Submission of OMB Review; Comment Request; Drug Accountability Record

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

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 Institutes of Health (NIH) 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 Record (Form NIH 2564)

and Transfer Investigation Drug Record (NIH form 2564-1). Type of

Information Collection Request: Extension, with no Changes OMB No.

0925-0240, Expiration Date 10/31/97. 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 Transfer Investigational Drug Form (NIH 2564-1)

permits intra-institutional transfer of drugs to other approved

investigators for other approved 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 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: 1700 audits are conducted of clinical research

sites, a minimum of three Drug Accountability Forms are reviewed at

each audit. Each form requires \1/2\ hour to review.

Number of Respondents: 1700.

Number of responses per Respondent: 3.

Average Burden per Response: 0.5 hours.

Annual Burden Hours: 18,250 hours.

Clinical Trial Site Burden: The annualized respondents' burden for

record keeping is estimated to require 3,650 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 investigation 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 36,500 items shipped by the PMB and the 1,200 items

transfer approvals in calendar year 1996.

Drug Transfer Forms

Number of Respondents: 1200.

Number of response per Respondent: 1.

Average Burden per Response: 0.1.

Annual Burden Hours: 120 hours.

Drug Accountability Forms

Number of Record Keepers: 4560.

Number of responses per Respondent: 8.

Average Burden per Response: 0.1.

Annual Burden Hours: 3650 hours.

Total Annualized Burden for Record Keeping and Reporting: 3,770

Hours.

There are no Capital Costs, Operating Costs, and/or 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:

To request more information on the proposed project or to obtain a copy

of the data collection plans and instruments, contact Joseph High,

Head, Drug Management and Authorization Section, Pharmaceutical

Management Branch, Cancer Therapy Evaluation Program, Division Cancer

Therapy, Diagnosis, and Centers, National Cancer Institute, Executive

Plaza North, Room 707, 9000 Rockville Pike, Bethesda, MD 20892 or call

non-toll-free number (301) 496-5725 or E-mail your request, including

your address to: JoeH[email protected].

Comments Due Date

Comments regarding this information collection are best assured of

having their full effect if received within 60 days of the date of this

publication.

Dated: June 30, 1997.

Nancie L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97-18008 Filed 7-9-97; 8:45 am]

BILLING CODE 4140-01-M