Document ID: FDA-2016-N-0001-0022
Agency: fda
Document Type: Notice
Title: Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal
Posted Date: 2016-02-26T05:00Z

[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Page 9864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04093]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Advisory Committee; Gastrointestinal 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 Gastrointestinal 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 
Gastrointestinal Drugs Advisory Committee for an additional 2 years 
beyond the charter expiration date. The new charter will be in effect 
until March 3, 2018.

DATES: Authority for the Gastrointestinal Drugs Advisory Committee will 
expire on March 3, 2018, unless the Commissioner formally determines 
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, Division of Advisory 
Committee and Consultant Management, Office of Executive Programs, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, 
Silver Spring, MD 20993-0002, 301-796-9001, email: GIDAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 41 CFR 102-3.65 and approval by the 
Department of Health and Human Services under 45 CFR part 11 and by the 
General Services Administration, FDA is announcing the renewal of the 
Gastrointestinal Drugs Advisory 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 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 for use in the treatment of gastrointestinal diseases 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 gastroenterology, endocrinology, surgery, clinical 
pharmacology, physiology, pathology, liver function, motility, 
esophagitis, and statistics. 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/GastrointestinalDrugsAdvisoryCommittee/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 visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: February 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04093 Filed 2-25-16; 8:45 am]
 BILLING CODE 4164-01-P