[Federal Register Volume 75, Number 193 (Wednesday, October 6, 2010)]
[Notices]
[Page 61763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25190]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission of OMB Review; Comment Request; Drug Accountability 
Record (Form NIH 2564) (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 4, 2010 (75 FR 
46945) 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.
    Proposed Collection: Title: Drug Accountability Record (NCI) (Form 
NIH 2564) (OMB No.0925-0240). Type of Information Collection Request: 
Extension with changes. 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 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: 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 is estimated to require 
6,714 hours (Table 1). There are no capital costs, operating costs, and 
maintenance cost to report.

                                    Table 1--Estimates of Annual Burden Hours
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                                                     Number of     Frequency of    Average time       Annnual
               Type of respondents                  respondents      response      per response    burden  hours
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Investigators, or Designees.....................           4,196              16            6/60           6,714
                                                                                           (0.1)
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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 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 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 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.

    Dated: September 27, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-25190 Filed 10-5-10; 8:45 am]
BILLING CODE 4140-01-P