[Federal Register Volume 74, Number 215 (Monday, November 9, 2009)]
[Notices]
[Pages 57684-57685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26875]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Clinical Trials Reporting 
Program (CTRP) Database (NCI)

    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: Clinical Trials Reporting Program 
(CTRP) Database. Type of Information Collection Request: Revision of 
currently approved collection [OMB No. 0925-0600, expiration date 01/
31/2010]. Need and Use of Information Collection: The NCI is developing 
an electronic resource, the NCI Clinical Trials Reporting Program 
(CTRP) Database, to serve as a single, definitive source of information 
about all NCI-supported clinical research, thereby enabling the NCI to 
execute its mission to reduce the burden of cancer and to ensure an 
optimal return on the nation's investment in cancer clinical research. 
Information will be submitted by clinical research administrators as 
designees of clinical investigators who conduct NCI-supported clinical 
research. Deployment and extension of the CTRP Database, which will 
allow the NCI to consolidate reporting, aggregate information and 
reduce redundant submissions, is an infrastructure development project 
that will be enabled by public funds expended pursuant to the American 
Recovery and Reinvestment Act of 2009, Public Law 111-5 (``Recovery 
Act''). This information collection adheres to The Public Health 
Service Act, Section 407(a)(4) (codified at 42 USC 285a-2(a)(2)(D)), 
which authorizes and requires the NCI to collect, analyze and 
disseminate all data useful in the prevention, diagnosis, and treatment 
of cancer, including the establishment of an international cancer 
research data bank to collect, catalog, store, and disseminate insofar 
as feasible the results of cancer research undertaken in any country 
for the use of any person

[[Page 57685]]

involved in cancer research in any country. Frequency of Response: Once 
per initial trial registration; four amendments per trial annually; and 
four accrual updates per trial annually. Affected Public: Individuals, 
business and other for-profits, and not-for-profit institutions. Type 
of Respondents: Clinical research administrators on behalf of clinical 
investigators. The annual reporting burden is estimated at 38,500 
hours.
    There are no Capital Costs, Operating Costs, and/or Maintenance 
Costs to report.

                                    A.12-1--Estimates of Annual Burden Hours
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                                                                                   Average time
                                     Survey          Number of     Frequency of    per response    Annual burden
      Type of respondents          instrument       respondents      response        (minutes/         hours
                                                                                      hours)
----------------------------------------------------------------------------------------------------------------
Clinical Trials...............  Initial                    5,500               1          120/60         11,000.
                                 Registration.
                                Amendment.......           5,500               4           60/60         22,000.
                                Accrual Updates.           5,500               4           15/60          5,500.
                               ---------------------------------------------------------------------------------
    Total.....................  ................          16,500  ..............  ..............         38,500.
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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) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) Evaluate 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) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) Minimize the burden of the collection of information on those who 
are 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 John Speakman, Associate Director for Clinical 
Trials Products and Programs, Center for Biomedical Informatics and 
Information Technology, National Cancer Institute, NIH, DHHS, 2115 E. 
Jefferson Street, Suite 6000, Rockville, MD 20892 or call non-toll-free 
number 301-451-8786 or e-mail your request, including your address to: 
[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: October 30, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-26875 Filed 11-6-09; 8:45 am]
BILLING CODE 4140-01-P