[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58401-58402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection: Comment Request: 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 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Cancer Institute 
(NCI), the National Institutes of Health (NIH) will publish periodic 
summaries of proposed projects to be submitted to the Office of 
Management and Budget (OMB) for review and approval.
    Proposed Collection: Title: Drug Accountability Report Form and 
Investigator Registration Procedure in the Conduct of Investigational 
Trials for the Treatment of Cancer (NCI) (OMB No. 0925-0613). Type of 
Information Collection Request: Revision. 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. 
Frequency of Response: Up to 16 times per year. Affected Public: 
Private sector including businesses, other for-profit organizations, 
and non-profit institutions. Type of Respondents: Investigators, 
pharmacists, nurses, pharmacy technicians, and data managers. The 
annualized respondents' burden for record keeping is estimated to 
require 14,223 hours (see Table 1). There are no capital costs, 
operating costs, or maintenance costs.

                                       Table 1--Estimates of Annual Burden
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
     Type of  respondents             Form           Number of     Frequency of    per response     Total hour
                                                    respondents      response         (hours)         burden
----------------------------------------------------------------------------------------------------------------
Investigators and Designee for  Statement of              20,112               1           15/60           5,028
 Investigator Registration and   Investigator.
 DARF.
                                Supplemental              20,112               1           10/60           3,352
                                 Investigator.
                                Financial                 20,112               1            5/60           1,676
                                 Disclosure.
                                Drug                       3,907              16            4/60           4,167
                                 Accountability
                                 Record Form
                                 (DARF and DARF-
                                 Oral).
                                                 ---------------------------------------------------------------
    Totals....................  ................  ..............  ..............  ..............          14,223
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[[Page 58402]]

Request for Comments

    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) The quality, utility, and clarity of the information 
collected; and (4) Minimize 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.

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, RPh, M.S., Chief, Pharmaceutical 
Management Branch, Cancer Therapy Evaluation Program, National Cancer 
Institute, Executive Plaza North, Room 7149, 9000 Rockville Pike, 
Bethesda, Maryland 20891. Or call non-toll-free number 301-496-5725 or 
email your request, include your address to: [email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60-days 
of the date of this publication.

    Dated: September 14, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-23243 Filed 9-19-12; 8:45 am]
BILLING CODE 4140-01-P