[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Notices]
[Pages 45251-45252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission of OMB Review; Comment Request; Drug Accountability 
Record

    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, the National Cancer Institute (NIH) will publish 
periodic summaries to the Office of Management and Budget (OMB) for 
review and approval.

Proposed Collection

    Title: Drug Accountability Record (Form NIH 2564).
    Type of Information Collection Request: Extension, with no Changes 
OMB No. 0925-0240, Expiration Date 11/30/07.
    Need and Use of Information Collection: Food and Drug 
Administration (FDA) regulations require investigators to establish a 
record of the receipt, use and disposition of all investigational 
agents. The National Cancer Institute, (NCI) as a sponsor 
investigational drug trials, has the responsibility to assure the FDA 
that investigators in its clinical trials program are maintaining 
systems for drug accountability. In order to fulfill

[[Page 45252]]

these requirements, a standard Investigational Drug Accountability 
Report Form (NIH 2564) was designed to account for drug inventories and 
usage by protocols. The data obtained from the drug accountability 
record will be used to keep track of the dispensing of investigational 
anticancer agents to patients. It is used by NCI management to ensure 
that investigational drug 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 once every three years. All comparisons are done with 
the intention of ensuring protocol, patient and drug compliance for 
patient and drug compliance for patient safety and protections.
    Frequency of Response: Daily.
    Affected Public: State or local governments, businesses or other 
for-profit. Federal agencies or employees, non-profit institutions, and 
small business or organizations.
    Type of Respondents: Investigators, pharmacist, nurses, pharmacy 
technicians, data manager. The annual reporting burden is divided into 
two major areas. These are the audits of Drug Accountability Forms by 
Government and its contractors and the use of the forms by clinical 
research sites. The burden is as follows:
    Federal Burden: 1,700 audits are conducted of clinical research 
sites, a minimum of three Drug Accountability Forms are reviewed at the 
audit. Each form requires a \1/2\ hour to review.
    Number of Respondents: 1,700.
    Number of Responses per Respondent: 3.
    Average Burden per Response: 0.5 hours.
    Annual Burden Hours: 2,250 hours.
    Clinical Trial Site Burden: The annualized respondents' burden for 
recordkeeping is estimated to require 6,240 hours. The recordkeeping 
burden represents an average time required for multiple entries (4 
minutes or 0.1 hour per entry) on the drug accountability form, the 
average number of forms maintained by each recordkeeper and the number 
of recordkeepers.

Drug Accountability Forms

    Number of Record Keepers: 3,990.
    Number of Responses per Respondent: 16.
    Average Burden per Response: 0.1.
    Annual Burden Hours: 6,240 hours.
    There are no Capital Costs, Operating Costs, and Maintenance Cost 
to report.

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 to be 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 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 e-mail your request, 
including your address to: [email protected].
    Due Date: Comments regarding this information collection are best 
assured of having their full effect if received within 60 days 
following the date of this publication.

    Dated: August 3, 2007.
Ann E. Duane,
Acting NCI Project Clearance Liaison, National Institutes of Health.
 [FR Doc. E7-15750 Filed 8-10-07; 8:45 am]
BILLING CODE 4140-01-P