[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12943-12944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04206]
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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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for
information and comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
publication of a discussion paper providing information for
stakeholders and soliciting public comments on a specific area of
emerging and advanced manufacturing technologies. 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
(AI) 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 (CBER)
stakeholders.
DATES: Submit either written or electronic comments and information by
May 1, 2023.
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 May 1, 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:
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
[[Page 12944]]
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-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 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.
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, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Advanced manufacturing is a term that describes an innovative
pharmaceutical manufacturing technology or approach that has the
potential to improve the reliability and robustness of the
manufacturing process and resilience of the supply chain. Advanced
manufacturing can: (1) integrate novel technological approaches, (2)
use established techniques in an innovative way, or (3) apply
production methods in a new domain where there are no defined best
practices. Advanced manufacturing can be used for new or currently
marketed large or small molecule drug products.
FDA has recognized and embraced the potential of advanced
manufacturing. In 2014, CDER established the Emerging Technology
Program (ETP) to work collaboratively with companies to support the use
of advanced manufacturing. CDER observed a rapid emergence of advanced
manufacturing technologies through the ETP and recognized that
regulatory policies and programs may need to evolve to enable timely
technological adoption.
The National Academies of Sciences, Engineering, and Medicine
issued a 2021 report titled Innovation in Pharmaceutical Manufacturing
on the Horizon: Technical Challenges, Regulatory Issues, and
Recommendations, highlighting innovations in integrated pharmaceutical
manufacturing processes. These innovations could have implications for
measurement, modeling, and control technologies used in pharmaceutical
manufacturing. AI may play a significant role in monitoring and
controlling advanced manufacturing processes.
This discussion paper presents areas associated with the
application of AI to pharmaceutical manufacturing that FDA has
identified for consideration as FDA evaluates our existing risk-based
regulatory framework. CDER scientific and policy experts identified
these areas from a comprehensive analysis of existing regulatory
requirements applicable to the approval of drugs manufactured using AI
technologies. The areas of consideration in this discussion paper are
those for which FDA would like public feedback.
There are additional areas of consideration not covered within this
document, for example, difficulties that could result from ambiguity on
how to apply existing regulations to AI or lack of Agency guidance or
experience. The areas of consideration presented in this discussion
paper focus on drug products that would be marketed under a new drug
application (NDA), abbreviated new drug application (ANDA), or biologic
license application (BLA). Public feedback will help inform CDER's
evaluation of our existing regulatory framework.
While the initial analysis focused on products regulated by CDER,
FDA's CBER has also encountered a rapid emergence of advanced
manufacturing technologies associated with AI. As such, both CDER and
CBER stakeholders are invited to provide feedback on the discussion
questions.
II. Requested Information and Comments
Interested persons are invited to provide detailed comments to CDER
and CBER on all aspects described in the discussion paper. To
facilitate input, FDA has developed a series of questions based on the
considerations articulated in the discussion paper. The questions are
not meant to be exhaustive, and FDA is also interested in any other
pertinent information stakeholders would like to share on this topic.
In all cases, FDA encourages stakeholders to provide the specific
rationale and basis for their comments, including any available
supporting data and information.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04206 Filed 2-28-23; 8:45 am]
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