E9-14089. 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.

Estimates of Annual Burden Hours

Type of respondents	Survey instrument	Number of respondents	Frequency of response	Average time per response (hours)	Annual burden hours
Clinical Trials	Initial Registration	5,500	1	2.0	11,000
	Amendment	5,500	4	1.0	22,000
Total					33,000

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 [e-mail] 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: [e-mail].

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.