Notice2022-05973
Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Renewal
Primary source
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Published
March 23, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 56 (Wednesday, March 23, 2022)</title>
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[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16477-16478]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<a href="/cdn-cgi/l/email-protection#3d726f68797c7e7d5b595c1355554e135a524b"><span class="__cf_email__" data-cfemail="b1fee3e4f5f0f2f1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a>.
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 <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/obstetrics-reproductive-and-urologic-drugs-advisory-committee</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
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
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