81 FR 12914 - Proposed Collection; 60-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 48 (March 11, 2016)

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. 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) 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. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Jose Galvez, MD, Office of the Director, National Cancer Institute, 9609 Medical Center Drive, 1W468, Rockville, MD 20852 or call non-toll-free number 240-276-5206 or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600, Expiration Date 05/31/2016--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 Web site 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.

[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12914-12915]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05425]


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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)

    Summary: In compliance with the requirement of Section 
3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity 
for public comment on proposed data collection projects, the National 
Cancer Institute, the National Institutes of Health (NIH) will publish 
periodic summaries of proposed projects to be submitted to the Office 
of Management and Budget (OMB) for review and approval.
    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) 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.
    To Submit Comments and For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Jose 
Galvez, MD, Office of the Director, National Cancer Institute, 9609 
Medical Center Drive, 1W468, Rockville, MD 20852 or call non-toll-free 
number 240-276-5206 or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: The Clinical Trials Reporting Program (CTRP) 
Database, 0925-0600, Expiration Date 05/31/2016--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 Web site 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.

[[Page 12915]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
      Type of respondents             Forms          Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Clinical Research               Initial                    3,000               1               1           3,000
 Administrators.                 Registration.
                                Amendment.......           3,000               4               1          12,000
                                Accrual Updates.           3,000               4           15/60           3,000
                                                 ---------------------------------------------------------------
    Totals....................  ................           9,000          27,000  ..............          18,000
----------------------------------------------------------------------------------------------------------------


    Dated: March 2, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2016-05425 Filed 3-10-16; 8:45 am]
 BILLING CODE 4140-01-P