[Federal Register Volume 81, Number 89 (Monday, May 9, 2016)]
[Notices]
[Pages 28084-28085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Anesthetic and Analgesic Drug Products
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 Anesthetic and Analgesic Drug Products 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 Anesthetic and Analgesic Drug Products Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until May 1, 2018.
DATES: Authority for the Anesthetic and Analgesic Drug Products
Advisory Committee will expire on May 1, 2016, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, 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 protected].
SUPPLEMENTARY INFORMATION: Issued in 41 CFR 102-3.65 and approval by
the Department of Health and Human Services issued in 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Anesthetic and Analgesic Drug Products Advisory
Committee. The committee is a discretionary Federal advisory committee
established to provide advice to the Commissioner. The Anesthetic and
Analgesic Drug Products Advisory Committee advises the Commissioner or
designee in discharging responsibilities
[[Page 28085]]
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 available data concerning the safety and effectiveness of
marketed and investigational human drug products including analgesics,
e.g., abuse-deterrent opioids, novel analgesics, and issues related to
opioid abuse, and those for use in anesthesiology 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 anesthesiology, analgesics (such as: abuse deterrent opioids,
novel analgesics, and issues related to opioid abuse) epidemiology or
statistics, and related specialties. Members will be invited to serve
for overlapping terms of up to four 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/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm094127.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). Since 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: May 3, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-10766 Filed 5-6-16; 8:45 am]
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