Notice2023-20902
Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments; Reopening 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
September 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice, published in the Federal Register of March 1, 2023, establishing a public docket and requesting information and comments. FDA is reopening the comment period to update comments and to receive any new information.
Full Text
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<title>Federal Register, Volume 88 Issue 186 (Wednesday, September 27, 2023)</title>
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[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Pages 66460-66461]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20902]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0487]
Discussion Paper: Artificial Intelligence in Drug Manufacturing,
Notice; Request for Information and Comments; Reopening of the Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for
information and comments; 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 notice, published in the Federal
Register of March 1, 2023, establishing a public docket and requesting
information and comments. FDA is reopening the comment period to update
comments and to receive any new information.
DATES: FDA is reopening the comment period on the notice published
March 1, 2023 (88 FR 12943). Either electronic or written comments must
be submitted by November 27, 2023.
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 November 27, 2023. 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,
[[Page 66461]]
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-N-0487 for ``Discussion Paper: Artificial Intelligence in Drug
Manufacturing, Notice; Request for Information and Comments.'' 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 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: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 4162, Silver Spring, MD 20993, 240-
402-7930, <a href="/cdn-cgi/l/email-protection#e7a28b8e9d868582938fc9a08e8696928e899388a7818386c98f8f94c9808891"><span class="__cf_email__" data-cfemail="ca8fa6a3b0aba8afbea2e48da3abbbbfa3a4bea58aacaeabe4a2a2b9e4ada5bc">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 1, 2023 (88
FR 12943), FDA established a public docket to solicit comments on the
``Discussion Paper: Artificial Intelligence in Drug Manufacturing.''
The discussion paper presents areas for consideration and policy
development identified by the Center for Drug Evaluation and Research
(CDER) scientific and policy experts associated with application of
artificial intelligence to pharmaceutical manufacturing. The discussion
paper includes a series of questions to stimulate feedback from the
public, including CDER and the Center for Biologics Evaluation and
Research stakeholders.
Interested persons were originally given until May 1, 2023, to
comment on the content of the discussion paper.
Following publication of the March 1, 2023, notice, FDA has decided
to reopen the public docket to allow interested persons additional time
to comment on the discussion paper. We note that there is also a public
workshop organized by FDA and the Product Quality Research Institute
entitled ``Regulatory Framework for the Utilization of Artificial
Intelligence in Pharmaceutical Manufacturing: An Opportunity for
Stakeholder Engagement,'' which is scheduled for September 26 and 27,
2023 (<a href="https://pqri.org/fda-pqri-aiworkshop/">https://pqri.org/fda-pqri-aiworkshop/</a>).
Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20902 Filed 9-26-23; 8:45 am]
BILLING CODE 4164-01-P
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