[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Page 23467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-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 (the Committee) by the Commissioner of Food and Drugs (the 
Commissioner). The Commissioner has determined that it is in the public 
interest to renew the Committee for an additional 2 years beyond the 
charter expiration date. The new charter will be in effect until May 1, 
2020.

DATES: Authority for the Committee will expire on May 1, 2020, unless 
the Commissioner formally determines that renewal is in the public 
interest.

FOR FURTHER INFORMATION CONTACT: Moon Hee Choi, 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 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 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.
    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 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 https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticandAnalgesicDrugProductsAdvisoryCommittee/default.htm 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: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10731 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P


