Document ID: FDA-2016-N-0001-0138
Agency: fda
Document Type: Notice
Title: Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal
Posted Date: 2018-03-27T04:00Z

[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13135-13136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06063]

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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, 2020.

DATES: Authority for the Gastrointestinal Drugs Advisory Committee will 
expire on March 3, 2020, unless the Commissioner formally determines 
that renewal is in the public interest.

[[Page 13136]]

FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, Division of Advisory 
Committee and Consultant Management, 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 Gastrointestinal Drugs Advisory Committee (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 for use in the treatment of gastrointestinal diseases 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 gastroenterology, endocrinology, surgery, clinical 
pharmacology, physiology, pathology, liver function, motility, 
esophagitis, and statistics. 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/GastrointestinalDrugsAdvisoryCommittee/ucm102959.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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06063 Filed 3-26-18; 8:45 am]
 BILLING CODE 4164-01-P