Notice2023-18235
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Extension of the Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 24, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is extending the comment period for the notice announcing the availability of a draft guidance entitled "Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry," that appeared in the Federal Register of July 14, 2023. We are 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 88 Issue 163 (Thursday, August 24, 2023)</title>
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[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Notices]
[Page 57959]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2436]
Manufacturing Changes and Comparability for Human Cellular and
Gene Therapy Products; Draft Guidance for Industry; Extension of the
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the notice announcing the availability of a draft
guidance entitled ``Manufacturing Changes and Comparability for Human
Cellular and Gene Therapy Products; Draft Guidance for Industry,'' that
appeared in the Federal Register of July 14, 2023. We are 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DATES: FDA is extending the comment period on the draft guidance
published July 14, 2023 (88 FR 45222). Submit either electronic or
written comments on the draft guidance by November 13, 2023, to ensure
that we consider your comment on the draft guidance before we begin
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-2023-D-2436 for ``Manufacturing Changes and Comparability for Human
Cellular and Gene Therapy Products; Draft Guidance for Industry.''
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.
<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.'' We will review
this copy, including the claimed confidential information, in our
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.
FOR FURTHER INFORMATION CONTACT: Karen Fikes, 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 14, 2023 (88
FR 45222), we published a notice of availability for a draft guidance
entitled ``Manufacturing Changes and Comparability for Human Cellular
and Gene Therapy Products; Draft Guidance for Industry.'' This action
opened a docket with a 60-day comment period.
We have received requests for a 30-day extension of the comment
period for the draft guidance. We have considered the requests and are
extending the comment period for the draft guidance for 60 days, until
November 13, 2023. (A 60-day extension would fall on November 11, 2023,
which is a Saturday, so we have extended the comment period until the
next business day, which is November 13, 2023.) We believe that a 60-
day extension allows adequate time for interested persons to submit
comments.
Dated: August 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18235 Filed 8-23-23; 8:45 am]
BILLING CODE 4164-01-P
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