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), 79630-79631 [2024-22383]
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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
79631
Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
A2: Investigational Agent Accountability Record for Oral
Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record Form
(eDARF).
Individuals ........
1,500
20
4/60
2,000
Individuals .........
2,500
20
1/60
833
Totals .......................................................................
...........................
5,000
100,000
........................
4,166
[FR Doc. 2024–22383 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meetings
Pursuant to section 1009 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.
ddrumheller on DSK120RN23PROD with NOTICES1
Average time
per response
(in hours)
Category of
respondent
Dated: September 25, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Small Research Grants (R03)
for New Investigators and Secondary Data
Analysis PARs Review.
Date: November 6–7, 2024.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental &
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Thomas John O’Farrell,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Activities, National Institute of Dental and
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892, (301) 584–4859, email:
tom.ofarrell@nih.gov.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Assessment of Climate at
Institutions (ACt) Award (RC2—Clinical Trial
Not Allowed).
VerDate Sep<11>2014
17:51 Sep 27, 2024
Jkt 262001
Number of
respondents
Number of
responses per
respondent
Form name
Date: November 8, 2024.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental &
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892 Virtual Meeting).
Contact Person: Christopher Campbell,
Ph.D., MD, Scientific Review Officer,
Scientific Review Branch, Division of
Extramural Activities, National Institute of
Dental and Craniofacial Research, 31 Center
Drive, Bethesda, MD 20892, (301) 827–4603,
email: christopher.campbell@nih.gov.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Prospective Observational
or Biomarker Validation Study Cooperative
Agreement.
Date: November 12, 2024.
Time: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental &
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Christopher Campbell,
Ph.D., MD, Scientific Review Officer,
Scientific Review Branch, Division of
Extramural Activities, National Institute of
Dental and Craniofacial Research, 31 Center
Drive, Bethesda, MD 20892, (301) 827–4603,
email: christopher.campbell@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: September 25, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–22371 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
PO 00000
Frm 00131
Fmt 4703
Sfmt 4703
Total annual
burden hours
Special Emphasis Panel, Optimizing
Outcomes of Children and Adolescents
with Perinatal HIV Exposure (U19),
November 07, 2024, 09:00 a.m. to 05:00
p.m., 6710 B Rockledge Drive, Bethesda,
MD 20892 which was published in the
Federal Register on August 28, 2024, FR
Doc. No. 2024–19290, 89 FR 68911.
This notice is being amended to
change the meeting from a one-day
meeting on November 7, 2024, 9:00 a.m.
to 5:00 p.m., to a two-day meeting
starting on November 7, 2024, 9:00 a.m.
to November 8, 2024, 5:00 p.m. The
meeting is closed to the public.
Dated: September 25, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–22375 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on
Aging Special Emphasis Panel; Dog Aging
Project.
Date: November 6, 2024.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79630-79631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22383]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
ADDRESSES: 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: [email protected].
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 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Form name Category of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
A1: Investigational Agent Accountability Record Individuals........................... 1,000 20 4/60 1,333
Form (DARF).
[[Page 79631]]
A2: Investigational Agent Accountability Record Individuals........................... 1,500 20 4/60 2,000
for Oral Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record Form Individuals........................... 2,500 20 1/60 833
(eDARF).
----------------------------------------------------------------
Totals..................................... ...................................... 5,000 100,000 .............. 4,166
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: September 25, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2024-22383 Filed 9-27-24; 8:45 am]
BILLING CODE 4140-01-P
