[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Notices]
[Pages 33681-33682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12504]


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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 Cancer Institute (NCI), the 
National Institutes of Health, has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on March 
11, 2016 (Vol. 81, P. 12914) 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, or request more information on the 
proposed project, contact: Jose Galvez, MD, Office of the Director, 
National Cancer Institute, 9609 Medical Center Drive, Rockville, MD 
20852 or call non-toll-free number 240-276-5206 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 (NCI), 0925-0600, Expiration Date 05/31/2016--Revision, 
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 18,000.

[[Page 33682]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of     Average time
      Type of respondents             Form           Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Clinical Trials...............  Initial                    3,000               1               1           3,000
                                 Registration.
                                Amendment.......           1,500               4               1           6,000
                                Update..........           1,500               4               1           6,000
                                Accrual Updates.           3,000               4           15/60            3000
                                                 ---------------------------------------------------------------
    Total.....................  ................           9,000          27,000  ..............          18,000
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    Dated: May 20, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-12504 Filed 5-26-16; 8:45 am]
BILLING CODE 4140-01-P