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[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 [www.gpo.gov]
[FR Doc No: 2024-28475]

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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.

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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 [email protected].

SUPPLEMENTARY INFORMATION: NIH is completing a multiyear initiative to 
modernize the ClinicalTrials.gov website to deliver an improved user 
experience on an updated platform that enhances efficiency. The 
modernized website integrates content from the 
prsinfo.clinicaltrials.gov 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 
ClinicalTrials.gov website at https://clinicaltrials.gov for 
convenience and ease of access. This address change necessitates 
amending the regulation to update the URL for the 
prsinfo.clinicaltrials.gov 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 ClinicalTrials.gov, 
in the format specified at https://prsinfo.clinicaltrials.gov.''
    The address change necessitates amending the regulation codified at 
42 CFR part 11 by removing the URL address https://prsinfo.clinicaltrials.gov wherever it appears in part 11, and adding, 
in its place, the URL https://clinicaltrials.gov or successor site.
    Specifically, this action results in removing the URL https://prsinfo.clinicaltrials.gov and adding, in its place, the URL https://clinicaltrials.gov 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 prsinfo.clinicaltrials.gov website into 
the modernized ClinicalTrials.gov 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 ``https://prsinfo.clinicaltrials.gov'' wherever it 
appears, and adding, in its place, the text ``https://clinicaltrials.gov 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
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