Notice2024-29962
Fiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
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Published
December 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled "FY 2025 Generic Drug Science and Research Initiatives Workshop." The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of interested parties--industry, academia, patient advocates, professional societies, and other interested parties--as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2026 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.
Full Text
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<title>Federal Register, Volume 89 Issue 243 (Wednesday, December 18, 2024)</title>
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[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102914-102916]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-29962]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0119]
Fiscal Year 2025 Generic Drug Science and Research Initiatives
Workshop; 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 or the Agency) is
announcing the following public workshop entitled ``FY 2025 Generic
Drug Science and Research Initiatives Workshop.'' The purpose of the
public workshop is to provide an overview of the status of science and
research initiatives for generic drugs and an opportunity for public
input on these initiatives. FDA is seeking this input from a variety of
interested parties--industry, academia, patient advocates, professional
societies, and other interested parties--as it fulfills its commitment
under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to
develop an annual list of science and research initiatives specific to
generic drugs. FDA will take the information it obtains from the public
workshop into account in developing its fiscal year (FY) 2026 Generic
Drug User Fee Amendments (GDUFA) science and research initiatives.
DATES: The public workshop will be held on June 3 and 4, 2025. Either
electronic or written comments on this public workshop must be
submitted by July 7, 2025. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public workshop will be held in person and will be
accessible virtually. Registrants will have an opportunity to indicate
their interest in attending the public workshop in person. If there are
restrictions imposed by applicable health guidelines for in-person
gatherings, or seating capacity limitations, registrants interested in
attending the public workshop in person will be contacted. The public
workshop will be held at the FDA White Oak Campus, 10903 New Hampshire
Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B
and C), Silver Spring, MD 20993-0002. Entrance for the public workshop
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
Information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
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 July 7, 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:
<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-2023-N-0119 for ``FY 2025 Generic Drug Science and Research
Initiatives Workshop; Public Workshop; Request for Comments.'' Received
comments,
[[Page 102915]]
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: Sam Raney, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4732, Silver Spring, MD 20993, 240-402-7967,
<a href="/cdn-cgi/l/email-protection#83d0e2eee6e6f1f0eaede4ebadd1e2ede6fac3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="2172404c44445352484f46490f73404f4458614745400f4949520f464e57">[email protected]</span></a>; or Robert Lionberger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-
7957, <a href="/cdn-cgi/l/email-protection#90c2fff2f5e2e4bedcf9fffef2f5e2f7f5e2d0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="6a3805080f181e4426030504080f180d0f182a0c0e0b44020219440d051c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In July 2012, Congress passed the Generic Drug User Fee Amendments
of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance
public access to safe, high-quality generic drugs and to modernize the
generic drug program. To support this goal, FDA agreed in the Generic
Drug User Fee Act Program Performance Goals and Procedures (GDUFA I
commitment letter) to work with industry and interested parties on
identifying science and research initiatives specific to generic drugs
for each fiscal year covered by GDUFA I.
In August 2017, GDUFA was reauthorized until September 2022 through
the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Public Law
115-52), and in September 2022, GDUFA was reauthorized until September
2027 through GDUFA III (Pub. L. 117-180, 136 Stat. 2155). In the GDUFA
Reauthorization Performance Goals and Program Enhancements Fiscal Years
2023-2027 (GDUFA III commitment letter),\1\ FDA agreed to conduct
annual public workshops to solicit input from industry and interested
parties for inclusion in an annual list of GDUFA III regulatory science
initiatives. This public workshop scheduled for June 3 and 4, 2025,
seeks to fulfill this agreement.
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\1\ The GDUFA III commitment letter is available at <a href="https://www.fda.gov/media/153631/download">https://www.fda.gov/media/153631/download</a>.
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II. Topics for Discussion at the Public Workshop
The purpose of this public workshop is to obtain input from
industry and other interested parties on identifying generic drug
science and research initiatives for FY 2026. FDA is interested in
receiving input about regulatory science initiatives for the ongoing
years of the GDUFA III science and research program, and particularly
for FY 2026.
Topics discussed during the workshop will focus on research that is
needed to address scientific knowledge gaps and associated challenges
impacting the development and regulatory assessment of generic
products, including complex generics. As examples, topics discussed
will likely focus on identifying what research is needed to clarify
technical details related to implementing bioequivalence approaches
recommended in FDA guidances for generic products with complex active
ingredients and associated challenges (e.g., related to
immunogenicity), or for those that are complex products (e.g., drug-
device combination products), or for other generic products where
research could address scientific uncertainties and, thereby,
facilitate a more efficient approval pathway (e.g., a waiver of in vivo
bioequivalence studies for solid oral dosage forms that currently do
not have proper alternative methods to support such waivers).
Additional topics that can enhance public access to high-quality, safe,
and effective generic products may also be discussed. Specific
presentations and discussions at this workshop will be announced at a
later date and may differ from the topics above. Input about the topics
above will help the Agency identify and expand its scientific focus for
the next fiscal year.
FDA will consider all comments made at this workshop or received
through the docket (see ADDRESSES) as it develops its FY 2026 science
and research initiatives. Information concerning the science and
research initiatives for generic drugs can be found on the Science &
Research website at <a href="https://www.fda.gov/drugs/generic-drugs/science-research">https://www.fda.gov/drugs/generic-drugs/science-research</a>.
III. Participating in the Public Workshop
Registration: Persons interested in attending this public workshop
must register online at <a href="https://fda.zoomgov.com/webinar/register/WN_wxxGXb5HSgKMAa2Q_sJLEw#/registration">https://fda.zoomgov.com/webinar/register/WN_wxxGXb5HSgKMAa2Q_sJLEw#/registration</a>. Registration may be performed
at any time before or during the workshop. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone number.
Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. Registrants will receive confirmation when they
have been accepted.
If you need special accommodations due to a disability, please
contact FDA via email at <a href="/cdn-cgi/l/email-protection#6f282b3a292e3d0a081a030e1b001d163c0c060a010c0a2f090b0e4107071c41080019"><span class="__cf_email__" data-cfemail="91d6d5c4d7d0c3f4f6e4fdf0e5fee3e8c2f2f8f4fff2f4d1f7f5f0bff9f9e2bff6fee7">[email protected]</span></a> no later
than 11:59 p.m. Eastern Time on May 20, 2025.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present your public comments and which topic(s)
you wish to address. Requests to provide public comments via a
prerecorded presentation or a live presentation, including in-person or
virtual presentations, should be submitted via email to
<a href="/cdn-cgi/l/email-protection#2b6c6f7e6d6a794e4c5e474a5f4459527848424e45484e6b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="2a6d6e7f6c6b784f4d5f464b5e4558537949434f44494f6a4c4e4b04424259044d455c">[email protected]</span></a>
[[Page 102916]]
by 11:59 p.m. Eastern Time on April 3, 2025. FDA will do its best to
accommodate requests to make public comments that are within the scope
of this public workshop; i.e., those that identify what research is
needed to address specific challenges for generic product development
or regulatory assessment. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations,
and request time for a joint presentation, or submit requests for
designated representatives to participate in the workshop. Based on the
public comment presentation requests received by April 3, 2025, at
11:59 p.m. Eastern Time, FDA will determine the amount of time allotted
to each presenter and the approximate time each oral presentation is to
begin; FDA will select and notify participants by April 30, 2025. If
selected for presentation, any presentation materials must be emailed
to <a href="/cdn-cgi/l/email-protection#256261706364774042504944514a575c76464c404b4640654341440b4d4d560b424a53"><span class="__cf_email__" data-cfemail="470003120106152220322b263328353e14242e2229242207212326692f2f3469202831">[email protected]</span></a> no later than May 20, 2025, 11:59
p.m. Eastern Time. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Please register online (as described above) to attend
the workshop remotely (virtually). Registrants will receive a hyperlink
that provides access to the webcast on both days. Although FDA verified
the website addresses in this document, please note that websites are
subject to change over time.
Transcripts: Please be advised that as soon as a video recording
and audio transcript of the public workshop are available, they will be
accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or via the Science & Research
FDA website accessible at <a href="https://www.fda.gov/drugs/generic-drugs/science-research">https://www.fda.gov/drugs/generic-drugs/science-research</a>. They may also be available for viewing at the Dockets
Management Staff (see ADDRESSES).
Dated: December 12, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-29962 Filed 12-17-24; 8:45 am]
BILLING CODE 4164-01-P
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