Notice2024-01782
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and Ethnicity Data in Clinical Trials and Clinical Studies for Food and Drug Administration-Regulated Medical Products; Draft Guidance for Industry; Availability
Primary source
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Published
January 30, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products."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 This draft guidance revises the final guidance for industry and FDA staff entitled "Collection of Race and Ethnicity Data in Clinical Trials" issued on October 26, 2016.
Full Text
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<title>Federal Register, Volume 89 Issue 20 (Tuesday, January 30, 2024)</title>
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[Federal Register Volume 89, Number 20 (Tuesday, January 30, 2024)]
[Notices]
[Pages 5911-5913]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Products; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Collection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: <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-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 <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.
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<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; 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\ <a href="https://www.fda.gov/media/89307/download">https://www.fda.gov/media/89307/download</a>.
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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
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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 <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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</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: 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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