National Human Genome Research Institute; Notice of Meeting, 60439-60440 [2024-16327]
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Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
heading of this document, into the
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and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Tiana Barnes, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6196,
Silver Spring, MD 20993–0002, 301–
796–2882, Tiana.Barnes@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Biosimilar User Fee Act
reauthorization, known as BsUFA III,1
authorizes FDA to assess and collect
user fees for certain activities in
connection with biosimilar product
development and review of applications
submitted under section 351(k) of the
Public Health Service Act (PHS Act) (42
U.S.C. 262(k)). An application
submitted under section 351(k) of the
PHS Act must demonstrate, among other
things, that a proposed biosimilar
product is highly similar to, and has no
clinically meaningful differences from,
an FDA-licensed reference product. To
date, FDA has issued a series of
guidance documents to facilitate
development of biosimilar products.
Under section 351(k)(8)(D) of the PHS
Act, if FDA issues product class-specific
guidance with respect to the licensure of
biosimilar products, the guidance must
include a description of the criteria that
FDA will use to determine whether a
biological product is highly similar to a
reference product in such product class
and the criteria, if available, that FDA
will use to determine whether a
biological product meets the standards
for interchangeability described in
section 351(k)(4) of the PHS Act.
Under BsUFA III, FDA has committed
to, among other things, the development
of guidance documents focusing on
formal meetings between FDA and
sponsors or applicants of BsUFA
products and topics related to
interchangeable biosimilar biological
products (interchangeable biosimilars or
interchangeable biosimilar products)
(see Biosimilar Biological Product
Reauthorization Performance Goals and
Procedures Fiscal Years 2023 Through
2027, available at https://www.fda.gov/
media/152279/download). These
guidance documents are not productspecific or product class-specific but
rather apply across many products and
product classes. In contrast, under the
GDUFA science and research program,
1 See https://www.fda.gov/industry/biosimilaruser-fee-amendments/bsufa-iii-fiscal-years-20232027.
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FDA conducts research in support of
various regulatory science initiatives,
the results of which support
development of both general and
product-specific guidance for industry.
As part of the BsUFA III program,
FDA has updated its biosimilar action
plan 2 and is revisiting how best to
advance the development of new
biosimilar products. FDA guidance can
enhance scientific and regulatory clarity
for the biosimilar product development
community and, when finalized,
represents FDA’s current thinking on
the matter.
II. Issues for Consideration and Request
for Information and Comments
FDA is seeking input from industry
on whether product-specific guidance
outlining the development program for
a particular product would be valuable
to the biosimilar product development
community. A model for this approach
is the GDUFA science and research
program that, among other things,
supports the issuance of productspecific guidance documents, of which
there are currently over 2,000.3
Alternatively, FDA is seeking input on
whether product class-specific
guidance, which may apply more
broadly to a class of products, would be
valuable to the biosimilar product
development community. Specifically,
FDA is seeking input on the following
questions:
1. Which would be more useful for
accelerating biosimilar development:
guidance documents that focus on a
particular product (product-specific
guidance), or guidance documents that
are cross-cutting for a class of biosimilar
products (product class-specific
guidance) such as monoclonal
antibodies?
2. Should FDA focus on development
of guidance documents for biological
products (or classes of biological
products) for which there are no
approved biosimilars? Or would it be
useful for FDA to continue to develop
guidance on biosimilar development
programs even after one or more
biosimilar products have been approved
for that biological product or class of
biological products?
Dated: July 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16405 Filed 7–24–24; 8:45 am]
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2 See https://www.fda.gov/drugs/biosimilars/
biosimilars-action-plan#clarity.
3 See the Product-Specific Guidances for Generic
Drug Development web page at https://
www.accessdata.fda.gov/scripts/cder/psg/
index.cfm.
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60439
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Human Genome Research.
This is a hybrid meeting held inperson and virtually and is open to the
public as indicated below. Individuals
who plan to attend in-person or view
the virtual meeting and need special
assistance or other reasonable
accommodations, should notify the
Contact Person listed below in advance
of the meeting. The meeting will be
videocast and can be accessed from
https://www.genome.gov/eventcalendar/103rd-Meeting-of-NationalAdvisory-Council-for-Human-GenomeResearch.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Human Genome Research.
Date: September 9–10, 2024.
Closed: September 09, 2024, 9:00 a.m. to
10:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700
Rockledge Drive, Suite 1100, Bethesda, MD
20892 (Hybrid Meeting).
Open: September 09, 2024, 10:00 a.m. to
6:00 p.m.
Agenda: Report of Institute Director and
Institute Staff.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 1100, Bethesda, MD
20892 (Hybrid Meeting).
Closed: September 10, 2024, 9:00 a.m. to
4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700
Rockledge Drive, Suite 1100, Bethesda, MD
20892 (Hybrid).
Contact Person: Jennifer L. Troyer, Ph.D.,
Director, Division of Extramural Operations,
National Human Genome Research Institute,
National Institutes of Health, NIH 6700
Rockledge Drive, Suite 3100, Bethesda, MD
20892, (301) 480–3565, troyerj@mail.nih.gov.
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60440
Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
Information is also available on the
Institute’s/Center’s home page: https://
www.genome.gov/council, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: July 19, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
Dated: July 19, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–16325 Filed 7–24–24; 8:45 am]
[FR Doc. 2024–16327 Filed 7–24–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
ddrumheller on DSK120RN23PROD with NOTICES1
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Clinical Informatics and Data Analytics II.
Date: August 13, 2024.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jessica Bellinger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
Bethesda, MD 20892, (301) 827–4446,
bellingerjd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cancer
Therapeutics.
Date: August 15, 2024.
Time: 1:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Careen K Tang-Toth,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, (301) 435–
3504, tothct@csr.nih.gov.
19:41 Jul 24, 2024
[FR Doc. 2024–16323 Filed 7–24–24; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2024–0619]
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Dated: July 19, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Great Lakes Pilotage Advisory
Committee Meeting; September 2024
Meeting
National Institutes of Health
AGENCY:
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; Industrialization and
Translation of Extracellular Vesicles for use
in Regenerative Medicine (ITERM).
Date: October 24, 2024.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 9609 Medical Center Drive,
Rockville, MD 20850.
Contact Person: Alumit Ishai, Ph.D.,
Scientific Review Officer, Office of Grants
Management and Scientific Review, National
Center for Advancing Translational Sciences,
National Institutes of Health, 9609 Medical
Center Drive, MSC 9793, Rockville, MD
20892 (301) 496–9539, alumit.ishai@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B—Cooperative
Agreements; 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
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U.S. Coast Guard, Department
of Homeland Security.
ACTION: Notice of open Federal advisory
committee meeting.
The Great Lakes Pilotage
Advisory Committee (Committee) will
meet in Massena, New York, to discuss
matters relating to Great Lakes Pilotage,
including review of proposed Great
Lakes Pilotage regulations and policies.
The meeting will be open to the public.
DATES:
Meeting: The Committee will meet on
Tuesday, September 10, 2024, from 8
a.m. to 5:30 p.m. Eastern Daylight Time
(EDT). Please note that this meeting may
adjourn early if the Committee has
completed its business.
Comments and supporting
documentations: To ensure your
comments are received by Committee
members prior to the meeting, submit
your written comments no later than
August 30, 2024.
ADDRESSES: The meeting will be held at
the Saint Lawrence Seaway Visitor
Center at Eisenhower Lock, 76 Barnhart
Island Road, Massena, NY 13662.
Pre-registration Information: Preregistration is not required for access to
the meeting.
The Great Lakes Pilotage Advisory
Committee is committed to ensuring all
participants have equal access
regardless of disability status. If you
require reasonable accommodation due
to a disability to fully participate, please
email Mr. Francis Levesque at
Francis.R.Levesque@uscg.mil. or call
(571) 308–4941 as soon as possible.
Instructions: You are free to submit
comments at any time, including orally
at the meeting, but if you want
Committee members to review your
comment before the meeting, please
submit your comments no later than
August 30, 2024. We are particularly
interested in comments on the topics in
the ‘‘Agenda’’ section below. We
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60439-60440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16327]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Advisory
Council for Human Genome Research.
This is a hybrid meeting held in-person and virtually and is open
to the public as indicated below. Individuals who plan to attend in-
person or view the virtual meeting and need special assistance or other
reasonable accommodations, should notify the Contact Person listed
below in advance of the meeting. The meeting will be videocast and can
be accessed from https://www.genome.gov/event-calendar/103rd-Meeting-of-National-Advisory-Council-for-Human-Genome-Research.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Advisory Council for Human Genome
Research.
Date: September 9-10, 2024.
Closed: September 09, 2024, 9:00 a.m. to 10:00 a.m.
Agenda: To review and evaluate grant applications.
Place: National Human Genome Research Institute, National
Institutes of Health, 6700 Rockledge Drive, Suite 1100, Bethesda, MD
20892 (Hybrid Meeting).
Open: September 09, 2024, 10:00 a.m. to 6:00 p.m.
Agenda: Report of Institute Director and Institute Staff.
Place: National Human Genome Research Institute, National
Institutes of Health, 6700B Rockledge Drive, Suite 1100, Bethesda,
MD 20892 (Hybrid Meeting).
Closed: September 10, 2024, 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Human Genome Research Institute, National
Institutes of Health, 6700 Rockledge Drive, Suite 1100, Bethesda, MD
20892 (Hybrid).
Contact Person: Jennifer L. Troyer, Ph.D., Director, Division of
Extramural Operations, National Human Genome Research Institute,
National Institutes of Health, NIH 6700 Rockledge Drive, Suite 3100,
Bethesda, MD 20892, (301) 480-3565, [email protected].
[[Page 60440]]
Information is also available on the Institute's/Center's home
page: https://www.genome.gov/council, where an agenda and any
additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human
Genome Research, National Institutes of Health, HHS)
Dated: July 19, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of Federal Advisory Committee
Policy.
[FR Doc. 2024-16327 Filed 7-24-24; 8:45 am]
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