One comment requests that annual reports be submitted after the start of the new calendar year, rather than on the anniversary of the date the certification request was deemed granted. The comment asserts that this would align the annual reporting requirements with reporting requirements stemming from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) ( Pub. L. 116-136 ). The comment also states that annual reports are provided for activities related to the original manufacturing operations of the applicant, and not for subsequent manufacturing activities.

(Response 46) FDA agrees with this comment. In particular, section 3112(e) of the CARES Act established new section 510(j)(3) of the FD&C Act ( 21 U.S.C. 360(j)(3) ), which requires all drug registrants to report annually on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution. We recognize that it may create efficiencies for firms to track information across multiple reports if the reports are submitted on the same reporting schedule. Therefore, we have revised § 230.80(a) to require annual reports to be submitted within 60 calendar days of the new calendar year. We also agree that annual reports cover activities related to the original manufacture of the designated medical gas.

(Comment 47) One comment requests deletion of the requirement in proposed § 230.80(b)(2) that annual reports include distribution data because, as required by the CARES Act, section 510(j)(3) of the FD&C Act requires similar distribution data. Specifically, section 510(j)(3)(A) requires that each person who registers with FDA under section 510 of the FD&C Act with regard to a drug must report annually to FDA on the amount of each drug listed that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

(Response 47) FDA appreciates the need to avoid duplicate submissions of information. However, we conclude it is appropriate to retain the proposed requirement that distribution data be included in designated medical gas annual reports. Certain information, such as the NDC number and quantities of gas distributed for domestic and foreign use, is important to retain.

FDA considers the requirement to submit distribution data in annual reports under § 230.80(b)(2) to have been met if: (1) the registrant of establishments identified in the application submits a timely and complete report under section 510(j)(3) of the FD&C Act; (2) the registrant of establishments identified in the application includes in its section 510(j)(3) report the amount of listed drug product (organized by NDC number) that was distributed for foreign use during the reporting period (in addition to the amount distributed in the United States); (3) the applicant's annual report provides the date(s) of the report(s) submitted under section 510(j)(3) of the FD&C Act that includes the domestic and foreign distribution information; and (4) the applicant's annual report submitted under § 230.80 contains all other information required in § 230.80(b). FDA believes that this would maintain the Agency's access to information that would enhance the Agency's ability to assess, prevent, and mitigate possible drug shortages, and would also address the potential reporting burden for applicants that are subject to both § 230.80 and section 510(j)(3) of the FD&C Act.

(Comment 48) One comment requests that the proposed requirement in § 230.80(b)(4) that the annual report contain a list of “current facilities” be revised to require a list of “the applicant's current original manufacturing facilities” because only original manufacturing locations are required to be listed.

(Response 48) Our intent in § 230.80(b)(4) is for applicants to submit information regarding their original manufacturing facilities, as opposed to any subsequent manufacturing facilities they operate. In light of the comment received, we have revised § 230.80(b)(4) consistent with the requirement in section 576(a)(1)(C) of the FD&C Act and what we proposed for § 230.50(b)(4), which both address information to be submitted as part of a certification request. Because the purpose of § 230.80(b)(4) is to receive updates of the same information, we have revised the provision to require that the annual report include a list of current facilities where the designated medical gas is initially produced, and a list of facilities that are no longer in use.

FDA proposed requirements regarding FDA's review of submissions (proposed § 230.100). We received no comments on the proposed requirements and are finalizing them as proposed with minor technical edits made on our own initiative.

FDA proposed requirements regarding when a submission is deemed granted (proposed § 230.105). We received no comments on the proposed requirements and are finalizing them as proposed.

FDA proposed withdrawal and revocation requirements in proposed § 230.150. We did not receive comments on the proposed revocation requirements in § 230.150(b) and are finalizing those requirements as proposed with minor technical and grammatical changes made on our own initiative.

FDA proposed in § 230.150(a)(1) and (2) several grounds for withdrawing approval of a designated medical gas application, subject to FDA notifying the applicant and affording an opportunity for a hearing. Under proposed § 230.150(a)(3), FDA will withdraw approval of an application if the applicant requests its withdrawal because the designated medical gas subject to the application is no longer being marketed, provided none of the conditions listed in § 230.150(a)(1) and (2) apply. FDA would consider such a written request to be a waiver of an opportunity for hearing, and such withdrawal would be without prejudice Start Printed Page 51753 to refiling. FDA proposed in § 230.150(a)(4) that we may notify an applicant that we believe a potential problem associated with a designated medical gas is sufficiently serious that the designated medical gas should be removed from the market and may ask the applicant to waive the opportunity for hearing otherwise provided for under this section, to permit FDA to withdraw approval of the application for the product, and to remove voluntarily the product from the market. Lastly, FDA proposed under § 230.150(a)(5) that, if FDA withdraws an approval, FDA will publish a notice in the Federal Register announcing the withdrawal.

(Comment 49) Regarding the proposed withdrawal requirements in § 230.150, one comment states that FDA should include a reason for voluntary withdrawals to clarify whether the designated medical gas was withdrawn for safety reasons. The comment asserts that, without such information, an applicant's reputation may be harmed.

(Response 49) FDA does not believe that posting a withdrawal notification without a rationale would necessarily be interpreted as a statement that the designated medical gas was withdrawn for safety or effectiveness reasons. Because designated medical gases are generally considered appropriate for the uses stated in the statute, many of the considerations relevant to drugs approved under section 505 of the FD&C Act are not applicable. Moreover, the withdrawal of a designated medical gas does not create the same follow-on considerations that the withdrawal of an NDA approved under section 505 of the FD&C Act would create for current and future ANDAs that reference the withdrawn NDA. Therefore, we decline to make the suggested revisions to § 230.150.

However, as discussed in response 61 below, FDA is revising § 230.150(a)(2)(i) to include failure to submit reports under § 314.81(b)(3). Because of this revision, it is unnecessary for § 314.81(d) to continue to apply to designated medical gases.

We proposed field alert reporting requirements for designated medical gases in § 230.205. Specifically, FDA proposed that applicants be required to submit FARs to the FDA district office responsible for the facility involved within 3 working days of receipt by the applicant, and that the information may be provided by telephone or other rapid communication, with prompt written followup. FDA also proposed formatting requirements for the FAR and its mailing cover. In proposed § 230.205(a), FDA proposed that a FAR is required for information concerning any incident that causes the designated medical gas or its labeling to be mistaken for, or applied to, another article. In proposed § 230.205(b), FDA proposed that a FAR is required for information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed designated medical gas, or any failure of one or more distributed batches of the designated medical gas to meet established specifications.

(Comment 50) One comment requests that the field alert reporting requirements apply to nonapplicants as well as applicants. The comment asserts that downstream entities are more directly linked to the end user and would have the most current and detailed information about any issues that might require a FAR.

(Response 50) FDA disagrees. We note that the proposed field alert reporting requirements are drafted for designated medical gases, as opposed to combinations of designated medical gases. This scope is also consistent with the field alert reporting requirements in § 314.81(b)(1), which require that applicants submit reports to the Agency. It is worth noting that the field alert reporting requirements in § 514.80(b)(1) ( 21 CFR 514.80(b)(1) ) require the applicant, or the nonapplicant through the applicant, to report, so in either case the applicant would submit the FAR to FDA.

(Comment 51) One comment expresses support for the proposed 3-working-day reporting period, but asserts that FARs may still be incomplete at that timepoint.

(Response 51) FDA acknowledges the concern that more information may be available after 3 working days, and thus, under the proposed reporting timeframe, FARs may be incomplete in some instances. FDA believes that a 45-day reporting deadline for certain FARs for designated medical gases is appropriate. The 3-working-day reporting period originally proposed would apply if the information suggests that the reportable incident may require a rapid response to address a public health risk. Therefore, as finalized, § 230.205 requires that an applicant submit a FAR as soon as possible but no later than 45 calendar days from the date the applicant, or its agent or contractor, obtained information suggesting that a reportable incident has occurred, and if the information suggests that the reportable incident may require a rapid response to address a public health risk, the applicant must submit the FAR as soon as possible, but no later than 3 working days from obtaining the information. Reporting as soon as possible but no later than 45 calendar days from the date the applicant, or its agent or contractor, obtained information suggesting that a reportable incident has occurred appropriately balances the need to report quickly with helping to ensure that the applicant collects sufficient information to enable an appropriate response.

FDA is not making further revisions to the field alert reporting requirements for designated medical gases to reflect the proposed changes to part 314. The Agency has not received many FARs for designated medical gases. Considering certain characteristics of these drug products (including that they are generally manufactured in a sealed, closed system, which makes contamination and stability less of a concern), we conclude that further revisions are unnecessary. However, as we gain more experience with designated medical gases and with any future revisions to the field alert reporting requirements in part 314, we will consider whether revisions to § 230.205 are needed.

FDA proposed general reporting requirements for designated medical gas adverse events (proposed § 230.210). We received no comments on the proposed requirements and are finalizing them as proposed.

FDA proposed human postmarketing safety reporting requirements in § 230.220. Under proposed § 230.220(a)(1), applicants and nonapplicants must submit each ICSR associated with the use of a designated medical gas in humans described in § 230.220(b) as soon as possible but no later than 15 calendar days from the date the applicant or nonapplicant met the reporting criteria and acquired a minimum data set for an ICSR for that adverse event. FDA further proposed that applicants and nonapplicants should not resubmit any ICSRs obtained from FDA's adverse event reporting database or forwarded to the applicant or nonapplicant by FDA (proposed § 230.220(a)(2)). Additionally, FDA proposed that applicants and nonapplicants must submit new information related to a previously submitted ICSR or an ICSR sent to the Start Printed Page 51754 applicant by FDA no later than 15 calendar days after the information is received or otherwise obtained (proposed § 230.220(a)(3)).

FDA proposed in § 230.220(b) to specify which adverse events must be reported in an ICSR. FDA proposed that applicants and nonapplicants must submit ICSRs for serious adverse events reported to the applicant or nonapplicant spontaneously (such as a report initiated by a patient, consumer, or healthcare provider) or obtained from published scientific and medical journals (either as case reports or as the result of a formal clinical trial) (proposed § 230.220(b)(1)(i) and (ii)). Proposed § 230.220(b)(1)(iii) explains that ICSRs are not required for reports of the death of a patient who was administered oxygen, unless the applicant or nonapplicant is aware of evidence to suggest that the death was caused by the administration of oxygen. In addition, under proposed § 230.220(b)(2), upon notification by FDA, applicants and nonapplicants must submit, in a timeframe established by FDA, ICSRs for any adverse event that are not required under § 230.220(b)(1).

Under proposed § 230.220(c), FDA proposed to specify how to complete and submit ICSRs required under § 230.220. FDA proposed to require that ICSRs and ICSR attachments be submitted in an electronic format that FDA can process, review, and archive, though applicants and nonapplicants may request, in writing, a temporary waiver of this requirement (proposed § 230.220(c)(1)). FDA further proposed to require that each ICSR be submitted only once, that separate ICSRs be submitted for each patient who experiences a reportable adverse event, that adverse event terms must be coded using standardized medical terminology, that all ICSRs must contain at least the minimum data set for an ICSR, that the applicant or nonapplicant must complete all known, available elements of an ICSR as specified in § 230.220(d), and that an applicant must submit autopsy reports, hospital discharge summaries, or published articles as specified (proposed § 230.220(c)(2)).

Proposed § 230.220(d) sets forth the information that must be included in an ICSR, including patient information, adverse event information, information about the suspect designated medical gas(es), information about the initial reporter, and applicant or nonapplicant information.

Under proposed § 230.220(e), FDA proposed recordkeeping requirements, including that applicants and nonapplicants maintain records of information relating to adverse events for 10 years, whether or not submitted to FDA (proposed § 230.220(e)(1)). FDA further proposed that such records must include raw data, correspondence, and any other information relating to the evaluation and reporting of adverse event information that is received or otherwise obtained by the applicant or nonapplicant (proposed § 230.220(e)(2)). Lastly, FDA proposed that, upon written notice by FDA, the applicant or nonapplicant must submit any or all of these records to FDA within 5 calendar days after receipt of the notice, and the applicant or nonapplicant must permit any authorized FDA employee, at reasonable times, to access, copy, and verify these established and maintained records (proposed § 230.220(e)(3)).

Proposed § 230.220(f) specified that applicants and nonapplicants must develop written procedures needed to fulfill the requirements of § 230.220 for the surveillance, receipt, evaluation, and reporting to FDA of adverse event information.

Proposed § 230.220(g) would establish requirements concerning patient privacy. Specifically, FDA proposed that an applicant or nonapplicant should not include in reports under § 230.220 the names and addresses of individual patients; instead, the applicant or nonapplicant should assign a unique code for identification of the patient. FDA further proposed that the applicant or nonapplicant should include the name of the reporter from whom the information was received as part of the initial reporter information, even when the reporter is the patient. Proposed § 230.220(g) further states that as set forth in FDA's public information regulations in 21 CFR part 20 , the Agency generally may not disclose the names of patients, individual reporters, healthcare professionals, hospitals, and geographical identifiers submitted to FDA in adverse event reports.

Before discussing the comments received regarding FDA's proposed human postmarketing safety reporting requirements, the Agency notes an additional set of revisions we are making to § 230.220 on our own initiative. We are revising proposed § 230.220(b)(1)(i) to describe more clearly the requirement that applicants and nonapplicants must submit ICSRs for serious adverse events reported to or otherwise received by the applicant or nonapplicant. This revision aligns with the requirement in § 230.210(a) for prompt review of all safety information that the applicant or nonapplicant receives or otherwise obtains from any source and is intended to help ensure that reports of serious adverse events otherwise received (or obtained) by the applicant or nonapplicant are submitted to the Agency. Accordingly, this requirement includes, for example, serious adverse event reports received at the request of the applicant or nonapplicant (such as reports received as part of a patient support program), in addition to unsolicited communications such as reports initiated by a patient, consumer, or healthcare professional.

In the proposed rule, FDA proposed that § 314.80(g) would continue to apply to designated medical gases, and proposed § 230.220(c)(1)(i) and (ii) included cross-references to § 314.80(g). After further consideration, the Agency believes that it would be most helpful and efficient to set forth the electronic format requirements in § 230.220 rather than referencing § 314.80(g). Therefore, we have revised § 230.220(c)(1)(i) to directly include the requirement that ICSRs and ICSR attachments be in an electronic format that FDA can process, review, and archive, rather than cross-reference § 314.80(g)(1). FDA intends to issue guidance on how to provide the electronic submission ( e.g., method of transmission, media, file formats, preparation and organization of files). We have also revised § 230.220(c)(1)(ii) to directly state that an applicant or nonapplicant may request, in writing, a temporary waiver of the electronic reporting requirements, and that these waivers will be granted on a limited basis for good cause shown, rather than cross-reference § 314.80(g)(2). FDA intends to issue guidance on requesting a waiver of the requirements in § 230.220(c)(1)(i).

Furthermore, we have revised § 314.1(c) to state that § 314.80, as a whole, does not apply to designated medical gases. These revisions have the same regulatory effect as the language included in the proposed rule on this issue.

(Comment 52) One comment maintains that some nonapplicants may be unable to comply with the proposed ICSR requirements.

(Response 52) FDA believes it is appropriate to apply the proposed ICSR requirements to nonapplicants. We note that nonapplicants are currently required to comply with the postmarketing safety reporting requirements in § 314.80(c)(1)(i) and (ii), although nonapplicants may comply by submitting all reports of serious adverse drug experiences to the applicant. Under § 230.220, the only difference will be that nonapplicants for designated medical gases must report to FDA, rather than the applicant. Start Printed Page 51755 Therefore, we do not believe that revisions are necessary.

(Comment 53) Regarding the proposed exception to the ICSR requirements for serious adverse events in proposed § 230.220(b)(1)(iii), one comment recommends expanding the exception to serious injuries of patients administered oxygen, unless the applicant or nonapplicant is aware of evidence to suggest that the serious injury was caused by the administration of oxygen. The comment references the proposed “no smoking” and “no vaping” warning statements in § 201.161(a)(1)(ii) and maintains that its suggested changes would be consistent with the warning statements.

(Response 53) FDA does not agree that this change is necessary. The purpose of the exception in § 230.220(b)(1)(iii) is to address cases where a patient being administered oxygen dies and there is no reason to believe that the oxygen contributed to the patient's death. This is very common because, as discussed in the proposed rule, oxygen is commonly administered during end-of-life care or to patients with a life-threatening disease or who are otherwise in critical condition ( 87 FR 31302 at 31329). This provision is not intended to address fire-related injuries.

(Comment 54) One comment expresses support for the proposed minimum data set requirements for human postmarketing safety reporting but asserts that the burden could be significant for firms. The comment maintains that, for purposes of complying with § 230.220(c)(2) or § 230.220 more generally, firms may need to hire or contract with medical professionals to evaluate potential ICSRs.

(Response 54) FDA appreciates the feedback regarding the proposed minimum data set requirements and acknowledges the concern regarding compliance burden. (Section VII below discusses the economic burden of compliance with § 230.220, including § 230.220(c)(2).) Nonetheless, FDA does not believe that firms will need to hire medical professionals. We further note that applicants (and nonapplicants by way of applicants) are currently required to submit adverse event reports to FDA under §§ 314.80 and 514.80 for human adverse drug experiences and animal adverse drug events, respectively. In both cases, this requires determining whether the event is unexpected, something that generally would not be required under § 230.220 or § 230.230. Required reports of serious adverse events must be submitted regardless of expectedness, and a causality assessment is only required in the event there is evidence to suggest that the death of a patient being administered oxygen was caused by such administration of oxygen.

(Comment 55) Regarding the proposed requirement in § 230.220(c)(2)(iii) that event terms in ICSRs be coded using standardized medical terminology, one comment requests that the word “must” be revised to “should.” The comment also requests that the recommendation that standardized medical terminology be used should only apply if the terminology is provided by the reporter. The comment maintains that medical gas firms do not necessarily have medical expertise available to code ICSR events.

(Response 55) FDA disagrees with these suggested revisions. We do not believe that coding using standardized medical terminology is a significant burden, nor do we believe that medical professionals are needed to code an event correctly. Standardized medical terminology generally includes terms commonly used by laypersons when describing adverse events. Moreover, because the reporter may be the patient or a relative, and thus not necessarily familiar with ICSR reporting or FDA regulation more broadly, it would be unreasonable to rely on the original reporter to properly code an event. Because the use of standardized medical terminology helps FDA track, evaluate, and respond to safety signals, we do not believe the requested revisions are appropriate.

(Comment 56) FDA received one comment concerning proposed § 230.220(c)(2)(vi)(B). The comment states that applicants and nonapplicants should be required to submit a reference to published articles, rather than the articles themselves, due to copyright restrictions. As an alternative, the comment suggests that FDA could require that the article be provided upon request, subject to copyright.

In light of these recommendations, the comment also requests deletion of the provisions requiring translation of the abstract of foreign language articles and describing the requirements for submitting more than one ICSR from the same published article. The comment maintains that the burden of these requirements would be significant, as firms would need to hire medical professionals to evaluate ICSRs.

(Response 56) FDA does not agree with these suggested changes. First, it is unclear why medical professionals would be needed to help an applicant or nonapplicant comply with the requirements in § 230.220(c)(2)(vi)(B). Additionally, we note that § 314.80(d) currently requires that a 15-day Alert report based on information in the scientific literature be accompanied by a copy of the published article.

Regarding the submission of foreign language articles, FDA recognizes that there may be additional burden associated with translating foreign language documents, but we proposed that only the abstract be translated and expect that the burden associated with this activity would be minimal. As such, we believe that requiring translation of only the abstract of a foreign language article is appropriate.

Because we are requiring in this final rule that the applicant or nonapplicant provide a copy of published articles as an attachment, we believe it is important to retain the language concerning the submission of multiple ICSRs from the same article.

(Comment 57) One comment asks that proposed § 230.220(g) be revised to create an exception to the recommendation that the applicant or nonapplicant should include the name of the reporter from whom the information was received as part of the initial reporter information, even when the reporter is the patient. Specifically, the comment requests an exception for when the reporter is the patient out of concern for disclosing the patient's personal information.

(Response 57) FDA disagrees. As noted in the sentence that immediately follows the referenced provision in § 230.220(g), FDA acknowledges that, as addressed in the Agency's public information regulations, FDA generally may not disclose the names of patients, individual reporters, healthcare professionals, hospitals, and geographical identifiers submitted to FDA in adverse event reports. Moreover, in situations in which the reporter is the patient, nothing in the submission necessarily makes that fact evident to the reader. Lastly, the language at issue is consistent with the current text of § 314.80(i) indicating that the name of the reporter be included even when the reporter is the patient.

(Comment 58) FDA sought comment on the Agency's decision not to propose periodic safety reporting requirements for designated medical gases and received comments in support and in opposition. Some comments maintain that this decision is consistent with FDA's March 2015 Compliance Program Guidance Manual 7356.002E (Ref. 3), while other comments assert that periodic safety reporting enables cumulative review of safety information.

(Response 58) After considering the comments, FDA does not believe it is necessary to include a periodic safety reporting requirement in this Start Printed Page 51756 rulemaking. Medical gases have historically been manufactured, labeled, and distributed in a manner different than most other drugs. Because of these differences, FDA believes that the likelihood of identifying new safety issues for medical gases is low, and that ICSRs are an adequate and efficient means of identifying any new safety issues for these products.

FDA proposed animal postmarketing safety reporting requirements in § 230.230. Under proposed § 230.230(a), applicants and nonapplicants must submit serious adverse events to FDA as soon as possible but no later than within 15 calendar days of first receiving the information. FDA proposed that applicants and nonapplicants must submit reports for each serious adverse event reported to the applicant or nonapplicant spontaneously (such as reports initiated by a patient, consumer, veterinarian, or other healthcare professional), regardless of whether the applicant or nonapplicant believes the events are related to the designated medical gas (proposed § 230.230(a)(1)(i)). FDA also proposed that applicants and nonapplicants must submit reports for each serious adverse event obtained from published scientific and medical literature regardless of whether the applicant or nonapplicant believes the events are related to the designated medical gas (proposed § 230.230(a)(1)(ii)). FDA proposed that adverse event reports not be required for reports of the death of an animal who was administered oxygen, unless the applicant or nonapplicant is aware of evidence to suggest that the death was caused by the administration of oxygen (proposed § 230.230(a)(1)(iii)). Under proposed § 230.230(a)(2), upon notification by FDA, applicants and nonapplicants must submit reports of adverse events associated with the use of a designated medical gas in animals that do not qualify for reporting under § 230.230(a)(1). FDA proposed under § 230.230(a)(3) that applicants and nonapplicants should not resubmit adverse event reports obtained from FDA's adverse event reporting database or forwarded to the applicant or nonapplicant by FDA.

FDA proposed in § 230.230(b) to require that adverse event reports be submitted in an electronic format that FDA can process, review, and archive, and that data provided in electronic submissions must be in conformance with the data elements in Form FDA 1932 and FDA technical documents describing transmission (proposed § 230.230(b)(1)). FDA further proposed that applicants and nonapplicants may request, in writing, a temporary waiver of this requirement (proposed § 230.230(b)(2)).

Under proposed § 230.230(c), FDA proposed recordkeeping requirements, including that applicants and nonapplicants maintain records of information relating to adverse event reports for 5 years, whether or not submitted to FDA (proposed § 230.230(c)(1)). FDA further proposed that such records must include raw data, correspondence, and any other information relating to the evaluation and reporting of adverse event information that is received or otherwise obtained by the applicant or nonapplicant (proposed § 230.230(c)(2)). Lastly, FDA proposed that, upon written notice by FDA, the applicant or nonapplicant must submit any or all of these records to FDA within 5 calendar days after receipt of the notice, and the applicant or nonapplicant must permit any authorized FDA employee, at reasonable times, to access, copy, and verify these established and maintained records (proposed § 230.230(c)(3)).

Before responding to a comment we received regarding the proposed animal postmarketing safety reporting requirements, the Agency notes a revision we have made on our own initiative. We have revised § 230.230(a)(1)(i) to more clearly specify that applicants and nonapplicants must submit reports for serious adverse events reported to or otherwise received by the applicant or nonapplicant. This revision aligns § 230.230(a)(1)(i) with the requirement in § 230.210(a) for prompt review of all safety information that the applicant or nonapplicant receives or otherwise obtains from any source, and helps ensure that reports of serious adverse events otherwise received (or obtained) by the applicant or nonapplicant are submitted to the Agency. Accordingly, § 230.230(a)(1)(i) includes, for example, serious adverse event reports received at the request of the applicant or nonapplicant, in addition to unsolicited communications such as reports initiated by a patient, consumer, veterinarian, or other healthcare professional.

(Comment 59) Regarding the proposed exception to the reporting requirements for serious adverse events in proposed § 230.230(a)(1)(iii), one comment recommends expanding the exception to serious injuries of animals administered oxygen, unless the applicant or nonapplicant is aware of evidence to suggest that the serious injury was caused by the administration of oxygen. The comment references the “no smoking” and “no vaping” warning statements in proposed § 201.161(a)(1)(ii) and maintains that the suggested changes would be consistent with the warning statements.

(Response 59) As discussed above, FDA does not agree that this change is necessary. The purpose of the exception in § 230.230(a)(1)(iii) is to address cases where an animal being administered oxygen dies and there is no reason to believe that the oxygen contributed to the animal's death. This is very common because, as discussed in the proposed rule, we expect that oxygen will be administered to animals that are in critical condition, and death is expected to be a common outcome ( 87 FR 31302 at 31331). This provision is not intended to address fire-related injuries.

FDA proposed carving out designated medical gases from certain provisions in part 314, either because a corresponding provision specific to designated medical gases was proposed to be added to part 230, or because the provision is not relevant to designated medical gases. Specifically, FDA proposed exempting designated medical gases from §§  314.50 through 314.72 (concerning certain information required in NDAs); §  314.80, except paragraph (g) (concerning certain postmarketing reporting requirements); §  314.81(a) and (b)(1) and (2) (concerning certain other postmarketing reports); §  314.90 (concerning waivers); subpart C (concerning ANDAs); §§  314.100 through 314.162 (concerning certain requirements related to FDA action on NDAs and ANDAs; subpart H (concerning accelerated approval); and subpart I (concerning approval of new drugs when human efficacy studies are not ethical or feasible). FDA received comments related to some of these proposed changes, to which we respond below.

(Comment 60) One comment requests that designated medical gases be exempted from § 314.81(b)(3), which includes requirements for submitting advertisements and promotional labeling, special reports requested by the Agency, the process for notifying FDA of a permanent discontinuance of manufacture of a drug product, and withdrawal of an approved drug product from sale. The comment asserts that, in light of the proposed revisions to the labeling requirements in part 201, it is not necessary for these provisions to apply to designated medical gases.

(Response 60) FDA does not agree that designated medical gases should be exempted from § 314.81(b)(3). The Start Printed Page 51757 Agency assumes that the comment is primarily focused on § 314.81(b)(3)(i), which concerns the submission of advertisements and promotional labeling, because of the comment's discussion of part 201. The other provisions in § 314.81(b)(3) are unrelated to labeling, and it is not clear how the changes FDA proposed to part 201 would address these requirements. Furthermore, we do not believe that the changes FDA is making to part 201 address the requirements in § 314.81(b)(3)(i), as part 201 does not include requirements for promotional labeling. Because FDA believes it is still important for promotional materials to be submitted to the Agency, we believe it is important to retain this provision.

(Comment 61) One comment requests that designated medical gases be exempted from § 314.81(c) because an original manufacturer will only have one application for each designated medical gas.

(Response 61) We assume the comment concerns only § 314.81(c)(1), regarding the submission of information common to more than one application, as the comment does not discuss the requirements of § 314.81(c)(2). FDA does not expect that designated medical gas applicants will have information common to more than one application. In addition, upon further consideration, FDA concludes it is not necessary to retain the requirements in § 314.81(c)(2) for designated medical gases because patient privacy information is not expected to be included in reports for designated medical gases submitted under § 314.81. For these reasons, we are revising the codified at § 314.1(c) such that § 314.81(c) no longer applies to designated medical gases.

In addition, because § 230.150 now provides for withdrawal of an application for a designated medical gas based on failure to submit reports required under § 314.81(b)(3) (see section V.I.11), it is not necessary for § 314.81(d) (which concerns withdrawal of approval for failure to make required reports) to continue to apply to designated medical gases. Accordingly, FDA has revised § 314.1(c)(3) to read “Section 314.81, except paragraph (b)(3)”.

FDA proposed carving out designated medical gases from provisions in part 514 ( 21 CFR part 514 ) to align with the provisions specific to designated medical gases that we proposed to add to part 230. We did not receive comments on the proposed revisions and are finalizing the provisions as proposed with minor technical changes made on our own initiative.

This rule is effective December 18, 2025, except for §§ 4.2, 4.3, and 4.4. The effective date for §§ 4.2, 4.3, and 4.4 will be February 2, 2026.

(Comment 62) One comment supports the proposed effective date of 18 months after publication of the final rule. The comment notes that firms will need time to update labeling information to ensure compliance with the new requirements.

(Response 62) FDA acknowledges this comment, and we believe that 18 months is an appropriate time after publication of the final rule to enable firms to comply with these requirements. However, we note that the recently published final rule “Medical Devices; Quality System Regulation Amendments” (the QSRA rule), which will become effective on February 2, 2026, [ 4 ] amends provisions of part 4 that are further revised by this rule. To prevent any confusion that may result from multiple amendments to part 4 occurring so close in time, FDA has determined that this rule's amendments to §§ 4.2, 4.3, and 4.4 will be effective on February 2, 2026, the same date the QSRA rule becomes effective.

We have examined the impacts of the final rule under Executive Order 12866 , Executive Order 13563 , Executive Order 14094 , the Regulatory Flexibility Act ( 5 U.S.C. 601-612 ), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act ( 5 U.S.C. 801 , Pub. L. 104-121 ), and the Unfunded Mandates Reform Act of 1995 ( Pub. L. 104-4 ).

Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866 Section 3(f)(1) (as amended by Executive Order 14094 ) if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of [the Office of Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” OIRA has determined that this final rule is not a significant regulatory action under Executive Order 12866 , section 3(f)(1).

Because this rule is not likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act, OIRA has determined that this rule does not fall within the scope of 5 U.S.C. 804(2) .

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule will better tailor the current good manufacturing practice requirements for medical gases and medically appropriate combinations of such gases and creates small net cost savings for small entities, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The 2022 threshold after adjustment for inflation is $177 million, using the (2022) Implicit Price Deflator for the Gross Domestic Product. This final rule will not result in an expenditure in any year that meets or exceeds this amount.

This final rule establishes, within part 213, CGMP regulations specific to medical gases. These regulations include many of the same categories of requirements as the general drug product CGMP regulations but are tailored to reflect differences in how medical gases are manufactured, packaged, labeled, stored, and distributed. This rule makes limited changes to the labeling requirements of part 201, including requiring that a “no smoking” statement, a “no vaping” statement, and graphic warning symbol be added to oxygen containers to reduce the risk of fire. This rule codifies and clarifies the process for obtaining a certification to market designated medical gases. Recommendations for how to request a certification for designated medical gases are currently included in a draft guidance. This rule makes changes to postmarketing safety reporting regulations for designated medical gases that address human and animal use and more specifically reflect Start Printed Page 51758 the development, manufacturing, and distribution of designated medical gases.

The costs of this final rule are primarily driven by new labeling requirements, clarification leading to firms becoming compliant with existing requirements, and added CGMP requirements, including a requirement for portable cryogenic containers to have a working gauge.

The cost savings of this final rule are primarily driven by removing or relaxing CGMP requirements that do not apply to medical gases, such as removing certain building and facility requirements, which may streamline inspections for industry and FDA.

Table 1 summarizes the estimated benefits and costs of the final rule. The annualized benefits will range from $0.00 million to $7.02 million with a primary estimate of $3.51 million over a 10-year span at a 7 percent discount rate. Annualized at a 3 percent discount rate these benefits will range from $0.00 million to $7.43 million with a primary estimate of $3.72 million. The annualized costs will range from $1.52 million to $5.30 million with a primary estimate of $3.24 million at a 7 percent discount rate. Annualized at a 3 percent discount rate these costs will range from $1.36 million to $5.11 million with a primary estimate of $3.07 million.

The present value of the estimated benefits will range from $0.00 million to $56.33 million with a primary estimate of $28.17 million at a 7 percent discount rate and from $0.00 million to $59.64 million with a primary estimate of $29.82 million at a 3 percent discount rate. The present value of the estimated costs will range from $12.23 million to $42.49 million with a primary estimate of $25.96 million at a 7 percent discount rate and from $12.98 million to $48.72 million with a primary estimate of $29.28 million at a 3 percent discount rate.

FDA conducted a regulatory flexibility analysis of the impact of the final rule on small entities. Approximately 41 percent of domestic entities that would be affected by the final rule are small according to Small Business Administration size standards. We estimate that the highest single year cost for a firm could be as high as 0.860 percent, while the average costs to receipts ratio is 0.007 percent. Therefore, our analysis of the impact of the final rule on small entities suggests that small firms will not be significantly affected by the final regulation. Start Printed Page 51759

We received one comment directed at the preliminary regulatory impact analysis (PRIA) and a few comments on the rule that we considered to be relevant to the economic analysis. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value, importance, or the order in which it was received.

(Comment 63) One comment maintains that entering a specific percentage of oxygen in the distribution records for each medical air cylinder is not necessary, because medical air contains a range of oxygen in nitrogen.

(Response 63) FDA agrees. We removed “medical air and” from the distribution records section to clarify. This clarification ensures no additional burden for distribution records.

(Comment 64) One comment suggests that transfilling be included in the distribution records and tracked, including which lots of gas material were added and on which date.

(Response 64) FDA declines to make this change. Including transfilling in the distribution records would be burdensome, and the tracking information might be of limited use for traceability due to the use of multiple batches and commingling.

(Comment 65) One comment states that the potential burden associated with the proposed minimum data set requirements for human postmarketing safety reporting on medical gas firms could be significant based on the number of adverse event reports received and the specific information required for individual case safety reports. The comment asserts that adverse event reporting would require all registered medical gas firms to hire or have available medical professionals or contractors to evaluate potential adverse events.

(Response 65) Adverse event reporting is already required for applicants and nonapplicants. This final rule requires nonapplicants to report adverse events directly to FDA rather than reporting to the applicant who in turn would report the adverse event to FDA. The Agency believes this will be less burdensome in the context of medical gases. Our analysis does anticipate a small increase in adverse event reporting for animals as a result of clarification of the requirements applicable to industry. However, because this is not a new requirement, we believe that the small increase is an accurate estimate of the additional burden for adverse event reports.

We do not anticipate an additional burden per adverse event report as a result of the minimum data set requirements established in the final rule. Collection of the minimum data set is already included in FDA's July 2009 guidance for industry “Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application,” and the March 2001 draft guidance for industry “Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines” (Refs. 4 and 5), and is industry practice.

FDA does not believe that firms will need to hire medical professionals. Reporters are not required to determine causality but only to report that an adverse event did occur. Additionally, adverse event reporting is not a new requirement.

(Comment 66) One comment maintains that the requirements do not reflect current industry practice and there may be additional economic burden on the industry that is not included in FDA's summary.

(Response 66) We appreciate the comment, but we believe we have sufficiently estimated all direct additional costs for new requirements not determined to be de minimis. We also acknowledged additional potential costs and possible sensitivities in the sensitivity analysis of the PRIA.

We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 6) and at https://www.fda.gov/​about-fda/​economics-staff/​regulatory-impact-analyses-ria .

We have determined under 21 CFR 25.30(h) , (j) , and (k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 ( 44 U.S.C. 3501-3521 ). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual reporting, recordkeeping, and third-party disclosure burden. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

Title: Information Collection for Rulemaking of Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases.

Description: This rulemaking is amending existing regulations and establishing new regulatory requirements pertaining to medical gases.

Description of Respondents: Respondents to this information collection are entities who manufacture, process, pack, label, or distribute certain medical gases.

FDA recognizes that some medical gases are marketed as part of a combination product. For example, a medical gas may be marketed with a device constituent part (for example, a portable liquid oxygen unit or a pressure regulator). Combination products are subject to information collection provisions found in parts 3 and 4, which prescribe content and format requirements associated with marketing applications, together with applicable recordkeeping and reporting requirements.

FDA is revising provisions in part 4 to account for combination products that contain a medical gas, as FDA is requiring medical gases to be subject to new part 213, and to clarify (where appropriate) applicable medical gases requirements throughout part 4. We believe that the new regulations impose no new burden associated with information collection currently approved under OMB control number 0910-0523.

Regulations in part 201 govern the statement of ingredients and declaration of net quantity of contents with regard to prescription drug product labeling.

The new regulations require that firms identify bulk or transport containers with the name of the product contained therein and that containers be accompanied by documentation that identifies the product as meeting applicable compendial standards. Bulk or transport containers are excluded from the definition of final use containers. Because these large containers are removed from the point of care and we do not expect that patients and healthcare practitioners Start Printed Page 51760 will use them directly to administer a designated medical gas, FDA does not believe that firms' bulk or transport containers need to bear the information required under § 201.161(a). However, to prevent mix-ups, it is essential that the identity of the gas inside such containers is evident to individuals who handle and transport the containers. FDA expects that these requirements will help prevent mix-ups and ensure that recipients of medical gases in bulk or transport containers are provided information indicating that such gases meet applicable compendial standards.

We estimate that 1,696 firms will label 4,000 containers and anticipate firms will expend 6 minutes (0.1 hours) to identify the containers with the name of the product and place documentation that identifies the product as meeting applicable compendial standards, totaling 400 hours annually.

Section 201.328(d) provides that the owner of a designated medical gas container or a container of a medically appropriate combination of designated medical gases may be identified on the container. This statement may appear on a separate sticker or decal on the container (that is, it need not be contiguous with other labeling on the container), but if the container owner is not the manufacturer, packer, or distributor of the gas, that information shall be clearly stated. FDA recognizes the complex distribution system for designated medical gases and medically appropriate combinations of designated medical gases and the importance of each entity in the distribution chain being clearly identified so that patients and healthcare professionals can contact the appropriate entity if necessary. We intend for this provision to help ensure that appropriate entities can be contacted about quality issues or adverse events. In addition, the labeling requirement facilitates the return of cylinders to owners who may not also be medical gas manufacturers. FDA believes that including the container owner's information will not cause the container owner to be a “relabeler” for purposes of FDA's registration and listing requirements.

We estimate that 1,696 firms will identify on a designated medical gas container or a container of a medically appropriate combination of designated medical gases the name of the container owner who may not also be the manufacturer, packer, or distributor of the gas. We estimate firms would include this label on 4,000 containers and will expend 6 minutes (0.1 hours) to perform this activity, totaling 400 hours annually.

We estimate the burden of the information collection as follows:

FDA is establishing new part 213 setting forth CGMP requirements applicable to medical gases. Part 213 applies to firms that manufacture a medical gas and establishes requirements applicable to firms that subsequently combine, commingle, refill, or distribute medical gases.

The regulations also include recordkeeping requirements pertaining to personnel qualifications and responsibilities of persons who are engaged in the manufacturing, processing, packing, or holding of a medical gas.

Provisions under § 213.42(c) include recordkeeping to document the development and implementation of written procedures to ensure that firms maintain a clean condition for any building used to manufacture, process, pack, or hold a medical gas so as to ensure the safety, identity, strength, quality, and purity of the gas. Firms also need to develop written procedures that apply to recordkeeping for cleaning and maintaining buildings. Based on available data, we estimate 1,696 firms will each develop and implement written procedures to maintain and clean buildings. We estimate it will take 13 hours to perform this activity, totaling 22,048 hours initially. Firms will also update these written procedures annually. Based on available data, we estimate 1,696 firms would each update written procedures to maintain and clean buildings and that it will take 39 minutes (0.65 hours) to perform this activity, totaling 1,102 hours annually.

Provisions under § 213.100 include development and maintenance of written procedures to ensure that production and process controls are designed to assure that medical gases have the appropriate qualities (identity, strength, quality, and purity) they are purported to possess. Based on available data, we estimate 1,696 firms will each develop and implement written procedures. We estimate it will take 13 hours to perform this activity, totaling 22,048 hours. Firms will also update these written procedures annually. Based on available data, we estimate 1,696 firms would each update written procedures to maintain and clean buildings and that it will take 39 minutes (0.65 hours) to perform this activity, totaling 1,102 hours annually.

In concert with §§ 213.42 and 213.80, under § 213.150, firms are required to establish and follow written procedures regarding warehousing and distribution of medical gases, including procedures for the quarantine of such gases before release by the quality unit. The distribution procedures are also required to include a system by which the distribution of each lot can be readily determined, to facilitate any necessary recalls. Based on available data, we estimate 1,696 firms will each develop and implement written procedures for warehousing and distribution of medical gases. We anticipate it will take approximately 13 hours to perform this activity totaling 22,048 hours initially. Firms will also update these written procedures annually. Based on available data, we estimate 1,696 firms would each update these written procedures annually and Start Printed Page 51761 that it will take 39 minutes (0.65 hours) to perform this activity, totaling 1,102 hours annually.

Similarly, under § 213.208, firms are required to develop and implement written procedures for the holding, testing, and use of salvaged medical gases. Based on available data, we estimate 1,696 firms will develop and implement written procedures for the holding, testing, and use of salvaged medical gases. We estimate it will take 13 hours for firms to perform this activity, totaling 22,048 hours. In addition, based on available data, we estimate that 1,696 firms will update their written procedures (1 procedure each) for the holding, testing, and use of salvaged medical gases. We estimate it takes 0.65 hours to perform the updates, totaling 1,102 hours annually.

The regulations under § 213.25 provide that employee training be included in the firm operations. Recordkeeping would be established to demonstrate that qualified individuals conduct training on a continuing basis and with sufficient frequency to allow employees to remain familiar with applicable requirements. Based on available data, we estimate that 1,696 firms will prepare written documentation pertaining to employee training. We estimate that 10 employees per firm will create 16,960 records (10 records per firm) and that it will take 5 minutes (0.083 hours) to prepare each record, for a total of 1,408 hours annually.

Under § 213.34, records demonstrating that consultants have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained will be required. Based on available data, we estimate that 1,696 firms will maintain 571 records of consultants' education, training, and experience, or any combination thereof and expect that it will take 30 minutes (0.5 hours) to perform this activity, totaling 286 hours annually.

In addition, under § 213.67(c), we estimate that 1,696 firms will maintain 74,230 records of equipment maintenance and cleaning and anticipate it will take 15 minutes (0.25 hours) to perform this activity, totaling 18,557 hours annually. We also anticipate that, under § 213.68(d), 1,696 firms will develop and implement 11,420 written procedures for automatic, mechanical, and electronic equipment and that firms will expend 15 minutes (0.25 hours) to perform this activity, totaling 2,855 hours annually.

As provided in the new regulation under § 213.82, once a shipment of an incoming designated medical gas is received, the firm will perform full compendial testing on the gas and record the results or verify and record that a signed certificate of analysis accompanies the shipment. If an incoming designated medical gas is obtained from a supplier other than the original manufacturer, the shipment would also need to include specific information. To ensure the reliability of appropriate assessment and testing, firms will be required to establish and maintain a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures. We estimate that 1,380 firms would verify and document records upon receipt of a designated medical gas. We anticipate that firms will maintain 575,460 records (417 records each (1 delivery per week of oxygen for 1 year (52 deliveries) plus 1 delivery per day of nitrogen for 1 year (365 deliveries)). We further estimate firms will expend 15 minutes (0.25 hours) each (104 hours in total for each firm) to perform this activity, totaling approximately 143,865 hours annually.

Section 213.89 requires that firms identify and control rejected components, containers, and closures under a quarantine system designed to prevent their use in operations for which they are unsuitable. Section 213.89 also applies to incoming designated medical gases. Quarantine systems would not need to include physical quarantining because other methods can adequately ensure that unsuitable products are not used. We estimate that 1,380 downstream firms would need to assess and document 33.4 million medical gas components, containers, and closures annually. We estimate that firms would reject 0 to 0.1 percent of all containers. These firms will maintain a total of 33,400 records of rejected components and we estimate they will expend 5 minutes (0.083 hours) to perform this activity, totaling 2,772 hours annually.

Under § 213.122(c), firms need to maintain records for each shipment received of each different labeling and packaging material indicating receipt, examination, and whether accepted or rejected. Based on available data, we estimate 1,696 firms will prepare 74,230 records to document each shipment received of each different labeling and packaging material indicating receipt, examination, and whether accepted or rejected. We estimate it will take 15 minutes (0.25 hours) to perform this activity, totaling 18,558 hours annually.

Under § 213.130(e), firms are required to document results of inspections concerning packaging and labeling in the batch production records. Based on available data, we estimate 1,696 firms will document results of inspections in the batch production records in approximately 114,200 records. We estimate it will take 15 minutes (0.25 hours) per record to perform this activity, totaling 28,550 hours annually.

Under § 213.180(d), firms are required to maintain written records so that data therein can be used for evaluating, at least annually, the quality standards of each medical gas to determine the need for changes in specifications or manufacturing or control procedures. Based on available data, we estimate 1,696 firms will prepare 457 records. We estimate it will take 15 minutes (0.25 hours) to perform this activity, totaling 114 hours annually.

Under § 213.182, firms are required to maintain a written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use. Based on available data, we estimate 1,696 firms will prepare 2,969 records documenting major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use. We estimate it will take 10 minutes (0.16 hours) to perform this activity, totaling 475 hours annually.

Under § 213.184, firms are required to maintain certain records concerning components, medical gas containers and closures, and labeling. We estimate 1,696 firms will prepare 4,454 records for components, medical gas containers and closures, and labeling. We estimate firms will expend 19.8 minutes (0.33 hours) to perform this activity, totaling 1,470 hours annually.

Under § 213.186, to ensure uniformity from batch to batch, firms are required to prepare, date, and sign master production and control records for each medical gas. We estimate 1,696 firms will prepare and maintain approximately 22,840 master production and control records and estimate that it will require 2 hours for firms to perform this activity, totaling 45,680 hours annually.

Under § 213.189, firms are required to maintain batch production and control records. These records would need to include documentation that the firm has accomplished each significant step in the manufacturing, processing, packing, or holding of the medical gas produced, including in-process and laboratory tests. We estimate 1,696 firms will prepare and maintain 37,115 batch production and control records. We anticipate it will require 78 minutes (1.3 hours) for firms to perform this activity, totaling 48,250 hours annually. Start Printed Page 51762

Section 213.192(a) describes production record review. Per paragraph (a), firms are required to maintain a written record of any investigation of errors, unexplained discrepancies in production, or failure of a batch or any component of a batch to meet specifications and include the conclusions and followup. We estimate 1,696 firms will prepare and maintain 4,568 laboratory records and that it will require 1 hour for firms to perform this activity, totaling 4,568 hours annually.

Under § 213.194(b) through (e), firms are required to maintain certain laboratory records. Based on available data, we estimate 1,696 firms will prepare and maintain 57,100 laboratory records and estimate it will require 30 minutes (0.5 hours) for firms to perform this activity, totaling 28,550 hours annually.

Section 213.196 describes certain requirements for distribution records. Based on available data, we estimate 1,696 firms will prepare and maintain 57,100 distribution records and estimate it will require 15 minutes (0.25 hours) for firms to perform this activity, totaling 14,275 hours annually.

Under § 213.198, firms are required to maintain written records of each complaint regarding medical gases. We estimate 1,696 firms will maintain 11,420 records of complaints. We estimate it will require approximately 1 hour for firms to perform this activity, totaling 11,420 hours annually.

Section 230.50 establishes the general requirements for requesting a designated medical gas certification for all submission types and outlines the information that must be included in certification request submissions (Form FDA 3864). The new regulations require applicants to include facility information in certification requests. Such information would include, among others, name and address of the original manufacturing facility or facilities where the gas is or will be manufactured.

Section 230.50 also provides for the submission of additional information if FDA deems it appropriate to determine Start Printed Page 51763 whether a medical gas meets the definition of a designated medical gas. This information would generally be in the form of a written request by FDA for the additional information. We estimate that five respondents will submit a total of five certification requests annually, including certification forms for original and resubmissions, and each certification request will require 3 hours to prepare and submit, totaling 15 hours annually.

Under § 230.65, applicants will be allowed to withdraw a certification request that has not been deemed granted. An applicant may notify FDA that it withdraws its certification request at any time before the certification is granted. Upon an applicant's withdrawal of a certification request, FDA will retain the certification request, and if the applicant requests a copy via a Freedom of Information Act request, FDA will provide it pursuant to the fee schedule in FDA's public information regulations. Since the passage of the Food and Drug Administration Safety and Innovation Act, FDA has received several certification requests but has not received any withdrawal requests. FDA has no other data on which to provide a burden estimate. Therefore, the Agency does not expect to receive withdrawal requests except in exceedingly rare situations.

Section 230.70 requires applicants to submit a supplement if any information in the granted certification has changed. The regulation prescribes information to be included in a supplement to the marketing application. We estimate four applicants will submit supplements, and each submission will require 3 hours to prepare, totaling 12 hours annually.

Section 230.72 governs changes in ownership of a granted certification. An example of when a change in ownership could occur is during a merger or acquisition. Upon a change in ownership, the regulations require that both the new and previous owner notify FDA. Based on related submissions received by FDA over the last few years and averaged accordingly, we estimate two respondents will submit four letters or other supporting documents, requiring 2 hours to complete each of the tasks, totaling 8 hours annually.

To assist respondents with the requirements associated with § 230.80 (annual reports), we are developing an annual report form (Form FDA 5025). We estimate that 57 applicants will submit 123 annual reports to FDA. We estimate firms will expend 2 hours per report to perform this activity, totaling 246 hours annually.

Our estimate associated with requirements in § 230.205 for field alert reporting for designated medical gases is based on our prior experience with similar reports that FDA receives. We estimate that FDA will receive a total of 3 field alert reports from the pool of 1,380 applicants and nonapplicants. We anticipate the respondents will each expend approximately 8 hours to perform this activity, totaling 24 hours annually.

Section 230.210 requires that applicants and nonapplicants promptly review all safety information that the applicant or nonapplicant receives or otherwise obtains from any source (including both foreign and domestic sources). Applicants and nonapplicants will generate reports from review of the safety information and will submit the reports under §§ 230.220 and 230.230. As described in § 230.220(a) through (d), firms are required to submit ICSRs associated with the use of a designated medical gas in humans.

Section 230.220 contains requirements for submission of ICSRs associated with the use of a designated medical gas in humans. Under § 230.220(a)(1), applicants and nonapplicants are required to submit each ICSR as soon as possible, but no later than 15 calendar days from the date the applicant or nonapplicant meets the reporting criteria under § 230.220(b) and acquires a minimum data set for an ICSR for that adverse event.

Under § 230.220(a)(3), applicants and nonapplicants will submit new information they receive or otherwise obtain about an ICSR previously submitted to FDA. The regulation prescribes reporting schedules to ensure FDA becomes aware of any new information about the adverse event in a timely manner.

Section 230.220(b) describes the types of ICSRs that applicants and nonapplicants are required to report for human use. Under § 230.220(b)(1), applicants and nonapplicants would be required to submit ICSRs for serious adverse events. Under § 230.220(b)(2), upon notification by FDA, an applicant is required to report to FDA, in a timeframe established by FDA, ICSRs for any adverse events that would not be required under § 230.220(b)(1).

Section 230.220(c) and (d) include additional requirements for the content and format of human designated medical gas ICSRs. Under § 230.220(a) through (d), we estimate that 1,430 applicants and nonapplicants will submit to FDA 172 ICSRs annually. We previously estimated it would take 6 hours for respondents to perform this activity. Upon considering recent estimates for safety reporting that describe a lower time burden (Ref. 6), we estimate it will be less burdensome than we previously expected in the proposed rule for designated medical gas applicants and nonapplicants to comply with ICSR reporting requirements. Moreover, we do not anticipate that safety reporting compliance will be more burdensome for human reports than for animal reports. Therefore, we estimate that it will take 4 hours for respondents to perform this activity, totaling 688 hours annually.

Under § 230.230(a)(1), an applicant or nonapplicant will submit serious adverse events related to the use of a designated medical gas in animals to FDA as soon as possible but no later than 15 calendar days from first receiving the information. The applicant or nonapplicant will submit the report to FDA in electronic format as described under § 230.230(b)(1), unless the applicant or nonapplicant obtains a waiver under § 230.230(b)(2) or FDA requests the report in an alternate format.

Under § 230.230(a)(2), upon notification by FDA, applicants and nonapplicants will submit reports of adverse events associated with the use of a designated medical gas in animals that do not qualify for reporting under § 230.230(a)(1). The notice will specify the adverse events to be reported and the reason for requiring the reports. We anticipate that eight records will be submitted per year. We previously estimated that it will take approximately 5 hours to perform this activity. Upon considering recent estimates for safety reporting that describe a lower time burden (Ref. 6; see also 84 FR 24798 , May 29, 2019), we estimate it will be less burdensome than we previously expected in the proposed rule for designated medical gas applicants and nonapplicants to comply with adverse event reporting requirements. Therefore, we estimate that it will take 4 hours for respondents to perform this activity, totaling 32 hours annually.

Under § 230.230(b)(2), an applicant or nonapplicant may request, in writing, a temporary waiver of the electronic submission requirements under § 230.230(b)(1). An applicant or nonapplicant will provide the initial request by telephone or email to Center for Veterinary Medicine's (CVM's) Division of Pharmacovigilance and Surveillance, with prompt written followup submitted as a letter to the granted certification or certifications. FDA will grant waivers on a limited basis for good cause shown. If FDA Start Printed Page 51764 grants a waiver, the applicant or nonapplicant is required to comply with the conditions for reporting specified by FDA upon granting the waiver. We estimate eight waiver requests will be submitted annually and anticipate it will take 5 hours to prepare and submit the request totaling 40 hours annually.

Section 230.220(e) prescribes requirements for keeping records pertaining to human designated medical gas adverse events. For a period of 10 years from the initial receipt of information, each applicant or nonapplicant is required to maintain records of information relating to adverse events, whether or not submitted to FDA. These records must include raw data, correspondence, and any other information relating to evaluating and reporting adverse event information that is received or otherwise obtained by the applicant or nonapplicant. Upon written notice by FDA, the applicant or nonapplicant will submit any and all of these records to FDA within 5 calendar days after receipt of the notice. The applicant or nonapplicant will permit any authorized FDA employee, at reasonable times, to access, copy, and verify the established and maintained records described in this section. We anticipate that 1,430 manufacturers will create 686 records pertaining to human designated medical gas requirements and it will take approximately 16 hours to perform this activity, totaling 10,976 hours annually.

Section 230.230(c) prescribes requirements for records to be maintained for animal designated medical gas adverse events. For a period of 5 years from the initial receipt of information, each applicant or nonapplicant is required to maintain records of information relating to adverse events, whether or not submitted to FDA. These records must include raw data, correspondence, and any other information relating to evaluating and reporting adverse event information that is received or otherwise obtained by the applicant or nonapplicant. Upon written notice by FDA, the applicant or nonapplicant will submit any and all of these records to FDA within 5 calendar days after receipt of the notice. The applicant or nonapplicant will permit any authorized FDA employee, at reasonable times, to access, copy, and verify the established and maintained records described in this section. We anticipate that 1,696 manufacturers will create eight records pertaining to animal designated medical gas requirements and it will take approximately 5 hours to perform this activity, totaling 40 hours annually.

The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the Paperwork Reduction Act of 1995. Before the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132 . We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. Start Printed Page 51765

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175 . We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a tribal summary impact statement is not required.

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m. Monday through Friday; they are also available electronically at https://www.regulations.gov . Although FDA has verified the website addresses in this document, please note that websites are subject to change over time.

1. FDA draft guidance for industry “Certification Process for Designated Medical Gases,” November 2015, available at https://www.fda.gov/​media/​85013/​download .

2. Kreiter, P., T.G. Bizjak, and R.L. Friedman, “Preventing Patients From Receiving Leaking or Empty Containers of Medical Gas: A Review of Inspectional Findings From 2003 to 2021,” CDER Office of Manufacturing Quality, December 2021, U.S. Food and Drug Administration.

3. FDA, Compliance Program Guidance Manual 7356.002E, “Compressed Medical Gases,” March 15, 2015, available at https://www.fda.gov/​media/​75194/​download .

4. FDA guidance for industry “Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application,” July 2009; available at https://www.fda.gov/​media/​77193/​download .

5. FDA draft guidance for industry “Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines,” March 2001, available at https://www.fda.gov/​media/​73593/​download .

6. FDA, Final Regulatory Impact Analysis: Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases, available at https://www.fda.gov/​about-fda/​economics-staff/​regulatory-impact-analyses-riahttps://www.fda.gov/​about-fda/​economics-staff/​regulatory-impact-analyses-riahttps://www.fda.gov/​about-fda/​economics-staff/​regulatory-impact-analyses-ria .

The following standards appear in the amendatory text of this document and were approved for § 4.4 in the final rule published at 89 FR 7496 (which will be effective February 2, 2026): ISO 13485 and ISO 9000. No changes are proposed to the incorporation by reference (IBR) material.

• Human cells and tissue-based products
• Incorporation by reference
• Medical devices
• Administrative practice and procedure
• Reporting and recordkeeping requirements
• Packaging and containers
• Laboratories
• Prescription drugs
• Animal drugs
• Confidential business information

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, chapter I of title 21 of the Code of Federal Regulations is amended as follows:

1. The authority citation for part 4 is revised to read as follows:

Authority: 21 U.S.C. 321 , 331 , 351 , 352 , 353 , 355 , 360 , 360b-360f , 360h-360j , 360l , 360hh-360ss , 360aaa-360bbb , 360ddd , 360ddd-1 , 371(a) , 372-374 , 379e , 381 , 383 , 394 ; 42 U.S.C. 216 , 262 , 263a , 264 , 271 .

2. Effective February 2, 2026, revise § 4.2 to read as follows:

The terms listed in this section have the following meanings for purposes of this subpart:

Biological product has the meaning set forth in § 3.2(d) of this chapter. A biological product also meets the definitions of either a drug or device as these terms are defined under this section.

Combination product has the meaning set forth in § 3.2(e) of this chapter.

Constituent part is a drug, device, or biological product that is part of a combination product.

Co-packaged combination product has the meaning set forth in § 3.2(e)(2) of this chapter.

Current good manufacturing practice operating system means the operating system within an establishment that is designed and implemented to address and meet the current good manufacturing practice requirements for a combination product.

Current good manufacturing practice requirements means the requirements set forth under § 4.3(a) through (e).

Device has the meaning set forth in § 3.2(f) of this chapter. A device that is a constituent part of a combination product is considered a finished device within the meaning of the Quality Management System Regulation (QMSR).

Drug has the meaning set forth in § 3.2(g) of this chapter and includes medical gas as defined in section 575(2) of the Federal Food, Drug, and Cosmetic Act. Medical gas includes designated medical gases as defined in section 575(1) of the Federal Food, Drug, and Cosmetic Act and medical gases approved under section 505 of the Federal Food, Drug, and Cosmetic Act. A drug other than a medical gas that is a constituent part of a combination product is considered a drug product within the meaning of the drug current good manufacturing practice (CGMP) requirements. A drug that is a medical gas that is a constituent part of a combination product is considered a medical gas within the meaning of the medical gas CGMP requirements.

Drug CGMP requirements refers to the current good manufacturing practice regulations set forth in parts 210 and 211 of this chapter.

HCT/Ps refers to human cell, tissue, and cellular and tissue-based products, Start Printed Page 51766 as defined in § 1271.3(d) of this chapter. An HCT/P that is not regulated solely under section 361 of the Public Health Service Act may be a constituent part of a combination product. Such an HCT/P is subject to part 1271 of this chapter and is also regulated as a drug, device, and/or biological product.

Manufacture includes, but is not limited to, designing, fabricating, assembling, filling, processing, testing, labeling, packaging, repackaging, holding, and storage.

Medical gas CGMP requirements refers to the current good manufacturing practice regulations set forth in part 213 of this chapter.

QMSR refers to the requirements under part 820 of this chapter.

Single-entity combination product has the meaning set forth in § 3.2(e)(1) of this chapter.

Type of constituent part refers to the category of the constituent part, which can be either a biological product, a device, or a drug, as these terms are defined under this section.

3. Effective February 2, 2026, amend § 4.3 by revising paragraphs (a), (c), and (d) and adding paragraph (e) to read as follows:

(a) The current good manufacturing practice requirements in parts 210 and 211 of this chapter apply to a combination product that includes a drug constituent part other than a medical gas;

(c) The current good manufacturing practice requirements among the requirements (including standards) for biological products in parts 600 through 680 of this chapter apply to a combination product that includes a biological product constituent part to which those requirements would apply if that constituent part were not part of a combination product;

(d) The current good tissue practice requirements including donor eligibility requirements for HCT/Ps in part 1271 of this chapter apply to a combination product that includes an HCT/P; and

(e) The current good manufacturing practice requirements in part 213 of this chapter apply to a combination product that includes a drug constituent part that is a medical gas.

4. Effective February 2, 2026, amend § 4.4 by:

a. Revising paragraphs (b)(1) introductory text and (b)(2) introductory text;

b. Redesignating paragraphs (b)(3) and (4) as paragraphs (b)(4) and (5), respectively;

c. Adding new paragraph (b)(3); and

d. Revising paragraph (e).

The revisions and addition read as follows:

(1) If the combination product includes a device constituent part and a drug constituent part, and the current good manufacturing practice operating system has been shown to comply with the drug CGMP requirements or the medical gas CGMP requirements, as applicable, the following clauses of ISO 13485 (together with the definitions in Clause 3 of ISO 9000), which is incorporated by reference into the QMSR under § 820.7 of this chapter, and certain other provisions within the QMSR must also be shown to have been satisfied; upon demonstration that these requirements have been satisfied, no additional showing of compliance with respect to the QMSR need be made:

(2) If the combination product includes a device constituent part and a drug constituent part other than a medical gas, and the current good manufacturing practice operating system has been shown to comply with the QMSR requirements for devices, the following provisions of the drug CGMP requirements must also be shown to have been satisfied; upon demonstration that these requirements have been satisfied, no additional showing of compliance with respect to the drug CGMP requirements need be made:

(3) If the combination product includes a device constituent part and a drug constituent part that is a medical gas, and the current good manufacturing practice operating system has been shown to comply with the QMSR regulation, the following provisions of the medical gas CGMP requirements must also be shown to have been satisfied; upon demonstration that these requirements have been satisfied, no additional showing of compliance with respect to the medical gas CGMP requirements need be made:

(i) Section 213.84 of this chapter. Testing and approval or rejection of components, containers, and closures.

(ii) Section 213.94 of this chapter. Medical gas containers and closures.

(iii) Section 213.122 of this chapter. Materials examination and usage criteria.

(iv) Section 213.165 of this chapter. Testing and release for distribution.

(v) Section 213.166 of this chapter. Stability testing and expiration dating for medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act.

(vi) Section 213.204 of this chapter. Returned medical gases.

(vii) Section 213.208 of this chapter. Salvaging of medical gases.

(e) The requirements set forth in this subpart and in parts 210, 211, 213, 820, 600 through 680, and 1271 of this chapter listed in § 4.3, supplement, and do not supersede, each other unless the regulations explicitly provide otherwise. In the event of a conflict between regulations applicable under this subpart to combination products, including their constituent parts, the regulations most specifically applicable to the constituent part in question shall supersede the more general.

5. The authority citation for part 16 continues to read as follows:

Authority: 15 U.S.C. 1451-1461 ; 21 U.S.C. 141-149 , 321-394 , 467f , 679 , 821 , 1034 ; 28 U.S.C. 2112 ; 42 U.S.C. 201-262 , 263b , 364 .

6. Amend § 16.1 by revising paragraph (b)(2) to read as follows:

(2) The regulatory provisions are as follows:

Table 1 to Paragraph ( b )(2)

Sections 1.634 and 1.664, relating to revocation of recognition of an accreditation body and withdrawal of accreditation of third-party certification bodies that conduct food safety audits of eligible entities in the food import supply chain and issue food and facility certifications.Section 1.1173, relating to the revocation of recognition of an accreditation body, and the disqualification of a laboratory, with respect to food testing conducted under part 1, subpart R of this chapter.Start Printed Page 51767Section 1.1174, relating to the issuance of a directed food laboratory order by FDA pursuant to § 1.1108.Section 56.121(a), relating to disqualifying an institutional review board or an institution.Section 58.204(b), relating to disqualifying a testing facility.Section 71.37(a), relating to use of food containing a color additive.Section 80.31(b), relating to refusal to certify a batch of a color additive.Section 80.34(b), relating to suspension of certification service for a color additive.Section 99.401(c), relating to a due diligence determination concerning the conduct of studies necessary for a supplemental application for a new use of a drug or device.Sections 112.201 through 112.213, (see part 112, subpart R of this chapter), relating to withdrawal of a qualified exemption.Sections 117.251 through 117.287 (part 117, subpart E of this chapter), relating to withdrawal of a qualified facility exemption.Section 130.17(1), relating to a temporary permit to vary from a food standard.Section 170.17(b), relating to use of food containing an investigational food additive.Section 202.1(j)(5), relating to approval of prescription drug advertisements.Section 230.150(b), relating to revocation of the grant of a certification for a designated medical gas.Section 312.70, relating to whether an investigator is eligible to receive test articles under part 312 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.Sections 312.70(d) and 312.44, relating to termination of an IND for a sponsor.Section 312.160(b), relating to termination of an IND for tests in vitro and in laboratory research animals for a sponsor.Section 507.60 through 507.85 (part 507, subpart D of this chapter) relating to withdrawal of a qualified facility exemption.Section 511.1(b)(5), relating to use of food containing an investigational new animal drug.Section 511.1(c)(1), relating to whether an investigator is eligible to receive test articles under part 511 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.Section 511.1(c)(4) and (d), relating to termination of an INAD for a sponsor.Section 812.119, relating to whether an investigator is eligible to receive test articles under part 812 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.Section 814.46(c) relating to withdrawal of approval of a device premarket approval application.Section 822.7(a)(3), relating to an order to conduct postmarket surveillance of a medical device under section 522 of the act.Section 830.130, relating to suspension or revocation of the accreditation of an issuing agency.Section 895.30(c), regarding a proposed regulation to ban a medical device with a special effective date.Section 900.7, relating to approval, reapproval, or withdrawal of approval of mammography accreditation bodies or rejection of a proposed fee for accreditation.Section 900.14, relating to suspension or revocation of a mammography certificate.Section 900.25, relating to approval or withdrawal of approval of certification agencies.Section 1003.11(a)(3), relating to the failure of an electronic product to comply with an applicable standard or to a defect in an electronic product.Section 1003.31(d), relating to denial of an exemption from notification requirements for an electronic product which fails to comply with an applicable standard or has a defect.Section 1004.6, relating to plan for repurchase, repair, or replacement of an electronic product.Section 1107.1(d), relating to rescission of an exemption from the requirement of demonstrating substantial equivalence for a tobacco product.Section 1107.50, relating to rescission of an order finding a tobacco product substantially equivalent.Section 1210.30, relating to denial, suspension, or revocation of a permit under the Federal Import Milk Act.Section 1270.43(e), relating to the retention, recall, and destruction of human tissue.Section 1271.440(e) relating to the retention, recall, and destruction of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and/or the cessation of manufacturing HCT/Ps.

7. The authority citation for part 201 is revised to read as follows:

Authority: 21 U.S.C. 321 , 331 , 343 , 351 , 352 , 353 , 355 , 358 , 360 , 360b , 360ccc , 360ccc-1 , 360ddd , 360ddd-1 , 360ee , 360gg-360ss , 371 , 374 , 379e ; 42 U.S.C. 216 , 241 , 262 , 264 .

8. Amend § 201.1 by revising paragraph (b) to read as follows:

(b) As used in this section, and for purposes of section 502(a) and (b)(1) of the Federal Food, Drug, and Cosmetic Act, the manufacturer of a drug product is the person who performs all of the following operations that are required to produce the product:

(1) Mixing;

(2) Granulating;

(3) Milling;

(4) Molding;

(5) Lyophilizing;

(6) Tableting;

(7) Encapsulating;

(8) Coating;

(9) Sterilizing;

(10) Filling sterile or aerosol drugs into dispensing containers; and

(11) With respect to a medical gas, fabricating the gas by chemical reaction, physical separation, compression of atmospheric air, purification ( e.g., re-processing an industrial gas into a medical gas), combining two or more distinct medical gases, or other process.

9. Amend § 201.10 by revising paragraph (d)(2) to read as follows:

(2) A statement of the percentage of an ingredient in a drug shall, if the term percent is used without qualification, mean percent weight-in-weight, if the ingredient and the drug are both solids, or if the ingredient is a liquid and the drug is a solid; percent weight in Start Printed Page 51768 volume at 68 °F (20 °C), if the ingredient is a solid and the drug is a liquid; percent volume in volume at 68 °F (20 °C), if both the ingredient and the drug are liquids, except that alcohol shall be stated in terms of percent volume of absolute alcohol at 60 °F (15.56 °C); and percent volume in volume if the ingredient is a designated medical gas (as defined in § 201.161(c)(1)).

10. Amend § 201.51 by revising paragraphs (a) and (b) to read as follows:

(a) The label of a prescription or insulin-containing drug in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The statement of quantity of drugs in tablet, capsule, ampule, or other unit dosage form shall be expressed in terms of numerical count; the statement of quantity for drugs in other dosage forms shall be in terms of weight if the drug is solid, semi-solid, or viscous, in terms of fluid measure if the drug is liquid, or in terms of volume measure if the drug is a designated medical gas (as defined in § 201.161(c)(1)) or a medically appropriate combination of designated medical gases in a gaseous state. When the drug quantity statement is in terms of the numerical count of the drug units, it shall be augmented to give the weight or measure of the drug units or the quantity of each active ingredient in each drug unit or, when quantity does not accurately reflect drug potency, a statement of the drug potency.

(b) Statements of weight of the contents shall in the case of prescription drugs be expressed in terms of avoirdupois pound, ounce, and grain or of kilogram, gram, and subdivisions thereof. A statement of liquid measure of the contents shall in the case of prescription drugs other than designated medical gases and medically appropriate combinations thereof be expressed in terms of the U.S. gallon of 231 cubic inches and quart, pint, fluid-ounce, and fluid-dram subdivisions thereof, or of the liter and milliliter, or cubic centimeter, and shall express the volume at 68 °F (20 °C). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be expressed in terms of the liter and milliliter, or cubic centimeter, and shall express the volume at 68 °F (20 °C). A statement of the measure of the contents shall in the case of designated medical gases (as defined in § 201.161(c)(1)) and medically appropriate combinations thereof be expressed as follows:

(1) If in a gaseous state in a high-pressure container, it shall be expressed in liters or cubic feet based on the filled pressure at 70 °F (21 °C);

(2) If in a liquefied compressed gas state in a high-pressure container, it shall be expressed in gaseous liters or by an appropriate net weight statement;

(3) If in a liquefied state in a portable cryogenic container, it shall be expressed in gaseous liters, liquid liters (if identified as a liquid measure), gallons, or by an appropriate net weight statement at the time of fill; and

(4) If in a bulk or transport container (as defined in § 201.161(c)(3)), labeling for net quantity of contents is not required.

11. Amend § 201.105 by revising the introductory text to read as follows:

A drug subject to the requirements of section 503(f)(1) of the act shall be exempt from section 502(f)(1) of the act if it is a designated medical gas (as defined in § 201.161(c)(1)) or a medically appropriate combination of designated medical gases and is in compliance with § 201.161, or if all the following conditions are met:

12. Revise § 201.161 to read as follows:

(a) The requirements of sections 503(b)(4) and 502(f) of the Federal Food, Drug, and Cosmetic Act are deemed to have been met for a designated medical gas or a medically appropriate combination of designated medical gases if the labeling on its final use container bears the following:

(1) In the case of oxygen:

(i) A warning statement providing that uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful; that oxygen should not be used on patients who have stopped breathing unless used in conjunction with resuscitative equipment; and, in the case of oxygen that may be provided without a prescription for use in the event of depressurization or other environmental oxygen deficiency, or for oxygen deficiency or for use in emergency resuscitation when administered by properly trained personnel, a warning statement providing that oxygen may be used for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation, and that for all other medical applications a prescription is required.

(ii) A clear and prominent warning containing the statements “No Smoking” and “No Vaping” and a graphic symbol conveying that smoking, vaping, and open flames near oxygen are dangerous.

(2) In the case of a designated medical gas other than oxygen, and in the case of medically appropriate combinations of any designated medical gases:

(i) A warning statement providing that the administration of the gas or gas combination (as applicable) may be hazardous or contraindicated; and that the gas or gas combination (as applicable) should be used only by or under the supervision of a licensed practitioner who is experienced in the use and administration of the gas or gas combination (as applicable) and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken.

(ii) The symbol “Rx only.”

(3) Appropriate directions and warnings concerning storage and handling.

(b) A designated medical gas or medically appropriate combination of designated medical gases in a bulk or transport container must be identified with the name of the product contained therein and accompanied by documentation identifying the product as meeting applicable compendial standards.

(c) For purposes of this section:

(1) A designated medical gas means a drug that:

(i) Is manufactured or stored in a liquefied, nonliquefied, or cryogenic state;

(ii) Is administered as a gas; and

(iii) Meets the definition in section 575(1) of the Federal Food, Drug, and Cosmetic Act.

(2) A final use container means a container that is for direct use or access by a patient or healthcare provider to administer a designated medical gas or medically appropriate combination of designated medical gases. The term final use container does not include bulk or transport containers and does not include containers that are described in § 868.5655 of this chapter.

(3) A bulk or transport container means a container used to transport or store designated medical gases or medically appropriate combinations of designated medical gases and that is not used directly to administer such gases to a patient.

13. Amend § 201.328 by revising paragraphs (a) introductory text and (a)(1) introductory text and adding paragraph (d) to read as follows:

(a) Portable cryogenic medical gas containers. For the purposes of this section a portable cryogenic medical gas container is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, health care entity, nursing home, other facility, or home health care setting, or is used to fill small cryogenic gas containers for use by individual patients. The term excludes cryogenic containers that are not designed to be connected to a medical gas supply system, e.g., tank trucks, trailers, rail cars, or small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter).

(1) Each portable cryogenic medical gas container must be conspicuously marked with a 360° wraparound label identifying its contents. Such label must meet the requirements of § 213.94(e)(3) of this chapter and the following additional requirements.

(d) Statement identifying owner or return address of medical gas containers. Notwithstanding § 201.1, a container filled with a designated medical gas (as defined in § 201.161(c)(1)) or medically appropriate combination of designated medical gases may bear a statement identifying the name of the owner of the container or the address to which the container should be returned after use. Such statement may appear on a separate sticker or decal. If the owner of the medical gas container is not the manufacturer, packer, or distributor of the designated medical gas or medically appropriate combination of designated medical gases, that shall be clearly stated on the container. The addition of such statement shall not cause the owner of the cylinder to be a “relabeler” for purposes of registration and listing under part 207 of this chapter.

14. The authority citation for part 210 is revised to read as follows:

Authority: 21 U.S.C. 321 , 351 , 352 , 355 , 360b , 360ddd , 360ddd-1 , 371 , 374 ; 42 U.S.C. 216 , 262 , 263a , 264 .

15. Amend § 210.1 by revising paragraphs (a) and (b) to read as follows:

(a) The regulations set forth in this part and in parts 211, 213, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.

(b) The failure to comply with any regulation set forth in this part and in parts 211, 213, 225, and 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.

16. Amend § 210.2 by revising paragraphs (a) and (b) to read as follows:

(a) The regulations in this part and in parts 211, 213, 225, and 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, or cellular or tissue-based product (HCT/P) that is regulated as a drug (subject to premarket review under an application submitted under section 505 of the act or under a biologics license application under section 351 of the Public Health Service Act); shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.

(b) If a person engages in only some operations subject to the regulations in this part and in parts 211, 213, 225, 226, 600 through 680, and 1271 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which the person is engaged.

17. The authority citation for part 211 is revised to read as follows:

18. Amend § 211.1 by revising paragraph (a) to read as follows:

(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs and medical gases as defined in § 213.3(b)(12) of this chapter) for administration to humans or animals.

19. Amend § 211.94 by removing paragraph (e).

20. Amend § 211.125 by revising paragraph (c) to read as follows:

(c) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of drug product finished and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with § 211.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with § 211.122(g)(2).

21. Amend § 211.132 by revising paragraph (c)(1) introductory text to read as follows:

(1) In order to alert consumers to the specific tamper-evident feature(s) used, each retail package of an OTC drug product covered by this section (except ammonia inhalant in crushable glass ampules or aerosol products that depend upon the power of a liquefied or compressed gas to expel the contents from the container) is required to bear a statement that:

22. Amend § 211.170 by revising paragraph (b) introductory text to read as follows:

(b) An appropriately identified reserve sample that is representative of each lot or batch of drug product shall be retained and stored under conditions consistent with product labeling. The reserve sample shall be stored in the same immediate container-closure system in which the drug product is marketed or in one that has essentially the same characteristics. The reserve sample consists of at least twice the quantity necessary to perform all the required tests, except those for sterility and pyrogens. Except for those for drug products described in paragraph (b)(2) of this section, reserve samples from representative sample lots or batches selected by acceptable statistical procedures shall be examined visually at least once a year for evidence of deterioration unless visual examination would affect the integrity of the reserve sample. Any evidence of reserve sample deterioration shall be investigated in accordance with § 211.192. The results of the examination shall be recorded and maintained with other stability data on the drug product. The retention time is as follows:

23. Revise § 211.196 to read as follows:

Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product.

24. Add part 213 to subchapter C to read as follows:

Authority: 21 U.S.C. 321 , 351 , 352 , 353 , 355 , 360b , 360ddd , 360ddd-1 , 371 , 374 .

The regulations in this part contain the minimum current good manufacturing practice for preparation of medical gases for administration to humans or animals.

(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable to such terms when used in this part.

(b) The following definitions of terms apply to this part:

(1) Acceptance criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).

(2) Batch means a specific quantity of a medical gas or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

(3) Commingling or commingled refers to the act of combining one lot of designated medical gas or component with another lot or lots of the same designated medical gas or component.

(4) Component means any ingredient intended for use in the manufacture of a medical gas, including those that may not appear in such gas. It does not include an incoming designated medical gas.

(5) Designated medical gas means a drug that is manufactured or stored in a liquefied, nonliquefied, or cryogenic state; is administered as a gas; and is defined in section 575(1) of the Federal Food, Drug, and Cosmetic Act.

(6) FDA means the Food and Drug Administration.

(7) In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the medical gas.

(8) Incoming designated medical gas means a designated medical gas received from one source that, after receipt, is commingled with the same gas from another source, used in a medically appropriate combination of designated medical gases or in the production of another medical gas, or further distributed.

(9) Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a medical gas produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.

(10) Lot number, control number, or batch number means any distinctive Start Printed Page 51771 combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of medical gas or other material can be determined.

(11) Manufacture, processing, packing, or holding of medical gases includes packaging and labeling operations, testing, and quality control.

(12) Medical gas has the meaning given the term in section 575(2) of the Federal Food, Drug, and Cosmetic Act.

(13) Original manufacturer means the person that initially produces a designated medical gas by chemical reaction, physical separation, compression of atmospheric air, purification ( e.g., re-processing an industrial gas into a medical gas), or other means.

(14) Quality unit means any person or persons designated with the authority and responsibility for overall quality management and other responsibilities as defined in § 213.22.

(15) Strength means:

(i) The concentration of the medical gas (for example, weight/weight, weight/volume, or unit dose/volume basis); and/or

(ii) The potency, that is, the therapeutic activity of the medical gas as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).

(a) There shall be a quality unit that shall have the responsibility and authority to approve or reject all components, medical gas containers and closures, in-process materials, packaging material, labeling, and medical gases, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality unit shall be responsible for approving or rejecting medical gases manufactured, processed, packed, or held under contract by another company.

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, medical gas containers and closures, packaging materials, in-process materials, and medical gases shall be available to the quality unit.

(c) The quality unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the medical gas.

(d) The responsibilities and procedures applicable to the quality unit shall be in writing; such written procedures shall be followed.

(e) Quality unit personnel may perform other functions provided appropriate written controls are in place to ensure any other functions are performed separately from quality unit responsibilities and such other functions do not interfere with the quality unit's responsibilities or subordinate the quality unit's responsibilities to any other unit.

(a) Each person engaged in the manufacture, processing, packing, or holding of a medical gas shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with current good manufacturing practice requirements applicable to them. Written documentation shall be maintained demonstrating the completion of employee training, and shall include the date of the training, the type of the training, and the results of any completion criteria, such as test results.

(b) There shall be an adequate number of qualified personnel to perform the manufacture, processing, packing, or holding of each medical gas.

(c) Only authorized personnel shall enter those areas of the buildings and facilities designated as limited-access areas.

Consultants advising on the manufacture, processing, packing, or holding of medical gases shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.

(a)(1) Any buildings and facilities used in the manufacture, processing, packing, or holding of a medical gas shall be of adequate design, including having adequate space, for the orderly placement of equipment and materials to prevent mix-ups between:

(i) Components;

(ii) Incoming designated medical gases;

(iii) Medical gas containers and closures;

(iv) Labeling;

(v) In-process materials; or

(vi) Medical gases.

(2) Such buildings and facilities shall also allow for adequate cleaning, maintenance, and proper operations.

(b)(1) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mix-ups during the course of the following procedures:

(i) Receipt, identification, storage, and withholding from use of components, incoming designated medical gases, medical gas containers and closures, and labeling, pending the appropriate sampling, testing, or examination by the quality unit before release for manufacturing or packaging;

(ii) Holding rejected components, incoming designated medical gases, medical gas containers and closures, and labeling before disposition;

(iii) Storage of released components, incoming designated medical gases, medical gas containers and closures, and labeling;

(iv) Storage of in-process materials;

(v) Manufacturing and processing operations;

(vi) Packaging and labeling operations;

(vii) Quarantine storage before release of medical gases;

(viii) Storage of medical gases after release; and

(ix) Control and laboratory operations.

(2) The flow of components, incoming designated medical gases, medical gas containers and closures, labeling, in-process materials, and medical gases through the buildings and facilities shall be designed to prevent contamination and mix-ups.

(c) Any building or facility used in the manufacture, processing, packing, or holding of a medical gas shall be maintained in a clean condition so as to assure the safety, identity, strength, quality, and purity of the medical gas. Written procedures applicable to the Start Printed Page 51772 maintenance and cleaning of buildings and facilities shall be established and followed.

Equipment used in the manufacture, processing, packing, or holding of a medical gas shall be of appropriate design and adequate size, and be suitably located to facilitate operations for its intended use and any necessary cleaning and maintenance.

(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or medical gases shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements.

(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, containers, closures, in-process materials, or medical gases so as to alter the safety, identity, strength, quality, or purity of the medical gas beyond the official or other established requirements.

(a) Written procedures shall be established, maintained, and followed for adequate cleaning and maintenance of equipment used in the manufacture, processing, packing, or holding of medical gases. These procedures shall include, but are not necessarily limited to, the following:

(1) Assignment of responsibility for cleaning and maintaining equipment;

(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;

(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;

(4) Removal or obliteration of previous batch identification;

(5) Protection of clean equipment from contamination prior to use; and

(6) Inspection of equipment for cleanliness immediately before use.

(b) The procedures described in paragraph (a) of this section shall not alter the safety, identity, strength, quality, or purity of the medical gas beyond the established requirements.

(c) Records shall be kept of cleaning, maintenance, and inspection as specified in §§ 213.180 and 213.182.

(a) Automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of medical gases shall be routinely calibrated, inspected, and checked according to a written program designed to ensure proper performance. Written procedures and records of calibration, inspections, and checks shall be maintained.

(b) Computerized systems that record, store, or use data shall be appropriately validated.

(c) A backup file of data entered into the computer system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes.

(d) Appropriate change control shall be used whenever modifications are made to computer systems to assure that any changes do not adversely affect data integrity or product quality. Records of such modifications shall be maintained.

(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components, incoming designated medical gases, and medical gas containers and closures; such written procedures shall be followed.

(b) Components, incoming designated medical gases, and medical gas containers and closures shall at all times be handled and stored in a manner to prevent contamination and mix-ups.

(c) Lots of incoming designated medical gases or components, whether used directly as supply or commingled with an existing supply, shall be assigned a unique identification number.

(a)(1) Upon receipt of each shipment of each incoming designated medical gas, the firm shall either perform full compendial testing on the gas and record the results or verify and record that a signed certificate of analysis from the supplier accompanies each different designated medical gas in a shipment. The certificate of analysis shall include the following:

(i) Supplier's name;

(ii) Name of the incoming designated medical gas;

(iii) Lot number or other unique identification number;

(iv) Actual analytical result obtained for strength, as well as the results of other tests performed;

(v) Identification of the test method(s) used for analysis;

(vi) New drug application and/or new animal drug application number of the incoming designated medical gas; and

(vii) Supplier representative's signature and the date of signature.

(2) If the incoming designated medical gas is obtained from a supplier other than the original manufacturer, the shipment shall also include complete information from the original manufacturer's certificate of analysis. The firm shall establish and maintain a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures.

(b) An identity test shall be performed upon receipt of the incoming designated medical gas.

(a) Components, containers, and closures (including valves) shall be examined for conformance with appropriate written procedures and specifications, and approved or rejected, prior to the manufacturing or filling process. In lieu of such examination by the firm, a statement of verification that the component, container, or closure meets specifications may be accepted from the supplier, provided that the firm establishes and maintains a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing provisions. Any rejected items shall be handled in accordance with § 213.89.

(b) Firms shall take appropriate actions to protect against container and closure leaks, which shall include performing leak tests on containers and closures at the time of fill and after fill but prior to release.

(c) Each component shall be sampled, tested, and approved or rejected as appropriate prior to use. This requirement can be met by performing testing for conformance with written specifications or by an identity test on the component accompanied by an acceptable certificate of analysis from the supplier, provided that the firm establishes and maintains a program to ensure the reliability of the supplier's capabilities through appropriate assessment and testing procedures.

Rejected components, incoming designated medical gases, and medical gas containers and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable and shall be documented and assessed.

(a) Medical gas containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the gas beyond the official or established requirements.

(b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the medical gas.

(c) Medical gas containers and closures shall be clean to assure that they are suitable for their intended use.

(d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning shall be written and followed for medical gas containers and closures.

(e) Medical gas containers and closures must meet the following requirements—

(1) Gas-specific use outlet connections. Portable cryogenic medical gas containers that are not manufactured with permanent gas use outlet connections ( e.g., those that have been silver-brazed) must have gas-specific use outlet connections that are attached to the valve body so that they cannot be readily removed or replaced (without making the valve inoperable and preventing the containers' use) except by the manufacturer. For the purposes of this paragraph (e)(1), the term manufacturer includes any individual or firm that fills high-pressure medical gas cylinders or cryogenic medical gas containers. For the purposes of this section, a portable cryogenic medical gas container is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, healthcare entity, nursing home, other facility, or home healthcare setting, or is used to fill small cryogenic gas containers for use by individual patients. The term excludes cryogenic containers that are not designed to be connected to a medical gas supply system, e.g., tank trucks, trailers, rail cars, or small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter).

(2) Gauges for certain medical gas containers. Portable cryogenic medical gas containers as described in paragraph (e)(1) of this section and small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter) must have a working gauge sufficient to assist the user in determining whether the container contains an adequate supply of medical gas for continued use.

(3) Label and coloring requirements. The labeling specified at § 201.328(a) of this chapter must be affixed to the container in a manner that does not interfere with other labeling. Each such label as well as materials used for coloring medical gas containers must be reasonably resistant to fading, durable when exposed to atmospheric conditions, and not readily soluble in water.

(a) There shall be written procedures for production and process controls designed to assure that medical gases have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality unit.

(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.

Written production and control procedures shall include the following, which are designed to assure that the medical gases produced have the identity, strength, quality, and purity they purport or are represented to possess:

(a) Except when a monograph or formulary specifies a range, the batch shall be formulated with the intent to provide 100 percent of the labeled or established amount of each medical gas. When a monograph or formulary specifies a range for the contents of a medical gas, the batch shall be formulated with the intent to provide an amount of the medical gas within such specified range.

(b) Components and incoming designated medical gases added to in-process supply or final product containers shall be weighed or measured as appropriate. In-process and final product containers shall identify the name of the component or designated medical gas or the name and percentage of each component or designated medical gas if they contain multiple components or designated medical gases, and the unique lot number assigned.

(a) In-process materials shall be tested for identity, strength, quality, and purity as appropriate, and approved or rejected by the quality unit during the production process.

(b) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes.

(c) Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and/or testing of labeling and packaging materials; such written procedures shall be followed. Labeling and packaging materials shall be representatively sampled, and examined or tested upon receipt and before use in packaging or labeling of a medical gas.

(b) Any labeling or packaging materials meeting appropriate written specifications may be approved and released for use. Any labeling or packaging materials that do not meet such specifications shall be rejected to prevent their use in operations for which they are unsuitable.

(c) Records shall be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination, and whether accepted or rejected.

(d) Labels and other labeling materials for each different medical gas, strength, Start Printed Page 51774 or quantity of contents shall be stored with suitable identification to avoid mix-ups. Access to the label storage area shall be limited to authorized personnel.

(e) Labels, labeling, and other packaging materials that are obsolete, outdated, or that do not meet applicable requirements shall be destroyed.

(f) Packaging and labeling operations shall include one of the following special control procedures:

(1) Dedication of labeling and packaging lines to each different strength of each different medical gas;

(2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations; or

(3) Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of labeling operations for hand-applied labeling. Such examination shall be performed by one person and independently verified by a second person.

(g) Printing devices on, or associated with, manufacturing lines used to imprint labeling upon the unit label or case shall be monitored to assure that all imprinting conforms to the print specified in the batch production record.

(h) Labels may be reused if they are legible, properly affixed to the container, and otherwise meet all applicable requirements.

(a) Labeling and packaging operations must be controlled to prevent labeling and product mix-ups. Procedures shall be written and followed describing in sufficient detail the control procedures employed for the issuance of labeling.

(b) Procedures shall be used to reconcile the quantities of labeling issued, used, and returned, and shall require evaluation of discrepancies found between the quantity of medical gas and the quantity of labeling issued when such discrepancies are outside narrow preset limits based on historical operating data. Such discrepancies shall be investigated in accordance with § 213.192. Labeling reconciliation is waived for cut or roll labeling if a 100-percent examination for correct labeling is performed in accordance with § 213.122(f)(2). Labeling reconciliation is also waived for 360° wraparound labels on portable cryogenic medical gas containers.

(c) All excess lot number stickers or decals bearing lot or control numbers shall be discarded.

(d) Bulk or transport containers (as defined in § 201.161(c)(3) of this chapter) are exempt from this section.

There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for medical gases; such written procedures shall be followed. These procedures shall incorporate the following features:

(a) Prevention of mix-ups by physical or spatial separation from operations on other products.

(b) Identification and handling of filled containers of medical gas that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container.

(c) Identification of the medical gas with a lot or control number that permits determination of the history of the manufacture and control of the batch. The lot or control number of the medical gas may be identified by use of a separate identification sticker or decal.

(d) Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record. Product labels, including 360° wraparound labels, can be reused provided they meet all applicable labeling requirements, all information on the label is legible, and the label is in good condition.

(e) Inspection of the packaging and labeling facilities immediately before use to assure that all medical gases have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records.

(f) Bulk or transport containers (as defined in § 201.161(c)(3) of this chapter) are exempt from this section provided they are identified with the name of the product contained therein and accompanied by documentation identifying the product as meeting applicable compendial standards.

(a) Written procedures shall be established, and followed, describing the distribution of medical gases and including a system by which the distribution of each lot can be readily determined to facilitate its recall if necessary.

(b) Written procedures shall be established, and followed, describing the warehousing of medical gases, including quarantine of such gases before release by the quality unit.

(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified.

(b) Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, medical gas containers and closures, in-process materials, labeling, and medical gases conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include:

(1) Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, medical gas containers and closures, and labeling used in the manufacture, processing, packing, or holding of a medical gas. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, container, or closure that is subject to deterioration.

(2) Determination of conformance to written specifications and a description of sampling and testing procedures for in-process materials. Such samples shall be representative and properly identified.

(3) Determination of conformance to written descriptions of sampling procedures and appropriate specifications for medical gases. Such Start Printed Page 51775 samples shall be representative and properly identified.

(4) The calibration or verification of calibration for instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording devices not meeting established specifications shall not be used.

(a) For each batch of medical gas, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the medical gas, including the identity and strength, prior to release.

(b) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling, the number of units per batch to be tested, and acceptance criteria. Such written procedures shall be followed.

(c) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 213.194(a)(2). The suitability of all testing methods shall be verified under actual conditions of use.

(d) Medical gases failing to meet established standards or specifications and any other relevant quality criteria shall be rejected.

(e) This section does not apply to the filling of a designated medical gas or medically appropriate combination of designated medical gases via liquid to liquid into a container at a delivery site.

(a) For medical gases marketed under applications submitted under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act, any stability testing performed and any expiration date established shall be in accordance with paragraph (b) of this section, subject to the conditions established in their approved applications, if any.

(b) To assure that the medical gas described in paragraph (a) of this section meets applicable standards of identity, strength, quality, and purity at the time of use:

(1) The stability testing program shall be designed to assess the stability characteristics of the medical gas and its container closure system. The results of stability testing shall be used in determining appropriate storage conditions and any expiration date included on the label. The stability program shall include the appropriate sample size, test intervals, container closure systems, and storage conditions for samples retained for testing.

(2) Any expiration dates included on the label shall appear in accordance with the requirements of § 201.17 of this chapter.

(3) Stability shall be evaluated periodically to ensure that the medical gas continues to meet the standards for identity, strength, quality, and purity stated on the labeling to support the expiration date.

(a) Record availability. All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred and are subject to copying as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph (a).

(b) Record requirements. All records must be legible, stored to prevent deterioration or loss, and original or accurate reproductions of the original records.

(c) Record retention period. Except where otherwise provided, all records required to be maintained in compliance with this part must be maintained for a period of at least 3 years after the distribution of the batch of medical gas.

(d) Maintenance of written records. Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each medical gas to determine the need for changes in specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for:

(1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch; and

(2) A review of complaints, recalls, returned or salvaged medical gases, and investigations conducted under § 213.192 for each gas.

(e) Written procedure requirements. A firm shall establish and follow written procedures to assure that responsible officials of the firm are notified in writing of any recalls, reports of inspectional observations by FDA, regulatory actions related to good manufacturing practices brought by FDA, or investigations resulting from adverse event complaints.

A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 213.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.

Records for components, medical gas containers and closures, and labeling shall include the following:

(a) The results of any test or examination performed (including those performed as required by § 213.84 or § 213.122) and the conclusions derived therefrom.

(b) Documentation of the examination and review of labels and labeling for conformity with established specifications in accordance with §§ 213.122 and 213.130.

(c) The disposition of rejected components, medical gas containers and closures, and labeling.

(a) To assure uniformity from batch to batch, master production and control records for each medical gas shall be prepared, dated, and signed. The preparation of master production and control records shall be described in a Start Printed Page 51776 written procedure and such written procedure shall be followed.

(b) Master production and control records shall include:

(1) The name and strength of the medical gas;

(2) A complete list of components and any incoming designated medical gases used in manufacturing designated by names or codes sufficiently specific to indicate any special quality characteristic;

(3) A description of the medical gas containers and closures, packaging materials, and labels; and

(4) Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.

(a) Batch production and control records shall be prepared for each batch of medical gas produced.

(b) These records shall include documentation that each significant step in the manufacture, processing, packing, or holding of the medical gas produced was accomplished, including:

(1) Dates of each significant step, including in-process and laboratory tests as applicable;

(2) A description of the container for the medical gas, including the number and size of the containers filled as applicable;

(3) Specific identification of each component and its source or in-process material used as applicable;

(4) Measures of components used in the course of processing as applicable;

(5) Testing results, including any in-process test results and finished product test results;

(6) Dated signature or initials of the persons performing and directly supervising or checking each significant step in the operation;

(7) Inspection of the packaging and labeling area before and after use;

(8) Complete labeling control records, including specimens or copies of all labeling used and label application and reconciliation records as appropriate; and

(9) Any investigation made according to § 213.192.

(a) Manufacturing production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality unit to determine compliance with all established, approved written procedures before a batch is released or distributed. The quality unit must review production records to determine whether errors or unexplained discrepancies have occurred prior to batch release. If errors or unexplained discrepancies have occurred, or a batch or any component of the batch fails to meet any of its specifications, the firm must thoroughly investigate and take appropriate corrective actions. A written record of the investigation shall be made and shall include the conclusions and followup.

(b) For production and control records of filling at a delivery site, quality unit review as described in paragraph (a) of this section shall be within one business day after fill.

(a) Laboratory records related to the manufacture of a medical gas must include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:

(1) A description of the sample, the batch or lot number to be tested, the date the sample was taken, and the date the sample was tested.

(2) The method used in the testing of the sample, the result of the test, how the results compare with established standards of identity, strength, quality, and purity for the component, container, closure, in-process materials (as applicable), and medical gas tested, a record of any calculations performed in connection with each test and any calculated results, and the unit of measurement of the result for each test. It is not necessary to provide the actual calculation where the result is evident through use of simple addition and subtraction.

(3) Where applicable, any graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific component, in-process material, or medical gas for each lot tested.

(4) The initials or signature of the person performing the test and the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.

(b) Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for the modification and data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method.

(c) Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions.

(d) Complete records shall be maintained of the periodic calibration or verification of calibration of laboratory instruments, apparatus, gauges, and recording devices required by § 213.160(b)(4).

(e) Complete records shall be maintained of all stability testing performed in accordance with § 213.166.

Distribution records shall contain the name of the medical gas, lot or batch number, name and address of the consignee, and date and quantity shipped. For medically appropriate combinations of designated medical gases, the distribution record shall include the percentage of each gas.

(a) Written procedures shall be established and followed for the receipt and handling of all written or oral complaints concerning a medical gas. These procedures must include quality unit review of any complaint involving the possible failure of a medical gas to meet any of its specifications and provisions for determining the need for an investigation in accordance with § 213.192 as well as determining whether the complaint represents an event that is required to be reported to FDA under part 230 of this chapter. Any complaint involving a possible leak of a container or closure must be reviewed, evaluated, and investigated in accordance with § 213.192.

(b) A written record of each complaint regarding a medical gas must be maintained. The record must include the name of the gas, the lot or batch number, the name of the complainant, the date the complaint was received, the nature of the complaint, and the response to the complaint. It must also include the findings of any investigation and followup. Where an investigation is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.

(c) Complaint files shall be maintained in a manner such that they are readily available for inspection by the firm or by FDA during an inspection. Complaint files shall be maintained for at least 1 year after the date the complaint was received or for at least 3 years after distribution of the medical gas, whichever is longer.

Returned medical gases shall be identified as such and held. If the conditions under which such returned gases have been held, stored, or shipped before or during their return, or if the condition of the gas, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality, or purity of the gas, the returned gas shall be destroyed unless examination, testing, or other investigations prove the gas meets appropriate standards of safety, identity, strength, quality, or purity. Records of returned medical gases shall be maintained and shall include the name, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned gas. If the reason for a medical gas being returned implicates associated batches, an appropriate investigation shall be conducted in accordance with the requirements of § 213.192. Procedures for the holding, testing, and use of returned medical gases shall be in writing and shall be followed. This section is not applicable to the routine refilling of cryogenic medical gas containers in the normal course of business unless the cryogenic medical gas container was returned due to a quality issue.

Medical gases in containers that have been subjected to improper storage conditions may be salvaged unless their containers have been subjected to adverse conditions that impact the identity, strength, quality, and purity of the gas or integrity of the container closure. Whenever there is a question whether medical gases have been subjected to such conditions, salvaging operations may be conducted only if there is evidence from laboratory tests that such gases meet all applicable standards of identity, strength, quality, and purity, and the integrity of the container closure system is not compromised. Procedures for the holding, testing, and use of salvaged medical gases shall be in writing and shall be followed.

25. Add part 230 to subchapter C to read as follows:

Authority: 21 U.S.C. 321 , 331 , 351 , 352 , 353 , 355 , 355a , 355f , 356 , 356a , 356b , 356c , 356e , 360b , 360cc , 360ddd , 360ddd-1 , 371 , 374 , 379e , 379k-1 , 381 .

This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of certifications to market designated medical gases under sections 575 and 576 of the Federal Food, Drug, and Cosmetic Act, as well as amendments and supplements to those certifications. This part also sets forth the postmarketing safety reporting requirements for designated medical gases.

The purpose of this part is to establish an efficient process for the certification of designated medical gases and to establish an effective system for surveillance of such gases.

(a) The definitions and interpretations contained in sections 201 and 575 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part.

(1) Adverse event means any untoward medical occurrence associated with the use of a designated medical gas in humans or animals, whether or not it is considered related to the designated medical gas. An adverse event can occur in the course of the use of a designated medical gas; from overdose of a designated medical gas, whether accidental or intentional; from abuse of a designated medical gas; from discontinuation of the designated medical gas ( e.g., physiological withdrawal); and it includes any failure of expected pharmacological action.

(2) Applicant means any person who submits a certification request for a designated medical gas under this part, including a supplement, and any person who owns a granted certification for a designated medical gas under this part.

(3) Certification request means a submission under section 576 of the Federal Food, Drug, and Cosmetic Act requesting certification of a medical gas as a designated medical gas.

(4) FDA or Agency means the Food and Drug Administration.

(5) Individual case safety report (ICSR) means a description of an adverse event related to an individual patient or subject.

(6) ICSR attachments means documents related to the adverse event described in an ICSR, such as medical records, hospital discharge summaries, or other documentation.

(7) Life-threatening adverse event means any adverse event that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse event as it occurred, i.e., it does not include an adverse event that, had it occurred in a more severe form, might have caused death.

(8) Minimum data set for an ICSR for an adverse event means the minimum four elements required for reporting an ICSR of an adverse event: An identifiable patient, an identifiable reporter, a suspect designated medical gas, and an adverse event.

(9) Nonapplicant means any person other than the applicant whose name appears on the label of a designated medical gas container as a manufacturer, packer, or distributor.

(10) Serious adverse event means:

(i) An adverse event is considered “serious” if it results in any of the following outcomes:

(B) A life-threatening adverse event;

(C) Inpatient hospitalization or prolongation of existing hospitalization;

(D) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; and/or

(E) A congenital anomaly/birth defect.

(ii) Other events that may be considered serious adverse events: Important medical events that may not result in one of the listed outcomes in this definition may be considered Start Printed Page 51778 serious adverse events when, based upon appropriate medical judgment, they may jeopardize the patient or study subject and may require medical or surgical intervention to prevent one of the outcomes listed in this paragraph (b)(10). Examples include: Allergic bronchospasm requiring intensive treatment in an emergency department or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of product dependency or product abuse. Additional examples in animals include: Severe hypersensitivity reactions or respiratory distress.

(a) Who must submit a request for certification. (1) The certification process described in this subpart applies to designated medical gases for the indications described in section 576(a)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act. Any person who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce shall file a request for certification. The certification process is the same for all designated medical gases, regardless of whether it is intended for human use, animal use, or both. The applicant must identify its intention to market its designated medical gas for human use, animal use, or both.

(2) Any person that proposes to market a medical gas that is a new drug for human use must obtain approval under part 314 of this chapter, and any person that proposes to market a medical gas that is a new animal drug for animal use must obtain approval under part 514 of this chapter, unless—

(i) The medical gas meets the definition of a designated medical gas; and

(ii) The medical gas is proposed to be marketed alone or in combination (as medically appropriate) with another designated medical gas or other designated medical gases, for which a certification or certifications have been granted, for a use described under section 576(a)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act.

(b) The applicant must include the following information in its certification request —(1) Applicant information. The applicant must identify the name, address, telephone number, and email address of the person requesting certification. If the address of the person requesting certification is not in the United States, the certification request is required to contain the name and address of, and be countersigned by, an attorney, agent, or other authorized official who resides or maintains a place of business within the United States.

(2) Type of submission. The applicant must indicate the type of submission as one of the following:

(i) Original certification request. An initial request submitted by an applicant for certification of a medical gas as a designated medical gas.

(ii) Amendment to a pending certification request. Any submission related to a pending submission that revises existing information or provides additional information, including responses to Information Request Letters.

(iii) Resubmission. Any submission that has been revised and submitted again following a previous denial. If an applicant chooses to resubmit its submission, it must provide a written response to the deficiencies identified in FDA's denial letter, along with other information required for certification requests.

(iv) Supplement to a granted certification. Any submission that contains a change to a granted certification.

(v) Other. Any submission that does not fit in one of the other categories.

(3) Description of medical gas. A separate certification request is required to be submitted for each designated medical gas for which certification is sought. Each designated medical gas certification request must include the name of the medical gas and a certification statement from the applicant that the designated medical gas meets the appropriate compendial standard.

(4) Facility information. Each certification request must include the name and address of the facility or facilities where the designated medical gas will be initially produced. For each facility, include a brief description of the manufacturing or processing activities performed, the FDA Establishment Identifier, if one exists, and the Unique Facility Identifier in accordance with the requirements of part 207 of this chapter and section 510 of the Federal Food, Drug, and Cosmetic Act. For amendments and supplements, only changes to the list of facilities are required to be included.

(5) Certification of adequate manufacture, processing, packaging, and holding of designated medical gas. The applicant must certify that the applicant's methods, facilities, and controls used for the manufacture, processing, packing, and holding of the designated medical gas, as applicable, are adequate to ensure its safety, identity, strength, quality, and purity.

(6) Additional information. The applicant must provide any other information which FDA deems appropriate to determine whether the medical gas is a designated medical gas. The applicant may also provide other information that the applicant believes will assist FDA in evaluating the request.

(c) Where and how to submit a request for certification. The applicant must submit a signed, completed request for certification form either in an electronic format that FDA can process, review, and archive, or in hard copy by submitting two paper copies to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705.

An applicant may at any time withdraw a certification request that is not yet deemed granted by notifying FDA in writing. A decision to withdraw the certification request is without prejudice to refiling. The Agency will retain the certification request and will provide a copy to the applicant on request under the fee schedule in § 20.45 of this chapter (FDA's public information regulations).

(a) The applicant must submit a supplement if any information in the certification request changes after the request has been deemed granted, including, but not limited to, the addition of a new facility manufacturing the designated medical gas, a change in contact information, or a change in the corporate name.

(b) Each supplement must include a signed, completed request for certification form with the updated information in accordance with § 230.50. The updated information must be submitted no later than 30 calendar days after the date the change occurred.

An applicant may transfer ownership of its certification. At the time of transfer the new and former owners are required to submit information to FDA as follows:

(a) The former owner must submit a letter or other document that states that all rights to the certification have been transferred to the new owner. Start Printed Page 51779

(b) The new owner must submit a supplement under § 230.70 signed by the new owner describing any changes in the conditions in the granted certification and a letter or other document containing the date that the change in ownership is effective.

(a) The applicant must submit each year within 60 calendar days of the new calendar year an annual report containing the information described in paragraph (b) of this section. The applicant must submit a signed, completed annual report form either in an electronic format that FDA can process, review, and archive, or in hard copy by submitting two paper copies to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705.

(b) The report must contain, for the prior calendar year, the following information in the order listed:

(1) Summary. A brief summary of significant new information that might affect the safety, effectiveness, or labeling of the designated medical gas, including any actions the applicant has taken or intends to take as a result of this new information.

(2) Distribution data. Information about the quantity of the designated medical gas distributed by the applicant. The information must include the National Drug Code (NDC) numbers, the quantities distributed for domestic use, and the quantities distributed for foreign use. Disclosure of financial or pricing data is not required.

(3) Administrative changes. Any changes to the applicant's name or contact information.

(4) Current facilities. A list of current facilities where the designated medical gas is initially produced, and a list of facilities that are no longer in use.

(a) In reviewing a submission pursuant to § 230.50, FDA will consider information provided with the submission along with any other available, relevant information of which FDA becomes aware, including information obtained from State or Federal officials, FDA inspection reports, or any other source.

(b) FDA will deny a submission if FDA finds that:

(1) The medical gas that is the subject of the submission is not a designated medical gas;

(2) The submission does not contain the required information or otherwise appears to lack sufficient information to determine that the medical gas is a designated medical gas;

(3) The applicant's methods, facilities, and controls used for the manufacture, processing, and handling of the designated medical gas, as applicable, are not adequate to ensure its safety, identity, strength, quality, and purity; or

(4) Denying the request is otherwise necessary to protect the public health.

(c) Within 60 calendar days of filing of a submission, FDA may contact the applicant to request additional information regarding the submission if it determines that required information is not included in the submission, that FDA needs such information to determine whether the medical gas is a designated medical gas, or that FDA determines such information is necessary to protect the public health. Upon receipt of an amendment to a pending certification request, this 60-day review period will restart. If FDA is not able to contact the applicant to obtain and evaluate the information within the 60-day review period, FDA may find that the submission lacks sufficient information to permit a determination that the medical gas is a designated medical gas and deny the submission. If FDA is able to contact the applicant but is not provided with the additional information requested within the 60-day review period, FDA may find that the request lacks sufficient information to permit a determination that the medical gas is a designated medical gas and deny the submission.

(d) Within 60 calendar days of filing of a submission, if FDA makes one of the findings described in paragraph (b) of this section, FDA will notify the applicant in writing that the submission is denied and provide the basis for FDA's determination.

Unless FDA makes one of the findings described in § 230.100(b) and notifies the applicant within 60 calendar days of filing that the submission is denied, the certification is deemed to be granted and the designated medical gas will be deemed to have in effect an approved application under section 505 or section 512 of the Federal Food, Drug, and Cosmetic Act, or both, as applicable, for the indications described in section 576(a)(3)(A)(i) of the Federal Food, Drug, and Cosmetic Act. FDA will notify the applicant in writing.

(a) Withdrawal. (1) FDA will notify the applicant, and afford an opportunity for a hearing on a proposal to withdraw approval of the application under the procedure in § 314.200 of this chapter, § 514.200 of this chapter, or both, as applicable, if any of the following apply:

(i) The Secretary of Health and Human Services has suspended the approval of the application for a designated medical gas on a finding that there is an imminent hazard to the public health. FDA will promptly afford the applicant an expedited hearing following summary suspension on a finding of imminent hazard to health.

(ii) FDA finds:

(A) That clinical or other experience, tests, or other scientific data show that the designated medical gas is unsafe for use under the conditions of use upon the basis of which the application was approved; or

(B) That new evidence of clinical experience not available to FDA until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available when the application was approved, reveal that the designated medical gas is not shown to be safe for use under the conditions of use upon the basis of which the application was approved; or

(C) Upon the basis of new information before FDA with respect to the designated medical gas, evaluated together with the evidence available when the application was approved, that there is a lack of substantial evidence from adequate and well-controlled investigations as defined in § 314.126 of this chapter, that the designated medical gas will have the effect it is purported or represented to have under the conditions of use prescribed, recommended, or suggested in its labeling; or

(D) That the application contains any untrue statement of a material fact.

(2) FDA may notify the applicant, and afford an opportunity for a hearing on a proposal to withdraw approval of the application under the procedure in § 314.200 of this chapter, § 514.200 of this chapter, or both, as applicable, if the Agency finds:

(i) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain required records or to make required reports applicable to designated medical gases, including under sections 505(k) and 512(l) of the Federal Food, Drug, and Cosmetic Act and this part, part 213 of this chapter, and § 314.81(b)(3) of this chapter, or that the applicant has refused to permit access to, or copying or verification of, its records. Start Printed Page 51780

(ii) That on the basis of new information before FDA, evaluated together with the evidence available when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the designated medical gas are inadequate to ensure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Agency.

(iii) That on the basis of new information before FDA, evaluated together with the evidence available when the application was approved, the labeling of the designated medical gas, based on a fair evaluation of all material facts, is false or misleading in any particular, and the labeling was not corrected by the applicant within a reasonable time after receipt of written notice from the Agency.

(iv) That the applicant has failed to comply with the notice requirements of section 510(j)(2) of the Federal Food, Drug, and Cosmetic Act.

(3) FDA will withdraw approval of an application if the applicant requests its withdrawal because the designated medical gas subject to the application is no longer being marketed, provided none of the conditions listed in paragraphs (a)(1) and (2) of this section applies to the designated medical gas. FDA will consider a written request for a withdrawal under this paragraph (a)(3) to be a waiver of an opportunity for hearing otherwise provided for in this section. Withdrawal of approval of an application under this paragraph (a)(3) is without prejudice to refiling.

(4) FDA may notify an applicant that it believes a potential problem associated with a designated medical gas is sufficiently serious that the designated medical gas should be removed from the market and may ask the applicant to waive the opportunity for hearing otherwise provided for under this section, to permit FDA to withdraw approval of the application for the product, and to remove voluntarily the product from the market. If the applicant agrees, the Agency will not make a finding under paragraph (a)(1) or (2) of this section, but will withdraw approval of the application in a notice published in the Federal Register that contains a brief summary of the Agency's and the applicant's views of the reasons for withdrawal.

(5) If FDA withdraws an approval, FDA will publish a notice in the Federal Register announcing the withdrawal of approval.

(b) Revocation. FDA may revoke the grant of a certification if FDA determines, after providing the applicant with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the request for certification contains any material omission or falsification.

The applicant shall submit a field alert report containing all information described in paragraphs (a) and (b) of this section about distributed designated medical gases and articles to the FDA district office that is responsible for the facility involved as soon as possible but no later than 45 calendar days from the date the applicant, or its agent or contractor, obtained information suggesting that a reportable incident has occurred. If the information suggests that the reportable incident may require a rapid response to address a public health risk, the applicant must as soon as possible, but no later than 3 working days from obtaining the information, submit a field alert report. The information may be provided by telephone or other rapid communication means, with prompt written followup. The report and its mailing cover should be plainly marked: “Designated Medical Gas—Field Alert Report.”

(a) Information concerning any incident that causes the designated medical gas or its labeling to be mistaken for, or applied to, another article.

(b) Information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed designated medical gas, or any failure of one or more distributed batches of the designated medical gas to meet established specifications.

(a) Review of safety information. Each applicant and nonapplicant must promptly review all safety information that the applicant or nonapplicant receives or otherwise obtains from any source, foreign or domestic, such as information derived from commercial marketing experience, reports in the published scientific and medical literature, unpublished scientific papers, and reports from regulatory authorities.

(b) Safety reporting disclaimer. (1) A report or information submitted by an applicant or nonapplicant (and any release by FDA of that report or information) under § 230.220 or § 230.230 does not necessarily reflect a conclusion by the applicant or nonapplicant or by FDA that the report or information constitutes an admission that the designated medical gas caused or contributed to an adverse effect.

(2) An applicant or nonapplicant need not admit, and may deny, that the report or information submitted under § 230.220 or § 230.230 constitutes an admission that the designated medical gas caused or contributed to an adverse effect.

(a) ICSR reporting —(1) General. Except as provided in paragraph (c) of this section, applicants and nonapplicants must submit each ICSR associated with the use of a designated medical gas in humans described in paragraph (b) of this section to FDA as soon as possible but no later than 15 calendar days from the date when the applicant or nonapplicant has met the reporting criteria described in paragraph (b) of this section and acquired a minimum data set for an ICSR for an adverse event.

(2) Copies of ICSRs obtained from FDA. An applicant or nonapplicant should not resubmit under this section any ICSRs obtained from FDA's adverse event reporting database or forwarded to the applicant or nonapplicant by FDA.

(3) Followup information. Applicants and nonapplicants must submit any new information that is related to a previously submitted ICSR or an ICSR that was sent to the applicant or nonapplicant by FDA no later than 15 calendar days after the information is received or otherwise obtained.

(b) Reporting requirements —(1) Serious adverse events —(i) Reported to or otherwise received by the applicant or nonapplicant. Applicants and nonapplicants must submit ICSRs for serious adverse events reported to or otherwise received by the applicant or nonapplicant (such as a report initiated by a patient, consumer, or healthcare professional, or received at the request of the applicant or nonapplicant).

(ii) Reported from the scientific literature. Applicants and nonapplicants must submit ICSRs for serious adverse events obtained from published scientific and medical journals either as case reports or as the result of a formal clinical trial.

(iii) Exception to reporting requirements for serious adverse events. Notwithstanding paragraphs (b)(1)(i) and (ii) of this section, ICSRs are not required for reports of the death of a patient who was administered oxygen, unless the applicant or nonapplicant is aware of evidence to suggest that the Start Printed Page 51781 death was caused by the administration of oxygen.

(2) Other adverse event reports to be submitted upon notification by FDA. Upon notification by FDA, applicants and nonapplicants must submit, in a timeframe established by FDA, ICSRs for any adverse events that are not required under paragraph (b)(1) of this section. The notification will specify the adverse events to be reported and the reason for requiring the reports.

(c) Completing and submitting ICSRs. This paragraph (c) describes how to complete and submit ICSRs required under this section.

(1) Electronic format for submissions. (i) ICSRs and ICSR attachments must be in an electronic format that FDA can process, review, and archive.

(ii) An applicant or nonapplicant may request, in writing, a temporary waiver of the requirements in paragraph (c)(1)(i) of this section. These waivers will be granted on a limited basis for good cause shown.

(2) Submitting ICSRs —(i) Single submission of each ICSR. Submit each ICSR only once.

(ii) Separate ICSR for each patient. The applicant or nonapplicant must submit a separate ICSR for each patient who experiences an adverse event reportable under paragraph (b) of this section.

(iii) Coding terms. The adverse event terms described in the ICSR must be coded using standardized medical terminology.

(iv) Minimum data set. All ICSRs submitted under this section must contain at least the minimum data set for an ICSR for an adverse event. The applicant or nonapplicant must actively seek the minimum data set in a manner consistent with the written procedures under paragraph (f) of this section. Applicants and nonapplicants must document and maintain records of their efforts to obtain the minimum data set.

(v) ICSR elements. The applicant or nonapplicant must complete all known, available elements of an ICSR as specified in paragraph (d) of this section.

(A) For adverse events, applicants and nonapplicants must actively seek any information needed to complete all applicable elements, consistent with their written procedures under paragraph (f) of this section.

(B) Applicants and nonapplicants must document and maintain records of their efforts to obtain the missing information.

(vi) Supporting documentation. An applicant or nonapplicant must submit the following types of supporting documentation in an ICSR, if available:

(A) A copy of the autopsy report if the patient died, or a copy of the hospital discharge summary if the patient was hospitalized. The applicant or nonapplicant must submit each document as an ICSR attachment. The ICSR attachment must be submitted either with the initial ICSR or no later than 15 calendar days after obtaining the document. English translations of foreign language documents must be provided.

(B) A copy of the published article as an ICSR attachment for each ICSR of an adverse event obtained from the published scientific and medical literature. Foreign language articles must be accompanied by an English translation of the abstract. When submitting more than one ICSR from the same published article, the applicant or nonapplicant must submit only one copy of the article with one of the ICSRs. For the remaining ICSRs not accompanied by a copy of the published article, the applicant or nonapplicant must include the cross-reference to the specific ICSR to which the article is attached.

(d) Information reported on ICSRs. ICSRs must include the following information, subject to paragraph (c)(2)(v) of this section:

(1) Patient information, which includes:

(i) Patient identification code;

(ii) Patient age at the time of adverse event, or date of birth;

(iii) Patient sex; and

(iv) Patient weight.

(2) Adverse event, which includes:

(i) Outcome attributed to adverse event;

(ii) Date of adverse event;

(iii) Date of ICSR submission;

(iv) Description of adverse event;

(v) Adverse event term(s);

(vi) Description of relevant tests conducted, including dates and laboratory data; and

(vii) Other relevant patient history, including preexisting medical conditions.

(3) Suspect designated medical gas(es), which includes:

(ii) Dose, frequency, and route of administration used;

(iii) Therapy dates;

(iv) Diagnosis for use (indication);

(v) Whether the adverse event abated after the use of the designated medical gas(es) stopped or the dose was reduced;

(vi) Whether the adverse event reappeared after reintroduction of the designated medical gas(es);

(vii) Lot number;

(viii) National Drug Code (NDC) number; and

(ix) Concomitant medical products and therapy dates.

(4) Initial reporter information, which includes:

(i) Name, address, email address, and telephone number;

(ii) Whether the initial reporter is a healthcare professional; and

(iii) Occupation, if a healthcare professional.

(5) Applicant or nonapplicant information, which includes:

(i) Applicant or nonapplicant name, address, email address, and telephone number;

(ii) Report source, such as spontaneous, literature, or study;

(iii) Date the report was received by applicant or nonapplicant;

(iv) New drug application and/or new animal drug application number;

(v) Whether the ICSR is an expedited report;

(vi) Whether the ICSR is an initial report or followup report; and

(vii) Unique case identification number, which must be the same in the initial report and any subsequent followup report(s).

(e) Recordkeeping. (1) For a period of 10 years from the initial receipt of information, each applicant or nonapplicant must maintain records of information relating to adverse events under this section, whether or not submitted to FDA.

(2) These records must include raw data, correspondence, and any other information relating to the evaluation and reporting of adverse event information that is received or otherwise obtained by the applicant or nonapplicant.

(3) Upon written notice by FDA, the applicant or nonapplicant must submit any or all of these records to FDA within 5 calendar days after receipt of the notice. The applicant or nonapplicant must permit any authorized FDA employee, at reasonable times, to access, copy, and verify these established and maintained records described in this section.

(f) Written procedures. The applicant or nonapplicant must develop written procedures needed to fulfill the requirements in this section for the surveillance, receipt, evaluation, and reporting to FDA of adverse event information, including procedures for employee training and for obtaining and processing adverse event information from other applicants and nonapplicants.

(g) Patient privacy. An applicant or nonapplicant should not include in reports under this section the names and addresses of individual patients; instead, the applicant or nonapplicant Start Printed Page 51782 should assign a unique code for identification of the patient. The applicant or nonapplicant should include the name of the reporter from whom the information was received as part of the initial reporter information, even when the reporter is the patient. As set forth in FDA's public information regulations in part 20 of this chapter, FDA generally may not disclose the names of patients, individual reporters, healthcare professionals, hospitals, and geographical identifiers submitted to FDA in adverse event reports.

(a) Report for adverse events. This report provides information on each adverse event associated with the use of a designated medical gas in animals, regardless of the source of the information.

(1) Serious adverse events. The applicant or nonapplicant must submit serious adverse events to FDA as soon as possible but no later than within 15 calendar days of first receiving the information. The report must be submitted to the Agency in electronic format as described in paragraph (b)(1) of this section, unless the applicant or nonapplicant obtains a waiver under paragraph (b)(2) of this section or FDA requests the report in an alternate format.

(i) Reported to or otherwise received by the applicant or nonapplicant. Applicants and nonapplicants must submit reports for each serious adverse event reported to or otherwise received by the applicant or nonapplicant (such as reports initiated by a patient, consumer, veterinarian, or other healthcare professional, or received at the request of the applicant or nonapplicant), regardless of whether the applicant or nonapplicant believes the events are related to the designated medical gas.

(ii) Reported from the scientific and medical literature. Applicants and nonapplicants must submit reports for each serious adverse event obtained from the published scientific and medical literature regardless of whether the applicant or nonapplicant believes the events are related to the designated medical gas.

(iii) Exception to reporting requirements for serious adverse events. Notwithstanding paragraphs (a)(1)(i) and (ii) of this section, reports are not required to be submitted for the death of an animal that was administered oxygen, unless the applicant or nonapplicant becomes aware of evidence to suggest that the death was caused by the administration of oxygen.

(2) Other adverse event reports to be submitted upon notification by FDA. Upon notification by FDA, applicants and nonapplicants must submit reports of adverse events associated with the use of a designated medical gas in animals that do not qualify for reporting under paragraph (a)(1) of this section. The notice will specify the adverse events to be reported and the reason for requiring the reports.

(3) Copies of adverse event reports obtained from FDA. An applicant or nonapplicant should not resubmit under this section any adverse event reports obtained from FDA's adverse event reporting database or forwarded to the applicant or nonapplicant by FDA.

(b) Format for submissions —(1) Electronic submissions. Reports submitted to FDA under this section must be submitted in an electronic format that FDA can process, review, and archive. Data provided in electronic submissions must be in conformance with the data elements in Form FDA 1932 and FDA technical documents describing transmission. As necessary, FDA will issue updated technical documents on how to provide the electronic submission ( e.g., method of transmission and processing, media, file formats, preparation and organization of files). Unless requested by FDA, paper copies of reports submitted electronically should not be submitted to FDA.

(2) Waivers. An applicant or nonapplicant may request, in writing, a temporary waiver of the electronic submission requirements in paragraph (b)(1) of this section. The initial request may be provided by telephone or email to the Center for Veterinary Medicine's Division of Pharmacovigilance and Surveillance, with prompt written followup submitted as a letter to the granted certification(s). FDA will grant waivers on a limited basis for good cause shown. If FDA grants a waiver, the applicant or nonapplicant must comply with the conditions for reporting specified by FDA upon granting the waiver.

(c) Records to be maintained. (1) For a period of 5 years from the initial receipt of information, each applicant or nonapplicant must maintain records of information relating to adverse event reports under this section, whether or not submitted to FDA.

26. The authority citation for part 314 is revised to read as follows:

Authority: 21 U.S.C. 321 , 331 , 351 , 352 , 353 , 355 , 355a , 355f , 356 , 356a , 356b , 356c , 356e , 360cc , 360ddd , 360ddd-1 , 371 , 374 , 379e , 379k-1 .

27. Amend § 314.1 by redesignating paragraph (c) as paragraph (d) and adding new paragraph (c) to read as follows:

(c) The following provisions do not apply to designated medical gases, which are subject to the certification and postmarketing reporting requirements under part 230 of this chapter:

(1) Sections 314.50 through 314.72;

(2) Section 314.80;

(3) Section 314.81, except paragraph (b)(3);

(4) Section 314.90;

(5) Subpart C of this part;

(6) Sections 314.100 through 314.162;

(7) Subpart H of this part; and

(8) Subpart I of this part.

28. The authority citation for part 514 is revised to read as follows:

Authority: 21 U.S.C. 321 , 331 , 351 , 352 , 354 , 356a , 360b , 360ccc , 360ddd , 360ddd-1 , 371 , 379e , 381 .

29. Amend § 514.1 by adding a sentence to the end of paragraph (a) to read as follows:

(a) * * * The following provisions do not apply to designated medical gases, which are subject to the certification requirements under part 230 of this chapter: §§ 514.1(b) and (c), 514.3 through 514.8, 514.12, and 514.15, and subpart B of this part.

30. Amend § 514.80 by:

a. In the introductory text table, adding an entry after the sixth entry; and Start Printed Page 51783

b. Adding paragraph (a)(6).

The additions read as follows:

The following table outlines the purpose for each paragraph of this section:

Purpose	21 CFR paragraph and title
*         *         *         *         *         *         *
Does this section apply to designated medical gases subject to the certification requirements under part 230?	514.80(a)(6)
*         *         *         *         *         *         *

(6) This section does not apply to designated medical gases, which are subject to the certification requirements under part 230 of this chapter. Part 230 of this chapter contains requirements related to records and reports concerning experience with the use of a designated medical gas in animals.

Dated: June 10, 2024.

Robert M. Califf,

Commissioner of Food and Drugs.

1.  Section 576(a)(3)(A)(i) of the FD&C Act provides that “[a] designated medical gas for which a certification is granted under paragraph (2) is deemed, alone or in combination, as medically appropriate, with another designated medical gas or gases for which a certification or certifications have been granted, to have in effect an approved application under section [505 or 512], subject to all applicable postapproval requirements,” for certain indications for use. FDA interprets the term “combination” in this section to mean two or more distinct designated medical gases that are mixed together. For example, a mixture of oxygen and nitrous oxide that each meet the standards set forth in an official compendium could constitute a medically appropriate combination of designated medical gases. However, the addition of oxygen to a container that already contains oxygen would not result in a medically appropriate combination of designated medical gases because only one kind of designated medical gas would be present in the container.

2.  See, e.g., Belmont Mun. Light Dep't v. FERC, 38 F.4th 173, 188 (D.C. Cir. 2022) (finding severability of a portion of an administrative action, applying the principle that severability is appropriate where “the agency prefers severability to overturning the entire regulation” and where the remainder of the regulation “could function sensibly without the stricken provision”) (citations omitted).

3.  “Gases not intended for human or animal drug use . . . do not fall within the definition of `medical gas' provided in section 575(2) of the FD&C Act, and are not subject to the certification process described in this guidance.”

4.  See 89 FR 7496 (February 2, 2024).

[ FR Doc. 2024-13190 Filed 6-17-24; 8:45 am]

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