National Institute of General Medical Sciences; Notice of Meeting, 15583 [2018-07396]
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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
VerDate Sep<11>2014
17:17 Apr 10, 2018
Jkt 244001
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 Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Page 15583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07396]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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
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,
[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, 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]
BILLING CODE 4140-01-P
