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Proposed Collection; Comment Request; Evaluation of National Cancer Institute's Cancer Trials Support Unit 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 Cancer Trials Support Unit To Improve Cancer Clinical Trials System. Type of Information Collection Request: NEW. Need and Use of Information Collection: This evaluation will examine the success of the Cancer Trials Support Unit (CTSU), a pilot project designed to improve physician and patient accessibility to NCI-sponsored phase 3 treatment trials and to facilitate data management and regulatory administration for these trials. This evaluation includes two surveys that will be available online to minimize respondent burden. The Online Information Survey will elicit information related to CTSU regulatory and data management systems, particularly with respect to the completeness of information, respondents' opinions about usability and their recommendations or modifications, as well as their assessment in relation to other systems in use. The Online Data Submission Survey will assess opinions about the online data submission process, reasons for choosing to continue submitting data on paper, perceived barriers or ease of use, and suggestions for improvement. The findings will provide valuable information concerning whether this program is meeting its intended goals and provide recommendations for change and further study. Frequency of Start Printed Page 43003Response: Once. Affected Public: Registered members of the CTSU and Clinical Trials Cooperative Group staff. Type of Respondents: The Online Information Survey will survey registered CTSU users and Cooperative Group staff. The Online Data Submission Survey will survey registered CTSU users and Cooperative Group staff. The annualized cost to respondents is estimated at $10,400. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated Number of Respondents: 520. Estimated Number of Responses per Respondent: 1. Average Burden per Response: 0.50 Hours. Estimated Total Annual Burden Hours Requested: 260.

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 requests
Online Information System Survey—registered CTSU users and Cooperative Group staff29010.50145
Online Data Submission Survey—registered CTSU users and Cooperative Group staff23010.50115
Total260

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 the date 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. 04-16315 Filed 7-16-04; 8:45 am]

BILLING CODE 4140-01-M