Advisory Committee; Food Advisory Committee, Renewal, 242 [2015-33171]
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Federal Register / Vol. 81, No. 2 / Tuesday, January 5, 2016 / Notices
approximately 132 TPPs per year. Based
on data received from the
Pharmaceutical Research and
Manufacturers of America, we estimate
that approximately 20 sponsors would
submit TPPs and that each TPP would
take approximately 20 hours to prepare
and submit to FDA. Based on the
previous methodology and assumptions,
the following table provides an estimate
of the annual reporting burden for the
voluntary submission of TPPs under the
draft guidance. FDA requests comments
on this analysis of information
collection burdens.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
20
6.6
132
20
2,640
Target Product Profiles (TPPs) ......................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
advisory committee established to
provide advice to the Commissioner.
I. Objectives and Scope of Activities
The Food Advisory Committee (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.
[FR Doc. 2015–33127 Filed 1–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Advisory Committee; Food Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Food 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
Food Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the December 18, 2017.
DATES: Authority for the Food Advisory
Committee will expire on December 18,
2017, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Karen Strambler, Center for Food Safety
and Applied Nutrition, Office of
Regulations, Policy, and Social
Sciences, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2589, karen.strambler@fda.hhs.gov.
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
Food Advisory Committee. The
committee is a discretionary Federal
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:43 Jan 04, 2016
Jkt 238001
II. Description of Duties
The Committee reviews and evaluates
emerging food safety, nutrition, and
other food- or cosmetic-related health
issues that FDA considers of primary
importance for its food and cosmetics
programs. The Committee may be
charged with reviewing and evaluating
available data and making
recommendations on matters such as
those relating to: (1) Broad scientific and
technical food- or cosmetic-related
issues; (2) the safety of food ingredients
and new foods; (3) labeling of foods and
cosmetics; (4) nutrient needs and
nutritional adequacy; and (5) safe
exposure limits for food contaminants.
The Committee may also be asked to
provide advice and make
recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
III. Membership and Designation
The Committee shall consist of a core
of 15 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of physical
sciences, biological and life sciences,
food science, risk assessment, nutrition,
food technology, molecular biology,
epidemiology, and other relevant
scientific and technical disciplines.
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
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Employees. The core of voting members
may include two technically qualified
member(s), selected by the
Commissioner or designee, who are
identified with consumer interests and
are recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
two non-voting member(s) who are
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
FoodAdvisoryCommittee/
ucm120646.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 https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–33171 Filed 1–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health
Office of Minority Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (DHHS) is hereby giving notice
that the Advisory Committee on
SUMMARY:
E:\FR\FM\05JAN1.SGM
05JAN1
]]>Agencies
[Federal Register Volume 81, Number 2 (Tuesday, January 5, 2016)]
[Notices]
[Page 242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33171]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Advisory Committee; Food Advisory Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Food 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 Food Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until the December 18, 2017.
DATES: Authority for the Food Advisory Committee will expire on
December 18, 2017, unless the Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Karen Strambler, Center for Food
Safety and Applied Nutrition, Office of Regulations, Policy, and Social
Sciences, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, 240-402-2589, karen.strambler@fda.hhs.gov.
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 Food Advisory Committee. The committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner.
I. Objectives and Scope of Activities
The Food Advisory Committee (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.
II. Description of Duties
The Committee reviews and evaluates emerging food safety,
nutrition, and other food- or cosmetic-related health issues that FDA
considers of primary importance for its food and cosmetics programs.
The Committee may be charged with reviewing and evaluating available
data and making recommendations on matters such as those relating to:
(1) Broad scientific and technical food- or cosmetic-related issues;
(2) the safety of food ingredients and new foods; (3) labeling of foods
and cosmetics; (4) nutrient needs and nutritional adequacy; and (5)
safe exposure limits for food contaminants. The Committee may also be
asked to provide advice and make recommendations on ways of
communicating to the public the potential risks associated with these
issues and on approaches that might be considered for addressing the
issues.
III. Membership and Designation
The Committee shall consist of a core of 15 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of physical sciences, biological and life sciences, food
science, risk assessment, nutrition, food technology, molecular
biology, epidemiology, and other relevant scientific and technical
disciplines. 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
two technically qualified member(s), selected by the Commissioner or
designee, who are identified with consumer interests and are
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include two non-voting member(s) who are identified with
industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/ucm120646.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 https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33171 Filed 1-4-16; 8:45 am]
BILLING CODE 4164-01-P
