[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Notices]
[Pages 43002-43003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Evaluation of National 
Cancer Institute's Cancer Trials Support Unit 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 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

[[Page 43003]]

Response: 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:

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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               requests
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Online Information System Survey--registered CTSU users and              290           1        0.50         145
 Cooperative Group staff.......................................
Online Data Submission Survey--registered CTSU users and                 230           1        0.50         115
 Cooperative Group staff.......................................
                                                                --------------
    Total......................................................  ...........  ..........  ..........         260
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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 the date of this publication.

    Dated: July 12, 2004.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 04-16315 Filed 7-16-04; 8:45 am]
BILLING CODE 4140-01-M