[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: JoeHigh@nih.gov.
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
