Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont), 2008 [2025-00340]

Download as PDF 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 Sfmt 4703 [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]
[Page 2008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00340]


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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.

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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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/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
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