National Antimicrobial Resistance Monitoring System 2026-2030 Strategic Plan; Request for Comments, 2007-2008 [2025-00342]
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Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices
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’’).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5538]
National Antimicrobial Resistance
Monitoring System 2026–2030
Strategic Plan; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA, we, or Agency) is
soliciting comments from the public
regarding the National Antimicrobial
Resistance Monitoring System (NARMS)
2026–2030 Strategic Plan. Comments
received will help inform the
development of a draft 2026–2030
Strategic Plan, to be discussed at a
public meeting in spring 2025. Specific
questions and information requests are
included in this notice to help guide
input from interested parties.
DATES: Submit either electronic or
written comments by March 26, 2025.
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
March 26, 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.
SUMMARY:
khammond on DSK9W7S144PROD with NOTICES
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
VerDate Sep<11>2014
17:28 Jan 08, 2025
Jkt 265001
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 FDA–N–2024–5538 for
‘‘National Antimicrobial Resistance
Monitoring System 2026–2030 Strategic
Plan; 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://
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
2007
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:
Heather Tate, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5454,
heather.tate@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Antimicrobial resistance (AMR) has
been ranked by the World Health
Organization as a top global health
challenge. Reducing human exposure to
antimicrobial resistant microorganisms
and their resistance determinants is key
to reducing the burden of antimicrobial
resistant infections. Food is a potential
source of human exposure. An
antimicrobial resistance monitoring
system is required to track resistance
among different population groups and
in different settings over time, detect
new resistance types, reveal the
underlying determinants of resistance in
different microorganisms, and measure
the effectiveness of interventions.
NARMS was established in 1996 as a
collaborative public health surveillance
program comprised of State and local
public health departments and
universities, FDA, the Centers for
Disease Control and Prevention (CDC),
and the U.S. Department of Agriculture
(USDA). The overall purpose of this
national program is to monitor trends in
antimicrobial resistance among enteric
(intestinal) bacteria from people (CDC),
retail meats (FDA), and food animals at
the time of slaughter (USDA) in the
United States; disseminate timely
information on antimicrobial resistance
to promote interventions that reduce
resistance among foodborne bacteria;
conduct research to better understand
the emergence, persistence, and spread
of antimicrobial resistance; provide
timely antimicrobial resistance data for
outbreak investigations; and provide
data that assist FDA in making decisions
related to the approval of safe and
effective antimicrobial drugs for
animals.
On August 18, 2020, FDA, CDC, and
USDA released the NARMS Strategic
Plan 2021–2025, listing the program’s
E:\FR\FM\10JAN1.SGM
10JAN1
2008
Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices
khammond on DSK9W7S144PROD with NOTICES
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
VerDate Sep<11>2014
17:28 Jan 08, 2025
Jkt 265001
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]
BILLING CODE 4164–01–P
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
Frm 00072
Fmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
SUMMARY:
PO 00000
BILLING CODE 4164–01–P
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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:
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 90, Number 6 (Friday, January 10, 2025)]
[Notices]
[Pages 2007-2008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00342]
[[Page 2007]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5538]
National Antimicrobial Resistance Monitoring System 2026-2030
Strategic Plan; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
soliciting comments from the public regarding the National
Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic
Plan. Comments received will help inform the development of a draft
2026-2030 Strategic Plan, to be discussed at a public meeting in spring
2025. Specific questions and information requests are included in this
notice to help guide input from interested parties.
DATES: Submit either electronic or written comments by March 26, 2025.
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 March 26, 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 FDA-N-2024-
5538 for ``National Antimicrobial Resistance Monitoring System 2026-
2030 Strategic Plan; 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: Heather Tate, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-5454, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Antimicrobial resistance (AMR) has been ranked by the World Health
Organization as a top global health challenge. Reducing human exposure
to antimicrobial resistant microorganisms and their resistance
determinants is key to reducing the burden of antimicrobial resistant
infections. Food is a potential source of human exposure. An
antimicrobial resistance monitoring system is required to track
resistance among different population groups and in different settings
over time, detect new resistance types, reveal the underlying
determinants of resistance in different microorganisms, and measure the
effectiveness of interventions.
NARMS was established in 1996 as a collaborative public health
surveillance program comprised of State and local public health
departments and universities, FDA, the Centers for Disease Control and
Prevention (CDC), and the U.S. Department of Agriculture (USDA). The
overall purpose of this national program is to monitor trends in
antimicrobial resistance among enteric (intestinal) bacteria from
people (CDC), retail meats (FDA), and food animals at the time of
slaughter (USDA) in the United States; disseminate timely information
on antimicrobial resistance to promote interventions that reduce
resistance among foodborne bacteria; conduct research to better
understand the emergence, persistence, and spread of antimicrobial
resistance; provide timely antimicrobial resistance data for outbreak
investigations; and provide data that assist FDA in making decisions
related to the approval of safe and effective antimicrobial drugs for
animals.
On August 18, 2020, FDA, CDC, and USDA released the NARMS Strategic
Plan 2021-2025, listing the program's
[[Page 2008]]
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 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]
BILLING CODE 4164-01-P
