[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]]
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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.
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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
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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 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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