[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).
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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