[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21130-21131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08270]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-day Comment Request: The Clinical 
Trials Reporting Program (CTRP) Database (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH), has 
submitted to the Office of Management and Budget (OMB) a request to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on February 1, 2013 (Volume 78, Page 7437) and allowed 60-days 
for public comment. No public comments were received. The purpose of 
this notice is to allow an additional 30 days for public comment. The 
National Cancer Institute (NCI), National Institutes of Health may not 
conduct or sponsor, and the respondent is not required to respond to, 
an information collection that has been extended, revised, or 
implemented on or after October 1, 1995, unless it displays a currently 
valid OMB control number.
    Direct Comments To OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: 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]. Formal 
requests for additional plans and instruments must be requested in 
writing.
    Proposed Collection: The Clinical Trials Reporting Program (CTRP) 
Database, 0925-0600, Expiration Date 3/31/2013--REINSTATEMENT WITH 
CHANGE, 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 33,000.

                                        Estimated Annualized Burden Hours
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                                                                     Number of     Average time
      Type of respondents          Instrument        Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
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Clinical Trials...............  Initial                    5,500               1               1           5,500
                                 Registration.
                                Amendment.......           5,500               4               1          22,000
                                Accrual Updates.           5,500               4           15/60           5,500
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[[Page 21131]]

    Dated: April 3, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, NCI, NIH.
[FR Doc. 2013-08270 Filed 4-8-13; 8:45 am]
BILLING CODE 4140-01-P