National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 79630 [2024-22377]
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79630
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Submission for OMB Review; 30-Day
Comment Request Investigational
Agent Accountability Record Forms
and International Investigator
Statement in the Conduct of
Investigational Trials for the Treatment
of Cancer (National Cancer Institute)
Pursuant to section 1009 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 SBIR Phase II
Clinical Trial Implementation Cooperative
Agreement (U44 Clinical Trial Required).
Date: October 24, 2024.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F40A,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Robert C. Unfer, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F40A, Rockville, MD
20892, (240) 669–5035, robert.unfer@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)
Dated: September 25, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
ddrumheller on DSK120RN23PROD with NOTICES1
[FR Doc. 2024–22377 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
SUMMARY:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Charles Hall, Chief,
Pharmaceutical Management Branch,
Cancer Therapy Evaluation Program,
Division of Cancer Diagnosis and
Treatment, National Cancer Institute,
9609 Medical Center Drive, Bethesda,
Maryland 20892 or call non-toll-free
number (240) 276–6575 or Email your
request, including your address to:
HallCh@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on July 12, 2024 (89 FR 57157)
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
ADDRESSES:
to allow an additional 30 days for public
comment. The National Cancer Institute
(NCI), National Institutes of Health, may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Investigational
Agent Accountability Record Forms and
International Investigator Statement in
the Conduct of Investigational Trials for
the Treatment of Cancer (National
Cancer Institute), 0925–0613, Expiration
Date 1/31/2025, REVISION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The Food and Drug
Administration (FDA) requires
Investigational New Drug Application
(IND) sponsors to maintain adequate
records on the shipment and disposition
of agents to investigators. The agent
accountability effort for the National
Cancer Institute/Division of Cancer
Treatment and Diagnosis/Cancer
Therapy Evaluation Program (NCI/
DCTD/CTEP) is managed by the
Pharmaceutical Management Branch
(PMB) at CTEP. The Investigational
Agent Accountability Records (a.k.a.
Drug Accountability Record Forms—
DARF) are used to provide a
standardized method of tracking agent
disposition across all institutions
participating in trials for which the NCI
provides agents. Institutional auditors
verify information on the agent
accountability forms for compliance. In
addition, PMB staff review
Investigational Agent Accountability
Record Forms against records
maintained in PMB systems to ensure
there is no inappropriate use or
diversion of investigational agents.
OMB approval is requested for 3
years. Respondents’ only cost is their
time. The total estimated annualized
burden is 4,166 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Category of
respondent
Form name
A1: Investigational Agent Accountability Record Form
(DARF).
VerDate Sep<11>2014
17:51 Sep 27, 2024
Jkt 262001
PO 00000
Individuals ........
Frm 00130
Fmt 4703
Number of
responses per
respondent
Number of
respondents
I
Sfmt 4703
1,000
I
E:\FR\FM\30SEN1.SGM
20
Average time
per response
(in hours)
I
30SEN1
4/60
Total annual
burden hours
I
1,333
]]>Agencies
[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Page 79630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22377]
[[Page 79630]]
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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 1009 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 SBIR Phase II Clinical Trial
Implementation Cooperative Agreement (U44 Clinical Trial Required).
Date: October 24, 2024.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3F40A,
Rockville, MD 20892 (Video Assisted Meeting).
Contact Person: Robert C. Unfer, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3F40A,
Rockville, MD 20892, (240) 669-5035, [email protected].
(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)
Dated: September 25, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-22377 Filed 9-27-24; 8:45 am]
BILLING CODE 4140-01-P
