[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Page 80116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA- 2019-N-4203]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of 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 Bone, 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, 2022, expiration date.

DATES: Authority for the Bone, Reproductive and Urologic Drugs Advisory 
Committee will expire on March 23, 2022 unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, 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: 
BRUDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Bone, Reproductive and Urologic Drugs Advisory 
Committee. The Committee is a discretionary Federal advisory committee 
established to provide advice to the Commissioner.
    The Bone, Reproductive and Urologic Drugs Advisory 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 osteoporosis and metabolic bone disease, 
obstetrics, gynecology, urology and related specialties, and makes 
appropriate recommendations to the Commissioner.
    Under 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 osteoporosis and metabolic bone disease, obstetrics, 
gynecology, urology, pediatrics, epidemiology, or statistics and 
related specialties. Members will be invited to serve for overlapping 
terms of up to 4 years. Almost all non-Federal members of this 
committee serve as Special Government Employees. 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/bone-reproductive-and-urologic-drugs-advisory-committee-formerly-reproductive-health-drugs-advisory 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 document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27289 Filed 12-10-20; 8:45 am]
BILLING CODE 4164-01-P


