E7-15750. Submission of OMB Review; Comment Request; Drug Accountability Record

Summary: In compliance with the requirement of Section 3506(c)(2)(A) 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) will publish periodic summaries to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection

Title: Drug Accountability Record (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 a sponsor 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: 1,700 audits are conducted of clinical research sites, a minimum of three Drug Accountability Forms are reviewed at the audit. Each form requires a 1/2 hour to review.

Number of Respondents: 1,700.

Number of Responses per Respondent: 3.

Average Burden per Response: 0.5 hours.

Annual Burden Hours: 2,250 hours.

Clinical Trial Site Burden: The annualized respondents' burden for recordkeeping is estimated to require 6,240 hours. The recordkeeping 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 recordkeeper and the number of recordkeepers.

Drug Accountability Forms

Number of Record Keepers: 3,990.

Number of Responses per Respondent: 16.

Average Burden per Response: 0.1.

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.

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 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: [e-mail].

Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days following the date of this publication.

Dated: August 3, 2007.

Ann E. Duane,

Acting NCI Project Clearance Liaison, National Institutes of Health.