National Cancer Institute; Notice of Closed Meetings, 28652-28653 [2018-13263]
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Federal Register / Vol. 83, No. 119 / Wednesday, June 20, 2018 / Notices
Vulnerabilities and Actionable
Process Steps
• Chapter Three—Mitigation Strategies
for Actionable Process Steps
• Chapter Four—Mitigation Strategies
Management Components: Food
Defense Monitoring
• Appendix—Food Defense Plan
Worksheets
We intend to announce the
availability for public comment of
additional and expanded chapters of the
draft guidance as we complete them.
II. Significance of Guidance
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on food defense
measures against intentional
adulteration for the regulation
‘‘Mitigation Strategies to Protect Food
Against Intentional Adulteration.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 507 have
been approved under OMB control
number 0910–0789.
IV. Electronic Access
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Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Regulatory
Information/Guidances/default.htm or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: June 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–13222 Filed 6–19–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Name: National Committee on Vital
and Health Statistics (NCVHS),
Standards Subcommittee Meeting.
Date and Times: Tuesday, July 17,
2018: 9:00 a.m.–5:00 p.m. (EDT),
Wednesday, July 18, 2018: 8:30 a.m.–
3:00 p.m. (EDT)
Place: U.S. Department of Health and
Human Services, Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Rm. 705A, Washington, DC 20201.
Status: Open. There will be three
opportunities for public comment
during the meeting: At the end of the
first day, at the end of the morning of
the second day, and prior to the meeting
close on the second day.
Purpose: The NCVHS Charter
stipulates that the Committee study the
issues related to the adoption of uniform
data standards for patient medical
record information and the electronic
exchange of such information and report
to the Secretary of Health and Human
Services (HHS) with recommendations
and legislative proposals for such
standards and electronic exchange.
NCVHS also is charged with advising
HHS on health data collection needs
and strategies, and reviewing and
monitoring the Department’s data and
information systems to identify needs,
opportunities, and problems.
In this regard, NCVHS is taking a
contemporary look at the health
terminology and vocabulary landscape
in order to advise the HHS Secretary
regarding: (1) The changing
environment and implications for
timing and approach to health
terminology and vocabulary standards
adoption; (2) Needs, opportunities, and
problems with development,
dissemination, maintenance, and
adoption of health terminology and
vocabulary standards; and (3) Actions
that HHS might take to improve
development, dissemination,
maintenance, and adoption of
standards.
NCVHS is holding an expert
roundtable meeting, in conjunction with
the National Library of Medicine (NLM)
in order to: (1) Assess strengths,
weaknesses and gaps in the U.S. health
terminology and vocabulary (T/V)
environment; (2) Consider areas for near
term improvement in the development,
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maintenance, dissemination and
adoption of named code sets; (3) Discuss
opportunities for improved governance,
coordination and communication across
terminology and vocabulary developers
and their stakeholders; (4) Identify top
priority gaps in the U.S. health
terminology and vocabulary coverage;
and (5) Envision a roadmap for
introducing improvements over the next
decade. Invited experts will have the
opportunity to provide extensive input
to the subcommittee as it studies these
questions and finalizes an
Environmental Scan report of the
current state of the U.S. health
terminology and vocabulary (T/V)
environment.
The times and topics for this meeting
are subject to change. Please refer to the
posted agenda for any updates.
Contact Persons for More Information:
Substantive program information may
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, telephone (301) 458–4715.
Information pertaining to meeting
content may be obtained from Vivian
Auld, National Institutes of Health,
National Library of Medicine, 8600
Rockville Pike, Bethesda, Maryland,
20894–3833, telephone (301) 496–7974.
Summaries of meetings and a roster of
Committee members are available on the
NCVHS website: www.ncvhs.hhs.gov,
where further information including a
meeting agenda and instructions to
access the live audio broadcast of the
meeting will be posted.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (770) 488–3210 as soon
as possible.
Dated: June 14, 2018.
Laina Bush,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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Federal Register / Vol. 83, No. 119 / Wednesday, June 20, 2018 / Notices
The meetings 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 and/or contract
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
grant and/or contract applications, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
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Name of Committee: National Cancer
Institute Special Emphasis Panel; Special
Emphasis Panel for Contract Review.
Date: July 10, 2018.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
7W530, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Shamala Srinivas, Ph.D.,
Scientific Review Officer, Office of Referral,
Review, and Program Coordination, Division
of Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W530, Bethesda, MD 20892–9750,
240–276–6442, ss537t@nih.gov.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
A—Cancer Centers.
Date: July 19, 2018.
Time: 8:00 a.m. to 3:45 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Shamala Srinivas, Ph.D.,
Scientific Review Officer, Office of Referral,
Review, and Program Coordination, Division
of Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W530, Bethesda, MD 20892–9750,
240–276–6442, ss537t@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: June 13, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–13263 Filed 6–19–18; 8:45 am]
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National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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
General Medical Sciences Special Emphasis
Panel; Review of IPERT Applications.
Date: July 26, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Marriott at Metro
Center, 775 12th Street NW, Washington, DC
20005.
Contact Person: Lisa A. Dunbar, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, 301–594–2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives; 93.859,
Biomedical Research and Research Training,
National Institutes of Health, HHS)
Dated: June 14, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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28653
The meetings 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;
Cardiovascular and Respiratory Academic
Research Enhancement Awards.
Date: July 12, 2018.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Abdelouahab Aitouche,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4222,
MSC 7814, Bethesda, MD 20892, 301–435–
2365, aitouchea@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR18–596:
Molecular Mechanisms of Alzheimer’s
Disease, Synaptic Function and
Neurodevelopment.
Date: July 17, 2018.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Carol Hamelink, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4192,
MSC 7850, Bethesda, MD 20892, (301) 213–
9887, hamelinc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Amyloid Polymorphisms and Gylcosylation
in Alzheimer’s Disease.
Date: July 17, 2018.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Brian H Scott, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301–
827–7490, brianscott@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Chemo/Dietary Prevention and
Cancer Biomarkers.
Date: July 17, 2018.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
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[Federal Register Volume 83, Number 119 (Wednesday, June 20, 2018)]
[Notices]
[Pages 28652-28653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13263]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
[[Page 28653]]
The meetings 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 and/or contract applications and the
discussions could disclose confidential trade secrets or commercial
property such as patentable material, and personal information
concerning individuals associated with grant and/or contract
applications, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Special Emphasis Panel for Contract Review.
Date: July 10, 2018.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Cancer Institute, Shady Grove, 9609 Medical
Center Drive, Room 7W530, Rockville, MD 20850 (Telephone Conference
Call).
Contact Person: Shamala Srinivas, Ph.D., Scientific Review
Officer, Office of Referral, Review, and Program Coordination,
Division of Extramural Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W530, Bethesda, MD 20892-9750, 240-
276-6442, [email protected].
Name of Committee: National Cancer Institute Initial Review
Group; Subcommittee A--Cancer Centers.
Date: July 19, 2018.
Time: 8:00 a.m. to 3:45 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: Shamala Srinivas, Ph.D., Scientific Review
Officer, Office of Referral, Review, and Program Coordination,
Division of Extramural Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W530, Bethesda, MD 20892-9750, 240-
276-6442, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: June 13, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-13263 Filed 6-19-18; 8:45 am]
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