Document ID: FDA-2016-N-0001-0047
Agency: fda
Document Type: Notice
Title: Advisory Committee; Anesthetic and Analgesic Drug Products Advisory
Committee, Renewal
Posted Date: 2016-05-09T04:00Z

[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]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, AADPAC@fda.hhs.gov.

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]
 BILLING CODE 4164-01-P