Notice2024-14284
Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability
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Published
June 28, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies." FDA is issuing this draft guidance as mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA) which requires that FDA update or issue guidance relating to the format and content of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 In addition, this draft guidance describes the criteria and process by which FDA will evaluate sponsors' requests for waivers from the FD&C Act.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by statute to specify the form and manner for the submission of Diversity Action Plans in guidance, insofar as this draft guidance specifies the form and manner for submission of Diversity Action Plans, when this guidance is finalized, it will have binding effect.
Full Text
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<title>Federal Register, Volume 89 Issue 125 (Friday, June 28, 2024)</title>
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[Federal Register Volume 89, Number 125 (Friday, June 28, 2024)]
[Notices]
[Pages 54010-54012]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Underrepresented Populations in Clinical Studies; Draft Guidance for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announcing the availability of a draft guidance for industry entitled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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#b9fafdebf1fad5d0d7d0dad8d5fccfd0dddcd7dadcf9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="6b282f39232807020502080a072e1d020f0e05080e2b0d0f0a45030318450c041d">[email protected]</span></a>.
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, <a href="/cdn-cgi/l/email-protection#5b0b091a082f3a3d3d1b3d3f3a75333328753c342d"><span class="__cf_email__" data-cfemail="1f4f4d5e4c6b7e79795f797b7e3177776c31787069">[email protected]</span></a>.
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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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