Notice2024-20665
The Food and Drug Administration's Draft Strategy Document on Innovative Manufacturing Technologies
Primary source
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Published
September 12, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 177 (Thursday, September 12, 2024)</title>
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[Federal Register Volume 89, Number 177 (Thursday, September 12, 2024)]
[Notices]
[Pages 74279-74280]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20665]
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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.
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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 <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 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:
<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-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 <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: 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, <a href="/cdn-cgi/l/email-protection#98ddf4f1ebf9b6d6f1fbf3edf5d8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="abeec7c2d8ca85e5c2c8c0dec6ebcdcfca85c3c3d885ccc4dd">[email protected]</span></a>; 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 (<a href="https://www.fda.gov/industry/prescription-drug-user-fee-amendments/completed-pdufa-vii-deliverables">https://www.fda.gov/industry/prescription-drug-user-fee-amendments/completed-pdufa-vii-deliverables</a>). 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
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