National Cancer Institute; Notice of Meeting, 15583-15584 [2018-07390]
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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
safety. These sections describe essential
considerations intended to provide
high-level guidance on the
implementation of these approaches in
pediatric drug development and have
been revised based on comments
received from global stakeholders.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘E11(R1)
Addendum: Clinical Investigation of
Medicinal Products in the Pediatric
Population.’’ 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.
II. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: April 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07375 Filed 4–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
amozie on DSK30RV082PROD with NOTICES
National Institute of General Medical
Sciences; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
General Medical Sciences Council.
The meeting will be open to the
public as indicated below, with a short
public comment period at the end.
Attendance is limited by the 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 open
session will also be videocast and can
be accessed from the NIH Videocasting
and Podcasting website (https://
videocast.nih.gov).
The meeting will be closed to the
public in accordance with the
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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 Comittee: National Advisory
General Medical Sciences Council.
Date: May 24–25, 2018.
Closed: May 24, 2018, 9:00 a.m. to 5:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Open: May 25, 2018, 8:30 a.m. to 12:00
p.m.
Agenda: For the discussion of program
policies and issues; opening remarks; report
of the Director, NIGMS; and other business
of the Council.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Contact Person: Ann A. Hagan, Ph.D.,
Associate Director for Extramural Activities,
NIGMS, NIH, DHHS, 45 Center Drive, Room
2AN24H, MSC 6200, Bethesda, MD 20892–
6200, (301) 594–4499, hagana@
nigms.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: https://
www.nigms.nih.gov/About/Council, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: April 5, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–07396 Filed 4–10–18; 8:45 am]
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15583
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Frederick National
Laboratory Advisory Committee to the
National Cancer Institute.
The meeting will be open to the
public, with 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 also be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://
videocast.nih.gov/).
Name of Committee: Frederick National
Laboratory Advisory Committee to the
National Cancer Institute.
Date: May 8, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: Ongoing and new activities at the
Frederick National Laboratory for Cancer
Research.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive,
Conference Room TE406, Rockville, MD
20850.
Contact Person: Caron A. Lyman, Ph.D.,
Executive Secretary, National Cancer
Institute, National Institutes of Health, 9609
Medical Center Drive, Room 7W–126,
Bethesda, MD 20892, 240–276–6348,
lymanc@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, NCI Shady Grove
has instituted stringent procedures for
entrance into the NCI Shady Grove building.
Visitors will be asked to show one form of
identification (for example, a governmentissued 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: https://
deainfo.nci.nih.gov/advisory/fac/fac.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(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)
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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
Dated: April 5, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–07390 Filed 4–10–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: April 5, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meetings
[FR Doc. 2018–07393 Filed 4–10–18; 8:45 am]
BILLING CODE 4140–01–P
amozie on DSK30RV082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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: National Institute on
Alcohol Abuse and Alcoholism Initial
Review Group; Neuroscience Review
Subcommittee (AA–4).
Date: June 6, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, Conference Room T508, 5635
Fishers Lane, Rockville, MD 20851.
Contact Person: Beata Buzas, Ph.D.,
Scientific Review Officer, Office of
Extramural Activities National Institute on
Alcohol Abuse and Alcoholism, 5635 Fishers
Lane, Room 2081, National Institutes of
Health, Rockville, MD 20852, 301–443–0800,
bbuzas@mail.nih.gov.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Initial
Review Group; Biomedical Research Review
Subcommittee (AA–1).
Date: June 12, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 5th Floor Conference Room,
5635 Fishers Lane, Rockville, MD 20851.
Contact Person: Philippe Marmillot, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, National Institute on Alcohol
Abuse and Alcoholism, National Institutes of
Health, 5635 Fishers Lane, Room 2017,
Bethesda, MD 20892, 301–443–2861,
marmillotp@mail.nih.gov.
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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, 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 Clinical Trial
Implementation Cooperative Agreement
(U01).
Date: May 1, 2018.
Time: 1:00 p.m. to 4:30 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: Nancy VazquezMaldonado, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of
Extramural Activities, Room 3F52B, National
Institutes of Health/NIAID, 5601 Fishers
Lane, MSC 9834, Bethesda, MD 20892–9834,
(240) 669–5044, nvazquez@niaid.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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Dated: April 5, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–07394 Filed 4–10–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Aging.
The meeting will be open to the
public as indicated below, with
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 on Aging.
Date: May 22–23, 2018.
Closed: May 22, 2018, 3:00 p.m. to 5:00
p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, C Wing 6th Floor Conference
Room 10, 9000 Rockville Pike, Bethesda, MD
20892.
Open: May 23, 2018, 8:00 a.m. to 2:00 p.m.
Agenda: Call to order and report from the
Director; Discussion of future meeting dates;
Consideration of minutes of last meeting;
Reports from Task Force on Minority Aging
Research, Working Group on Program;
Council Speaker; Program Highlights
Place: National Institutes of Health,
Building 31, C Wing 6th Floor Conference
Room 10, 9000 Rockville Pike, Bethesda, MD
20892.
Contact Person: Robin Barr, Director,
National Institute on Aging, Office of
Extramural Activities, Gateway Building,
7201 Wisconsin Avenue, Bethesda, MD
20814, (301) 496–9322, barrr@nia.nih.gov.
Any interested person may file written
comments with the committee by forwarding
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]]>Agencies
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15583-15584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07390]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Meeting
Pursuant to section 10(a) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the Frederick National
Laboratory Advisory Committee to the National Cancer Institute.
The meeting will be open to the public, with 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 also be videocast and can be
accessed from the NIH Videocasting and Podcasting website (https://videocast.nih.gov/).
Name of Committee: Frederick National Laboratory Advisory
Committee to the National Cancer Institute.
Date: May 8, 2018.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: Ongoing and new activities at the Frederick National
Laboratory for Cancer Research.
Place: National Cancer Institute Shady Grove, 9609 Medical
Center Drive, Conference Room TE406, Rockville, MD 20850.
Contact Person: Caron A. Lyman, Ph.D., Executive Secretary,
National Cancer Institute, National Institutes of Health, 9609
Medical Center Drive, Room 7W-126, Bethesda, MD 20892, 240-276-6348,
[email protected].
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, NCI Shady Grove has instituted
stringent procedures for entrance into the NCI Shady Grove building.
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: https://deainfo.nci.nih.gov/advisory/fac/fac.htm, where an
agenda and any additional information for the meeting will be posted
when available.
(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)
[[Page 15584]]
Dated: April 5, 2018.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-07390 Filed 4-10-18; 8:45 am]
BILLING CODE 4140-01-P
