Document ID: FDA-2022-N-0335-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Renewal
Posted Date: 2022-03-23T04:00Z

[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16477-16478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05973]

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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 Committee; 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) is announcing the 
renewal of the Obstetrics, Reproductive and Urologic Drugs Advisory 
Committee (formerly known as the Bone, 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, 
2024, expiration date.

DATES: Authority for the Obstetrics, Reproductive and Urologic Drugs 
Advisory Committee (formerly known as the Bone, Reproductive and 
Urologic Drugs Advisory Committee) will expire on March 23, 2024, 
unless the Commissioner formally determines that renewal is in the 
public interest.

FOR FURTHER INFORMATION CONTACT: Joyce Frimpong, Division of Advisory 
Committee and Consultant Management, 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: 
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services, 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 appropriate recommendations to the Commissioner.
    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.
    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 or by

[[Page 16478]]

contacting the Designated Federal Officer (see FOR FURTHER INFORMATION 
CONTACT). Due to a change in the Committee name and description of 
duties, a final rule will be published in the Federal Register amending 
21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. App.). For general information related to FDA advisory 
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: March 16, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs, 
U.S. Food and Drug Administration.
[FR Doc. 2022-05973 Filed 3-22-22; 8:45 am]
BILLING CODE 4164-01-P