[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.......................................
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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