[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11209-11210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission of OMB Review; Comment Request (30-Day FRN):

    Drug Accountability Report Form and Investigator Registration 
Procedure in the Conduct of Investigational Trials for the Treatment of 
Cancer (NCI)
SUMMARY: In compliance with the requirement of Section 3507(a)(1)(D) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Cancer Institute 
(NIH) has submitted to the Office of Management and Budget (OMB) a 
request for review and approval of the information collected below. 
This proposed information collection was previously published in the 
Federal Register on September 20, 2012 (77 FR 58401) and allowed 60-
days for public comment. No public comments were received. The purpose 
of this notice is to allow an additional 30 days for public comment. 
The 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 March 1, 
2011, unless it displays a valid OMB control number.
    Written comments or suggestions regarding the item(s) contained in 
this notice, especially regarding the estimated public burden and 
associated response times, should be directed to the Attention: NIH 
Desk Officer, Office of Management and Budget, at [email protected] or by fax to 202-395-6974. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and instruments, contact Charles L. Hall, Jr., Chief, 
Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, 
Division of the Cancer Treatment and Diagnosis, and Centers, National 
Cancer Institute, Executive Plaza North, Room 7148, 9000 Rockville 
Pike, Bethesda, MD 20892 or call non-toll-free number 301-496-5725 or 
Email your request, including your address to: [email protected].
    Comments regarding this information collection are best assured of 
having their full effect if received within 30 days following the date 
of this publication.
    Proposed Collection: Drug Accountability Report Form and 
Investigator Registration Procedure in the Conduct of Investigational 
Trials for the Treatment of Cancer (NCI), OMB No.0925-0613, Expiration 
Date: 2/28/2013, 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) 
responsible, as a sponsor of investigational drug trials, for the 
collection of information about the clinical investigators who 
participate in these trials and to assure the FDA that systems for 
accountability are being maintained by investigators in its clinical 
trials program. The information collected is used to identify qualified 
investigators and to facilitate the submission and distribution of 
important information relative to the investigational drug and the 
response of the patient to that drug. Investigators are physicians who 
specialize in the treatment of patients with cancer. Data obtained from 
the Drug Accountability Record is used to track the dispensing of 
investigational anticancer agents from receipt from the NCI to 
dispensing or administration to patients. NCI and/or its auditors use 
this information for compliance purposes.
    OMB approval is requested for 3 years. There are no costs to the 
respondents other than their time. The total estimated annualized 
burden hours are 14,328.

[[Page 11210]]



                                                               Estimates of Annual Burden
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                                                                                                             Number of     Average time
              Type of respondents                               Form name                    Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in Hours)      burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigators and Designee for Investigator      Statement of Investigator..............          20,220               1           15/60           5,050
 Registration and DARF.
                                                 Supplemental Investigator..............          20,112               1           10/60           3,352
                                                 Financial Disclosure...................          20,800               1            5/60           1,733
                                                 Electronic Curriculum Vitae............             100               1           15/60              25
                                                 Drug Accountability Record Form (DARF             3,907              16            4/60           4,168
                                                  and DARF-Oral).
                                                                                         ---------------------------------------------------------------
    Totals.....................................  .......................................  ..............  ..............  ..............          14,328
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: February 11, 2013.
Vivian Horovitch-Kelley,
National Cancer Institute Project Clearance Liaison, National Cancer 
Institute, National Institutes of Health.
[FR Doc. 2013-03571 Filed 2-14-13; 8:45 am]
BILLING CODE 4140-01-P