Notice2021-19741
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)
Primary source
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Published
September 14, 2021
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide 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.
Full Text
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<title>Federal Register, Volume 86 Issue 175 (Tuesday, September 14, 2021)</title>
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[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51168-51169]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19741]
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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)
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 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: 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#8ec6efe2e2cde6cee3efe7e2a0e0e7e6a0e9e1f8"><span class="__cf_email__" data-cfemail="9bd3faf7f7d8f3dbf6faf2f7b5f5f2f3b5fcf4ed">[email protected]</span></a>. 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 3/31/2022, REVISION, National Cancer
[[Page 51169]]
Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information 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 systems for accountability are being maintained by
investigators in its clinical trials program. 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 the tracking
of investigational agents under an Investigational New Drug Application
are outlined in title 21 Code of Federal Regulations (CRF) part 312.
NCI and/or its auditors use this information to ensure compliance with
federal regulations and NCI policies. Two additional forms have been
added to this submission. The Electronic Agent Accountability Record
Form Report (aka electronic Drug Accountability Record Form-eDARF) will
be phased into use to replace two of the currently existing forms and
will improve tracking and distribution of investigational agents. A
second form, the International Investigator Statement (IIS), will
ensure compliance of international investigators' participation on CTEP
studies.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden are 4,831 hours.
Estimated Annualized Burden Hours
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Number of Average time
Form name Category of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hours
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A1: Investigational Agent Individuals 760 20 4/60 1,013
Accountability Record Form
(DARF).........................
A2: Investigational Agent Individuals 2,280 20 4/60 3,040
Accountability Record for Oral
Agents Form (DARF-Oral)........
A3: Electronic Agent Individuals 760 20 1/60 253
Accountability Record Form
(eDARF)........................
A4: International Investigator Individuals 2,100 1 15/60 525
Statement (IIS) (Initial
Response)......................
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Totals...................... .............. 5,900 78,100 .............. 4,831
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Dated: September 8, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2021-19741 Filed 9-13-21; 8:45 am]
BILLING CODE 4140-01-P
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