Document ID: FDA-2016-N-0001-0052
Agency: fda
Document Type: Notice
Title: Advisory Committee; Drug Safety and Risk Management Advisory  Committee, Renewal
Posted Date: 2016-05-19T04:00Z

[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31644-31645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11773]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Advisory Committee; Drug Safety and Risk Management 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 Drug Safety and Risk Management 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 Drug 
Safety and Risk Management Advisory Committee for an additional 2 years 
beyond the charter expiration date. The new charter will be in effect 
until May 31, 2018.

DATES: Authority for the Drug Safety and Risk Management Advisory 
Committee will expire on May 31, 2016, unless the Commissioner formally 
determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Philip A. Bautista, 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, DSARM@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 Drug Safety and Risk Management Advisory Committee. The 
committee is a discretionary Federal advisory committee established to 
provide advice to the Commissioner. The Drug Safety and Risk Management 
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 information on risk management, risk 
communication, and quantitative evaluation of spontaneous reports for 
drugs for human use and for any other product for which the Food and 
Drug Administration has regulatory responsibility. The Committee also 
advises the Commissioner of Food and Drugs regarding the scientific and 
medical evaluation of all information gathered by the Department of 
Health and Human Services and the Department of Justice with regard to 
safety, efficacy, and abuse potential of drugs or other substances, and 
recommends actions to be taken by the Department of Health and Human 
Services with regard to the marketing, investigation, and control of 
such drugs or other substances.
    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 risk communication, risk management, drug safety, medical, 
behavioral, and biological sciences as they apply to risk management, 
and drug abuse. 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/DrugSafetyandRiskManagementAdvisoryCommittee/ucm094886.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 visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

[[Page 31645]]

    Dated: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11773 Filed 5-18-16; 8:45 am]
BILLING CODE 4164-01-P