[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Page 37069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18008]


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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