[Federal Register Volume 89, Number 111 (Friday, June 7, 2024)]
[Notices]
[Pages 48653-48654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0335]


Advisory Committee; Obstetrics, Reproductive and Urologic Drugs 
Advisory; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the renewal of the Obstetrics, Reproductive and Urologic 
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 Obstetrics, Reproductive and Urologic Drugs 
Advisory Committee for an additional 2 years beyond the charter 
expiration date. The new charter will be in effect until the March 23, 
2026, expiration date.

DATES: Authority for the Obstetrics, Reproductive and Urologic Drugs 
Advisory Committee will expire on March 23, 2026, unless the 
Commissioner formally determines that renewal is in the public 
interest.

FOR FURTHER INFORMATION CONTACT: Joyce Frimpong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7973, email: [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 Obstetrics, 
Reproductive and Urologic Drugs 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 data on the safety and 
effectiveness of marketed and investigational human drug products for 
use in the practice of obstetrics, gynecology, urology, and related 
specialties, and makes

[[Page 48654]]

appropriate recommendations to the Commissioner.
    Pursuant to its Charter, the Committee shall consist of a core of 
11 voting members including the Chair. Members and the Chair are 
selected by the Commissioner or designee from among authorities 
knowledgeable in the fields of obstetrics, gynecology, urology, 
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, representatives, or Ex-Officio members. 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/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee-formerly-bone-reproductive-and 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: June 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12528 Filed 6-6-24; 8:45 am]
BILLING CODE 4164-01-P