45585115dftrv1.docx 

Collection of Race and Ethnicity Data in 

Clinical Trials and Clinical Studies for 

FDA-Regulated Medical Products

Guidance for Industry

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 90 days of 

publication in the Federal Register of the notice announcing the availability of the draft 

guidance. Submit electronic comments to https://www.regulations.gov. Submit written 

comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 

docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact (CDER) CDEROMP@fda.hhs.gov, 301-

796-2500; (CBER) Office of Communication, Outreach and Development, 800-835-4709 or 

240-402-8010; or (OMHHE) Office of Minority Health and Health Equity, 

healthequity@fda.hhs.gov.

U.S. Department of Health and Human Services

Food and Drug Administration

Office of the Commissioner (OC)

Office of Minority Health and Health Equity (OMHHE)

Office of Women’s Health (OWH)

Office of Clinical Policy (OCLiP)

Office of Pediatric Therapeutics (OPT)

Center for Drug Evaluation and Research (CDER) 

Center for Biologics Evaluation and Research (CBER) 

Center for Devices and Radiologic Health (CDRH)

Oncology Center of Excellence (OCE)

January 2024

Clinical/Medical

Revision 1
Collection of Race and Ethnicity Data in Clinical Trials 

and Clinical Studies for FDA-Regulated Medical Products

Guidance for Industry

Additional copies are available from:

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and/or

Office of Communication, Outreach and Development

Center for Biologics Evaluation and Research

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Email: ocod@fda.hhs.gov

https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 

and/or

Office of Policy

Center for Devices and Radiological Health

Food and Drug Administration

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Email: CDRH-Guidance@fda.hhs.gov

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devicesand-radiation-emitting-products

U.S. Department of Health and Human Services

Food and Drug Administration

Office of the Commissioner (OC)

Office of Minority Health and Health Equity (OMHHE)

Office of Women’s Health (OWH)

Office of Clinical Policy (OCLiP)

Office of Pediatric Therapeutics (OPT)

Center for Drug Evaluation and Research (CDER) 

Center for Biologics Evaluation and Research (CBER) 

Center for Devices and Radiologic Health (CDRH)

Oncology Center of Excellence (OCE)

January 2024

Clinical/Medical

Revision 1
Contains Nonbinding Recommendations

Draft — Not for Implementation

TABLE OF CONTENTS

I. INTRODUCTION............................................................................................................. 1

II. BACKGROUND ............................................................................................................... 4

III. COLLECTING RACE AND ETHNICITY DATA IN CLINICAL TRIALS AND 

CLINICAL STUDIES .................................................................................................................. 5

A. Two-Question Format ...................................................................................................... 5

B. Self-Reporting ................................................................................................................... 5

C. Ethnicity............................................................................................................................. 5

D. Race .................................................................................................................................... 6

E. Use of More-Detailed Racial and Ethnic Categories ..................................................... 6

IV. PRESENTATION OF RACE AND ETHNICITY DATA IN CLINICAL TRIALS AND 

CLINICAL STUDIES...................................................................................................................... 7
Contains Nonbinding Recommendations

Draft — Not for Implementation

1

1 Collection of Race and Ethnicity Data in Clinical Trials and Clinical 

2 Studies for FDA-Regulated Medical Products

Guidance for Industry1 3

4

5

6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 

7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 

8 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 

9 requirements of the applicable statutes and regulations. To discuss an alternative approach, 

10 contact the FDA staff responsible for this guidance as listed on the title page. 

11

12

13

14

15 I. INTRODUCTION 

16

17 The purpose of this guidance is to provide FDA’s expectations for, and recommendations on, use 

18 of a standardized approach for collecting and reporting race and ethnicity data in submissions

including information collected and reported from clinical trials and clinical studies2 19 for FDAregulated medical products.3,4 20 Using standard terminology for race and ethnicity helps ensure 

21 that data are collected and reported consistently in submissions to FDA. FDA’s recommended 

22 approach is based on the Office of Management and Budget (OMB) Statistical Policy Directive

No. 15 (Policy Directive 15)5 23 and was developed in accordance with section 4302 of the 

Affordable Care Act;6 24 the Health and Human Services (HHS) Implementation Guidance on Data 

1

This guidance has been developed by the Office of the Commissioner, the Office of Minority Heath and Health 

Equity, the Office of Women’s Health, the Office of Clinical Policy, the Office of Pediatric Therapeutics, the Center 

for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and 

Radiological Health, and the Oncology Center of Excellence at the Food and Drug Administration.

2 Going forward in this guidance, we use the term clinical studies to refer broadly to research that evaluates human 

health outcomes associated with the use of medical products. We use the term clinical studies to include 

interventional (clinical trial) and non-interventional (observational) designs. Some recommendations in this 

guidance are specific to clinical trials and are identified as such when relevant.

3 See the guidance for industry Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical 

Device Clinical Studies (September 2017). We update guidances periodically. For the most recent version of a 

guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments.

4 For the purposes of this guidance, the term medical products refers to drugs, including biological products, and 

devices as defined by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301–392) unless otherwise specified.

5 OMB Statistical Policy Directive No. 15, Revisions to the Standards for the Classification of Federal Data on Race 

and Ethnicity (Policy Directive 15) (October 30, 1997), available at 

https://obamawhitehouse.archives.gov/omb/fedreg_1997standards.

6 Patient Protection and Affordable Care Act, Public Law 111–148, section 4302 (42 U.S.C. 300kk) (March 23,

2010), available at https://www.gpo.gov/fdsys/pkg/CREC-2009-11-19/pdf/CREC-2009-11-19-pt1-PgS11607-

3.pdf#page=127.
Contains Nonbinding Recommendations

Draft — Not for Implementation

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Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status;7 25 and the 

Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan.8 26

27 This guidance revises the guidance for industry and FDA staff Collection of Race and Ethnicity 

28 Data in Clinical Trials issued in October 2016. When finalized, this guidance will replace the 

29 October 2016 guidance.

30

31 Current OMB standards for the classification of Federal data on race and ethnicity were 

32 developed to provide a common framework for uniformity and consistency in the collection and 

33 use of data on race and ethnicity by Federal Agencies. 

34

35 On January 27, 2023, OMB announced a formal review of OMB Policy Directive 15 and

36 requested public comments on initial proposals to revise the directive to account for large 

37 societal, political, and economic demographic shifts in the United States over the 25 years since 

its publication.

9 38 FDA began the process to update this guidance before the OMB announcement. 

39 FDA continued the process to update this guidance, including updating references and contact 

40 information for FDA and revising the title, to ensure the appropriate collection and reporting of 

41 race and ethnicity data in submissions from clinical studies and clinical trials for FDA-regulated 

42 medical products. FDA will update this guidance as appropriate if OMB revises Policy 

43 Directive 15.

44

45 This guidance provides recommendations on:

46

1. Meeting the requirements set forth in the 1998 final rule10 47 regarding presentation of 

48 demographic data in investigational new drug applications (INDs) and new drug 

49 applications (NDAs) (known as the Demographic Rule) 

50

51 2. Collection of race and ethnicity data in biologics license applications (BLAs) and medical 

device applications11 52

53

54 3. Addressing the FDASIA Section 907 Action Plan to improve the completeness and 

55 quality of demographic data collection and reporting

56

7 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and 

Disability Status (October 31, 2011), available at https://aspe.hhs.gov/reports/hhs-implementation-guidance-datacollection-standards-race-ethnicity-sex-primary-language-disability-0.

8 See the FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data (FDASIA

Section 907 Action Plan), August 2014, available at https://www.fda.gov/media/89307/download.

9 See OMB Federal Register notice (88 FR 5375), https://www.federalregister.gov/documents/2023/01/27/2023-

01635/initial-proposals-for-updating-ombs-race-and-ethnicity-statistical-standards.

10 1998 final rule, “Investigational New Drug Applications and New Drug Applications” (the Demographic Rule),

see 63 FR 6854 (February 11, 1998) (codified at 21 CFR 312.33(a)(2) and 21 CFR 314.50(d)(5)), available at 

https://www.gpo.gov/fdsys/pkg/FR-1998-02-11/pdf/98-3422.pdf.

11 For medical devices, see also the guidance for industry and FDA staff Evaluation and Reporting of Age-, Race-, 

and Ethnicity-Specific Data in Medical Device Clinical Studies.
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57 For drugs, the Demographic Rule requires the sponsor of an IND to tabulate in an IND annual 

58 report the number of participants enrolled in the clinical trial by certain demographic subgroups 

59 including race and requires NDA submissions to include summaries of effectiveness and safety 

data for demographic subgroups, including racial subgroups.12 60 FDA also strongly recommends 

61 the collection and reporting of ethnicity data (Hispanic or Latino or not Hispanic or Latino) 

consistent with OMB standards.13 62

63

64 This guidance is also intended to help an applicant preparing a BLA or a device premarket 

65 submission, which should be done in accordance with the OMB standards regarding collection 

and reporting of race and ethnicity data described herein.14 66

67

68 This guidance also recommends the use of the OMB race and ethnicity categories in proposed 

69 medical product labeling. 

70

71 Sponsors of investigational new drugs and investigational devices should enroll participants who 

reflect the population that will use the medical product if approved.

15 72 Sections 505(z) and 

73 520(g) of the Federal Food, Drug, and Cosmetic Act, as amended by section 3601 of the Food 

74 and Drug Omnibus Reform Act of 2022 (FDORA) require that such sponsors submit a diversity 

75 action plan outlining (1) the sponsor’s goals for enrollment in the clinical trial, (2) the sponsor’s 

76 rationale for such goals, and (3) an explanation of how the sponsor intends to meet such goals. 

77 As described in section 3602 of FDORA, this requirement will apply with respect to clinical 

78 trials for medical products for which enrollment commences 180 days after the publication of a 

final guidance on diversity action plans.

16 79 This guidance does not address diversity action plans 

80 or the appropriate population for a clinical study. For questions related to enrollment of 

81 clinically relevant demographic subpopulations in clinical trials, sponsors should consult with the 

review division of the appropriate centers and offices.17 82

83

84 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 

85 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 

86 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 

87 the word should in Agency guidances means that something is suggested or recommended, but 

88 not required.

89

90

12 See footnote 10.

13 See footnote 5.

14 Ibid.

15 See also the guidance for industry Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, 

Enrollment Practices, and Trial Designs (November 2020).

16 See Food and Drug Omnibus Reform Act of 2022 (FDORA) available at 

https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf.

17 See also the draft guidance for industry Diversity Plans to Improve Enrollment of Participants from

Underrepresented Racial and Ethnic Populations in Clinical Trials (April 2022). When final, this guidance will 

represent FDA’s current thinking on this topic.
Contains Nonbinding Recommendations

Draft — Not for Implementation

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91 II. BACKGROUND

92

93 Although uncommon, differences in response to medical products have been observed in racially 

and ethnically distinct populations in the United States.18 94 In some cases, differences in the 

95 pharmacokinetics, efficacy, or safety of medical products that lead to these different responses

96 may be attributable to intrinsic factors (e.g., genetics, metabolism, elimination, skin 

97 pigmentation), extrinsic factors (e.g., diet, environmental exposure, socioeconomic status, 

culture), or interactions between these factors.19 98 Collecting data on race and ethnicity is critical 

99 to identifying population-specific signals. 

100

101 In 1997, OMB issued its revised recommendations for the collection and use of race and 

ethnicity data by Federal Agencies (Policy Directive 15).20 102 OMB stated that the recommended 

103 race and ethnicity categories were not anthropologically or scientifically based designations, but 

104 instead are categories that describe the sociocultural construct of our society.

105

106 In 1999, HHS issued the report Improving the Collection and Use of Racial and Ethnic Data in 

HHS.

21 107 The report describes HHS policy on collecting and reporting data on race and ethnicity 

108 for HHS programs. The report recommends inclusion of race and ethnicity categories in HHS109 funded and sponsored data collection and reporting systems in all HHS programs to (1) help 

110 monitor HHS programs, (2) determine whether Federal funds are being used in a 

111 nondiscriminatory manner, and (3) promote the availability of standard race and ethnicity data 

112 across various agencies to facilitate HHS responses to major health and human services issues.

This policy, updated in 2011,22 113 states that the minimum standard categories in OMB Policy 

114 Directive 15 should be used when collecting and reporting data in HHS data systems or when

115 reporting HHS-funded statistics. On September 21, 2016, HHS issued the final rule, “Clinical 

116 Trials Registration and Results Information Submission” (81 FR 64982) (42 CFR part 11). The 

117 final rule requires the submission of race and ethnicity information with summary results 

118 information if it is collected during the trial.

119

120

18 For example, in 2005, FDA approved BiDil (isosorbide dinitrate and hydralazine hydrochloride tablets), the first 

drug approved by the Agency to treat a disease only in patients who identified by a specific racial subgroup. BiDil 

is approved for the treatment of heart failure as an adjunct to standard therapy in self-identified Black patients to 

improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional 

status. Although the sponsor’s initial two trials in certain patients with heart failure failed to show a benefit in the 

overall population (sum of all racial groups), there was a suggestion of benefit of BiDil in one racial subgroup (i.e., 

Black patients). In a subsequent study in 1,050 self-identified Black patients with a certain type of heart failure, 

BiDil was shown to be safe and effective for the treatment of heart failure as an adjunct to standard therapy. 

19 Ramamoorthy A, MA Pacanowski, J Bull, L Zhang, 2015, Racial/Ethnic Differences in Drug Disposition and 

Response: Review of Recently Approved Drugs, Clin Pharmacol Ther, Mar;97(3):263–273.

20 See footnote 5.

21 Improving the Collection and Use of Racial and Ethnic Data in HHS (December 1, 1999), available at 

https://aspe.hhs.gov/report/improving-collection-and-use-racial-and-ethnic-data-hhs.

22 See footnote 7.
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121 III. COLLECTING RACE AND ETHNICITY DATA IN CLINICAL TRIALS AND 

CLINICAL STUDIES23 122

123

124 OMB Policy Directive 15 provides a minimum standard for maintaining, collecting, and 

125 presenting data on race and ethnicity for Federal reporting purposes. As previously stated, the 

126 categories in this classification are social-political constructs and should not be interpreted as 

127 being scientific or anthropological in nature. OMB recommends a two-question format to 

128 provide flexibility and ensure data quality for reporting race and ethnicity as described below. 

129

130 A. Two-Question Format

131

132 To remain consistent with OMB Policy Directive 15, FDA recommends using the two-question 

133 format for requesting race and ethnicity information, with the ethnicity question preceding the 

question about race.24 134 For example:

135

136 Question 1 (answer first): Are you Hispanic/Latino or not Hispanic/Latino?

137

Question 2 (answer second): What is your race?25 138 More than one choice is acceptable.

139

140 B. Self-Reporting

141

142 Consistent with best practices, FDA recommends that trial participants self-report race and 

143 ethnicity information and that those individuals be permitted to designate a multiracial identity. 

144 When the collection of self-reported designations is not feasible (e.g., because of the 

145 participant’s inability to respond), FDA recommends requesting information from a first-degree 

146 relative or other knowledgeable representative. Race and ethnicity should not be assigned by the 

147 study team conducting the trial. While data on race and ethnicity may be available in a patient’s 

148 medical record, FDA recommends that investigators and/or other clinical study staff verify the 

149 accuracy of the information provided in the medical record with the study participant.

150

151 C. Ethnicity

152

153 For ethnicity, we recommend the following minimum choices be offered:

154

155 • Hispanic or Latino

156

157 • Not Hispanic or Latino

158

23 FDA recognizes that the collection of race and ethnicity data in clinical practice may vary considerably and 

impact demographic data available for analysis in non-interventional studies. Sponsors seeking to conduct noninterventional studies to support regulatory decision-making should discuss the availability of race and ethnicity data 

with the relevant review division.

24 For more information on the basic racial and ethnic categories for Federal statistics and program reporting, see

OMB Policy Directive 15, described in footnote 5.

25 Note: Please see racial designations in section III.D of this guidance.
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159 D. Race

160

For race, we recommend the following minimum choices26 161 be offered:

162

163 • American Indian or Alaska Native

164

165 • Asian

166

167 • Black or African American

168

169 • Native Hawaiian or Other Pacific Islander

170

171 • White

172

173 FDA recommends offering an option of selecting one or more racial designations or additional 

174 subgroup designations. Recommended forms for the instruction accompanying the multiple 

175 response questions are “Mark one or more” and “Select one or more.”

176

177 Sponsors should report the number of respondents in each racial category who self-reported as 

178 Hispanic or Latino. When aggregate data are presented, data producers should provide the 

179 number of respondents who marked (or selected) only one category, separately for each of the 

180 five racial categories. In addition to these numbers, sponsors are encouraged to provide the 

181 detailed distributions, including all possible combinations of multiple responses to the race 

182 question. If data on multiple responses are condensed, at a minimum the total number of 

183 respondents reporting “more than one race” should be reported.

184

185 E. Use of More-Detailed Racial and Ethnic Categories

186

187 In certain situations, as recommended in OMB Policy Directive 15, more-detailed race and/or 

188 ethnicity information may be desired. For example, for clinical trials enrolling participants 

189 outside the United States, FDA recognizes that the recommended categories for race and 

190 ethnicity were developed in the United States and that these categories may not adequately 

191 describe racial and ethnic groups in other countries. 

192

193 Where appropriate, FDA recommends using more-detailed categories by geographic region to 

194 provide sponsors flexibility in characterizing race and ethnicity. FDA recommends that these 

195 characterizations be aligned with the five minimum designations for race and the two 

196 designations for ethnicity listed previously in subsections D and C, respectively. If additional 

197 granularity or more-detailed characterizations of race or ethnicity are collected to enhance 

198 understanding of the trial participants, FDA recommends following the 2011 HHS 

199 Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary 

Language, and Disability Status,27 200 as described below.

26 As explained in the next section of this guidance (section III.E), sponsors may include more-detailed categories,

and doing so is recommended where appropriate.

27 See footnote 7.
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201 Ethnicity Data Standard

202 Are you Hispanic or Latino? (One or more categories may be selected.)

203

204 a. No, not Hispanic or Latino

205 b. Yes, Mexican, Mexican American, Chicano

206 c. Yes, Puerto Rican

207 d. Yes, Cuban

208 e. Yes, Other Hispanic or Latino 

209

210 Race Data Standard

211 What is your race? (One or more categories may be selected.)

212

213 a. White

214 b. Black or African American

215 c. American Indian or Alaska Native

216 d. Asian Indian

217 e. Chinese

218 f. Filipino

219 g. Japanese

220 h. Korean

221 i. Vietnamese

222 j. Other Asian

223 k. Native Hawaiian

224 l. Guamanian or Chamorro

225 m. Samoan

226 n. Other Pacific Islander

227

228 OMB Policy Directive 15 states that the term nonwhite is not acceptable for use in the 

229 presentation of Federal Government data. It should not be used in publication or text of any 

230 report. If there are questions or concerns regarding the collection of race or ethnicity categories, 

231 sponsors are encouraged to discuss the matter with the appropriate review division.

232

233

234 IV. PRESENTATION OF RACE AND ETHNICITY DATAIN CLINICAL TRIALS AND 

235 CLINICAL STUDIES

236

237 For INDs, NDAs, and BLAs, we recommend that the submission of demographic data for all

238 new clinical trials and clinical studies be tabulated using the characterizations of race and 

239 ethnicity described in this guidance. For medical device submissions, see also the guidance for 

240 industry Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical 

241 Device Clinical Studies (September 2017)

242

These categories are part of the 

Asian category of the OMB standard

These categories are part of the 

Hispanic or Latino category of 

the OMB standard

These categories are part of the 

OMB standard

These categories are part of the Native Hawaiian 

or Other Pacific Islander category of the OMB 

standard
Contains Nonbinding Recommendations

Draft — Not for Implementation

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243 The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation 

and Research (CBER) require marketing applications to be submitted electronically.28 244 CDER 

245 and CBER use the electronic common technical document (eCTD) as the standard for their 

246 electronic applications. When submitting an electronic application, presentation of demographic 

247 data is described in the ICH guidance for industry M4E(R2): The CTD – Efficacy (July 2017),

248 which suggests a tabular display of demographic characteristics, including race, by treatment 

group (e.g., active drug, placebo).29 249 

250

251 FDA recommends that applicants include race and ethnicity information (using the categories 

252 described in section III of this guidance) in their proposed product labeling. For example, the 

253 CLINICAL STUDIES section of drug and biological product labeling should include the 

baseline demographics (including racial and ethnic characteristics) of the studied population.30 254 

255 The ADVERSE REACTIONS section of drug and biological product labeling should include the 

baseline demographics of the safety population.31 256 If the baseline demographics in the safety and 

257 efficacy populations are generally the same and the description of the baseline demographics are 

258 included in the CLINICAL STUDIES section, instead of repeating the same baseline 

259 demographics in the ADVERSE REACTIONS section, the ADVERSE REACTIONS section 

260 can cross-reference the CLINICAL STUDIES section. OMB Policy Directive 15 states that the 

261 term nonwhite is not acceptable for use in the presentation of Federal Government data. It 

262 should not be used in publication or text of any report. If there are questions or concerns 

263 regarding the collection of race or ethnicity categories, sponsors are encouraged to discuss the 

matter with the appropriate review division.

32 264 

265

28 See the guidance for industry Providing Regulatory Submissions in Electronic Format – Certain Human

Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (February 2020).

29 See the revision of M4E Guideline on Enhancing the Format and Structure of Benefit-Risk Information in the 

International Council for Harmonisation (ICH) guidance for industry M4E(R2): The CTD – Efficacy (July 2017).

30 See section III.B.4 in the guidance for industry Clinical Studies Section of Labeling for Human Prescription Drug 

and Biological Products – Content and Format (January 2006).

31 See the guidance for industry Adverse Reactions Section of Labeling for Human Prescription Drug and Biological 

Products – Content and Format (January 2006).

32 See section III.E of this guidance.