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

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Information about this document as published in the Federal Register.

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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:

Type of respondentsEstimated number of respondentsEstimated number of responses per respondentAverage burden per responseEstimated total annual burden hours requested
IRB chairs, IRB coordinators, principal investigators22510.50112.50
Clinical Trials Cooperative Group operations and regulations staff5410.5027
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Total139.50

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.

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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: reeveb@mail.nih.gov.

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of this publication.

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Dated: July 12, 2004.

Rachelle Ragland-Greene,

NCI Project Clearance Liaison, National Institutes of Health.

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[FR Doc. 04-16316 Filed 7-16-04; 8:45 am]

BILLING CODE 4140-01-M