[Federal Register Volume 65, Number 241 (Thursday, December 14, 2000)]
[Notices]
[Pages 78175-78176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31829]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request Drug Accountability Form and 
Drug Transfer Form

SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995 for public comment on proposed data 
collection projects, the National Institutes of Health (NIH), National 
Cancer Institute (NCI) 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: Drug Accountability Form and Drug Transfer Form.
    Type of Information Collection Request: Revision. (OMB No. 0925-
0240, expires 4/30/2002).
    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 a standardized investigational Drug 
Accountability Report Form (NIH 2564) designed to account for drug 
inventories and usage by protocol. The Transfer Investigational Drug 
Form (NIH-2564-1) 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 3,648 hours for drug accountability and

[[Page 78176]]

120 hours for drug transfer. The reporting burden is the average time 
(4 minutes or 0.1 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 0.1 hour per entry) on the drug 
accountability form, the average number of forms maintained by each 
record keeper and the number of record keepers. These estimates are 
based on the items shipped by the PMB and the number of transfer 
approvals in the calendar year 1999.

----------------------------------------------------------------------------------------------------------------
                                                                                                      Est. total
                                                 Est. number  Est. number  Ave. burden                  annual
              Type of respondents                     of           of        hrs per    Ave. burden     burden
                                                 respondents   responses-    response      hours        hours
                                                              respondents                             requested
----------------------------------------------------------------------------------------------------------------
Drug Transfer Form.............................        1,200            1          0.1          120          120
Drug Accountability Form.......................        4,560            8          0.1        3,648        3,648
                                                ----------------------------------------------------------------
    Total......................................        5,760                                               3,768
----------------------------------------------------------------------------------------------------------------

    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.

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 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 
HuntleyC&ctep.nci.nih.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received on or before 
February 12, 2001.

    Dated: December 5, 2000.
Reesa Nichols,
NCI Project Clearance Liaison.
[FR Doc. 00-31829 Filed 12-13-00; 8:45 am]
BILLING CODE 4140-01-M