Office of the Director, National Institutes of Health Amended Notice of Meeting, 64909 [2019-25478]
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Federal Register / Vol. 84, No. 227 / Monday, November 25, 2019 / Notices
protections afforded by this section for
perpetuity.
Based on the number of CoC requests
we have received prior to the Cures Act,
we estimate receiving approximately
150 discretionary CoC requests
annually. We estimate that
approximately 150 sponsors, sponsorinvestigators, or authorized
representatives will submit requests.
64909
Preparing and sending each request
would take approximately 2 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Draft guidance for sponsors, sponsor-investigators,
researchers, industry, and FDA staff on CoCs
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submissions of CoC Requests From Sponsors, SponsorInvestigators, or Authorized Representatives ..................
150
1
150
2
300
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
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may obtain the draft guidance at either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.
Dated: November 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–25551 Filed 11–22–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board:
Public Meeting
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The HHS Office of the
Secretary is hosting the National
Biodefense Science Board (NBSB)
Public Meeting in Washington, DC,
December 3, 2019. The purpose of the
meeting is to gather information to
develop expert advice provided by
NBSB and guidance to the Secretary on
scientific, technical, and other matters
of special interest to HHS regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate. Retiring NBSB board
members will also be presented with
certificates and a signed letter of
appreciation.
DATES: The NBSB Public Meeting is
being held December 3, 2019, from
10:30 a.m. to 4:30 p.m. Eastern Daylight
Time (EDT).
ADDRESSES: Please visit the NBSB
website (https://www.phe.gov/nbsb) for
all additional information regarding the
NBSB or meeting details.
FOR FURTHER INFORMATION CONTACT:
CAPT Christopher Perdue, MD, MPH,
SUMMARY:
VerDate Sep<11>2014
17:31 Nov 22, 2019
Jkt 250001
Designated Federal Official, NBSB,
ASPR, HHS; 202–401–5837;
christopher.perdue@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to section 319M of the Public Health
Service Act, HHS has established the
NBSB to provide expert advice and
guidance to the Secretary on scientific,
technical, and other matters of special
interest to HHS regarding current and
future chemical, biological, nuclear, and
radiological agents, whether naturally
occurring, accidental, or deliberate.
Availability of Materials: Participants
are encouraged to visit the NBSB
website (https://www.phe.gov/nbsb) for
information about the meeting,
including the agenda.
Procedures for Providing Public Input:
Members of the public are encouraged
to go to the NBSB website (https://
www.phe.gov/nbsb) for instructions
about the submission of written
comments.
Dated: November 20, 2019.
Robert P. Kadlec,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2019–25544 Filed 11–22–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Advisory Committee
to the Director, National Institutes of
Health, December 12, 2019, 9:00 a.m. to
December 13, 2019, 1:00 p.m., NIH,
Building 1, Wilson Hall, 1 Center Drive,
Bethesda, MD 20892 which was
published in the Federal Register on
May 2, 2019, 84 FR 18853.
The meeting notice is amended to add
an additional agenda topic entitled, NIH
Wide Strategic Plan for Fiscal Years
PO 00000
Frm 00090
Fmt 4703
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2021–2025. The meeting is open to the
public.
Dated: November 19, 2019.
Natasha M. Copeland,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–25478 Filed 11–22–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine Notice of
Closed Meetings
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 materials,
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 Library of
Medicine Special Emphasis Panel; COI/
Career Award.
Date: March 19, 2020.
Time: 11:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine/Center
for Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Yanli Wang, Ph.D.,
Scientific Review Officer, Division of
Extramural Programs, National Library of
Medicine, NIH, 6705 Rockledge Drive, Suite
301, Bethesda, MD 20892–7968, 301–827–
7092, yawang@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
E:\FR\FM\25NON1.SGM
25NON1
Agencies
[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Notices]
[Page 64909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25478]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of the Director, National Institutes of Health Amended
Notice of Meeting
Notice is hereby given of a change in the meeting of the Advisory
Committee to the Director, National Institutes of Health, December 12,
2019, 9:00 a.m. to December 13, 2019, 1:00 p.m., NIH, Building 1,
Wilson Hall, 1 Center Drive, Bethesda, MD 20892 which was published in
the Federal Register on May 2, 2019, 84 FR 18853.
The meeting notice is amended to add an additional agenda topic
entitled, NIH Wide Strategic Plan for Fiscal Years 2021-2025. The
meeting is open to the public.
Dated: November 19, 2019.
Natasha M. Copeland,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-25478 Filed 11-22-19; 8:45 am]
BILLING CODE 4140-01-P