```

[Federal Register Volume 89, Number 243 (Wednesday, December 18, 2024)]
[Notices]
[Pages 102914-102916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29962]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 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:
     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 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 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 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.
---------------------------------------------------------------------------

    \1\ The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.
---------------------------------------------------------------------------

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 https://www.fda.gov/drugs/generic-drugs/science-research.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online at https://fda.zoomgov.com/webinar/register/WN_wxxGXb5HSgKMAa2Q_sJLEw#/registration. 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 [email protected] 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 
[email protected]

[[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 [email protected] 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 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: 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
```