[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 19978-19979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07908]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
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 March 23, 2018.
DATES: Authority for the Bone, Reproductive and Urologic Drugs Advisory
Committee will expire on March 23, 2018, 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:
[email protected].
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 the Food and Drug Administration
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 of Food and
Drugs.
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 member who is
identified with industry interests.
Further information regarding the most recent charter and other
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm107572.htm or by contacting
the Designated Federal Officer (see FOR FURTHER INFORMATION
[[Page 19979]]
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 visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: April 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-07908 Filed 4-5-16; 8:45 am]
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