Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability, 54010-54012 [2024-14284]
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Federal Register / Vol. 89, No. 125 / Friday, June 28, 2024 / Notices
Produce Regulatory Program Standards
OMB Control Number—0910–NEW
This information collection helps
establish and implement FDA’s
‘‘Produce Regulatory Program
Standards.’’ Section 1012 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
399c) authorizes FDA to administer
training and education programs for
employees of State, local, Territorial,
and Tribal food safety authorities
relating to regulatory programs. Also,
under section 205 of the FDA Safety
Modernization Act (codified in 21
U.S.C. 2224), FDA, together with the
Centers for Disease Control and
Prevention is directed to enhance
foodborne illness surveillance to
improve the collection, analysis,
reporting, and usefulness of data on
foodborne illnesses. As part of this
effort, we have initiated programs that
include developing and instituting
regulatory standards intended to reduce
the risk of foodborne illness through
coordinated efforts with our strategic
partners. Regulatory program standards
establish a uniform foundation for the
design and management of State, local,
Tribal, and Territorial programs that
have the responsibility for regulating
human and animal food. Partnering
with other regulatory officials also helps
maximize limited resources in
administering FDA regulations
pertaining to the manufacturing/
processing, packing, or holding of food
for consumption in the United States.
The PRPS are the result of external
collaboration and coordination with the
Association of Food and Drug Officials
(AFDO), the National Association of
State Departments of Agriculture
(NASDA), and state produce regulatory
programs. FDA, NASDA, AFDO, and
states worked collaboratively to develop
the content of the PRPS. A copy of the
standards and accompanying
worksheets and forms is available in the
Federal Register docket for this notice.
We recommend that State and
Territorial produce safety regulatory
programs use these program standards
as the framework to design and manage
their produce safety regulatory
programs. The states that assisted in the
development of PRPS were
representative of the 43 State and
Territorial programs regulatory
programs enrolled currently conducting
produce safety inspections via funding
from a cooperative agreement grant,
‘‘The FDA’s Cooperative Agreement
Program for States and Territories to
Implement a National Produce Safety
Program, PAR–21–174,’’ (this program
also includes 4 programs which do not
conduct inspections). For more
information on this cooperative
agreement, we invite you to visit our
website at: https://www.fda.gov/federalstate-local-tribal-and-territorialofficials/grants-and-cooperativeagreements/fda-state-produce-safetyimplementation-cooperative-agreementprogram.
The PRPS identifies and includes
resource and training material for the
following standards: regulatory
foundations; training; inspection;
product-specific illnesses, outbreaks
and hazard response; compliance and
enforcement; industry and community
relations; program assessments; and
product sampling and testing. We
recommend using the worksheets and
forms contained in the standards,
however, alternate forms that are
equivalent may be used. The
educational worksheets and resource
materials include recordkeeping and
reporting activities that help FDA verify
participation and successful completion
of the respective requirements. In the
first year of enrollment, information is
used to conduct a baseline selfassessment to determine whether the
materials meet the elements of each
standard. In subsequent years, we use
the information to conduct a
comprehensive review and evaluate
program effectiveness and participation.
We modify the program standards based
on the ongoing assessments as well as
comments and informal feedback
obtained from participants.
Description of Respondents:
Respondents are State Departments of
Agriculture or Health regulatory
officials who enroll in the PRPS (State
or Territorial governments). Currently
we estimate 43 respondents to the
information collection based on
expected participation.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Information collection activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
State or Territorial Governments; Development and reporting of data consistent with PRPS ....................................
43
11
473
88
41,624
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1
There are no capital costs or operating and maintenance costs associated with this collection of information.
To demonstrate conformance with the
standards prior to and after enrollment
in the grant program, State and
Territorial governments participating in
the PRPS (respondents) will submit
comprehensive program assessments
and evaluations to their technical
advisors at FDA using a dedicated
email. The information required for
these submissions is outlined in the
provided worksheets. Additionally, the
PRPS requires ongoing documentation
to verify conformance. We estimate,
based on the implementation of other
standards programs and informal
consultation with the affected State and
Territorial governments, that the
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19:25 Jun 27, 2024
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information collection activities will
average 968 hours annually for each of
the 43 participants, for a total of 41,624
hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[Docket No. FDA–2021–D–0789]
[FR Doc. 2024–14329 Filed 6–27–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Food and Drug Administration
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.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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Federal Register / Vol. 89, No. 125 / Friday, June 28, 2024 / Notices
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:
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
19:25 Jun 27, 2024
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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-201509-18/pdf/2015-23389.pdf.
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54011
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,
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
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54012
Federal Register / Vol. 89, No. 125 / Friday, June 28, 2024 / Notices
‘‘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
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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
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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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information (RFI): National
Institute for Mental Health Strategic
Plan Evaluation.
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institute of
Mental Health (NIMH), National
Institutes of Health (NIH) is soliciting
feedback on its current Strategic Plan for
Research to inform the development of
future strategic plans.
DATES: Comments must be received on
or before (11:59:59 p.m. ET) on July 24,
2024 to ensure consideration.
ADDRESSES: Responses to this RFI must
be submitted electronically using the
web-based form at: https://rfi.grants.
nih.gov/?s=662fcf74748dc0f159063c02.
FOR FURTHER INFORMATION CONTACT:
Eliza Jacobs-Brichford, Ph.D., Science
Policy and Evaluation Branch, Office of
Science Policy, Planning, and
Communications (OSPPC), National
Institute of Mental Health, 6001
Executive Boulevard, MSC 9663,
Telephone: 1–866–615–6464 (toll-free),
1–301–443–8431 (TTY), 1–866–415–
8051 (TTY toll-free), Fax: 1–301–443–
4279, Email: NIMHStratPlan@
mail.nih.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28JNN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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
[[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]
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