National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 41978-41979 [2016-15163]
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Federal Register / Vol. 81, No. 124 / Tuesday, June 28, 2016 / Notices
Purpose: 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 provides sciencebased 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 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.
The Secretary of HHS approved
establishment of the 2018 PAGAC as a
discretionary federal advisory
committee. The Committee will provide
the Department with independent,
science-based advice and
recommendations. The 2018 PAGAC
consists of a panel of experts who are
selected from the private sector.
Individuals who are selected to serve on
the 2018 PAGAC must have current
scientific knowledge in the field of
human physical activity and health
promotion or the prevention of chronic
disease.
Appointed Committee Members: As
stipulated in the charter, the 2018
PAGAC will be composed of 11–17
members. Members of the Committee
are appointed by the Secretary.
Information on Committee membership
is available at www.health.gov/
paguidelines.
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 2018 PAGAC will
examine the current PAG, take into
consideration new scientific evidence
and current resource documents, and
develop a report to the Secretary of HHS
that outlines its science-based advice
and recommendations for development
of the PAG, second edition. The
Committee will hold approximately five
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public meetings to review and discuss
recommendations. 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 final
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 2018 PAGAC will
occur in a public forum. At this
meeting, the 2018 PAGAC will be
oriented to the PAG revision process
and begin its deliberations.
Meeting Agenda: The meeting agenda
will include (a) review of operations for
the Committee members, (b) a
presentation on the history of the PAG
and how they are used, (c) presentation
on the literature review process, and (d)
plans for future Committee work.
Meeting Registration: The meeting is
open to the public. The meeting will be
accessible by webcast or by attendance
in-person. Pre-registration is required
for both web viewing and in-person
attendance. To pre-register, please visit
www.health.gov/paguidelines. To
request a special accommodation, please
email niheventapproval@mail.nih.gov.
Webcast Public Participation: After
pre-registration, individuals
participating by webcast will receive
webcast access information via email.
In-Person Public Participation and
Building Access: For in-person
participants, the meeting will be held
within the National Institutes of Health
(NIH) PNRC, Building 35, as noted
above in the ADDRESSES section. Details
regarding registration capacity and
directions will be posted on
www.health.gov/paguidelines. For inperson participants, check-in at the
registration desk onsite at the meeting is
required and will begin at 7:30 a.m.
E.D.T. each day. Please note that all
visitors must enter through the NIH
Gateway Center, which opens at 6:00
a.m. E.D.T. You will be asked to submit
to a vehicle or personal inspection and
provide a government-issued ID.
Public Comments and Meeting
Documents: Written comments from the
public will be accepted throughout the
Committee’s deliberative process;
opportunities to present oral comments
to the Committee will be provided at a
future meeting. Written public
comments can be submitted and/or
viewed at www.health.gov/paguidelines
using the ‘‘Submit Comments’’ and
‘‘Read Comments’’ links, respectively.
Documents pertaining to Committee
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deliberations, including meeting
agendas and summaries will be
available on www.health.gov/
paguidelines, and meeting materials
will be available for public viewing at
the meeting. 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: June 22, 2016.
Don Wright,
Deputy Assistant Secretary for Health, (Office
of Disease Prevention and Health Promotion).
[FR Doc. 2016–15206 Filed 6–27–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Investigator Initiated
Program Project Applications (P01).
Date: July 21, 2016.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: James T. Snyder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities/
Room 3G31B National Institutes of Health,
NIAID, 5601 Fishers Lane MSC 9823,
Rockville, MD 20892, (240) 669–5060,
james.snyder@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS).
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Federal Register / Vol. 81, No. 124 / Tuesday, June 28, 2016 / Notices
Dated: June 22, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–15163 Filed 6–27–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up
Exclusive License: Premarket
Approved Diagnostic for Identifying JC
Virus
National Institutes of Health.
Notice.
AGENCY:
ACTION:
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institute of
Neurological Disorders and Stroke
(NINDS), National Institutes of Health
(NIH), Department of Health and Human
Services, is contemplating the grant of a
start-up exclusive license to Pro Arc
Diagnostics, Inc., which is located in
Missouri, to practice the inventions
embodied in the following patents: U.S.
Patent Application 14/408,919, filed
December 17, 2014 (HHS reference E–
088–2012/0–US–03).
The patent rights in these inventions
have been assigned to the United States
of America. The prospective start-up
exclusive license territory may be
worldwide and the field of use may be
limited to FDA premarket approved
(PMA) diagnostics for the detection of
JC Virus.
DATES: Only written comments and/or
applications for a license which are
received by NINDS Technology Transfer
on or before July 13, 2016 will be
considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated start-up exclusive license
should be directed to: Susan Ano, Ph.D.,
NINDS Technology Transfer, 31 Center
Drive, Suite 8A52, MS2540, Bethesda,
MD 20892; Telephone: (301) 435–5515;
Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention provides a multiplex PCRbased method for detecting JC virus, and
distinguishing between the nonpathogenic and pathogenic JC virus that
causes progressive multifocal
leukoencephalopathy (PML) in
individuals that are
immunocompromised. The invention
helps to identify individuals at risk of
developing PML by detecting two
regions of the viral genome. The assay
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SUMMARY:
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detects JC viral DNA with high
sensitivity using the T protein coding
DNA that is highly specific and does not
allow mutations. It also detects a
genome variable region in the noncoding region that detects changes from
the nonpathogenic genotype in the urine
to the pathogenic type seen in tissues
especially in the brain, bone marrow,
plasma/serum or immune cells of PML
patients.
The prospective start-up exclusive
license may be granted unless within
fifteen (15) days from the date of this
published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR part 404.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated start-up
exclusive license. Comments and
objections submitted to this notice will
not be made available for public
inspection and, to the extent permitted
by law, will not be released under the
Freedom of Information Act, 5 U.S.C.
552.
Dated: June 21, 2016.
Susan Ano,
Technology Development Coordinator NINDS
Technology Transfer, National Institutes of
Health.
[FR Doc. 2016–15165 Filed 6–27–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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 contract proposals 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: Eunice Kennedy
Shriver National Institute of Child Health
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and Human Development Special Emphasis
Panel Systematic Review of Neonatal
Medicine.
Date: August 2, 2016.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6710 B
Rockledge Drive, Room 2131D, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6710 B Rockledge
Drive, Room 2131D, Bethesda, MD 20892,
(301) 435–6680, skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: June 22, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–15164 Filed 6–27–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Infectious Diseases.
Date: July 6, 2016.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: John C. Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3114,
MSC 7808, Bethesda, MD 20892, (301) 435–
2398, pughjohn@csr.nih.gov.
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Agencies
[Federal Register Volume 81, Number 124 (Tuesday, June 28, 2016)]
[Notices]
[Pages 41978-41979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15163]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
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 Institute of Allergy and Infectious
Diseases Special Emphasis Panel NIAID Investigator Initiated Program
Project Applications (P01).
Date: July 21, 2016.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 5601 Fishers Lane,
Rockville, MD 20892 (Telephone Conference Call).
Contact Person: James T. Snyder, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities/Room 3G31B National Institutes of Health, NIAID, 5601
Fishers Lane MSC 9823, Rockville, MD 20892, (240) 669-5060,
james.snyder@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS).
[[Page 41979]]
Dated: June 22, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-15163 Filed 6-27-16; 8:45 am]
BILLING CODE 4140-01-P