[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51168-51169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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)......................
                                                 ---------------------------------------------------------------
    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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