Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal, 2008-2009 [2025-00357]

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 khammond on DSK9W7S144PROD with NOTICES Federal Register / Vol. 90, No. 6 / Friday, January 10, 2025 / Notices Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and makes appropriate recommendations to the Commissioner of Food and Drugs. Pursuant to its charter, the Committee shall consist of a core of 13 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. NonFederal members of this committee will serve as Special Government Employees or representatives. Federal members will serve as Regular Government Employees or Ex-Officios. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative. The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members) or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. Because of the size of the Committee and the variety in the types of issues that it will consider, FDA may, VerDate Sep<11>2014 17:28 Jan 08, 2025 Jkt 265001 in connection with a particular committee meeting, specify a quorum that is less than a majority of the current voting members. The Agency’s regulations (21 CFR 14.22(d)) authorize a committee charter to specify quorum requirements. If functioning as a medical device panel, an additional non-voting representative member of consumer interests and an additional non-voting representative member of industry interests will be included in addition to the voting members. Further information regarding the most recent charter and other information can be found at https:// www.fda.gov/advisory-committees/ antimicrobial-drugs-advisorycommittee-formerly-known-antiinfective-drugs-advisory-committee/ antimicrobial-drugs-advisorycommittee-formerly-known-antiinfective-drugs-advisory-committee or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This notice is issued under the Federal Advisory Committee Act as amended (5 U.S.C. 1001 et seq.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: December 31, 2024. P. Ritu Nalubola, Associate Commissioner for Policy. [FR Doc. 2025–00357 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–2018–N–3233] Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. SUMMARY: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 2009 Nominations will be accepted for current and upcoming vacancies effective January 1, 2025, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Nominations received on or before March 11, 2025, will be given first consideration for membership on TEPRSSC. Nominations received after March 11, 2025, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be sent electronically by accessing FDA’s Advisory Committee Membership Nomination Portal at https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s website at https:// www.fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Office of Management Services, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993–0002, 301– 636–0512, email: Akinola.Awojope@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members on TEPRSSC that include five general public representatives and five government representatives. I. General Description of the Committee’s Duties The committee provides advice and consultation to the Commissioner of Food and Drugs (the Commissioner) on the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation from such products, and may recommend electronic product radiation safety standards to the Commissioner for consideration. II. Criteria for Voting Members The committee consists of a core of 15 voting members including the Chair. Members and the Chair are selected by E:\FR\FM\10JAN1.SGM 10JAN1

Agencies

[Federal Register Volume 90, Number 6 (Friday, January 10, 2025)]
[Notices]
[Pages 2008-2009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00357]


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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, [email protected].

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

[[Page 2009]]

Advisory Committee (the Committee). The Committee is a discretionary 
Federal advisory committee established to provide advice to the 
Commissioner. The Committee advises the Commissioner or designee in 
discharging responsibilities as they relate to helping to ensure safe 
and effective drugs for human use and, as required, any other product 
for which FDA has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of infectious diseases and disorders 
and makes appropriate recommendations to the Commissioner of Food and 
Drugs.
    Pursuant to its charter, the Committee shall consist of a core of 
13 voting members including the Chair. Members and the Chair are 
selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of infectious disease, internal medicine, 
microbiology, pediatrics, epidemiology or statistics, and related 
specialties. Members will be invited to serve for overlapping terms of 
up to 4 years. Non-Federal members of this committee will serve as 
Special Government Employees or representatives. Federal members will 
serve as Regular Government Employees or Ex-Officios. The core of 
voting members may include one technically qualified member, selected 
by the Commissioner or designee, who is identified with consumer 
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the 
voting members, the Committee may include one non-voting representative 
member who is identified with industry interests. There may also be an 
alternate industry representative.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees 
(normally not to exceed 10 members) to serve temporarily as voting 
members and to designate consultants to serve temporarily as voting 
members when: (1) expertise is required that is not available among 
current voting standing members of the Committee (when additional 
voting members are added to the Committee to provide needed expertise, 
a quorum will be based on the combined total of regular and added 
members) or (2) to comprise a quorum when, because of unforeseen 
circumstances, a quorum is or will be lacking. Because of the size of 
the Committee and the variety in the types of issues that it will 
consider, FDA may, in connection with a particular committee meeting, 
specify a quorum that is less than a majority of the current voting 
members. The Agency's regulations (21 CFR 14.22(d)) authorize a 
committee charter to specify quorum requirements.
    If functioning as a medical device panel, an additional non-voting 
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in 
addition to the voting members.
    Further information regarding the most recent charter and other 
information can be found at https://www.fda.gov/advisory-committees/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee/antimicrobial-drugs-advisory-committee-formerly-known-anti-infective-drugs-advisory-committee or by contacting 
the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). 
In light of the fact that no change has been made to the committee name 
or description of duties, no amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act as 
amended (5 U.S.C. 1001 et seq.). For general information related to FDA 
advisory committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: December 31, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00357 Filed 1-8-25; 8:45 am]
BILLING CODE 4164-01-P


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