Meeting of the Advisory Committee on Minority Health, 242-243 [2015-33157]
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242
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draft guidance.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]
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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
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SUMMARY:
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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
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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]
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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:
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Federal Register / Vol. 81, No. 2 / Tuesday, January 5, 2016 / Notices
Minority Health (ACMH) will hold a
meeting. This meeting will be open to
the public. Preregistration is required
for both public attendance and
comment. Any individual who wishes
to attend the meeting and/or participate
in the public comment session should
email OMH–ACMH@hhs.gov.
Dated: December 29, 2015.
Minh Wendt,
Alternate Designated Federal Officer, ACMH,
Office of Minority Health, U.S. Department
of Health and Human Services.
The meeting will be held on
Thursday, January 28, 2016, from 9:00
a.m. to 5:00 p.m. and on Friday, January
29, 2016, from 9:00 a.m. to 1:00 p.m.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DATES:
The meeting will be held at
the Omni Shoreham Hotel, 2500 Calvert
St. NW., Washington, DC 20008.
ADDRESSES:
Dr.
Minh Wendt, Alternate Designated
Federal Officer, ACMH; Tower Building,
1101 Wootton Parkway, Suite 600,
Rockville, Maryland 20852. Phone: 240–
453–8222, Fax: 240–453–8223; OMH–
ACMH@hhs.gov
FOR FURTHER INFORMATION CONTACT:
In
accordance with Public Law 105–392,
the ACMH was established to provide
advice to the Deputy Assistant Secretary
for Minority Health in improving the
health of each racial and ethnic
minority group and on the development
of goals and specific program activities
of the Office of Minority Health.
Topics to be discussed during this
meeting will include strategies to
improve the health of racial and ethnic
minority populations through the
development of health policies and
programs that will help eliminate health
disparities, as well as other related
issues.
Public attendance at this meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
designated contact person at least
fourteen (14) business days prior to the
meeting. Members of the public will
have an opportunity to provide
comments at the meeting. Public
comments will be limited to three
minutes per speaker. Individuals who
would like to submit written statements
should mail or fax their comments to
the Office of Minority Health at least
seven (7) business days prior to the
meeting. Any members of the public
who wish to have printed material
distributed to ACMH committee
members should submit their materials
to the Designated Federal Officer,
ACMH, Tower Building, 1101 Wootton
Parkway, Suite 600, Rockville,
Maryland 20852, prior to close of
business on Thursday, January 21, 2016.
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SUPPLEMENTARY INFORMATION:
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[FR Doc. 2015–33157 Filed 1–4–16; 8:45 am]
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Meeting of the Presidential Advisory
Council on HIV/AIDS
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA) will be holding a
meeting to continue discussions and
possibly develop recommendations
regarding People Living with HIV/AIDS.
PACHA members will have discussions
regarding Health System
Transformations, community
approaches to implementing the
Updated National HIV/AIDS Strategy,
and food as medicine. The meeting will
be open to the public.
DATES: The meeting will be held on
January 28, 2016, from 8:30 a.m. to
approximately 5:00 p.m. (ET) and
January 29, 2016, from 9:00 a.m. to
approximately 12:30 p.m. (ET).
ADDRESSES: 200 Independence Avenue
SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, Public Health Analyst,
Presidential Advisory Council on HIV/
AIDS, Department of Health and Human
Services, 200 Independence Avenue
SW., Room 443H, Hubert H. Humphrey
Building, Washington, DC 20201; (202)
205–1178. More detailed information
about PACHA can be obtained by
accessing the Council’s Web site
www.aids.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996. The Council was established
to provide advice, information, and
recommendations to the Secretary
regarding programs, policies, and
research to promote effective treatment,
prevention, and cure of HIV disease and
AIDS, including considering common
co-morbidities of those infected with
HIV as needed to promote effective
prevention and treatment and quality
SUMMARY:
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243
services to persons living with HIV
disease and AIDS. The functions of the
Council are solely advisory in nature.
The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House
Office on National AIDS Policy. The
agenda for the upcoming meeting will
be posted on the Council’s Web site at
www.aids.gov/pacha. PACHA was
established by Executive Order 12963,
dated June 14, 1995 as amended by
Executive Order 13009, dated June 14,
1996. The Council was established to
provide advice, information, and
recommendations to the Secretary
regarding programs and policies to
promote effective prevention and cure
of HIV disease and AIDS. The functions
of the Council are solely advisory in
nature.
The Council consists of not more than
25 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House
Office on National AIDS Policy. The
agenda for the upcoming meeting will
be posted on the AIDS.gov Web site at
www.aids.gov/pacha.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify Caroline
Talev at caroline.talev@hhs.gov. Due to
space constraints, pre-registration for
public attendance is advisable and can
be accomplished by contacting Caroline
Talev at caroline.talev@hhs.gov by close
of business on January 21, 2016.
Members of the public will have the
opportunity to provide comments at the
meeting. Any individual who wishes to
participate in the public comment
session must register with Caroline
Talev at caroline.talev@hhs.gov by close
of business on January 21, 2016;
registration for public comment will not
be accepted by telephone. Individuals
are encouraged to provide a written
statement of any public comment(s) for
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Agencies
[Federal Register Volume 81, Number 2 (Tuesday, January 5, 2016)]
[Notices]
[Pages 242-243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Minority Health
AGENCY: Office of Minority Health, Office of the Secretary, Department
of Health and Human Services.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: 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
[[Page 243]]
Minority Health (ACMH) will hold a meeting. This meeting will be open
to the public. Preregistration is required for both public attendance
and comment. Any individual who wishes to attend the meeting and/or
participate in the public comment session should email OMH-ACMH@hhs.gov.
DATES: The meeting will be held on Thursday, January 28, 2016, from
9:00 a.m. to 5:00 p.m. and on Friday, January 29, 2016, from 9:00 a.m.
to 1:00 p.m.
ADDRESSES: The meeting will be held at the Omni Shoreham Hotel, 2500
Calvert St. NW., Washington, DC 20008.
FOR FURTHER INFORMATION CONTACT: Dr. Minh Wendt, Alternate Designated
Federal Officer, ACMH; Tower Building, 1101 Wootton Parkway, Suite 600,
Rockville, Maryland 20852. Phone: 240-453-8222, Fax: 240-453-8223; OMH-ACMH@hhs.gov
SUPPLEMENTARY INFORMATION: In accordance with Public Law 105-392, the
ACMH was established to provide advice to the Deputy Assistant
Secretary for Minority Health in improving the health of each racial
and ethnic minority group and on the development of goals and specific
program activities of the Office of Minority Health.
Topics to be discussed during this meeting will include strategies
to improve the health of racial and ethnic minority populations through
the development of health policies and programs that will help
eliminate health disparities, as well as other related issues.
Public attendance at this meeting is limited to space available.
Individuals who plan to attend and need special assistance, such as
sign language interpretation or other reasonable accommodations, should
notify the designated contact person at least fourteen (14) business
days prior to the meeting. Members of the public will have an
opportunity to provide comments at the meeting. Public comments will be
limited to three minutes per speaker. Individuals who would like to
submit written statements should mail or fax their comments to the
Office of Minority Health at least seven (7) business days prior to the
meeting. Any members of the public who wish to have printed material
distributed to ACMH committee members should submit their materials to
the Designated Federal Officer, ACMH, Tower Building, 1101 Wootton
Parkway, Suite 600, Rockville, Maryland 20852, prior to close of
business on Thursday, January 21, 2016.
Dated: December 29, 2015.
Minh Wendt,
Alternate Designated Federal Officer, ACMH, Office of Minority Health,
U.S. Department of Health and Human Services.
[FR Doc. 2015-33157 Filed 1-4-16; 8:45 am]
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