Meeting of the 2018 Physical Activity Guidelines Advisory Committee, 12614-12615 [2017-04170]
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Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list prescription FLONASE
(fluticasone propionate) Nasal Spray,
0.05 mg, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to prescription
FLONASE (fluticasone propionate)
Nasal Spray, 0.05 mg, may be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–04231 Filed 3–3–17; 8:45 am]
BILLING CODE 4164–01–P
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4842, FAX: 301–796–9858,
email: larry.bauer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of a rare
pediatric disease product application.
Under section 529 of the FD&C Act (21
U.S.C. 360ff), which was added by
FDASIA, FDA will award priority
review vouchers to sponsors of rare
pediatric disease product applications
that meet certain criteria. FDA has
determined that SPINRAZA
(nusinersen), manufactured by Biogen
Inc., meets the criteria for a priority
review voucher. SPINRAZA
(nusinersen) is indicated for the
treatment of spinal muscular atrophy in
pediatric and adult patients.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about SPINRAZA
(nusinersen), go to the ‘‘Drugs@FDA’’
Web site at https://www.accessdata.fda.
gov/scripts/cder/daf/.
Dated: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–04228 Filed 3–3–17; 8:45 am]
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
rare pediatric disease product
applications that meet certain criteria.
FDA has determined that SPINRAZA
(nusinersen), manufactured by Biogen
Inc., meets the criteria for a priority
review voucher.
FOR FURTHER INFORMATION CONTACT:
Larry Bauer, Rare Diseases Program,
Center for Drug Evaluation and
Research, Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
19:24 Mar 03, 2017
Meeting of the 2018 Physical Activity
Guidelines Advisory Committee
U.S. Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, Office of Disease Prevention and
Health Promotion.
ACTION: Notice.
AGENCY:
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 241001
As stipulated by the Federal
Advisory Committee Act (FACA), the
U.S. Department of Health and Human
Services (HHS) is hereby giving notice
that the third meeting of the 2018
Physical Activity Guidelines Advisory
Committee (2018 PAGAC or Committee)
will be held. This meeting will be open
to the public via videocast.
DATES: The meeting will be held on
March 23, 2017, from 8:00 a.m. E.T. to
5:30 p.m. E.T.
ADDRESSES: The meeting will be
accessible by videocast on the Internet.
SUMMARY:
PO 00000
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FOR FURTHER INFORMATION CONTACT:
Designated Federal Officer, 2018
Physical Activity Guidelines Advisory
Committee, Richard D. Olson, M.D.,
M.P.H. and/or Alternate Designated
Federal Officer, Katrina L. Piercy, Ph.D.,
R.D., Office of Disease Prevention and
Health Promotion (ODPHP), Office of
the Assistant Secretary for Health
(OASH), HHS; 1101 Wootton Parkway,
Suite LL–100; Rockville, MD 20852;
Telephone: (240) 453–8280. Additional
information is available at
www.health.gov/paguidelines.
SUPPLEMENTARY INFORMATION: The
inaugural Physical Activity Guidelines
for Americans (PAG), issued in 2008,
represents the first comprehensive
guidelines on physical activity issued
by the federal government. 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 for Americans. Five years
after the first edition 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 second edition of the PAG
will build upon the first edition and
provide a foundation for federal
recommendations and education for
physical activity programs for
Americans, including those at risk for
chronic disease.
Appointed Committee Members: The
Secretary of HHS appointed 17
individuals to serve as members of the
2018 PAGAC in June 2016. Information
on Committee membership is available
at www.health.gov/paguidelines/secondedition/committee/.
Committee’s Task: The work of the
2018 PAGAC will be time-limited and
solely advisory in nature. The
Committee will develop
recommendations based on the
preponderance of current scientific and
medical knowledge using a systematic
review approach. The Committee will
examine the current PAG, take into
consideration new scientific evidence
and current resource documents, and
develop a scientific report to the
Secretary of HHS that outlines its
science-based advice and
recommendations for development of
the second edition of the PAG. The
Committee will hold approximately five
public meetings to review and discuss
recommendations. The first meeting was
held in July 2016 and the second in
E:\FR\FM\06MRN1.SGM
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12615
Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices
October 2016. It is anticipated that
future meetings will be held in the third
weeks of July 2017 and October 2017.
Meeting dates, times, locations, and
other relevant information will be
announced at least 15 days in advance
of each meeting via Federal Register
notice. As stipulated in the charter, the
Committee will be terminated after
delivery of its report to the Secretary of
HHS or two years from the date the
charter was filed, whichever comes first.
Purpose of the Meeting: In accordance
with FACA and to promote
transparency of the process,
deliberations of the Committee will
occur in a public forum. At this
meeting, the Committee will continue
its deliberations from the last public
meeting.
Meeting Agenda: The meeting will
include review of subcommittee work
since the last public meeting and
deliberation by the full Committee,
discussion of overarching issues, and
plans for future Committee work.
Meeting Registration: The meeting is
open to the public via videocast; preregistration is required. To register,
please visit www.health.gov/
paguidelines. After registration,
individuals will receive videocast
access information via email. To request
a special accommodation, please email
jennifer.gillissen@kauffmaninc.com.
Public Comments and Meeting
Documents: Written comments from the
public will be accepted throughout the
Committee’s deliberative process and
can be submitted and/or viewed at
www.health.gov/paguidelines/pcd/.
Documents pertaining to Committee
deliberations, including meeting
agendas and summaries will be
available on www.health.gov/
paguidelines. Meeting information,
thereafter, will continue to be accessible
online and upon request at the Office of
Disease Prevention and Health
Promotion, OASH/HHS; 1101 Wootton
Parkway, Suite LL100 Tower Building;
Rockville, MD 20852; Telephone: (240)
453–8280; Fax: (240) 453–8281.
Dated: February 23, 2017.
Don Wright,
Deputy Assistant Secretary for Health,
Disease Prevention and Health Promotion.
[FR Doc. 2017–04170 Filed 3–3–17; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: 0990–0278–60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). The ICR is for extending the use
of the approved information collection
assigned OMB control number 0990–
0278, which expires on August 31,
2017. Prior to submitting the ICR to
OMB, OS seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on the ICR must be
received on or before May 5, 2017.
SUMMARY:
Submit your comments to
Information.CollectionClearance@
hhs.gov and Sherrette.Funn@hhs.gov or
by calling (202) 795–7714.
Information Collection Request Title:
Federal-wide Assurance Forms.
Abstract: Assistant Secretary for
Health, Office for Human Research
Protections is requesting Office of
Management and Budget, OMB approval
on a three year extension of the Federalwide Assurance (FWA). The FWA is
designed to provide a simplified
procedure for institutions engaged in
HHS-conducted or supported research
to satisfy the assurance requirements of
Section 491(a) of the Public Health
Service Act and HHS Regulations for the
protection of human subjects at 45 CFR
46.103. The respondents are institutions
engaged in human subject research that
is conducted or supported by HHS.
Need and Proposed Use of the
Information: OHRP is the HHS
component charged with fulfilling the
statutory mandates of these provisions
of the PHS Act and enforcing HHS
regulations at 45 CFR part 46. The FWA
provides a simplified assurance process
that replaced the prior assurance
mechanisms used by OHRP, all of
which were more complicated and
burdensome than the FWA. The
information collected by OHRP through
the FWA is the minimum necessary to
satisfy the assurance requirements of the
PHS Act and the requirements of HHS
regulations at 45 CFR 46.103.
Likely Respondents: Individuals or
households, business or other for-profit,
not-for-profit institutions, Federal, State,
Local, or Tribal Governments.
The total annual burden hours
estimated for this ICR are summarized
in the table below.
ADDRESSES:
ESTIMATED ANNUALIZED BURDEN IN HOURS TABLE
Number of
respondents
Number of
responses
per
respondent
Hours per
response
Response
burden hours
Federal-wide Assurance (FWA) .......................................................................
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Form name
14,000
2.0
0.50
14,000
OS specifically requests comments on
(1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
VerDate Sep<11>2014
19:24 Mar 03, 2017
Jkt 241001
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Terry S. Clark,
Asst. Information Collection Clearance
Officer.
National Institutes of Health
[FR Doc. 2017–04249 Filed 3–3–17; 8:45 am]
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PO 00000
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Child Health and Human Development
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]]>Agencies
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12614-12615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the 2018 Physical Activity Guidelines Advisory
Committee
AGENCY: U.S. Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health, Office of
Disease Prevention and Health Promotion.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act (FACA),
the U.S. Department of Health and Human Services (HHS) is hereby giving
notice that the third meeting of the 2018 Physical Activity Guidelines
Advisory Committee (2018 PAGAC or Committee) will be held. This meeting
will be open to the public via videocast.
DATES: The meeting will be held on March 23, 2017, from 8:00 a.m. E.T.
to 5:30 p.m. E.T.
ADDRESSES: The meeting will be accessible by videocast on the Internet.
FOR FURTHER INFORMATION CONTACT: Designated Federal Officer, 2018
Physical Activity Guidelines Advisory Committee, Richard D. Olson,
M.D., M.P.H. and/or Alternate Designated Federal Officer, Katrina L.
Piercy, Ph.D., R.D., Office of Disease Prevention and Health Promotion
(ODPHP), Office of the Assistant Secretary for Health (OASH), HHS; 1101
Wootton Parkway, Suite LL-100; Rockville, MD 20852; Telephone: (240)
453-8280. Additional information is available at www.health.gov/paguidelines.
SUPPLEMENTARY INFORMATION: The inaugural Physical Activity Guidelines
for Americans (PAG), issued in 2008, represents the first comprehensive
guidelines on physical activity issued by the federal government. 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 for Americans. Five years after the first
edition 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 second edition of the PAG
will build upon the first edition and provide a foundation for federal
recommendations and education for physical activity programs for
Americans, including those at risk for chronic disease.
Appointed Committee Members: The Secretary of HHS appointed 17
individuals to serve as members of the 2018 PAGAC in June 2016.
Information on Committee membership is available at www.health.gov/paguidelines/second-edition/committee/.
Committee's Task: The work of the 2018 PAGAC will be time-limited
and solely advisory in nature. The Committee will develop
recommendations based on the preponderance of current scientific and
medical knowledge using a systematic review approach. The Committee
will examine the current PAG, take into consideration new scientific
evidence and current resource documents, and develop a scientific
report to the Secretary of HHS that outlines its science-based advice
and recommendations for development of the second edition of the PAG.
The Committee will hold approximately five public meetings to review
and discuss recommendations. The first meeting was held in July 2016
and the second in
[[Page 12615]]
October 2016. It is anticipated that future meetings will be held in
the third weeks of July 2017 and October 2017. Meeting dates, times,
locations, and other relevant information will be announced at least 15
days in advance of each meeting via Federal Register notice. As
stipulated in the charter, the Committee will be terminated after
delivery of its report to the Secretary of HHS or two years from the
date the charter was filed, whichever comes first.
Purpose of the Meeting: In accordance with FACA and to promote
transparency of the process, deliberations of the Committee will occur
in a public forum. At this meeting, the Committee will continue its
deliberations from the last public meeting.
Meeting Agenda: The meeting will include review of subcommittee
work since the last public meeting and deliberation by the full
Committee, discussion of overarching issues, and plans for future
Committee work.
Meeting Registration: The meeting is open to the public via
videocast; pre-registration is required. To register, please visit
www.health.gov/paguidelines. After registration, individuals will
receive videocast access information via email. To request a special
accommodation, please email jennifer.gillissen@kauffmaninc.com.
Public Comments and Meeting Documents: Written comments from the
public will be accepted throughout the Committee's deliberative process
and can be submitted and/or viewed at www.health.gov/paguidelines/pcd/.
Documents pertaining to Committee deliberations, including meeting
agendas and summaries will be available on www.health.gov/paguidelines.
Meeting information, thereafter, will continue to be accessible online
and upon request at the Office of Disease Prevention and Health
Promotion, OASH/HHS; 1101 Wootton Parkway, Suite LL100 Tower Building;
Rockville, MD 20852; Telephone: (240) 453-8280; Fax: (240) 453-8281.
Dated: February 23, 2017.
Don Wright,
Deputy Assistant Secretary for Health, Disease Prevention and Health
Promotion.
[FR Doc. 2017-04170 Filed 3-3-17; 8:45 am]
BILLING CODE 4150-32-P
