81 FR 9864 - Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 38 (February 26, 2016)

Page Range		9864-9864
FR Document		2016-04093

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.

Federal Register, Volume 81 Issue 38 (Friday, February 26, 2016)

[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Page 9864]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

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

9864 Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Develop internal compliance check program ...................... 270,600 1 270,600 8 2,164,800

Total .............................................................................. ........................ ........................ ........................ ........................ 6,765,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
Number of Total annual Average burden per
Activity records per Total hours
recordkeepers records recordkeeper
recordkeeper

Training program ............................................. 270,600 4 1,082,400 0.25 (15 minutes) ............... 270,600
Written policy against sales to minors and 270,600 4 1,082,400 0.10 (6 minutes) ................. 108,240
employee acknowledgement.
Internal compliance check program ................ 270,600 2 541,200 0.5 (30 minutes) ................. 270,600

Total ......................................................... ........................ ........................ ........................ ............................................. 649,440
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 23, 2016. Ave., Bldg. 31, Rm. 2417, Silver Spring, or designee, who is identified with
Leslie Kux, MD 20993–0002, 301–796–9001, email: consumer interests and is recommended
Associate Commissioner for Policy. GIDAC@fda.hhs.gov. by either a consortium of consumer-
[FR Doc. 2016–04176 Filed 2–25–16; 8:45 am] SUPPLEMENTARY INFORMATION: Under 41 oriented organizations or other
BILLING CODE 4164–01–P CFR 102–3.65 and approval by the interested persons. In addition to the
Department of Health and Human voting members, the Committee may
Services under 45 CFR part 11 and by include one non-voting member who is
DEPARTMENT OF HEALTH AND the General Services Administration, identified with industry interests.
HUMAN SERVICES FDA is announcing the renewal of the
Gastrointestinal Drugs Advisory Further information regarding the
Food and Drug Administration Committee. The Committee is a most recent charter and other
discretionary Federal advisory information can be found at http://
[Docket No. FDA–2016–N–0001] www.fda.gov/AdvisoryCommittees/
committee established to provide advice
Advisory Committee; Gastrointestinal to the Commissioner. CommitteesMeetingMaterials/Drugs/
Drugs Advisory Committee, Renewal The Committee advises the GastrointestinalDrugsAdvisory
Commissioner or designee in Committee/default.htm or by contacting
AGENCY: Food and Drug Administration, discharging responsibilities as they the Designated Federal Officer (see FOR
HHS. relate to helping to ensure safe and FURTHER INFORMATION CONTACT). In light
ACTION:Notice; renewal of advisory effective drugs for human use and, as of the fact that no change has been made
committee. required, any other product for which to the committee name or description of
the Food and Drug Administration has duties, no amendment will be made to
SUMMARY: The Food and Drug regulatory responsibility.
Administration (FDA) is announcing the 21 CFR 14.100.
The Committee reviews and evaluates
renewal of the Gastrointestinal Drugs available data concerning the safety and This document is issued under the
Advisory Committee by the effectiveness of marketed and Federal Advisory Committee Act (5
Commissioner of Food and Drugs (the investigational human drug products for U.S.C. app.). For general information
Commissioner). The Commissioner has use in the treatment of gastrointestinal related to FDA advisory committees,
determined that it is in the public diseases and makes appropriate please visit us at http://www.fda.gov/
interest to renew the Gastrointestinal recommendations to the Commissioner. AdvisoryCommittees/default.htm.
Drugs Advisory Committee for an The Committee shall consist of a core Dated: February 22, 2016.
additional 2 years beyond the charter of 11 voting members including the
expiration date. The new charter will be Leslie Kux,
Chair. Members and the Chair are
in effect until March 3, 2018. selected by the Commissioner or Associate Commissioner for Policy.
DATES: Authority for the Gastrointestinal designee from among authorities [FR Doc. 2016–04093 Filed 2–25–16; 8:45 am]
Drugs Advisory Committee will expire knowledgeable in the fields of BILLING CODE 4164–01–P
on March 3, 2018, unless the gastroenterology, endocrinology,
Commissioner formally determines that
mstockstill on DSK4VPTVN1PROD with NOTICES

surgery, clinical pharmacology,
renewal is in the public interest. physiology, pathology, liver function,
FOR FURTHER INFORMATION CONTACT: motility, esophagitis, and statistics.
Cindy Hong, Division of Advisory Almost all non-Federal members of this
Committee and Consultant committee serve as Special Government
Management, Office of Executive Employees. The core of voting members
Programs, Food and Drug may include one technically qualified
Administration, 10903 New Hampshire member, selected by the Commissioner

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Document Created: 2018-02-02 14:37:12
Document Modified: 2018-02-02 14:37:12

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; renewal of advisory committee.
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.
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: [email protected]
FR Citation		81 FR 9864

81 FR 9864 - Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 38 (February 26, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration