[Federal Register Volume 75, Number 149 (Wednesday, August 4, 2010)]
[Notices]
[Page 46945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19158]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; the Drug Accountability
Record (Form NIH 2564) (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: The Drug Accountability Record (Form NIH 2564) (OMB No.
0925-0240). Type of Information Collection Request: Extension with
changes. Need and Use of Information Collection: The Food and Drug
Administration (FDA) regulations require investigators to establish a
record of receipt, use and disposition of all investigational agents.
The National Cancer Institute (NCI), as a sponsor of investigational
agent trials, has the responsibility to assure the FDA that
investigators in its clinical trials program are maintaining systems
for agent accountability. In order to fulfill these requirements, a
standard Investigational Drug Accountability Report Form (DARF) NIH-
2564, was designed to account for agent inventories and usage by
protocols. The data obtained from the agent accountability record will
be used to keep track of the dispensing of investigational agent
anticancer agents to patients. It is used by the NCI management to
ensure that investigational agent supplies are not diverted for
inappropriate protocol or patient use. The information is also compared
to patient flow sheets (protocol reporting forms) during site visits
conducted for each investigator every three years. All comparisons are
done with the intention of ensuring protocol, patient and agent
compliance for patient safety and protection. Frequency of Response:
Approximately 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 6,714 hours (Table
1). There are no capital costs, operating costs, or maintenance costs
to report.
Table 1--Estimates of Annual Burden Hours
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Number of Frequency of Average time Annual burden
Type of respondents respondents response per response hours
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Investigators, or Designees..................... 4,196 16 6/60 (0.1) 6,714
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Request for Comments
Written comments and/or suggestions from the public and affected
agencies are invited on 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) Ways to enhance the quality, utility, and clarity of the
information collected; and (4) Ways to 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
e-mail 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: July 28, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-19158 Filed 8-3-10; 8:45 am]
BILLING CODE 4140-01-P