[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54010-54012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14284]


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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Underrepresented Populations in Clinical Studies; Draft Guidance for 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.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is

[[Page 54011]]

announcing the availability of a draft guidance for industry entitled 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draft guidance as mandated under the Food and Drug Omnibus Reform Act 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 In addition, this draft 
guidance describes the criteria and process by which FDA will evaluate 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of Diversity Action Plans in guidance, insofar as this draft guidance 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DATES: Submit either electronic or written comments on the draft 
guidance by September 26, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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, 301-796-1125; or James 
Myers, Office of Communication, Outreach and Development, Center of 
Biologics Evaluation and Research, Bldg. 71, Rm. 7301, Silver Spring, 
MD 20993-0002, 240-402-7911; or Josh Chetta, Center for Devices and 
Radiological Health, Bldg. 66, Rm. 5554, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 240-402-4910, 
[email protected].
    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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled

[[Page 54012]]

``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 
60-day 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 6-27-24; 8:45 am]
BILLING CODE 4164-01-P