4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-0789]
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented
Populations in Clinical Studies; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing the
availability of a draft guidance for industry entitled “Diversity Action Plans to Improve
Enrollment of Participants from Underrepresented Populations in Clinical Studies.” FDA is
issuing this draft guidance as mandated under the Food and Drug Omnibus Reform Act of 2022
(FDORA) which requires that FDA update or issue guidance relating to the format and content
of Diversity Action Plans required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by FDORA. This guidance describes the format and content of Diversity Action Plans,
including the timing and process for submitting such plans by application or notification type. In
addition, this draft guidance describes the criteria and process by which FDA will evaluate
sponsors’ requests for waivers from the FD&C Act. Because FDA is required by statute to
specify the form and manner for the submission of Diversity Action Plans in guidance, insofar as
this draft guidance specifies the form and manner for submission of Diversity Action Plans,
when this guidance is finalized, it will have binding effect.
DATES: Submit either electronic or written comments on the draft guidance by [INSERT
DATE 90 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER] to ensure
that the Agency considers your comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as follows:

Electronic Submissions
Submit electronic comments in the following way:
•

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for
submitting comments. Comments submitted electronically, including attachments, to
https://www.regulations.gov will be posted to the docket unchanged. Because your
comment will be made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else’s Social Security number, or
confidential business information, such as a manufacturing process. Please note that if
you include your name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on
https://www.regulations.gov.

•

If you want to submit a comment with confidential information that you do not wish to be
made available to the public, submit the comment as a written/paper submission and in
the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions
Submit written/paper submissions as follows:
•

Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

•

For written/paper comments submitted to the Dockets Management Staff, FDA will post
your comment, as well as any attachments, except for information submitted, marked and
identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2021-D-0789

for “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented
Populations in Clinical Studies.” Received comments will be placed in the docket and, except

for those submitted as “Confidential Submissions,” publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday, 240-402-7500.
•

Confidential Submissions--To submit a comment with confidential information that you
do not wish to be made publicly available, submit your comments only as a written/paper
submission. You should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states “THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy,
including the claimed confidential information, in its consideration of comments. The
second copy, which will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this information as
“confidential.” Any information marked as “confidential” will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA’s posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and

written/paper comments received, go to https://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the “Search” box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the draft guidance to the Division of Drug
Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001
New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or Office
of Communication, Outreach and Development, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,
MD 20993-0002; or Office of the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Lola Fashoyin-Aje, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993-0002, 240-402-0205; Tamy Kim, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-7961125; or James Myers, Office of Communication, Outreach and Development, Center of
Biologics Evaluation and Research, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240402-7911; or Josh Chetta, Center for Devices and Radiological Health, Bldg. 66, Rm. 5554,
10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-4910,
CDRHClinicalEvidence@fda.hhs.gov.
For PRA comments: Domini Bean, Office of Operations, Food and Drug Administration, Three
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry entitled “Diversity
Action Plans to Improve Enrollment of Participants from Underrepresented Populations in

Clinical Studies.” FDA is issuing this guidance as mandated under section 3602 of FDORA,
which requires that FDA update or issue guidance relating to the format and content of diversity
action plans required by sections 505(z) and 520(g) of the FD&C Act (21 U.S.C. 355(z) and
360j(g) as amended by section 3601 of FDORA. This draft guidance describes the form, content,
and manner of diversity action plans, the applicable medical products, and clinical studies for
which a diversity action plan is required, the timing and process for submitting diversity action
plans, and the criteria and process by which FDA will evaluate sponsors’ requests for waivers
from the requirement to submit a Diversity Action Plan. This draft guidance replaces the draft
guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants From
Underrepresented Racial and Ethnic Populations in Clinical Trials,” published April 14, 2022 (87
FR 22211). The 2022 draft guidance, which issued prior to FDORA becoming law on December
29, 2022, provided recommendations to sponsors developing medical products on the approach
for developing a Race and Ethnicity Diversity Plan to enroll representative numbers of
participants in clinical trials from underrepresented racial and ethnic populations in the United
States.
Clinical studies characterize the safety and effectiveness of medical products intended for
the prevention, treatment, or diagnosis of many conditions or diseases. Some populations in the
United States are frequently underrepresented in biomedical research including in clinical
studies, even when they have a disproportionate burden for certain conditions or diseases relative
to their proportional representation in the general population. There are myriad reasons for this,
including but not limited to assumptions regarding the feasibility of enrolling a population in a
clinical study that is representative of the intended use population and the impact on study
timelines, and the lack of the prospective development and implementation of a strategy that
helps ensure enrollment and retention of a clinical study population representative of the
intended use population.

Consistent with section 3602(a) of FDORA, this draft guidance primarily focuses on
Diversity Action Plans for the enrollment and retention of a clinically relevant study population,
to help ensure adequate representativeness of study participants that reflect different age groups,
sexes, and racial and ethnic demographic characteristics. However, FDA recognizes the broader
issues regarding health disparities and differential access to health care and clinical studies that
may occur based on other factors, including but not limited to, geographic location, gender
identity, sexual orientation, socioeconomic status, physical and mental disabilities, pregnancy
status, lactation status, and comorbidity, and encourages sponsors to consider such additional
factors when developing Diversity Action Plans. We welcome comments on how sponsors could
effectively consider such additional factors, as appropriate, to broaden their Diversity Action
Plans to include all clinically relevant populations. This draft guidance is one of many efforts by
FDA to help address the participation of underrepresented populations to help ensure that clinical
trials relating to FDA regulated products appropriately test the product against a representative
sample of the product’s intended use population.
In general, FDA’s guidance documents do not establish legally enforceable
responsibilities. See 21 CFR 10.115(d). Instead, guidances describe the Agency’s current
thinking on a topic and should be viewed only as recommendations, unless specific regulatory or
statutory requirements are cited. The use of the word should in Agency guidances means that
something is suggested or recommended, but not required.
An exception to that framework derives from the requirement in section 3601 of FDORA
for FDA to specify in guidance the form and manner for the submission of Diversity Action
Plans. Accordingly, insofar as Section VII of this document specifies the form and manner for
submission of a Diversity Action Plan, it will have binding effect, once this guidance is finalized,
as indicated by the use of the words, must, shall, or required.
II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. This draft guidance contains proposed
collections of information. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5
CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit
reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA
(44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to publish a 60-day notice in the Federal
Register soliciting public comment on each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement, FDA will publish a 60day notice on the proposed collections of information in this draft guidance in a separate issue of
the Federal Register.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

Dated: June 25, 2024.

Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-14284 Filed: 6/27/2024 8:45 am; Publication Date: 6/28/2024]