Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal, 2008-2009 [2025-00357]
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2008
Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices
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strategic goals and objectives, as well as
its challenges and opportunities. A
central theme of the 2021–2025 NARMS
Strategic Plan is One Health, which is
a collaborative, multisectoral, and
transdisciplinary approach to health—
working at the local, regional, national,
and global levels—with the goal of
achieving optimal health outcomes by
recognizing the interconnection
between people, animals, plants, and
their shared environment. In accord
with the principles of One Health,
NARMS has collaborated with FDA’s
Veterinary Laboratory Investigation and
Response Network (Vet-LIRN), with
USDA’s Animal and Plant Health
Inspection Service (APHIS), and with
the U.S. Environmental Protection
Agency (EPA) to test for various
pathogens.
NARMS is now seeking input from
interested parties for its 2026–2030
Strategic Plan. The feedback received
will help inform the development of a
draft 2026–2030 NARMS Strategic Plan,
to be discussed at a public meeting to
be held in spring 2025.
II. Questions for Consideration
We seek input on the following
questions:
1. How do you use NARMS human,
animal, and retail data? Do you use
other sources of AMR data for your
program?
2. Are you using these data for risk
management activities, including
implementation of mitigation and
prevention strategies?
3. What aspects of the NARMS data
do you find most useful and why?
4. Is there additional AMR
information that you would want
NARMS to collect that is not currently
being collected? Alternatively, are there
any current aspects of NARMS that
could or should be discontinued and, if
so, why?
5. Considering that One Health is an
approach that recognizes that the health
of people is closely connected to the
health of animals and our shared
environment, what approaches could
NARMS use to conduct monitoring
within the One Health framework?
6. What data-sharing capacities are
available for interested parties to
collaborate with NARMS more
effectively?
7. What type of NARMS analyses,
data visualization, and/or reporting do
you think are needed to demonstrate
whether there are changes in AMR as a
result of antimicrobial stewardship and
animal management practices?
8. What research do you think is
needed to demonstrate whether there
are changes in AMR as a result of
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antimicrobial stewardship and animal
management practices?
9. If not covered under the above
questions, specifically include at least
one item that you think should be
considered in the development of the
2026–2030 NARMS Strategic Plan.
Dated: January 2, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00342 Filed 1–8–25; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
pediatric patients 4 years of age and
older with classic congenital adrenal
hyperplasia.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about CRENESSITY
(crinecerfont), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: January 3, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00340 Filed 1–8–25; 8:45 am]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product;
CRENESSITY (crinecerfont)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that CRENESSITY
(crinecerfont), approved on December
13, 2024, manufactured by Neurocrine
Biosciences, Inc., meets the criteria for
a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that CRENESSITY (crinecerfont),
manufactured by Neurocrine
Biosciences, Inc., meets the criteria for
a priority review voucher. CRENESSITY
(crinecerfont) is indicated for the
treatment to glucocorticoid replacement
to control androgens in adults and
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
SUMMARY:
PO 00000
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[Docket No. FDA–2024–N–5829]
Advisory Committee; Antimicrobial
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing the renewal of the
Antimicrobial Drugs Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Antimicrobial Drugs Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
October 7, 2026, expiration date.
DATES: Authority for the Antimicrobial
Drugs Advisory Committee will expire
on October 7, 2026, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Yvette Waples, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, AMDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Antimicrobial Drugs
SUMMARY:
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khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of infectious
diseases and disorders and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
Pursuant to its charter, the Committee
shall consist of a core of 13 voting
members including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities knowledgeable in the fields
of infectious disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Members will be invited to serve for
overlapping terms of up to 4 years. NonFederal members of this committee will
serve as Special Government Employees
or representatives. Federal members
will serve as Regular Government
Employees or Ex-Officios. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting representative member
who is identified with industry
interests. There may also be an alternate
industry representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members) or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
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in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, an additional non-voting
representative member of consumer
interests and an additional non-voting
representative member of industry
interests will be included in addition to
the voting members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
antimicrobial-drugs-advisorycommittee-formerly-known-antiinfective-drugs-advisory-committee/
antimicrobial-drugs-advisorycommittee-formerly-known-antiinfective-drugs-advisory-committee or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This notice is issued under the
Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For
general information related to FDA
advisory committees, please visit us at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 31, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00357 Filed 1–8–25; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3233]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Technical Electronic
Product Radiation Safety Standards
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Technical Electronic
Product Radiation Safety Standards
Committee (TEPRSSC) in the Center for
Devices and Radiological Health.
SUMMARY:
PO 00000
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2009
Nominations will be accepted for
current and upcoming vacancies
effective January 1, 2025, with this
notice. FDA seeks to include the views
of women and men, members of all
racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before March 11, 2025, will be given
first consideration for membership on
TEPRSSC. Nominations received after
March 11, 2025, will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by accessing FDA’s
Advisory Committee Membership
Nomination Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Akinola Awojope, Office of
Management Services, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216,
Silver Spring, MD 20993–0002, 301–
636–0512, email: Akinola.Awojope@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on TEPRSSC that include five
general public representatives and five
government representatives.
I. General Description of the
Committee’s Duties
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (the Commissioner) on
the technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
II. Criteria for Voting Members
The committee consists of a core of 15
voting members including the Chair.
Members and the Chair are selected by
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Agencies
[Federal Register Volume 90, Number 6 (Friday, January 10, 2025)]
[Notices]
[Pages 2008-2009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5829]
Advisory Committee; Antimicrobial Drugs Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Antimicrobial Drugs Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the
Antimicrobial Drugs Advisory Committee for an additional 2 years beyond
the charter expiration date. The new charter will be in effect until
the October 7, 2026, expiration date.
DATES: Authority for the Antimicrobial Drugs Advisory Committee will
expire on October 7, 2026, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Yvette Waples, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Antimicrobial
Drugs
[[Page 2009]]
Advisory Committee (the Committee). The Committee is a discretionary
Federal advisory committee established to provide advice to the
Commissioner. The Committee advises the Commissioner or designee in
discharging responsibilities as they relate to helping to ensure safe
and effective drugs for human use and, as required, any other product
for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of infectious diseases and disorders
and makes appropriate recommendations to the Commissioner of Food and
Drugs.
Pursuant to its charter, the Committee shall consist of a core of
13 voting members including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of infectious disease, internal medicine,
microbiology, pediatrics, epidemiology or statistics, and related
specialties. Members will be invited to serve for overlapping terms of
up to 4 years. Non-Federal members of this committee will serve as
Special Government Employees or representatives. Federal members will
serve as Regular Government Employees or Ex-Officios. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the
voting members, the Committee may include one non-voting representative
member who is identified with industry interests. There may also be an
alternate industry representative.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) expertise is required that is not available among
current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members) or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee or by contacting
the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT).
In light of the fact that no change has been made to the committee name
or description of duties, no amendment will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act as
amended (5 U.S.C. 1001 et seq.). For general information related to FDA
advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: December 31, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00357 Filed 1-8-25; 8:45 am]
BILLING CODE 4164-01-P