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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