[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44318-44319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18202]


-----------------------------------------------------------------------

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)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30 days of the date of 
this publication.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, 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

[[Page 44319]]

your request, including your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on June 3, 2019, page 
25550 (Vol. 84, No. 106 FR 25550) 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.
    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction 
Act of 1995, the National Institutes of Health (NIH) has submitted to 
the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below.
    Proposed Collection: The Clinical Trials Reporting Program (CTRP) 
Database (NCI), 0925-0600, Expiration Date 08/31/2019--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 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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondents      respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
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.....................  ................  ..............          27,000  ..............          18,000
----------------------------------------------------------------------------------------------------------------


Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2019-18202 Filed 8-22-19; 8:45 am]
 BILLING CODE 4140-01-P