[Federal Register Volume 69, Number 58 (Thursday, March 25, 2004)]
[Notices]
[Pages 15347-15348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Proposed Collection; Comment Request; the 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 
(NCI), 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: The Drug Accountability Record. Type of 
Information Collection Request: Revision. Need and Use of Information 
Collection: FDA regulations require investigators: To maintain adequate 
records of the disposition of all investigational drugs received from 
the sponsor; to prepare and maintain adequate case histories of treated 
patients and controls; and to furnish reports to the drug sponsor who 
is responsible for evaluating the results of the investigation. 
Similarly, 21 CFR 312.1 includes requirements for sponsors to maintain 
adequate records on the shipment of drugs to investigators; to make 
individual patient records available to the FDA for inspection; and to 
submit accurate progress reports of the drug investigation to the FDA. 
The NCI, as an IND sponsor has developed the ``Drug Accountability 
Record'' form (DARF: NIH 2564) to help investigators using NCI 
sponsored drugs under NCI protocols to meet FDA requirements. Frequency 
of Response: Daily. Affected Public: Individuals or households; 
businesses or other for-profit; not-for-profit institutions; Federal 
Government; State, local or tribal government. Type of Respondents: 
Pharmacists, nurses and investigators or their designee at medical 
institutions to keep track of the dispensing of investigational 
anticancer drugs to patients use the information entered onto the DARF. 
NCI uses the data from the DARF to ensure compliance with NCI's 
responsibilities as an IND sponsor. NCI Management request copies of 
the DARF at any time for audit and review and DARFs are reviewed at 
least once every 3 years during site audits. The information contained 
in the DARF is compared to PMB-IMS Inventory Module histories for each 
investigator and clinical site to ensure no diversion of 
investigational drug supplies to inappropriate protocol or patient use. 
The accountability information is also compared to patient flow sheets 
(protocol reporting forms) during site visits conducted for each 
investigator. All comparisons are completed with the intention of 
ensuring protocol integrity, patient safety, and compliance with FDA 
regulations. Record keeping of drug accountability information in a 
standard format is required to allow an investigator to receive, and 
continue to receive NCI-sponsored drugs. This information is reviewed 
at the time of site visit audits, which currently occur at least once 
every 3 years. The IND sponsor may also request the DARF at any time. 
This requirement is an essential part of investigational agent 
accountability process and motivates the investigator to maintain 
accurate, appropriate records. The record keeping retention period is 
specified by FDA regulation, and the NCI does not deviate from that 
requirement. As noted above, the FDA requires IND sponsors to maintain 
adequate records on the shipment and disposition of drugs to 
investigators. Permitting intra-institutional transfer of drugs to 
other NCI sponsored protocols and other approved investigators 
necessitates that NCI be notified of these transfers. It is for this 
purpose and use that the Transfer of Investigational Drug form (TID: 
NIH 2564-1) was developed. The annual reporting burden is as follows: 
Estimated Number of Respondents: 7,371; Estimated Number of Responses 
per Respondent: 8; Average Burden Hours Per Response: 0.67; and 
Estimated Total Annual Burden Hours Requested: 3,378. The annualized 
respondent's burden for record keeping is estimated to require 3,298 
hours for the DARF and 80 hours for the TID form. The annualized cost 
to the respondents is estimated at $84,450.00. There are no Capital 
Costs to report. There are no Operating or Maintenance Costs to report.

[[Page 15348]]



                                         A.12-1 Estimates of Hour Burden
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                                                     Number of     Frequency of    Average time     Annual hour
               Type of respondents                  respondents      response      per response       burden
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                                            Drug Accountability Form
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Investigators, or Designees.....................           6,171               8    0.0668 hours           3,298
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                                               Drug Transfer Form
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Investigators and/or their Designees............           1,200               1          0.0668              80
                                                                                                 ---------------
    Total Annual Hours for Investigators and/or   ..............  ..............  ..............           3,378
     their Designees............................
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    Estimate of Other Total Annual Cost Burden To Respondents or Record 
keepers: None.
    Annualized Cost to the Federal Government: The annualized cost to 
the Federal government for printing is estimated at $4,000. The 
annualized cost to the Federal government for distributing the forms is 
estimated at $2,000.
    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 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, Hall, R.PH., M.S., Chief, Pharmaceutical 
Management Branch, Cancer Therapy Evaluation Program, National Cancer 
Institute, Executive Plaza North, Room 7149, 9000 Rockville Pike, 
Bethesda, Maryland 20891. Or call non-toll-free number 301-496-5725 or 
e-mail your request, include your address to [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: March 18, 2004.
Rachelle Ragland-Greene,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 04-6733 Filed 3-24-04; 8:45 am]
BILLING CODE 4140-01-M