[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22211-22212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07978]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0789]


Diversity Plans To Improve Enrollment of Participants From 
Underrepresented Racial and Ethnic Populations in Clinical Trials; 
Draft Guidance for Industry; Availability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 or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Diversity 
Plans to Improve Enrollment of Participants from Underrepresented 
Racial and Ethnic Populations in Clinical Trials.'' The purpose of this 
guidance is to provide recommendations to sponsors developing medical 
products on the approach for developing a Race and Ethnicity Diversity 
Plan (referred to as the ``Plan'') to enroll adequate numbers of 
participants in clinical trials from underrepresented racial and ethnic 
populations in the United States.

DATES: Submit either electronic or written comments on the draft 
guidance by June 13, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 Plans to Improve Enrollment of 
Participants from Underrepresented Racial and Ethnic Populations in 
Clinical Trials.'' 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, Center for Drug 
Evaluation and Research (HFD-150), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-0205; or 
Office of Communication, Outreach and Development, Center of Biologics 
Evaluation and Research, 800-835-4709 or 240-402-8010; or Center for 
Devices and Radiological Health, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Diversity Plans to Improve Enrollment of Participants from 
Underrepresented Racial and Ethnic Populations in Clinical Trials.'' 
The purpose of this guidance is to provide recommendations to sponsors 
developing medical products on the approach for developing a Race and 
Ethnicity Diversity Plan (referred to as the ``Plan'') to help enroll 
adequate numbers of participants in clinical trials from 
underrepresented racial and ethnic

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populations in the United States, such as Black or African American, 
Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian 
and Other Pacific Islanders, and other persons of color. Adequate 
representation in clinical trial(s) and studies supporting regulatory 
submissions helps ensure that the data generated in the development 
program reflects the racial and ethnic diversity of intended use 
population for the medical product, if approved, and may potentially 
identify safety or efficacy outcomes that may be associated with, or 
occurring more frequently, within these populations. This is one of 
many efforts by FDA to help address the participation of 
underrepresented populations in clinical trials relating to FDA 
regulated products.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Diversity 
Plans to Improve Enrollment of Participants from Unrepresented Racial 
and Ethnic Populations in Clinical Trials.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR parts 50 and 56 have been approved under OMB 
control number 0910-0130; the collections of information in 21 CFR part 
314 have been approved under OMB control number 0910-0001; the 
collections of information in 21 CFR part 312 have been approved under 
OMB control number 0910-0014; the collections of information in 21 CFR 
part 601 have been approved under OMB control number 0910-0338; the 
collections of information in 21 CFR part 800 have been approved under 
OMB control number 0910-0625; and the collections of information 
pertaining to submission of a biologics license application under 
section 351(k) of the Public Health Service Act have been approved 
under OMB control number 0910-0719.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either 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: April 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07978 Filed 4-13-22; 8:45 am]
BILLING CODE 4164-01-P