[Federal Register Volume 66, Number 43 (Monday, March 5, 2001)]
[Notices]
[Pages 13332-13333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5174]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Drug Accountability 
Record

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute (NCI), the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on December 
14, 2000, pages 78175-78176, 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 October 1, 1995, unless it displays 
a currently valid OMB control number.

Proposed Collection

    Title: Drug Accountability Record. Type of Information Collection 
Request: Revision. (OMB No. 0925-0240, expires 3/31/2001). Need and use 
of Information Collection: The regulations of the Food and Drug 
Administration (FDA) 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 for assuring to the FDA that systems for 
drug accountability are being maintained by investigators in its 
clinical trials program. In order to fulfill these requirements, we 
have developed two standardized forms. One, the investigational Drug 
Accountability Report Form (NIH 2564) designed to account for drug 
inventories and usage by protocol and the other, Transfer 
Investigational Drug Form (NIH-2564-1) that permits intra-institutional 
transfer of agents to NCI approved protocols for use by the 
investigator or other NCI registered investigators on approved 
protocols. The data obtained from the drug accountability record is 
used to track the dispensing of investigational anticancer drugs from 
receipt from NCI to dispensing or administration to patients. NCI uses 
the accountability data to ensure that investigational drug supplies 
are not diverted for inappropriate protocol or patient use. The drug 
accountability information is used to validate patient protocol 
reporting forms during site audits conducted at each of the Cooperative 
Groups. The intent is to ensure the investigational agents are used 
according to protocol guidelines and to ensure the patient's safety and 
protection. 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. Types of Respondents: Investigators and their designees, 
pharmacists, nurses, pharmacy technicians, data managers. 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: 
The annualized respondents' burden for record keeping is estimated to 
require 2,436 hours for drug accountability and 80 hours for drug 
transfer. The reporting burden is the average time (4 minutes or 0.0668 
hours) required to complete the transfer investigational drug form 
multiplied by the number of forms completed annually. The record 
keeping burden represents an average time required for multiple entries 
(4 minutes or 0.0668 hours per entry) on the drug accountability form, 
the average number of forms maintained by each record keeper and the 
number of record keepers. These estimates are based on the items 
shipped by the PMB and the number of transfer approvals in the calendar 
year 1999.

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                                                                                                    Est. total
                                  Est. number of  Est. number of    Avg. burden     Avg. burden    annual burden
       Type of respondents          respondents     responses/       hours per         hours           hours
                                                    respondents      response                        requested
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Drug transfer, form.............           1,200               1          0.0668              80              80
Drug, accountability, form......           4,560               8          0.0668           2,436           2,436
                                 -------------------------------------------------------------------------------
      Total.....................           5,760  ..............  ..............  ..............           2,516
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[[Page 13333]]

    There are no Capital Costs to report. There are no Operating or 
Maintenance Costs 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 
proposed performance of the functions of the agency, including whether 
the information shall 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 comment and/or suggestions regarding the item(s) contained 
in this notice, especially regarding the estimated public burden and 
associated response time, 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 
Carl Huntley, Head Drug Management and Authorization Section, 
Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, 
Division of Cancer Therapy and Diagnosis, National Cancer Institute, 
Executive Plaza North, Room 7112, 9000 Rockville Pike, Bethesda, 
Maryland 20892. 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 on or before April 14, 2001.

    Dated: February 26, 2001.
Reesa Nichols,
NCI Project Clearance Liaison.
[FR Doc. 01-5174 Filed 3-2-01; 8:45 am]
BILLING CODE 4140-01-M