[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Notices]
[Pages 43003-43004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Evaluation of National 
Cancer Institute's Central Institutional Review Board To Improve Cancer 
Clinical Trials System

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: Evaluation of National Cancer 
Institute's Central Institutional Review Board To Improve Cancer 
Clinical Trials System. Type of Information Collection Request: NEW. 
Need and Use of Information Collection: This study will evaluate the 
success of the Central Institutional Review Board (CIRB), a pilot 
project designed to streamline the protocol activation process by 
conducting human subject protection reviews that can be utilized by 
local Institutional Review Boards (IRBs) for facilitated approval of 
multi-institutional, NCI-sponsored phase III clinical trails. This 
evaluation includes two surveys that will be made available online to 
minimize respondent burden. The CIRB Survey will assess acceptance 
level and satisfaction of local IRB chairs, coordinators, and principal 
investigators with the CIRB. The Cooperative Group Staff survey will 
assess the opinions and experiences of the operations and regulations 
staff of the nine Clinical Trials Cooperative Groups about CIRB 
operations, office processes, and procedures. The findings will provide 
valuable information concerning whether the CIRB is meeting its 
intended goals and will provide recommendations for change and further 
study. Frequency of Response: Once. Affected Public: Registered members 
of the CIRB and Clinical Trials Cooperative Group staff. Type of 
Respondents: IRB chairs, IRB coordinators, principal investigators, and 
the operations and regulations staff of Clinical Trials Cooperative 
Groups. The annualized cost to respondents is estimated at $5,500. 
There are no Capital Costs to report. There are no Operating or 
Maintenance Costs to report. Estimated Number of Respondents: 279. 
Estimated Number of Responses per Respondent: 1. Average Burden per 
Response: 0.50 Hours. Estimated Total Annual Burden Hours Requested: 
139.50.
    The total burden estimate per respondent is shown below:

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                                                                                                       Estimated
                                                                               Estimated                 total
                                                                  Estimated    number of    Average     annual
                      Type of respondents                         number of    responses  burden per    burden
                                                                 respondents      per      response      hours
                                                                              respondent               requested
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IRB chairs, IRB coordinators, principal investigators..........          225           1        0.50      112.50
Clinical Trials Cooperative Group operations and regulations              54           1        0.50          27
 staff.........................................................
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[[Page 43004]]

 
    Total......................................................  ...........  ..........  ..........      139.50
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    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 functions 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 those who are able 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: Bryce B. Reeve, Ph.D, Outcomes Research Branch, 
ARP, DCCPS, National Cancer Institute, 6130 Executive Blvd. MSC 7344, 
Bethesda, MD 20892-7344. Phone: (301) 594-6574, e-mail: 
[email protected].
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60-days 
of this publication.

    Dated: July 12, 2004.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 04-16316 Filed 7-16-04; 8:45 am]
BILLING CODE 4140-01-M