[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P