[Federal Register Volume 90, Number 151 (Friday, August 8, 2025)]
[Notices]
[Pages 38475-38477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15083]
[[Page 38475]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2489]
Onshoring Manufacturing of Drugs and Biological Products; Public
Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the establishment of a docket to solicit public comments on
issues related to accelerating the establishment of new pharmaceutical
manufacturing facilities in the United States. FDA is also announcing
the following public meeting entitled ``Onshoring Manufacturing of
Drugs and Biological Products.'' At this meeting, FDA will present a
draft framework that seeks to facilitate onshoring of pharmaceutical
manufacturing. Participants will then engage in a guided discussion
regarding the proposed framework, its strengths, weaknesses, and
opportunities. The group will also discuss additional considerations
that may help overcome current challenges faced by industry to
onshoring the manufacturing of pharmaceuticals, including active
pharmaceutical ingredients (APIs) and finished drug and biological
products, and ideas and options within the bounds of FDA's statutory
authority that could facilitate such onshoring of manufacturing.
DATES: The hybrid public meeting will be held on September 30, 2025,
from 9:00 a.m. to 4:00 p.m. Eastern Time and will take place in person
and virtually. Either electronic or written comments on this public
meeting must be submitted by October 30, 2025. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public meeting will be held in person at the FDA White
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the
Great Room, Silver Spring, MD 20993-0002 and virtually using Microsoft
Teams. Participants must be REAL ID compliant to access federal
facilities. For additional information regarding REAL ID, refer to
https://www.dhs.gov/real-id/real-id-faqs. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/about-fda/visitor-information.
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 on October 30, 2025. 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-2025-N-2489 for ``Onshoring Manufacturing of Drugs and Biological
Products; Public Meeting; Request for 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: Maya Thompson, Office of External
Affairs, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5335, Silver Spring, MD 20993-
0001, 301-837-7398, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A resilient supply chain for medical products, and specifically,
pharmaceuticals (i.e., drugs and
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biological products), is critical for the safety and security of the
United States. The globalization of pharmaceutical production over the
past several decades complicates these challenges.
Until the 2000s, pharmaceutical manufacturing was largely a
domestic enterprise. In the last several decades, however, such
manufacturing has increasingly moved offshore. Today, more than half of
the pharmaceuticals distributed in the U.S. are manufactured overseas.
As of June 2025, approximately 53% of brand drug products and 69% of
generic drug products have at least one manufacturer outside of the
United States. Additionally, as of 2025, 9% of API (Type II) Drug
Master File (DMF) holders are in the United States, 22% are in China,
and 44% are in India.
To help bolster pharmaceutical supply chain resiliency in the U.S.,
on May 5, 2025, the President issued Executive Order (E.O.) 14293,
``Regulatory Relief to Promote Domestic Production of Critical
Medicines.'' E.O. 14293 sets forth a policy intended to streamline the
regulation of manufacturing pharmaceutical products to facilitate the
restoration of a robust domestic pharmaceutical manufacturing base.
E.O. 14293 directs FDA to review existing regulations and guidance that
pertain to the development of domestic pharmaceutical manufacturing and
take steps to ``eliminate any duplicative or unnecessary requirements .
. .; maximize the timeliness and predictability of agency review; and
streamline and accelerate the development of domestic pharmaceutical
manufacturing.''
In response to E.O. 14293, FDA has developed a proposal, ``FDA
PreCheck,'' to accelerate the establishment of high priority new
pharmaceutical manufacturing facilities in the U.S. and strengthen the
domestic pharmaceutical supply chain. Specifically, the proposal
consists of a two-phase approach: (1) Facility Readiness Phase, and (2)
Application Submission Phase.
Phase 1: Facility Readiness Phase
The following elements of the Facility Readiness Phase are intended
to help enable early facility engagement and support:
Pre-operational Review:
Enables manufacturers to seek FDA feedback, as applicable,
at critical facility development stages including facility design, pre-
construction, construction/equipment installation and qualification,
and pre-production phases.
Provides manufacturers insight into whether their planned
facility and manufacturing operations as designed are likely to comply
with Current Good Manufacturing Practice (CGMP) requirements.
Manufacturing Facility Information Provided via Type V DMF:
Offers industry an opportunity to provide FDA with a
comprehensive master file that contains facility-specific information
including, for example, site operations layout and description found in
a Site Master File, Pharmaceutical Quality System elements, and Quality
Management Maturity practices.
Helps FDA to provide timely feedback on consistency and
effectiveness of quality procedures to reduce the risk of CGMP
deficiencies that could compromise product quality, patient safety, and
application approval.
Serves as a living document that is updated throughout the
facility lifecycle that, as appropriate, can be incorporated by
reference into a drug application, and can be leveraged to streamline
facility assessments during application reviews.
Phase 2: Application Submission Phase
The following element of the Application Submission Phase is
intended to help facilitate enhanced and accelerated quality
assessment:
Pre-application Meetings and Engagements:
Provide applicants and their manufacturers the opportunity
to give FDA advanced awareness of facility and manufacturing strategies
for specific drugs in forthcoming applications, while enabling earlier
assessment and inspection activities within the review cycle.
Enable FDA to provide Chemistry, Manufacturing and
Controls (CMC) feedback on anticipated data or logistical needs to
support timely review and inspection processes.
Allow FDA to accelerate quality element assessments for
applications from new U.S. facilities through early facility engagement
and frontloaded assessment activities.
FDA PreCheck aims to support faster establishment of new U.S.
pharmaceutical manufacturing capacity through earlier regulatory input,
enhanced engagement, and efficient CMC assessments. FDA PreCheck
support will be commensurate with regulatory resources available to
operationalize the effort.
II. Topics for Discussion at the Public Meeting
To facilitate discussion on enhancing domestic pharmaceutical
manufacturing, FDA has developed a proposal to facilitate the
establishment of new pharmaceutical manufacturing facilities in the
U.S. to strengthen the domestic pharmaceutical supply chain. FDA is
seeking input on the proposal, as well as other ideas to incentivize or
strengthen pharmaceutical manufacturing in the U.S. In all cases, FDA
encourages stakeholders to provide the specific rationale and basis for
their comments, including any available supporting data and
information. FDA will also post a planned agenda for the meeting on the
FDA website at https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025.
On the proposal, FDA is seeking specific input on the following:
1. What do you consider the most significant regulatory hurdle in
establishing a new domestic pharmaceutical manufacturing facility?
2. Which element(s) described in the FDA PreCheck proposal are most
likely to help the establishment of new US pharmaceutical manufacturing
facilities?
3. Are there additional elements or implementation considerations
that should be considered in the FDA PreCheck proposal?
4. Would your company be willing to provide information about
manufacturing facilities relevant to FDA oversight (e.g., facility
design relevant to CGMP compliance, quality systems, processes and
controls, qualification or validation data) in advance of, or separate
from, an application submission? What concerns might you have about
sharing this information outside the context of a drug application?
FDA is also interested in participants' other ideas relevant to FDA
authorities that may help incentivize or strengthen pharmaceutical
manufacturing in the U.S.
III. Participating in the Public Meeting
Registration: This meeting is open to the public and attendance
will be available in-person and virtually. When registering, please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Additionally,
attendees are encouraged to provide additional details on the product
types they intend to manufacture domestically, facility capabilities,
and manufacturing experience within their companies, so the meeting
will have a representative cross section of the drug manufacturing
industry. With this information, FDA will prioritize limited space for
in person participation to those registrants that best represent the
breadth of
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domestic pharmaceutical manufacturers.
Registration is free and based on space availability, with priority
for in-person participation given to registrants that, in FDA's view,
represent higher priority areas for Domestic Manufacturing. Persons
interested in attending this public meeting must register by September
2, 2025, 11:59 p.m. Eastern Time. Register to attend the public meeting
in-person or virtually at this link: https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025. Early registration is recommended
because seating is limited. For this meeting, FDA is limiting the
number of in-person participants per company/entity to facilitate a
broad representation of the drug manufacturing industry. FDA will
confirm registration for in-person participants based on the
information requested above. Registrants that are not confirmed for in
person participation may join the meeting virtually.
If you need special accommodations due to a disability, please
contact Maya Thompson, Office of External Affairs, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5335, Silver Spring, MD 20993-0001, 301-837-7398,
[email protected] no later than September 23, 2025.
Virtual Participation in the Public Meeting: The public will also
have the option to participate through an online teleconferencing and/
or video conferencing platform. This public meeting will also be
webcast. Virtual attendees will receive a confirmation email containing
the website link after their registration has been submitted.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at FDA website at https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-onshoring-manufacturing-drugs-and-biological-products-09302025.
Although FDA verified the website addresses in this document,
please note that websites are subject to change over time.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: August 5, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15083 Filed 8-7-25; 8:45 am]
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