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 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.

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.