National Institutes of Health, 785 [2019-00447]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Page 785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00447]



[[Page 785]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institutes of Health

Submission for OMB Review; 30-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 Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, 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: HallCh@mail.nih.gov.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on October 25, 2018 (83 FR 
53885) and allowed 60 days for public comment. One public comment was 
received. The purpose of this notice is to allow an additional 30 days 
for public comment. The National Cancer Institute (NCI), National 
Institutes of Health, may not conduct or sponsor, and the respondent is 
not required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: 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
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. 2019-00447 Filed 1-30-19; 8:45 am]
 BILLING CODE 4140-01-P