Notice2024-22383
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)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 30, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 189 (Monday, September 30, 2024)</title>
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[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79630-79631]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22383]
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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.
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="/cdn-cgi/l/email-protection#9dd5fcf1f1def5ddf0fcf4f1b3f3f4f5b3faf2eb"><span class="__cf_email__" data-cfemail="c48ca5a8a887ac84a9a5ada8eaaaadaceaa3abb2">[email protected]</span></a>.
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
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Number of Average time
Form name Category of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hours
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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).
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Totals..................................... ...................................... 5,000 100,000 .............. 4,166
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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
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