[Federal Register Volume 90, Number 158 (Tuesday, August 19, 2025)]
[Notices]
[Pages 40371-40373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15799]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2396]
Lessons Learned From the Chemistry, Manufacturing, and Controls
Development and Readiness Pilot Program; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a virtual-only public workshop entitled ``Lessons Learned
[[Page 40372]]
From the Chemistry, Manufacturing, and Controls (CMC) Development and
Readiness Pilot (CDRP) Program.'' This workshop fulfills a commitment
in the seventh authorization of the Prescription Drug User Fee Act
(PDUFA VII) to hold a public meeting to discuss best practices and
lessons learned from this pilot program. Convened by the Duke-Robert J.
Margolis, MD Center for Health Policy (Duke-Margolis) and supported by
a cooperative agreement between FDA and Duke-Margolis, the workshop
will feature sponsors and FDA experience under this pilot program and
will solicit input on future directions for FDA policy and programs to
facilitate expedited CMC development of products under an
investigational new drug application (IND), where indicated based upon
the anticipated clinical benefits.
DATES: The public workshop will be held virtually on September 10,
2025, from 1:00 p.m. to 5:00 p.m. Eastern Time. Either electronic or
written comments on this public workshop must be submitted by October
15, 2025. See the SUPPLEMENTARY INFORMATION section for registration
date and information.
ADDRESSES: The public workshop will be held virtually using the Zoom
platform. The link for the public workshop will be sent to registrants
upon registration.
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
Standard Time (EST) on October 15, 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-2022-N-2396 for ``Lessons Learned from the Chemistry,
Manufacturing, and Controls (CMC) Development and Readiness Pilot
(CDRP) program; Public Workshop; 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. EST, 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: Tanya Clayton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4506, Silver Spring, MD 20993-0002, 301-
796-0871.
SUPPLEMENTARY INFORMATION:
I. Background
Development programs for the Center for Biologics Evaluation and
Research (CBER)- and the Center for Drug Evaluation and Research
(CDER)-regulated drugs and biologics intended to diagnose, treat, or
prevent a serious disease or condition where there is an unmet medical
need may have accelerated clinical development timelines. Yet,
marketing applications for products in expedited development programs
still need to meet FDA's approval standards, including manufacturing
facility compliance with current good manufacturing practice (CGMP).
Products with accelerated clinical development activities may face
challenges in expediting CMC development activities to align with the
accelerated clinical timelines.
As described in the PDUFA VII Commitment Letter for fiscal years
(FYs) 2023 Through 2027, FDA implemented the CDRP program to facilitate
CMC readiness for selected CBER- and CDER-regulated products with
accelerated clinical development timelines. To accelerate CMC
development and facilitate CMC readiness, the pilot features increased
communication between FDA and sponsors and explores the use of science-
and risk-based regulatory approaches, such as those described in the
FDA guidance for industry entitled ``Expedited Programs
[[Page 40373]]
for Serious Conditions--Drugs and Biologics'' (May 2014), as
applicable. Under this CDRP program, participating sponsors are able to
discuss their product development strategies and goals with FDA review
staff during two dedicated Type B meetings, as well as additional CMC-
focused discussions.
This public workshop fulfills FDA's commitment under the PDUFA VII
letter (available at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027; see section
N.4.c.) to hold a public meeting focused on CMC aspects of expedited
development including case studies, lessons learned, and stakeholder
input regarding the CDRP, and to solicit industry and public feedback.
II. Topics for Discussion at the Public Workshop
This public workshop is intended as an information gathering step
in support of the strategy paper FDA will subsequently develop. That
strategy paper will outline FDA's planned policy and programmatic
response to support expediting CMC readiness when the clinical benefit
of an investigational-stage product warrants it. The public workshop
will feature discussions on CMC aspects of expedited development,
including case studies, illustrating best practices and lessons learned
from the CDRP. The workshop will also provide a forum for industry and
the public to make recommendations on expediting CMC development.
Workshop updates, agenda, and background materials, if any, will be
made available prior to the workshop at the CDRP web page https://www.fda.gov/drugs/pharmaceutical-quality-resources/chemistry-manufacturing-and-controls-development-and-readiness-pilot-cdrp-program.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: https://healthpolicy.duke.edu/events/lessons-learned-chemistry-manufacturing-and-controls-cmc-development-and-readiness-pilot-0. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone. Registration will end at 11:59 p.m. Eastern Time on
September 9, 2025. Registration is free, and persons interested in
attending this public workshop must register to receive a link to the
meeting. Registrants will receive a confirmation email after they
register. If you need special accommodations due to a disability,
please contact [email protected] no later than 5:00 p.m. Eastern
Time on August 27, 2025. Please note, closed captioning will be
available automatically.
Transcript: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management
Staff (see ADDRESSES).
Dated: August 14, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15799 Filed 8-18-25; 8:45 am]
BILLING CODE 4164-01-P