97558 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Rules and Regulations 

(21) Nebraska Administrative Code Title 

126 Chapter 1.001, 1.005, 1.011, 1.013, 

1.020–1.022, 1.024, 1.030.01, 1.031, 1.033– 

1.034, 1.036–1.038, 1.040, 1.045. 

(22) Nebraska Administrative Code Title 

126 Chapter 18. 

(23) Nebraska Administrative Code Title 

178 Chapters 12.001, 12–03, 12–06—12–07, 

12–09, 12–011.01—12–011.01B1, 12– 

011.01C—12–012.08B, 12–012.08D—12– 

012.08F2, 12–012.09—12–14, the tables and 

figures, and the following definitions found 

at Title 178, Chapter 12–002 Annular Fill, 

Annular Space, Aquifer, Aquifer Seal, 

Primary Aquifer Seal, Surface Seal, Backflow 

Preventer, Bentonite, Bentonite Seal, Bored 

or Dug Well, Casing, Cesspool, Clay, 

Community Water System, Confining Layer, 

Construction of Water Wells, Contamination, 

Decommissioned when used in relation to a 

water well, Department, Dewatering Well, 

Discharge Pipe, Distribution Piping, Good 

Cause, Gravel Pack, Ground Water, Grout, 

Installation of Pumps and Pumping 

Equipment, Monitoring Well, Non-potable 

Well, Observation Well, Person, Pitless Unit, 

Pollution, Potable Well, Primary Aquifer 

Seal, Public Water System, (Licensed) Pump 

Installation Contractor, (Licensed) Pump 

Installation Supervisor, Pumps and Pumping 

Equipment, Recovery Well, Sanitary Well 

Seal, Screen Apertures, Screened Vent, 

Secure Cover or Cap, Seepage Pit, Septic 

Tank, Soil Absorption System (Septic Lateral 

Field), Static Water Level, Substantially 

Equivalent, Subsurface Disposal System, 

Supervision or its derivatives, Surface Seal, 

Test Hole, Tremie Pipe, Watertight Casing, 

Watertight Secure Cover, Water Well, 

(Licensed) Water Well Contractor, (Licensed) 

Water Well Drilling Supervisor, Well 

Development, Well Pit, Well Screen. 

[FR Doc. 2024–28140 Filed 12–6–24; 8:45 am] 

BILLING CODE 6560–50–P 

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 

dhernandez@od.nih.gov. 

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 

§§ 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 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Rules and Regulations 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 

■ 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). 

§§ 11.4, 11.8, 11.44, 11.48, 11.54, and 11.64 

[Amended] 

■ 2. Amend §§ 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 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 90 

[WP Docket No. 07–100; FCC 23–3; FR ID 

261942] 

Improving Public Safety 

Communications in the 4.9 GHz Band 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule, announcement of 

compliance date. 

SUMMARY: In this document, the Federal 

Communications Commission (FCC) 

announces that the Office of 

Management and Budget (OMB) has 

approved, for a period of three years, the 

information collections associated with 

certain rules adopted in the Seventh 

Report and Order, in WP Docket No. 07– 

100; FCC 23–3. This document is 

consistent with the Seventh Report and 

Order, which directs the Public Safety 

and Homeland Security Bureau and the 

Wireless Telecommunications Bureau to 

publish a document in the Federal 

Register announcing a compliance date 

for the rule section and revise the rule 

accordingly. 

DATES: 

Effective Date: December 9, 2024. 

Compliance Date: Compliance with 

47 CFR 90.1207(e) and (f) published at 

88 FR 12565 on February 28, 2023, is 

required as of December 9, 2024. 

ADDRESSES: Federal Communications 

Commission, 45 L St. NE, Washington, 

DC 20554. 

FOR FURTHER INFORMATION CONTACT: 

Brian Marenco of the Public Safety and 


ddrumheller on DSK120RN23PROD with RULES1