[Federal Register Volume 72, Number 211 (Thursday, November 1, 2007)]
[Notices]
[Pages 61889-61890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21475]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission of OMB Review; Comment Request; Drug Accountability 
Record (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, 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 August 
13, 2007, Vol. 72, No. 55, Page 45251 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 December 1, 2007, unless 
it displays a valid OMB control number.
    Proposed Collection: Title: Drug Accountability Record (NCI) (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

[[Page 61890]]

a sponsor of 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 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: 1700 audits are conducted of clinical research 
sites, a minimum of three Drug Accountability Forms are reviewed at the 
audit. Each form requires \1/2\ hour to review.
    Number of Respondents: 1700.
    Number of Responses per Respondent: 3.
    Average Burden per Response: 0.5 hours.
    Annual Burden Hours: 2,250 hours.
    Clinical Trial Site Burden: The annual respondents' burden for 
record keeping is estimated to require 6,240 hours. The record keeping 
burden represents an average time required for multiple entries (6 
minutes or 0.1 hour per entry) on the drug accountability form, the 
average number of forms maintained by each record keeper and the number 
of record keepers.

Drug Accountability Forms

    Number of Record Keepers: 3990.
    Number of Responses per Respondent: 16.
    Average Burden per Response: 0.1 (6 minutes).
    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.
    Direct Comments to OMB: 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 Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. 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].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
following the date of this publication.

Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E7-21475 Filed 10-31-07; 8:45 am]
BILLING CODE 4140-01-P