[Federal Register Volume 89, Number 29 (Monday, February 12, 2024)]
[Notices]
[Pages 9855-9857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02841]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0119]
Fiscal Year 2024 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, the Agency, or we) is
announcing the following public workshop entitled ``FY 2024 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
stakeholders--
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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) 2025 Generic
Drug User Fee Amendments (GDUFA) science and research initiatives.
DATES: The public workshop will be held on May 20 and 21, 2024. Either
electronic or written comments on this public workshop must be
submitted by June 21, 2024. 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 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 at the end of June 21, 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-2023-N-0119 for ``FY 2024 Generic Drug Science and Research
Initiatives Workshop; 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., 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: 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,
[email protected]; 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, [email protected].
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 stakeholders 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) (Pub. L. 115-
52), and in September 2022, GDUFA was reauthorized until September 2027
through the Generic Drug User Fee Amendments of 2022 (GDUFA III) (Pub.
L. 117-180, 136 Stat. 2155). In the GDUFA Reauthorization
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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 stakeholders for
inclusion in an annual list of GDUFA III regulatory science
initiatives.'' This public workshop scheduled for May 20 and 21, 2024,
seeks to fulfill this agreement.
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\1\ The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.
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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 stakeholders on identifying generic drug
science and research initiatives for FY 2025. 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 2025.
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 relate to nitrosamine drug substance-related impurities,
drug-device combination products, predictive tools to improve the
efficiency of generic product development, and other topics that can
enhance public access to high quality, safe and effective generic
products. 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 2025 science
and research initiatives. Information concerning the science and
research initiatives for generic drugs can be found on the Science &
Research website at https://www.fda.gov/drugs/generic-drugs/science-research.
III. Participating in the Public Workshop
Registration: Registration is free. Persons interested in attending
this public workshop must register online at https://fda.zoomgov.com/webinar/register/WN_qwJcEJcWQeeglLeZMD2MCg. Registration may be
performed at any time before or during the workshop.
If you need special accommodations due to a disability, please
contact FDA via email at [email protected] no later
than 11:59 p.m. eastern time on May 10, 2024.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present your public comments. Requests to
provide public comments via a pre-recorded presentation or a live
presentation, including in-person or virtual presentations, should be
submitted via email to [email protected] by 11:59 p.m.
Eastern Time on March 8, 2024. We will do our best to accommodate
requests to make public comments. 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 upon the public comment presentation requests received by March
8, 2024, at 11:59 p.m. eastern time, we will determine the amount of
time allotted to each presenter and the approximate time each oral
presentation is to begin; we will select and notify participants by
April 1, 2024. If selected for presentation, any presentation materials
must be emailed to [email protected] no later than May
10, 2024, 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
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 https://www.regulations.gov or via the Science & Research
FDA website accessible at https://www.fda.gov/drugs/generic-drugs/science-research. They may also be available for viewing at the Dockets
Management Staff (see ADDRESSES).
Dated: February 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02841 Filed 2-9-24; 8:45 am]
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