[Federal Register Volume 89, Number 134 (Friday, July 12, 2024)]
[Notices]
[Pages 57157-57158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15352]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-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 (NCI)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide an opportunity for public comment on proposed 
data collection projects, the National Cancer Institute (NCI) will 
publish periodic summaries of proposed projects to be submitted to the 
Office of Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact Tali Johnson, 
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]. Formal requests for additional 
plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires written comments and/or suggestions from 
the public, and affected agencies are invited to address one or more of 
the following points: (1) Whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) The accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) Ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) Ways 
to minimizes the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Proposed Collection Title: Investigational Agent Accountability 
Record Forms and International Investigator Statement in the Conduct of 
Investigational Trials for the Treatment of Cancer, 0925-0613, 
Expiration Date 1/31/2025, REVISION, National Cancer Institute (NCI), 
National Institutes of Health (NIH).
    Need and Use of Information Collection: This is a request for OMB 
to approve the revision of the collection titled ``Investigational 
Agent Accountability Record Forms in the Conduct of Investigational 
Trials for the Treatment of Cancer National Cancer Institute (NCI)'' 
for an additional three years of data collection. The U.S. Food and 
Drug Administration (FDA) holds the National Cancer Institute (NCI), 
Division of Cancer Treatment and Diagnosis/Cancer Therapy Evaluation 
Program (NCI/DCTD/CTEP), and the Division of Cancer Prevention (DCP) 
responsible as a sponsor of investigational drug trials, to assure the 
FDA that investigators in its clinical trials program are maintaining 
systems for accountability. Data obtained from the Investigational 
Agent Accountability Record Forms (aka. Drug Accountability Record 
Forms--DARF) are used to track the dispensing of investigational 
anticancer agents from receipt from the NCI to dispensing or 
administration to patients. Requirements for tracking investigational 
agents under an Investigational New Drug Application are outlined in 
title 21 Code of Federal Regulations (CFR) part 312. NCI and/or its 
auditors use this information to ensure compliance with federal 
regulations and NCI policies. This revision removes the International 
Investigator Statement (IIS) form as it was transitioned to the CTEP 
Branch and Support Contracts Forms and Surveys (OMB#0925-0753) 
submission.
    OMB approval is requested for 3 years. There are no costs to 
respondents

[[Page 57158]]

other than 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     Individuals................................           1,000              20            4/60           1,333
 Record Form (DARF).
A2: Investigational Agent Accountability     Individuals................................           1,500              20            4/60           2,000
 Record for Oral Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record   Individuals................................           2,500              20            1/60             833
 Form (eDARF).
                                                                                         ---------------------------------------------------------------
    Totals.................................  ...........................................           5,000         100,000  ..............           4,166
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    Dated: July 9, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2024-15352 Filed 7-11-24; 8:45 am]
BILLING CODE 4140-01-P