[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Notices]
[Pages 61825-61826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30323]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Drug Accountability Record; Submission of OMB Review; Comment 
Request

SUMMARY: Under the provisions of Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute, the National 
Institutes of Health (NIH) has submitted to the Office of Management 
and Budget (OMB) a request to review and approve the information 
collection listed below. This proposed information collection was 
previously published in the Federal Register on July 10, 1997, page 
37069 and allowed 60-days for public comment. No public comments were 
received. The purpose of this notice is to allow an additional 30-days 
for public comment. The National Institutes

[[Page 61826]]

of Health may not conduct or sponsor, and the respondent is not 
required to respond to, an information collection that has been 
extended, revised, or implemented on or after October 1, 1995, unless 
it displays a currently valid OMB control number.

PROPOSED COLLECTION: Title: Drug Accountability Record (NIH form 2564) 
and Transfer Investigational Drug Record (NIH form 2564-1). Type of 
Information Collection Request: Revision of a currently approved 
collection, OMB No. 0925-0240, Expiration Date 1/31/98. 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 trails, 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 comparison 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 managers. The annual reporting burden is as 
follows: The annualized burden estimate for record keeping is estimated 
to require 3,650 hours for drug accountability and 120 hours for drug 
transfer. The annualized cost to the respondents is estimated at 
$94,500. The reporting burden is the average time (4 minutes or 0.0666 
hour) 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 0.0666 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 PMB and the 1,200 items transfer approvals in calendar year 
1996. Cost estimates are based upon burden hours at an average cost of 
$25.00 per hour.
Drug Accountability Form:
    No. Of Respondents--4560
    No. Of responses per respondent--8
    Average Burden per response--0.0666
    Annual Burden hours--2430
Drug Transfer Form:
    No. Of respondents--1200
    No. Of responses per respondent--1
    Average burden per response--0.0666
    Annual Burden hours--80
Total Annualized Burden For Record Keeping and Reporting: 2,510.

    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.

Direct Comments To OMB

    Written comments and/or suggestions regarding the item(s) contained 
in this notice, especially regarding the estimated public burden and 
associated response time, should be directed to the: Office of 
Management and Budget, Office of Regulatory Affairs, New Executive 
Office Building, Room 10235, Washington, D.C. 20503, Attention: Desk 
Officer for NIH. To request 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<a href="/cdn-cgi/l/email-protection#48212f2008262120662f273e"><span class="__cf_email__" data-cfemail="1a737d725a747372347d756c">[email protected]</span></a>.

COMMENTS DUE DATE: Comments regarding this information collection are 
best assured of having their full effect if received on or before 
December 19, 1997.
    Dated: November 12, 1997.
Nancie L. Bliss,
OMB Project Clearance Liaison.
[FR Doc. 97-30323 Filed 11-18-97; 8:45 am]
BILLING CODE 4140-07-M


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