Rule2024-28475
Clinical Trials Registration and Results Information Submission
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
December 9, 2024
Effective
December 9, 2024
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), is amending its regulation governing clinical trials registration and results information submission to update throughout the regulation the internet web address or uniform resource locator (URL) of the site that provides information about formatting of information for submission, procedures, and tools as specified in the regulation.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 236 (Monday, December 9, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Rules and Regulations]
[Pages 97558-97559]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-28475]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 11
[Docket No. NIH-2024-0001]
RIN 0925-AA71
Clinical Trials Registration and Results Information Submission
AGENCY: National Institutes of Health, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS), through the
National Institutes of Health (NIH), is amending its regulation
governing clinical trials registration and results information
submission to update throughout the regulation the internet web address
or uniform resource locator (URL) of the site that provides information
about formatting of information for submission, procedures, and tools
as specified in the regulation.
DATES: This final rule is effective December 9, 2024.
FOR FURTHER INFORMATION CONTACT: Daniel Hernandez, NIH Regulations
Officer, Office of Management Assessment, Division of Management
Support, 6011 Executive Boulevard, Suite 601, Rockville, Maryland
20852-7669, telephone 301-435-3343, email <a href="/cdn-cgi/l/email-protection#93f7fbf6e1fdf2fdf7f6e9d3fcf7bdfdfafbbdf4fce5"><span class="__cf_email__" data-cfemail="e2868a87908c838c868798a28d86cc8c8b8acc858d94">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: NIH is completing a multiyear initiative to
modernize the <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> website to deliver an improved user
experience on an updated platform that enhances efficiency. The
modernized website integrates content from the
<a href="http://prsinfo.clinicaltrials.gov">prsinfo.clinicaltrials.gov</a> website, which is referenced in several
sections of 42 CFR part 11 as the web address for obtaining information
on formatting and other guidance, into the centralized
<a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> website at <a href="https://clinicaltrials.gov">https://clinicaltrials.gov</a> for
convenience and ease of access. This address change necessitates
amending the regulation to update the URL for the
<a href="http://prsinfo.clinicaltrials.gov">prsinfo.clinicaltrials.gov</a> successor site. NIH considered other options
and concluded that this final rule technical amendment is necessary
because the current codified URL is referenced throughout the
regulation itself (i.e., as opposed to the Preamble alone). Moreover,
the ``or successor site'' modifier is not always used in the
regulation; for example, 42 CFR 11.8 states ``Information submitted
under this part must be submitted electronically to <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>,
in the format specified at <a href="https://prsinfo.clinicaltrials.gov">https://prsinfo.clinicaltrials.gov</a>.''
The address change necessitates amending the regulation codified at
42 CFR part 11 by removing the URL address <a href="https://prsinfo.clinicaltrials.gov">https://prsinfo.clinicaltrials.gov</a> wherever it appears in part 11, and adding,
in its place, the URL <a href="https://clinicaltrials.gov">https://clinicaltrials.gov</a> or successor site.
Specifically, this action results in removing the URL <a href="https://prsinfo.clinicaltrials.gov">https://prsinfo.clinicaltrials.gov</a> and adding, in its place, the URL <a href="https://clinicaltrials.gov">https://clinicaltrials.gov</a> or successor site in Sec. Sec. 11.4(c)(2)(ii) and
(c)(3), 11.8, 11.44(e)(3)(i), 11.48(a)(5) and (b), 11.54(a)(1) and
(b)(1), and 11.64(b)(1) in part 11.
Amending the regulation is time sensitive, as NIH completed
integration of content from the <a href="http://prsinfo.clinicaltrials.gov">prsinfo.clinicaltrials.gov</a> website into
the modernized <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> website in June 2024. The address
change is cost neutral, editorial in nature, and does not impose any
new regulatory requirements on affected parties.
Matters of Regulatory Procedure
Administrative Procedure Act
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
The APA generally exempts rules from the requirements of notice and
comment rulemaking when an agency ``for good cause finds (and
incorporates the finding and a brief statement of reasons therefor in
the rule issued) that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest'' (5
U.S.C. 553(b)(B)).
HHS has determined that notice and public comment are unnecessary
because this amendment to the regulation provides only technical or
non-substantive, administrative changes to specify the location of
information about formatting of information for submission, procedures,
and tools as specified in the regulation.
Additionally, HHS finds good cause for these amendments to become
effective on the date of publication of this rulemaking action. The APA
allows an effective date of less than 30 days after publication as
``provided by the agency for good cause found and published with the
rule'' (5 U.SC. 553(d)(3). A delayed effective date is unnecessary in
this case because the amendments do not impose any new regulatory
requirements on affected parties. As a result, affected parties do not
need time to prepare before the rule takes effect. Therefore, HHS finds
good cause for this correction to become effective on the date of
publication of this rulemaking action.
Further, it is in the public interest that correct and up-to-date
information be contained in the affected sections of the regulation at
42 CFR part 11 as soon as possible.
Regulatory Impact Analysis
NIH examined the impacts of this rule under Executive Order 12866,
Regulatory Planning and Review; Executive Order 13563, Improving
Regulation and Regulatory Review; Executive Order 14094, Modernizing
Regulatory Review; Executive Order 13132, Federalism; the Regulatory
Flexibility Act (5 U.S.C. 601-612); and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is
[[Page 97559]]
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). The Executive Order 14094
entitled ``Modernizing Regulatory Review'' amends section 3(f) of
Executive Order 12866 (Regulatory Planning and Review). The amended
section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a rule
that may: (1) have an annual effect on the economy of $200 million or
more in any 1 year (adjusted every 3 years by the Administrator of OIRA
for changes in gross domestic product); or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, territorial, or Tribal governments or communities; (2) create a
serious inconsistency or otherwise interfere with an action taken or
planned by another agency; (3) materially alter the budgetary impacts
of entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise legal or policy issues
for which centralized review would meaningfully further the President's
priorities or the principles set forth in this Executive order, as
specifically authorized in a timely manner by the Administrator of OIRA
in each case.
A regulatory impact analysis (RIA) must be prepared for major rules
with significant regulatory action/s and/or with significant effects as
per section 3(f)(1) ($200 million or more in any 1 year). OMB's Office
of Information and Regulatory Affairs has determined that this
rulemaking is ``not significant'' under section 3(f) and does not meet
the criteria set forth in 5 U.S.C. 804(2) under subtitle E of the Small
Business Regulatory Enforcement Fairness Act of 1996 (also known as the
Congressional Review Act). Thus, a RIA is unnecessary.
Executive Order 13132
Executive Order 13132, ``Federalism,'' requires that Federal
agencies consult with State and local government officials in the
development of regulatory policies with federalism implications. The
Secretary, HHS, has reviewed this rule as required under the Executive
order and determined that it will not have federalism implications. The
Secretary, HHS, certifies that the rule will not have effect on the
States or on the distribution of power and responsibilities among
various levels of government.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires
agencies to analyze regulatory options that would minimize the
significant economic impact of a rule on small entities. The Secretary
has determined that this rule will not have a significant economic
impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
agencies to prepare a written statement, to include an assessment of
anticipated costs and benefits, before proposing any rule that includes
a Federal mandate that may result in the expenditure by State, local
and Tribal governments or more, in the aggregate or by the private
sector, of $100,000.000 [adjusted annually for inflation (with base
year 1995)] in any 1 year. The current inflation-adjusted statutory
threshold as of January 2024 is approximately $183 million based on the
Bureau of Labor Statistics inflation calculator. The Secretary, HHS,
certifies that that this rule does not mandate any spending by State,
local, or Tribal government in the aggregate or by the private sector.
Paperwork Reduction Act
The Paperwork Reduction Act (44 U.S.C. chapter 35) is not
applicable, because this rule does not contain any new information
collection or record keeping requirements that require the approval of
the Office of Management and Budget, and this rule does not impact
information collection and recordkeeping requirements in part 11 that
are already approved under OMB Control Number 0925-0586.
Congressional Review Act
The Secretary, HHS, has determined this rule is a non-major rule
under the Congressional Review Act (5 U.S.C. chapter 8) and has
provided a report thereon to the Senate, House of Representatives and
General Accounting Office in accordance with that law.
List of Subjects in 42 CFR Part 11
Biologics, Drugs, Human research subjects, Information,
Laboratories, Medical devises, Medical research, Reporting and
recordkeeping requirements.
Accordingly, under the authority of 42 U.S.C. 216, the Department
of Health and Human Services amends 42 CFR part 11 by making the
following technical amendment:
PART 11--CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION
SUBMISSION
0
1. The authority citation for part 11 continues to read as follows:
Authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42
U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b).
Sec. Sec. 11.4, 11.8, 11.44, 11.48, 11.54, and 11.64 [Amended]
0
2. Amend Sec. Sec. 11.4, 11.8, 11.44, 11.48, 11.54, and 11.64 by
removing the URL ``<a href="https://prsinfo.clinicaltrials.gov">https://prsinfo.clinicaltrials.gov</a>'' wherever it
appears, and adding, in its place, the text ``<a href="https://clinicaltrials.gov">https://clinicaltrials.gov</a> or successor site''.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-28475 Filed 12-6-24; 8:45 am]
BILLING CODE 4140-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on December 9, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.