Announcement of Intent To Establish the 2018 Physical Activity Guidelines Advisory Committee and Solicitation of Nominations for Appointment to the Committee Membership, 79049-79050 [2015-31837]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: May 22, 2012.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
XTANDI (NDA 203–415) was initially
submitted on May 22, 2012.
3. The date the application was
approved: August 31, 2012. FDA has
verified the applicant’s claim that NDA
203–415 was approved on August 31,
2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 101 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: December 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31824 Filed 12–17–15; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:20 Dec 17, 2015
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Intent To Establish
the 2018 Physical Activity Guidelines
Advisory Committee and Solicitation of
Nominations for Appointment to the
Committee Membership
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The U.S. Department of
Health and Human Services (HHS)
announces the intent to establish a
Physical Activity Guidelines Advisory
Committee (Committee). It is planned
for the Committee to be established in
calendar year 2016. This notice also
serves to announce that an invitation is
being extended for nominations of
qualified candidates to be considered
for appointment as a member of the
Committee.
SUMMARY:
Nominations for membership on
the Committee must be submitted by
6:00 p.m. ET on Friday, February 5,
2016.
DATES:
Nominations should be
submitted by email to
PAGACnominations@hhs.gov. This
address can be accessed online at the
following address: www.health.gov/
paguidelines. Nominations may also be
sent to the following address: Richard D.
Olson, M.D., M.P.H., Designated
Program Official, 2018 Physical Activity
Guidelines Advisory Committee; HHS/
OASH/ODPHP; 1101 Wootton Parkway,
Suite LL–100; Rockville, MD 20852;
Telephone: (240) 453–8280.
FOR FURTHER INFORMATION CONTACT:
Designated Program Official, 2018
Physical Activity Guidelines Advisory
Committee, Richard D. Olson and/or
Alternate Designated Program Official,
Katrina L. Piercy, Ph.D., R.D., HHS/
OASH/ODPHP; 1101 Wootton Parkway,
Suite LL–100; Rockville, MD 20852;
Telephone: (240) 453–8280. Additional
information is available at
www.health.gov/paguidelines.
SUPPLEMENTARY INFORMATION:
Purpose: The inaugural Physical
Activity Guidelines for Americans
(PAG), issued in 2008, represents the
first major federal review of the benefits
of physical activity. The PAG provides
science-based advice on how physical
activity can help promote health and
reduce the risk of chronic disease. The
PAG serves as the benchmark and
primary, authoritative voice of the
federal government for providing
ADDRESSES:
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
79049
science-based guidance on physical
activity, fitness, and health in the
United States. Five years after the first
edition of the PAG was released,
ODPHP, in collaboration with the
Centers for Disease Control and
Prevention (CDC), the National
Institutes of Health (NIH), and the
President’s Council on Fitness, Sports,
and Nutrition (PCFSN) led development
of the PAG Midcourse Report: Strategies
to Increase Physical Activity Among
Youth. The 2nd edition of the Physical
Activity Guidelines will build upon the
1st edition and provide a foundation for
federal recommendations and education
for physical activity programs for
Americans, including those at risk for
chronic disease.
The Committee will be established as
a discretionary federal advisory
committee and governed by the
provisions of the Federal Advisory
Committee Act (FACA), Public Law 92–
463, as amended (5 U.S.C., App.). The
work of the Committee will be solely
advisory in nature and time-limited.
Formation of the Committee is
necessary and in the public interest. The
Committee will examine the current
PAG, take into consideration new
scientific evidence and current resource
documents, and then develop a
scientific advisory report to be
submitted to the Secretary of HHS that
outlines its science-based
recommendations and rationale. The
scientific report will be used by the
federal government to develop the 2nd
edition of the Physical Activity
Guidelines for Americans. The
Committee’s duties do not include
developing the policy, a draft of the
policy, or determining how future
policy might be implemented by the
federal government. For those interested
in reviewing the Physical Activity
Guidelines for Americans, the 2008
Advisory Committee Scientific Report,
or the PAG Midcourse Report, they are
available at www.health.gov/
paguidelines.
The Committee is expected to begin
meeting in summer of 2016. The
Committee is expected to meet
approximately five times during the
course of its operation. Pursuant to
FACA, all meetings of the full
Committee will be open to the public.
Individuals selected for appointment
to the Committee will be invited to
serve as members until the charter
expires or the Committee accomplishes
its mission. In keeping with FACA, the
charter will expire two years from the
date it is established. The Committee
will operate until its report is delivered
to the Secretary or the charter expires,
whichever comes first. There will be no
E:\FR\FM\18DEN1.SGM
18DEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
79050
Federal Register / Vol. 80, No. 243 / Friday, December 18, 2015 / Notices
stipend authorized to be paid to the
members for performance of their
official duties. However, Committee
members will be authorized to receive
per diem and reimbursement for travel
expenses incurred for attending public
meetings.
Structure: It is proposed that the
Committee will consist of 11–17
members; one or two members will be
selected to serve as the Chair, Vice
Chair, and/or Co-Chairs. To be eligible
for consideration of appointment to the
Committee, individuals should be
knowledgeable of current scientific
research in human physical activity and
be respected and published experts in
their fields. They should be familiar
with the purpose, communication, and
application of federal physical activity
guidelines and have demonstrated
interest in the public’s health and wellbeing through their research and/or
educational endeavors. Expertise is
sought in specific specialty areas related
to physical activity and health
promotion or disease prevention,
including but not limited to: Health
promotion and chronic disease
prevention; bone, joint, and muscle
health and performance; obesity and
weight management; physical activity
and risk of musculoskeletal injury;
physical activity and cognition; physical
activity within specific settings, such as
preschool/childcare, schools (e.g.,
activity breaks, physical education), or
the community/built environment;
physical activity dose-response;
sedentary behavior; behavior change;
systematic reviews; and special
populations including children, older
adults, individuals with disabilities, or
women who are pregnant.
Nominations: HHS will consider
nominations, including selfnominations, for Committee
membership of individuals qualified to
carry out the above-mentioned tasks.
The following information should be
included in the package of material
submitted for each individual being
nominated for consideration: (1) The
name, address, daytime telephone
number, and email address of the
nominator and the individual being
nominated; (2) a letter of nomination
that clearly states the name and
affiliation of the nominee, the basis for
the nomination (i.e., specific attributes
which qualify the nominee for service in
this capacity), and a statement from the
nominee that the nominee is willing to
serve as a member of the Committee;
and (3) a current copy of the nominee’s
curriculum vitae (CV) no more than 10
pages in length. Inclusion of the
following is requested in the CV: (1)
Current and/or past grant awards; (2)
VerDate Sep<11>2014
19:20 Dec 17, 2015
Jkt 238001
publications showing both breadth and
experience in areas of specialization; (3)
paid and non-paid board and advisory
appointments; and (4) education and
occupational history.
All nominations must include the
required information. Incomplete
nominations will not be processed for
consideration. Federal employees
should not be nominated for
consideration of appointment to this
Committee.
Equal opportunity practices regarding
membership appointments to the
Committee will be aligned with HHS
policies. When possible, every effort
will be made to ensure that the
Committee is a diverse group of
individuals with representation from
various geographic locations, racial and
ethnic minorities, all genders, and
persons with disabilities. Individuals
will be appointed to serve as members
of the Committee to represent balanced
viewpoints of the scientific evidence,
not to represent the viewpoints of any
specific group.
Members of the Committee will be
classified as special government
employees (SGEs) during their term of
appointment to the Committee, and as
such are subject to the ethical standards
of conduct for federal employees. Upon
entering the position and annually
throughout the term of appointment,
members of the Committee will be
required to complete and submit a
report of their financial holdings,
consultancies, and research grants and/
or contracts. The purpose of this report
is to determine if the individual has any
interest and/or activities in the private
sector that may conflict with
performance of their official duties as a
member of the Committee.
Dated: December 15, 2015.
Don Wright,
Deputy Assistant Secretary for Health, Office
of Disease Prevention and Health Promotion.
[FR Doc. 2015–31837 Filed 12–17–15; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for Nursing
Research.
The meeting will be open to the
public as indicated below, with
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
attendance 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 Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Nursing Research.
Date: January 26–27, 2016.
Open: January 26, 2016, 1:00 p.m. to 4:45
p.m.
Agenda: Discussion of Program Policies
and Issues.
Place: National Institutes of Health, Porter
Neuroscience Research Center, Building 35A,
Convent Drive, Room 620/630, Bethesda, MD
20892.
Closed: January 27, 2016, 9:00 a.m. to 1:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Porter
Neuroscience Research Center, Building 35A,
Convent Drive, Room 620/630, Bethesda, MD
20892.
Contact Person: Ann R. Knebel, DNSC, RN,
FAAN, Deputy Director, National Institute of
Nursing Research, National Institutes of
Health, 31 Center Drive, Building 31, Room
5B05, Bethesda, MD 20892, 301–496–8230,
knebelar@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: www.nih.gov/
ninr/aadvisory.html, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
E:\FR\FM\18DEN1.SGM
18DEN1
]]>Agencies
[Federal Register Volume 80, Number 243 (Friday, December 18, 2015)]
[Notices]
[Pages 79049-79050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31837]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Announcement of Intent To Establish the 2018 Physical Activity
Guidelines Advisory Committee and Solicitation of Nominations for
Appointment to the Committee Membership
AGENCY: Office of Disease Prevention and Health Promotion, Office of
the Assistant Secretary for Health, Office of the Secretary, Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. Department of Health and Human Services (HHS)
announces the intent to establish a Physical Activity Guidelines
Advisory Committee (Committee). It is planned for the Committee to be
established in calendar year 2016. This notice also serves to announce
that an invitation is being extended for nominations of qualified
candidates to be considered for appointment as a member of the
Committee.
DATES: Nominations for membership on the Committee must be submitted by
6:00 p.m. ET on Friday, February 5, 2016.
ADDRESSES: Nominations should be submitted by email to
PAGACnominations@hhs.gov. This address can be accessed online at the
following address: www.health.gov/paguidelines. Nominations may also be
sent to the following address: Richard D. Olson, M.D., M.P.H.,
Designated Program Official, 2018 Physical Activity Guidelines Advisory
Committee; HHS/OASH/ODPHP; 1101 Wootton Parkway, Suite LL-100;
Rockville, MD 20852; Telephone: (240) 453-8280.
FOR FURTHER INFORMATION CONTACT: Designated Program Official, 2018
Physical Activity Guidelines Advisory Committee, Richard D. Olson and/
or Alternate Designated Program Official, Katrina L. Piercy, Ph.D.,
R.D., HHS/OASH/ODPHP; 1101 Wootton Parkway, Suite LL-100; Rockville, MD
20852; Telephone: (240) 453-8280. Additional information is available
at www.health.gov/paguidelines.
SUPPLEMENTARY INFORMATION:
Purpose: The inaugural Physical Activity Guidelines for Americans
(PAG), issued in 2008, represents the first major federal review of the
benefits of physical activity. The PAG provides science-based advice on
how physical activity can help promote health and reduce the risk of
chronic disease. The PAG serves as the benchmark and primary,
authoritative voice of the federal government for providing science-
based guidance on physical activity, fitness, and health in the United
States. Five years after the first edition of the PAG was released,
ODPHP, in collaboration with the Centers for Disease Control and
Prevention (CDC), the National Institutes of Health (NIH), and the
President's Council on Fitness, Sports, and Nutrition (PCFSN) led
development of the PAG Midcourse Report: Strategies to Increase
Physical Activity Among Youth. The 2nd edition of the Physical Activity
Guidelines will build upon the 1st edition and provide a foundation for
federal recommendations and education for physical activity programs
for Americans, including those at risk for chronic disease.
The Committee will be established as a discretionary federal
advisory committee and governed by the provisions of the Federal
Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C.,
App.). The work of the Committee will be solely advisory in nature and
time-limited. Formation of the Committee is necessary and in the public
interest. The Committee will examine the current PAG, take into
consideration new scientific evidence and current resource documents,
and then develop a scientific advisory report to be submitted to the
Secretary of HHS that outlines its science-based recommendations and
rationale. The scientific report will be used by the federal government
to develop the 2nd edition of the Physical Activity Guidelines for
Americans. The Committee's duties do not include developing the policy,
a draft of the policy, or determining how future policy might be
implemented by the federal government. For those interested in
reviewing the Physical Activity Guidelines for Americans, the 2008
Advisory Committee Scientific Report, or the PAG Midcourse Report, they
are available at www.health.gov/paguidelines.
The Committee is expected to begin meeting in summer of 2016. The
Committee is expected to meet approximately five times during the
course of its operation. Pursuant to FACA, all meetings of the full
Committee will be open to the public.
Individuals selected for appointment to the Committee will be
invited to serve as members until the charter expires or the Committee
accomplishes its mission. In keeping with FACA, the charter will expire
two years from the date it is established. The Committee will operate
until its report is delivered to the Secretary or the charter expires,
whichever comes first. There will be no
[[Page 79050]]
stipend authorized to be paid to the members for performance of their
official duties. However, Committee members will be authorized to
receive per diem and reimbursement for travel expenses incurred for
attending public meetings.
Structure: It is proposed that the Committee will consist of 11-17
members; one or two members will be selected to serve as the Chair,
Vice Chair, and/or Co-Chairs. To be eligible for consideration of
appointment to the Committee, individuals should be knowledgeable of
current scientific research in human physical activity and be respected
and published experts in their fields. They should be familiar with the
purpose, communication, and application of federal physical activity
guidelines and have demonstrated interest in the public's health and
well-being through their research and/or educational endeavors.
Expertise is sought in specific specialty areas related to physical
activity and health promotion or disease prevention, including but not
limited to: Health promotion and chronic disease prevention; bone,
joint, and muscle health and performance; obesity and weight
management; physical activity and risk of musculoskeletal injury;
physical activity and cognition; physical activity within specific
settings, such as preschool/childcare, schools (e.g., activity breaks,
physical education), or the community/built environment; physical
activity dose-response; sedentary behavior; behavior change; systematic
reviews; and special populations including children, older adults,
individuals with disabilities, or women who are pregnant.
Nominations: HHS will consider nominations, including self-
nominations, for Committee membership of individuals qualified to carry
out the above-mentioned tasks. The following information should be
included in the package of material submitted for each individual being
nominated for consideration: (1) The name, address, daytime telephone
number, and email address of the nominator and the individual being
nominated; (2) a letter of nomination that clearly states the name and
affiliation of the nominee, the basis for the nomination (i.e.,
specific attributes which qualify the nominee for service in this
capacity), and a statement from the nominee that the nominee is willing
to serve as a member of the Committee; and (3) a current copy of the
nominee's curriculum vitae (CV) no more than 10 pages in length.
Inclusion of the following is requested in the CV: (1) Current and/or
past grant awards; (2) publications showing both breadth and experience
in areas of specialization; (3) paid and non-paid board and advisory
appointments; and (4) education and occupational history.
All nominations must include the required information. Incomplete
nominations will not be processed for consideration. Federal employees
should not be nominated for consideration of appointment to this
Committee.
Equal opportunity practices regarding membership appointments to
the Committee will be aligned with HHS policies. When possible, every
effort will be made to ensure that the Committee is a diverse group of
individuals with representation from various geographic locations,
racial and ethnic minorities, all genders, and persons with
disabilities. Individuals will be appointed to serve as members of the
Committee to represent balanced viewpoints of the scientific evidence,
not to represent the viewpoints of any specific group.
Members of the Committee will be classified as special government
employees (SGEs) during their term of appointment to the Committee, and
as such are subject to the ethical standards of conduct for federal
employees. Upon entering the position and annually throughout the term
of appointment, members of the Committee will be required to complete
and submit a report of their financial holdings, consultancies, and
research grants and/or contracts. The purpose of this report is to
determine if the individual has any interest and/or activities in the
private sector that may conflict with performance of their official
duties as a member of the Committee.
Dated: December 15, 2015.
Don Wright,
Deputy Assistant Secretary for Health, Office of Disease Prevention and
Health Promotion.
[FR Doc. 2015-31837 Filed 12-17-15; 8:45 am]
BILLING CODE 4150-32-P
