[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Notices]
[Page 13905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04778]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
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, 2022.
DATES: Authority for the Gastrointestinal Drugs Advisory Committee will
expire on March 3, 2022, unless the Commissioner formally determines
that renewal is in the public interest.
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, Fax: 301-847-
8533, email: [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3, 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.
Pursuant to its Charter, 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 representative
member who is identified with industry interests. There may also be an
alternate industry representative.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/human-drug-advisory-committees/gastrointestinal-drugs-advisory-committee 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 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04778 Filed 3-9-20; 8:45 am]
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