Notice2022-20083
Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 16, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 179 (Friday, September 16, 2022)</title>
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[Federal Register Volume 87, Number 179 (Friday, September 16, 2022)]
[Notices]
[Pages 56965-56966]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20083]
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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.
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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 recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open
[[Page 56966]]
for Public Comments'' or by using the search function.
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 your request, including your address to:
<a href="/cdn-cgi/l/email-protection#c6a1afb5a3aaa3e8b5a7b4a9b5bf86a8afaee8a1a9b0"><span class="__cf_email__" data-cfemail="bed9d7cddbd2db90cddfccd1cdc7fed0d7d690d9d1c8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on June 29, 2022, page
38765 (Vol. 87, No. 124) and allowed 60 days for public comment. One
public comment was 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 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) 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 data, and reduce redundant submissions. Clinical
research administrators submit information 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. After registration, four amendments and
four study subject accrual updates occur per trial annually.
OMB approval is requested for three 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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Dated: September 13, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2022-20083 Filed 9-15-22; 8:45 am]
BILLING CODE 4140-01-P
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