Fiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments, 102914-102916 [2024-29962]
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: March 31, 2021. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
SOHONOS (NDA 215559) was initially
submitted on March 31, 2021.
3. The date the application was
approved: August 16, 2023. FDA has
verified the applicant’s claim that NDA
215559 was approved on August 16,
2023.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 69 days 1,209 days
or 1,773 days of patent term extension.
III. Petitions
khammond on DSK9W7S144PROD with NOTICES
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
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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.
Notice of public workshop;
request for comments.
ACTION:
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 inperson 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
SUMMARY:
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performed. For parking and security
Information, please refer to https://
www.fda.gov/about-fda/visitorinformation.
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,
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
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-201509-18/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,
Sameersingh.Raney@fda.hhs.gov; 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, Robert.Lionberger@fda.hhs.gov.
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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.
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
1 The GDUFA III commitment letter is available
at https://www.fda.gov/media/153631/download.
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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 GDUFARegulatoryScience@
fda.hhs.gov 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
GDUFARegulatoryScience@fda.hhs.gov
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Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices
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 GDUFARegulatoryScience@
fda.hhs.gov 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.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2022–E–0681; FDA–
2022–E–0682; FDA–2022–E–0683]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BYLVAY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BYLVAY and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by February 18, 2025.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
June 16, 2025. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: 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
February 18, 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.
DATES:
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
PO 00000
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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 Nos. FDA–
2022–E–0681, FDA–2022–E–0682, and
FDA–2022–E–0683 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
BYLVAY.’’ 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
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]]>Agencies
[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.
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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 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
