[Federal Register Volume 74, Number 114 (Tuesday, June 16, 2009)]
[Notices]
[Pages 28506-28507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14089]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Emergency Review; Comment Request; NIH NCI 
Clinical Trials Reporting Program (CTRP) Database (NCI)

SUMMARY: In accordance with Section 3507(j) of the Paperwork Reduction 
Act of 1995, the National Cancer Institute (NCI), the National 
Institutes of Health (NIH), has submitted to the Office of Management 
and Budget (OMB) a request to Emergency review and approve the 
information collection by July 1, 2009. Given the long term nature of 
this project and the Recovery Act timelines, the NCI has requested 
approval to conduct emergency processing of information collections 
pursuant to 5 CFR 1320.13. NIH cannot reasonably comply with the normal 
clearance procedures for information collection, because the use of 
regular procedures would delay the collection and hinder the agency in 
accomplishing its mission and meeting new statutory requirements, to 
the detriment of the public good. The NIH 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.

Proposed Collection

    Title: NIH NCI Clinical Trials Reporting Program (CTRP) Database.
    Type of Information Collection Request: Emergency.
    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 U.S.C. 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 involved in cancer research in any country.
    Frequency of Response: Once per initial trial registration; four 
amendments 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 
33,000 hours (see Table below).
    There are no Capital Costs, Operating Costs, and/or Maintenance 
Costs to report.

[[Page 28507]]



                                        Estimates of Annual Burden Hours
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                                                                                   Average time
      Type of respondents            Survey          Number of     Frequency of    per response    Annual burden
                                   instrument       respondents      response         (hours)          hours
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Clinical Trials...............  Initial                    5,500               1             2.0          11,000
                                 Registration.
                                Amendment.......           5,500               4             1.0          22,000
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          33,000
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    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address 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.
    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 Attention: NIH Desk Officer, Office of Management and 
Budget, at [email protected] or by fax to 202-395-6974. 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 15 days 
of the date of this publication.

    Dated: June 9, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. E9-14089 Filed 6-15-09; 8:45 am]
BILLING CODE 4140-01-P