[Federal Register Volume 89, Number 177 (Thursday, September 12, 2024)]
[Notices]
[Pages 74279-74280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20665]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3945]


The Food and Drug Administration's Draft Strategy Document on 
Innovative Manufacturing Technologies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the publication of a draft Strategy Document for public comment 
outlining specific actions FDA will take during fiscal years 2023-2027 
to facilitate the use of innovative manufacturing technologies. As part 
of the Prescription Drug User Fee Act (PDUFA) Reauthorization 
Performance Goals and Procedures Fiscal Years 2023-2027 (PDUFA VII), 
FDA committed to advance the use and implementation of innovative 
manufacturing. In connection with this effort, on June 8, 2023, FDA 
participated in a public workshop on the use of innovative 
manufacturing technologies for products regulated by the Center for 
Drug Evaluation and Research (CDER) and the Center for Biologics 
Evaluation and Research (CBER), including barriers to their adoption. 
FDA also committed to issuing this draft Strategy Document for public 
comment. The actions described in the draft Strategy Document are based 
on lessons learned from FDA's experiences with submissions involving 
advanced manufacturing technologies as well as feedback from the 
workshop and other public input.

DATES: Either electronic or written comments on the draft Strategy 
Document must be submitted by November 12, 2024.

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 November 12, 2024.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 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-2024-N-3945 for ``FDA's Strategy Document on Innovative 
Manufacturing Technologies.'' 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: Elisa A. Nickum, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4521, Silver Spring, MD 20993, 301-796-
4226, [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.

SUPPLEMENTARY INFORMATION:

I. Background

    Innovative manufacturing technologies--including but not limited to 
continuous manufacturing, distributed manufacturing, modern aseptic 
manufacturing equipment, and

[[Page 74280]]

novel analytical methods--can increase product development speed, 
bolster supply chains, and prevent drug shortages. On June 8, 2023, FDA 
cosponsored and participated in a public workshop hosted by the Duke-
Margolis Center for Health Policy on ``Advancing the Utilization and 
Supporting the Implementation of Innovative Manufacturing Approaches.'' 
At this workshop, interested parties from industry shared feedback on 
their interactions with FDA's CDER Emerging Technology Program (ETP) 
and CBER Advanced Technologies Team (CATT) to guide submissions from 
persons or organizations using innovative manufacturing technologies. 
Regulators, academic researchers, and industry representatives 
discussed the current barriers to using these technologies and shared 
ideas on how initiatives such as the newly created Advanced 
Manufacturing Technologies Designation Program (AMTDP) could alleviate 
these barriers. The workshop fulfilled a PDUFA VII commitment related 
to advancing utilization and implementation of innovative 
manufacturing, as well as section 506L(e)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356L(e)(1)), as amended by section 3213 of 
the Food and Drug Omnibus Reform Act of 2022 regarding the AMTDP.
    Based on lessons learned from the Agency's experience with 
submissions involving advanced manufacturing, the topics discussed 
during the June 8, 2023, workshop, and other public input, FDA 
developed the draft Strategy Document on Innovative Manufacturing 
Technologies, which outlines the specific activities FDA intends to 
undertake to facilitate the use of innovative manufacturing 
technologies. Specifically, under the draft strategic plan FDA intends 
to undertake the following activities: continue to enhance the ETP and 
CATT as a mechanism to support innovation; implement the AMTDP in a 
manner that reflects feedback on eligibility criteria; continue to 
identify opportunities for international harmonization in support of 
advanced manufacturing; support and utilize ongoing initiatives for 
advanced manufacturing to address potential barriers; and support 
training in advanced manufacturing for FDA assessment staff.

II. Requested Information and Comments

    The draft Strategy Document on Innovative Manufacturing 
Technologies is available on FDA's website for Completed PDUFA VII 
Deliverables (https://www.fda.gov/industry/prescription-drug-user-fee-amendments/completed-pdufa-vii-deliverables). Interested persons are 
invited to provide detailed comments on all aspects of the draft 
Strategy Document. FDA encourages interested parties to provide the 
specific rationale and basis for their comments, including any 
available supporting data and information.

    Dated: September 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20665 Filed 9-11-24; 8:45 am]
BILLING CODE 4164-01-P