[Federal Register Volume 75, Number 19 (Friday, January 29, 2010)]
[Notices]
[Pages 4827-4828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1988]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request 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 (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 November 
9, 2009, (Vol. 74, No. 215, p. 57684) and allowed 60-days for public 
comment. Two public comments were received. The first comment, received 
November 11, 2009, questioned the purpose and safety of clinical trials 
conducted outside of the United States. An e-mail response was sent on 
January 6, 2010, acknowledging the commenter's concern. The response 
noted that the NCI's Clinical Trials Reporting Program is an 
information collection activity intended to assist the NCI in 
management of the NCI's clinical trials portfolio, which is global in 
nature. The response further stated that while CTRP is not directly 
related to the conduct of a clinical trial, the NCI hopes to use the 
information to facilitate routine review of safety, efficacy, and 
administrative data reported from on-going cancer trials. On January 6, 
2010, the same commenter sent a subsequent comment concerning 
corruption in clinical trials conducted by large pharmaceutical 
companies. The NCI sent an e-mail response on January 8, 2010, thanking 
the commenter for her additional comments and noting that they would be 
taken into consideration.
    The purpose of this notice is to allow an additional 30 days for 
public comment. The 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.
    Proposed Collection: Title: Clinical Trials Reporting Program 
(CTRP) Database. Type of Information Collection Request: REVISION of 
currently approved collection [OMB No. 0925-0600, expiration date 01/
31/2010]. 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; and four accrual updates 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 38,500 hours (see Table below). There 
are no Capital Costs, Operating Costs, and/or Maintenance Costs to 
report.

                                                        A.12-1--Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                           Average time  per
       Type of respondents         Survey instrument   Number of  respondents   Frequency  of response     response (minutes/      Annual burden  hours
                                                                                                                 hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical Trials.................  Initial                               5,500                        1                   120/60                   11,000
                                   Registration.
                                  Amendment.........                    5,500                        4                    60/60                   22,000
                                  Accrual Updates...                    5,500                        4                    15/60                    5,500
                                                     ---------------------------------------------------------------------------------------------------
    Total.......................  ..................                   16,500  .......................  .......................                   38,500
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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,

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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 30 days 
of the date of this publication.

    Dated: January 15, 2010.
Kristine Miller,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-1988 Filed 1-28-10; 8:45 am]
BILLING CODE 4140-01-P