[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]


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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 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: <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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