[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