[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Notices]
[Pages 7437-7438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02123]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request (60-Day FRN); The 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 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.
    Written comments and/or suggestions from the public and affected 
agencies are invited to address one or more of the following points: 
(1) 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) 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) 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. To submit comments 
in writing, request more information on the proposed project, or to 
obtain a copy of the data collection plans and instruments, contact: 
Jose Galvez, Office of the Director, National Cancer Institute, 2115 
East Jefferson Street, Rockville, MD 20852 or call non-toll-free number 
301-443-6141 or Email your request, including your address to: 
[email protected].
    Comments regarding this information collection are best assured of 
having their full effect if received within 60 days of the date of this 
publication.
    Proposed Collection: The Clinical Trials Reporting Program (CTRP) 
Database, 0925-0600, Expiration Date 3/31/2013--EXTENSION, National 
Cancer Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The Clinical Trials 
Reporting Program (CTRP) is an electronic resource that serves as a 
single, definitive source of information about all NCI-supported 
clinical research. This resource allows the NCI to consolidate 
reporting, aggregate information and reduce redundant submissions. 
Information is submitted by clinical research administrators as 
designees of clinical investigators who conduct NCI-supported clinical 
research. The designees can electronically access the CTRP Web site to 
complete the initial trial registration. Subsequent to registration, 
four amendments and four study subject accrual updates occur per trial 
annually.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The estimated annualized burden 
hours are 38,500.

[[Page 7438]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of     Average time
      Type of respondents          Instrument        Number of     responses per   per response    Annual burden
                                                    respondents     respondent      (in hours)         hours
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Clinical Trials...............  Initial                    5,500               1               2          11,000
                                 Registration.
                                Amendment.......           5,500               4               1          22,000
                                Accrual Updates.           5,500               4           15/60           5,500
                                                 ---------------------------------------------------------------
    Total.....................  ................          16,500  ..............  ..............          38,500
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    Dated: January 25, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Cancer Institute (NCI), 
National Institutes of Health (NIH).
[FR Doc. 2013-02123 Filed 1-31-13; 8:45 am]
BILLING CODE 4140-01-P