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[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

[[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
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