Notice2022-10040
Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal
Primary source
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Published
May 11, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 the March 3, 2024, expiration date.
Full Text
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<title>Federal Register, Volume 87 Issue 91 (Wednesday, May 11, 2022)</title>
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[Federal Register Volume 87, Number 91 (Wednesday, May 11, 2022)]
[Notices]
[Page 28834]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10040]
[[Page 28834]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0619]
Advisory Committee; Gastrointestinal Drugs Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal 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 the March 3, 2024, expiration date.
DATES: Authority for the Gastrointestinal Drugs Advisory Committee will
expire on March 3, 2024, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Rhea Bhatt, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-9001, email:
<a href="/cdn-cgi/l/email-protection#c0878984818380a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="57101e13161417313336793f3f2479303821">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services 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.
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. Non-Federal members of this
committee will serve as Special Government Employees, representatives,
or Ex-Officio members. Federal members will serve as Regular Government
Employees or Ex-Officios. 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 <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/gastrointestinal-drugs-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/gastrointestinal-drugs-advisory-committee</a> 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 notice 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 <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: May 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10040 Filed 5-10-22; 8:45 am]
BILLING CODE 4164-01-P
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