[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
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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
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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