Notice2022-13847
Proposed Collection; 60-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)
Primary source
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Published
June 29, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 124 (Wednesday, June 29, 2022)</title>
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[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Pages 38765-38766]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13847]
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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: <a href="/cdn-cgi/l/email-protection#ec8b859f898089c29f8d9e839f95ac828584c28b839a"><span class="__cf_email__" data-cfemail="99fef0eafcf5fcb7eaf8ebf6eae0d9f7f0f1b7fef6ef">[email protected]</span></a>. 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 minimizes 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 10/31/2022-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 Number of responses per per response Total annual
respondents 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
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Totals.................... 9,000 27,000 18,000
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[[Page 38766]]
Dated: June 24, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2022-13847 Filed 6-28-22; 8:45 am]
BILLING CODE 4140-01-P
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