[Federal Register Volume 89, Number 20 (Tuesday, January 30, 2024)]
[Notices]
[Pages 5911-5913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01782]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3561]


Collection of Race and Ethnicity Data in Clinical Trials and 
Clinical Studies for Food and Drug Administration-Regulated Medical 
Products; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Collection 
of Race and Ethnicity Data in Clinical Trials and Clinical Studies for 
FDA-Regulated Medical Products.'' The purpose of this guidance is to 
provide FDA's expectations for, and recommendations on, use of a 
standardized approach for collecting and reporting race and ethnicity 
data in submissions including information collected and reported from 
clinical studies and clinical trials for FDA-regulated medical 
products. Using standard terminology for race and ethnicity helps 
ensure that data are collected and reported consistently in submissions 
to FDA. This draft guidance revises the final guidance for industry and 
FDA staff entitled ``Collection of Race and Ethnicity Data in Clinical 
Trials'' issued on October 26, 2016.

DATES: Submit either electronic or written comments on the draft 
guidance by April 29, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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.
    <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-2016-D-3561 for ``Collection of Race and Ethnicity Data in Clinical 
Trials and Clinical Studies for FDA-Regulated Medical Products.'' 
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.

[[Page 5912]]

    <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 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; the 
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 
the Office of Policy, Center for Devices and Radiological Health, Food 
and Drug Administration, 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: Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002, 301-796-2500; James 
Myers, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7256, Silver 
Spring, MD 20993, 240-402-7911; or Office of Minority Health and Health 
Equity, <a href="/cdn-cgi/l/email-protection#83ebe6e2eff7ebe6f2f6eaf7fac3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="08606d69647c606d797d617c71486e6c692660607b266f677e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Collection of Race and Ethnicity Data in Clinical Trials and 
Clinical Studies for FDA-Regulated Medical Products.'' FDA's 
recommended approach is based on the Office of Management and Budget 
(OMB) Statistical Policy Directive No. 15 (Policy Directive 15) and was 
developed in accordance with section 4302 of the Affordable Care Act 
(42 U.S.C. 300kk); the Health and Human Services Implementation 
Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary 
Language, and Disability Status; and the Food and Drug Administration 
Safety and Innovation Act (FDASIA) Section 907 Action Plan.\1\
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    \1\ https://www.fda.gov/media/89307/download.
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    OMB standards for the classification of Federal data on race and 
ethnicity were developed to provide a common framework for uniformity 
and consistency in the collection and use of data on race and ethnicity 
by Federal agencies (Policy Directive 15). This guidance provides 
recommendations on:
    1. Meeting the requirements set forth in the 1998 final rule (63 FR 
6854, February 11, 1998) regarding presentation of demographic data in 
investigational new drug applications and new drug applications (known 
as the Demographic Rule);
    2. Collection of race and ethnicity data in biologics license 
applications (BLAs) and medical device applications; and
    3. Addressing the FDASIA Section 907 Action Plan to improve the 
completeness and quality of demographic data collection and reporting.
    This guidance is also intended to help an applicant preparing a BLA 
or medical device application, which should be done in accordance with 
the OMB standards described in the guidance.
    In the Federal Register of January 27, 2023 (88 FR 5375) OMB 
announced a formal review of OMB Policy Directive 15 and requested 
public comments on initial proposals to revise the directive to account 
for large societal, political, and economic demographic shifts in the 
United States over the 25 years since its publication. FDA intends to 
update this guidance as appropriate if OMB revises Policy Directive 15.
    This guidance revises the final guidance for industry and FDA staff 
entitled ``Collection of Race and Ethnicity Data in Clinical Trials'' 
issued in October 2016. When finalized, this guidance will replace the 
October 2016 guidance. Changes from the 2016 version include broadening 
the draft guidance to include non-interventional (observational) 
clinical studies in addition to the interventional clinical trials 
discussed in the 2016 guidance. Other changes include a revised title 
and editorial changes for clarity, as well as updated references and 
contact information for FDA.
    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 ``Collection 
of Race and Ethnicity Data in Clinical Trials and Clinical Studies for 
FDA-Regulated Medical Products.'' 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 new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). 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 314 have been approved under 
OMB Control Number 0910-0001; 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 807, subpart E, have been 
approved under OMB Control Number 0910-0120; the collections of 
information in 21 CFR part 812 have been approved under OMB Control 
Number 0910-0078; the

[[Page 5913]]

collections of information in 21 CFR part 814, subparts A through E, 
have been approved under OMB Control Number 0910-0231; the collections 
of information in 21 CFR part 814, subpart H, have been approved under 
OMB Control Number 0910-0332; the collections of information in 21 CFR 
part 860, subpart D, have been approved under OMB Control Number 0910-
0844; and the collections of information in 42 CFR part 11 have been 
approved under OMB Control Number 0925-0586.

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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: January 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01782 Filed 1-29-24; 8:45 am]
BILLING CODE 4164-01-P


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