Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices 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, 

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 


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2008 Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / 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 

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] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product; 

CRENESSITY (crinecerfont) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 

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] 

BILLING CODE 4164–01–P 

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, 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 


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