[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53885-53886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23313]


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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 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: [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 in the Conduct of Investigational Trials for the Treatment 
of Cancer, 0925-0613, Expiration Date 3/31/2019, Revision, National 
Cancer 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. Previously, the investigator 
registration forms and process were part of this submission. These 
forms were more appropriately submitted and approved under the CTEP 
Branch and Support Contracts Forms and Surveys in July 2018 (OMB No. 
0925-0753; Expiration Date 7/31/2021). Thus, the investigator 
registration forms are no longer included in this request.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden are 3,033 hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of     Average time
             Category of respondent                  Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
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Individuals (DARF)..............................           2,133              16            4/60           2,275

[[Page 53886]]

 
Individuals (DARF-Oral).........................             711              16            4/60             758
                                                 ---------------------------------------------------------------
    Total.......................................           2,844          45,504  ..............           3,033
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Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2018-23313 Filed 10-24-18; 8:45 am]
 BILLING CODE 4140-01-P