[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11985-11986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04026]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-5601]
E6(R3) Good Clinical Practice: Annex 2; International Council for
Harmonisation; Draft Guidance for Industry; Reopening of the Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the draft guidance for industry
entitled ``E6(R3) Good Clinical Practice: Annex 2,'' announced in the
Federal Register of December 30, 2024. The Agency is taking this action
to allow interested persons additional time to submit comments.
DATES: FDA is reopening the comment period on the draft guidance
published December 30, 2024 (89 FR 106519). Submit either electronic or
written comments on the draft guidance by March 31, 2025, to ensure
that the Agency considers your comment on this draft guidance before it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
[[Page 11986]]
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-2024-D-5601 for ``E6(R3) Good Clinical Practice: Annex 2.''
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)).
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Amy Chi, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6334, Silver Spring, MD 20993-0002, [email protected]; or
James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002, 301-796-5259,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of December 30, 2024
(89 FR 106519), FDA published a notice of availability with a 60-day
period to provide comments on the draft guidance entitled ``E6(R3) Good
Clinical Practice: Annex 2.'' The draft guidance provides guidance on
good clinical practices for trial design and conduct, with a focus on
trials with decentralized and pragmatic elements as well as trials that
utilize real-world data. Since the original E6 guidance was published
in 1996, clinical trials have evolved significantly with new designs
and technological innovations. Annex 2 provides additional
considerations to the previously published draft guidance entitled
``E6(R3) Good Clinical Practice (GCP),'' which includes a Principles
document and Annex 1. This draft guidance, entitled ``E6(R3) Good
Clinical Practice: Annex 2,'' is intended to be read and implemented
with E6(R3) Principles and Annex 1.
Interested persons were originally given until February 28, 2025,
to submit comments to the docket. FDA has received requests to extend
the comment period to allow sufficient time to develop and submit
meaningful comments. FDA has considered the requests and is reopening
the comment period until March 31, 2025. The Agency believes that
reopening the comment period until March 31, 2025, allows adequate
additional time for interested persons to submit comments.
Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04026 Filed 3-12-25; 8:45 am]
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