[Federal Register Volume 84, Number 106 (Monday, June 3, 2019)]
[Notices]
[Page 25550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; The Clinical Trials 
Reporting Program (CTRP) Database (NCI)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Cancer Institute (NCI) will publish 
periodic summaries of proposed projects to be submitted to the Office 
of Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Gisele 
Sarosy, MD, Coordinating Center for Clinical Trials (CCCT), National 
Cancer Institute, 9609 Medical Center Drive, 6W134, Rockville, MD 20852 
or call non-toll-free number 240-276-6172 or Email your request, 
including your address to: [email protected]. Formal requests for 
additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: Written comments and/or suggestions 
from the public and affected agencies are invited to address one or 
more of the following points: (1) 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) 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) Ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) Ways 
to 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.
    Proposed Collection Title: The Clinical Trials Reporting Program 
(CTRP) Database, 0925-0600, Expiration Date 08/31/2019--EXTENSION, 
National Cancer Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The Clinical Trials 
Reporting Program (CTRP) Database 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 website 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.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of     Average time
                   Form name                               Type of  respondents              Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)     burden hours
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Initial Registration...........................  Clinical Trials........................           3,000               1               1           3,000
Amendment.                                                                                         1,500               4               1           6,000
Update.                                                                                            1,500               4               1           6,000
Accrual Updates.                                                                                   3,000               4           15/60           3,000
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................           9,000          27,000  ..............          18,000
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Patricia M. Busche,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2019-11459 Filed 5-31-19; 8:45 am]
BILLING CODE 4140-01-P