Proposed Rule2022-24689
Protection of Human Subjects and Institutional Review Boards, and Institutional Review Boards; Cooperative Research; Extension of Comment Period
Primary source
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Published
November 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 218 (Monday, November 14, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<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-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 <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.
<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
[[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: <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.
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]
BILLING CODE 4164-01-P
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