[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
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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).
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Totals..................................... ....................................... .............. .............. .............. 14,328
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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