[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
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Average time
Type of respondents Form Number of Frequency of per response Total hour
respondents response (hours) burden
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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).
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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