Document ID: FDA-2021-N-0286-0030
Agency: fda
Document Type: Proposed Rule
Title: Protection of Human Subjects and Institutional Review Boards, and
Institutional Review Boards; Cooperative Research; Extension of Comment Period
Posted Date: 2022-11-14T05:00Z

[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Proposed Rules]
[Pages 68118-68119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24689]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50, 56, and 812

[Docket Nos. FDA-2021-N-0286 and FDA-2019-N-2175]
RIN 0910-AI07 and 0910-AI08

Protection of Human Subjects and Institutional Review Boards, and 
Institutional Review Boards; Cooperative Research; Extension of Comment 
Period

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Proposed rules; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for two proposed rules that appeared in 
the Federal Register of September 28, 2022. In the proposed rule 
entitled ``Protection of Human Subjects and Institutional Review 
Boards,'' FDA requested comments on proposed changes to its regulations 
regarding obtaining and documenting informed consent from research 
participants, and institutional review board membership and functions, 
including continuing review (Docket No. FDA-2021-N-0286). In the 
proposed rule entitled ``Institutional Review Boards; Cooperative 
Research,'' FDA requested comment on a change to its regulations that 
would require any institution located in the United States 
participating in FDA-regulated cooperative research to rely on approval 
by a single institutional review board (IRB) for that portion of the 
research that is conducted in the United States, with some exceptions 
(Docket No. FDA-2019-N-2175). The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rules 
published in the Federal Register on September 28, 2022 (87 FR 58733 
and 87 FR 58752). Either electronic or written comments must be 
submitted by December 28, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 28, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

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-N-0286 for ``Protection of Human Subjects and Institutional 
Review Boards'' and/or Docket No. FDA-2019-N-2175 for ``Institutional 
Review Boards; Cooperative Research.'' Received comments, those filed 
in a timely manner (see ADDRESSES), 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

[[Page 68119]]

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.

FOR FURTHER INFORMATION CONTACT: With regard to Docket No. FDA-2021-N-
0286: Sheila Brown, Office of Clinical Policy, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-6563. With regard to Docket No. FDA-2019-N-2175: David Markert, 
Office of Clinical Policy, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0752.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 28, 
2022, FDA published two proposed rules with a 60-day comment period to 
request comments on proposed changes to its regulations regarding 
obtaining and documenting informed consent from research participants, 
and institutional review board membership and functions, including 
continuing review, as well as a change to its regulations that would 
require any institution located in the United States participating in 
FDA-regulated cooperative research to rely on approval by a single IRB 
for that portion of the research that is conducted in the United 
States, with some exceptions. Comments on the proposed rules will 
inform FDA's rulemaking to establish regulations for Protection of 
Human Subjects and Institutional Review Boards.
    The Agency has received requests for a 60-day extension of the 
comment period for both proposed rules. The requests conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rules.
    FDA has considered the requests and is extending the comment 
periods for the proposed rules for 30 days. The Agency believes that a 
30-day extension allows adequate time for interested persons to submit 
comments without significantly delaying rulemaking on these important 
issues.

    Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24689 Filed 11-10-22; 8:45 am]
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