Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 2549 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for part 870 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 870.2345 to subpart C to read 

as follows: 

§ 870.2345 Electrocardiograph software 

for over-the-counter use. 

(a) Identification. An 

electrocardiograph software device for 

over-the-counter use creates, analyzes, 

and displays electrocardiograph data 

and can provide information for 

identifying cardiac arrhythmias. This 

device is not intended to provide a 

diagnosis. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing under 

anticipated conditions of use must 

demonstrate the following: 

(i) The ability to obtain an 

electrocardiograph of sufficient quality 

for display and analysis; and 

(ii) The performance characteristics of 

the detection algorithm as reported by 

sensitivity and either specificity or 

positive predictive value. 

(2) Software verification, validation, 

and hazard analysis must be performed. 

Documentation must include a 

characterization of the technical 

specifications of the software, including 

the detection algorithm and its inputs 

and outputs. 

(3) Non-clinical performance testing 

must validate detection algorithm 

performance using a previously 

adjudicated data set. 

(4) Human factors and usability 

testing must demonstrate the following: 

(i) The user can correctly use the 

device based solely on reading the 

device labeling; and 

(ii) The user can correctly interpret 

the device output and understand when 

to seek medical care. 

(5) Labeling must include: 

(i) Hardware platform and operating 

system requirements; 

(ii) Situations in which the device 

may not operate at an expected 

performance level; 

(iii) A summary of the clinical 

performance testing conducted with the 

device; 

(iv) A description of what the device 

measures and outputs to the user; and 

(v) Guidance on interpretation of any 

results. 

Dated: January 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00827 Filed 1–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Part 575 

Annual Adjustment of Civil Monetary 

Penalty To Reflect Inflation 

AGENCY: National Indian Gaming 

Commission. 

ACTION: Final rule. 

SUMMARY: In compliance with the 

Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 (the Act) and Office of 

Management and Budget (OMB) 

guidance, the National Indian Gaming 

Commission (NIGC or Commission) is 

amending its civil monetary penalty 

rule to reflect an annual adjustment for 

inflation in order to improve the 

penalty’s effectiveness and maintain its 

deterrent effect. The Act provides that 

the new penalty level must apply to 

penalties assessed after the effective 

date of the increase, including when the 

penalties whose associated violation 

predate the increase. 

DATES: This rule is effective January 18, 

2022. This final rule is applicable 

beginning on January 15, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Armando J. Acosta, Senior Attorney, 

Office of General Counsel, National 

Indian Gaming Commission, at (202) 

632–7003; fax (202) 632–7066 (not tollfree numbers). 

SUPPLEMENTARY INFORMATION: 

I. Background 

On November 2, 2015, the President 

signed into law the Federal Civil 

Penalties Inflation Adjustment Act 

Improvements Act of 2015 (Sec. 701 of 

Pub. L. 114–74). Beginning in 2017, the 

Act requires agencies to make annual 

inflationary adjustments to their civil 

monetary penalties by January 15th of 

each year, in accordance with annual 

OMB guidance. 

II. Calculation of Annual Adjustment 

In December of every year, OMB 

issues guidance to agencies to calculate 

the annual adjustment. According to 

OMB, the cost-of-living adjustment 

multiplier for fiscal year 2022 is 

1.06222, based on the Consumer Price 

Index for the month of October 2021, 

not seasonally adjusted. 

Pursuant to this guidance, the 

Commission has calculated the annual 

adjustment level of the civil monetary 

penalty contained in 25 CFR 575.4 

(‘‘The Chairman may assess a civil fine, 

not to exceed $54,157 per violation, 

against a tribe, management contractor, 

or individual operating Indian gaming 

for each notice of violation . . .’’). The 

2022 adjusted level of the civil 

monetary penalty is $57,527 ($54,157 × 

1.06222). 

III. Regulatory Matters 

Regulatory Planning and Review 

This final rule is not a significant rule 

under Executive Order 12866. 

(1) This rule will not have an effect of 

$100 million or more on the economy or 

will not adversely affect, in a material 

way, the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or state, local, or 

tribal governments or communities. 

(2) This rule will not create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another agency. 

(3) This rule does not involve 

entitlements, grants, user fees, or loan 

programs or the rights or obligations of 

recipients. 

(4) This regulatory change does not 

raise novel legal or policy issues. 

Regulatory Flexibility Act 

The Commission certifies that this 

rule will not have a significant 

economic effect on a substantial number 

of small entities under the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) 

because the rule makes annual 

adjustments for inflation. 

Small Business Regulatory Enforcement 

Fairness Act 

This final rule is not a major rule 

under 5 U.S.C. 804(2), the Small 

Business Regulatory Enforcement 

Fairness Act. It will not result in the 

expenditure by state, local, or tribal 

governments, in the aggregate, or by the 

private sector of $100 million or more 

in any one year. The rule will not result 

in a major increase in costs or prices for 

consumers, individual industries, 

Federal, state, or local government 

agencies, or geographic regions. Nor will 

this rule have significant adverse effects 

on competition, employment, 

investment, productivity, innovation, or 

the ability of the U.S.-based enterprises 

to compete with foreign-based 

enterprises. 

Unfunded Mandates Reform Act 

This final rule does not impose an 

unfunded mandate of more than $100 

million per year on state, local, or tribal 


khammond on DSKJM1Z7X2PROD with RULES
2550 Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations 

governments or the private sector. The 

rule also does not have a significant or 

unique effect on state, local, or tribal 

governments or the private sector. 

Therefore, a statement containing the 

information required by the Unfunded 

Mandates Reform Act (2 U.S.C. 1531 et 

seq.) is not required. 

Takings 

Under the criteria in Executive Order 

12630, this final rule does not affect 

individual property rights protected by 

the Fifth Amendment nor does it 

involve a compensable ‘‘taking.’’ Thus, 

a takings implication assessment is not 

required. 

Federalism 

Under the criteria in Executive Order 

13132, this final rule has no substantial 

direct effect on the states, on the 

relationship between the National 

Government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

Civil Justice Reform 

This final rule complies with the 

requirements of Executive Order 12988. 

Specifically, this rule has been reviewed 

to eliminate errors and ambiguity and 

written to minimize litigation. It is 

written in clear language and contains 

clear legal standards. 

Consultation With Indian Tribes 

In accordance with the President’s 

memorandum of April 29, 1994, 

Government-to-Government Relations 

with Native American Tribal 

Governments, Executive Order 13175 

(59 FR 22951, November 6, 2000), the 

Commission has determined that 

consultations with Indian gaming tribes 

is not practicable, as Congress has 

mandated that annual civil penalty 

adjustments in the Act be implemented 

no later than January 15th of each year. 

Paperwork Reduction Act 

This final rule does not affect any 

information collections under the 

Paperwork Reduction Act. 

National Environmental Policy Act 

This final rule does not constitute a 

major Federal action significantly 

affecting the quality of the human 

environment. 

Information Quality Act 

In developing this final rule, the 

Commission did not conduct or use a 

study, experiment, or survey requiring 

peer review under the Information 

Quality Act (Pub. L. 106–554). 

Effects on the Energy Supply 

This final rule is not a significant 

energy action under the definition in 

Executive Order 13211. A Statement of 

Energy Effects is not required. 

Clarity of This Regulation 

The Commission is required by 

Executive Orders 12866 and 12988 and 

by the Presidential Memorandum of 

June 1, 1998, to write all rules in plain 

language. This means that each rule that 

the Commission publishes must: 

(a) Be logically organized; 

(b) use the active voice to address 

readers directly; 

(c) use clear language rather than 

jargon; 

(d) be divided into short sections and 

sentences; and 

(e) use lists and tables wherever 

possible. 

Required Determinations Under the 

Administrative Procedure Act 

In accordance with the Act, agencies 

are to annually adjust civil monetary 

penalties without providing an 

opportunity for notice and comment, 

and without a delay in its effective date. 

Therefore, the Commission is not 

required to complete a notice and 

comment process prior to promulgation. 

List of Subjects in 25 CFR Part 575 

Administrative practice and 

procedure, Gaming, Indian lands, 

Penalties. 

For the reasons set forth in the 

preamble, the Commission amends 25 

CFR part 575 as follows: 

PART 575—CIVIL FINES 

■ 1. The authority citation for part 575 

continues to read as follows: 

Authority: 25 U.S.C. 2705(a), 2706, 2713, 

2715; and Sec. 701, Pub. L. 114–74, 129 Stat. 

599. 

§ 575.4 [Amended] 

■ 2. Amend the introductory text of 

§ 575.4 by removing ‘‘$54,157’’ and 

adding in its place ‘‘$57,527’’. 

Dated: January 12, 2022. 

E. Sequoyah Simermeyer, 

Chairman. 

Jeannie C. Hovland, 

Vice Chair. 

[FR Doc. 2022–00835 Filed 1–14–22; 8:45 am] 

BILLING CODE 7565–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2022–0006] 

RIN 1625–AA00 

Safety Zone; St. Clair Icy Bazaar 

Fireworks, St. Clair River, MI 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

navigable waters within a 50-yard 

radius of a portion of the St. Clair River, 

St. Clair, MI. This zone is necessary to 

protect spectators and vessels from 

potential hazards associated with the St. 

Clair Icy Bazaar Fireworks. 

DATES: This temporary final rule is 

effective from 6 p.m. on January 22, 

2022, through 6:30 p.m. on January 23, 

2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0006 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

rule, call or email Tracy Girard, 

Prevention Department, Sector Detroit, 

Coast Guard; telephone 313–568–9564, 

or email Tracy.M.Girard@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port Detroit 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of Proposed Rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b) (B), the Coast Guard finds that 


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