Notice2025-21244
Proposed Collection; 60-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)
Primary source
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Published
November 26, 2025
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 Library of Medicine (NLM), 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.
Full Text
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<title>Federal Register, Volume 90 Issue 226 (Wednesday, November 26, 2025)</title>
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[Federal Register Volume 90, Number 226 (Wednesday, November 26, 2025)]
[Notices]
[Pages 54340-54341]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21244]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-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 requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Library of Medicine (NLM), 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.
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: Vivian Le,
Office of Administration, National Library of Medicine, 8600 Rockville
Pike, Building 38A, 4N401Q5, Bethesda, Maryland, 20894 or call non-
toll-free number 301-827-6328 or Email your request, including your
address to: <a href="/cdn-cgi/l/email-protection#93e5fae5faf2fdbdfff6d3fdfafbbdf4fce5"><span class="__cf_email__" data-cfemail="a3d5cad5cac2cd8dcfc6e3cdcacb8dc4ccd5">[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 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.
Proposed Collection Title: Information Program on Clinical Trials:
Maintaining a Registry and Results Databank, 0925-0586, Expiration
Date: 03/31/2026, 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 submit results information
voluntarily, 42 CFR part 11 requires the registration of certain
applicable clinical trials of drug, biological, and device products and
the submission of results information for completed 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 1,411,181.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total annual
Submission type respondents responses per response (in burden hour
respondent hours)
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Registration--Attachment 2:
Initial................................... 7,400 1 8 59,200
Updates................................... 7,400 8 2 118,400
Triggered, voluntary...................... 182 1 8 1,456
Initial, non-regulated, NIH Policy........ 1,200 1 8 9,600
Updates, non-regulated, NIH Policy........ 1,200 8 2 19,200
Initial, voluntary and non-regulated...... 23,130 1 8 185,040
Updates, voluntary and non-regulated...... 23,130 8 2 370,080
Results Information Submission--Attachment 5:
Initial................................... 7,400 1 40 296,000
Updates................................... 7,400 2 10 148,000
Triggered, voluntary--also attachment 2... 61 1 45 2,745
Initial, non-regulated, NIH Policy........ 1,200 1 40 48,000
Updates, non-regulated, NIH Policy........ 1,200 2 10 24,000
Initial, voluntary and non-regulated...... 2,100 1 40 84,000
[[Page 54341]]
Updates, voluntary and non-regulated...... 2,100 2 10 42,000
Other:
Certification to delay results--attachment 5,150 1 30/60 2,575
6........................................
Extension requests and Appeals--attachment 175 1 2 350
7........................................
Initial, expanded access--attachment 3.... 213 1 2 426
Updates, expanded access--attachment 3.... 213 2 15/60 107
Waiver requests and appeals............... 1 1 2 2
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Total................................. .............. 323,878 .............. 1,411,181
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Vivian K. Le,
Project Clearance Liaison, National Library of Medicine, National
Institutes of Health.
[FR Doc. 2025-21244 Filed 11-25-25; 8:45 am]
BILLING CODE 4140-01-P
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