Notice2023-02381
Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)
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
February 6, 2023
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 88 Issue 24 (Monday, February 6, 2023)</title>
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[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Notices]
[Pages 7743-7745]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02381]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Information
Program on Clinical Trials: Maintaining a Registry and Results Databank
(National Library of Medicine)
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.
[[Page 7744]]
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 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: Christeenna Iraheta, Office of Administrative and
Management Analysis Services, National Library of Medicine, Building
38A, Room B2N12A, 8600 Rockville Pike, Bethesda, MD 20894, or call non-
toll-free number (301) 480-7605, or Email your request, including your
address to: <a href="/cdn-cgi/l/email-protection#12517a607b616677777c7c733c7b60737a776673527c7b7a3c757d64"><span class="__cf_email__" data-cfemail="74371c061d070011111a1a155a1d06151c110015341a1d1c5a131b02">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on November 15, 2022,
pages 68508-9 (87 FR 68508) 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 Library of
Medicine (NLM), 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: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank, 0925-0586, Expiration Date
02/28/2023--EXTENSION, National Library of Medicine (NLM), National
Institutes of Health (NIH).
Need and Use of Information Collection: The National Institutes of
Health operates <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>, which was established as a clinical
trial registry under section 113 of the Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include
a results data bank by title VIII of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) and by the Clinical Trials Registration
and Results Information Submission regulations at 42 CFR part 11.
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> collects registration and results information for
clinical trials and other types of clinical studies (e.g.,
observational studies and patient registries) with the objectives of
enhancing patient enrollment and providing a mechanism for tracking
subsequent progress of clinical studies to the benefit of public
health. It is widely used by patients, physicians, and medical
researchers; in particular those involved in clinical research. While
many clinical studies are registered and results information submitted
voluntarily, 42 CFR part 11 requires the registration and submission of
results information for certain applicable clinical trials of drug,
biological, and device products whether or not they are approved,
licensed, or cleared by the Food and Drug Administration.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 1,219,801.
Estimated Annualized Burden Hours
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Number of Average time
Submission type Number of responses per per response Total annual
respondents respondent (in hours) burden hours
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Registration--attachment 2
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Initial......................................... 7,400 1 8 59,200
Updates......................................... 7,400 8 2 118,400
Triggered, voluntary............................ 141 1 8 1,128
Initial, non-regulated, NIH Policy.............. 940 1 8 7,520
Updates, non-regulated, NIH Policy.............. 940 8 2 15,040
Initial, voluntary and non-regulated............ 17,860 1 8 142,880
Updates, voluntary and non-regulated............ 17,860 8 2 285,760
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Results Information Submission--attachment 5
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Initial......................................... 7,400 1 40 296,000
Updates......................................... 7,400 2 10 148,000
Triggered, voluntary--also attachment 2......... 47 1 45 2,115
Initial, non-regulated, NIH Policy.............. 940 1 40 37,600
Updates, non-regulated, NIH Policy.............. 940 2 10 18,800
Initial, voluntary and non-regulated............ 1,400 1 40 56,000
Updates, voluntary and non-regulated............ 1,400 2 10 28,000
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Other
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Certification to delay results--attachment 6.... 5,150 1 30/60 2,575
Extension request and Appeal--attachment 7...... 125 1 2 250
Initial, expanded access--attachment 3.......... 213 1 2 426
Updates, expanded access--attachment 3.......... 213 2 15/60 107
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Total....................................... 77,769 271,122 .............. 1,219,801
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[[Page 7745]]
Dated: January 31, 2023.
Christeenna M. Iraheta,
Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2023-02381 Filed 2-3-23; 8:45 am]
BILLING CODE 4140-01-P
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