Annual Adjustment of Civil Monetary Penalty To Reflect Inflation, 2549-2550 [2022-00835]

Download as PDF Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Rules and Regulations PART 870—CARDIOVASCULAR DEVICES Dated: January 7, 2022. Lauren K. Roth, Associate Commissioner for Policy. 1. The authority citation for part 870 continues to read as follows: [FR Doc. 2022–00827 Filed 1–14–22; 8:45 am] ■ BILLING CODE 4164–01–P Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 870.2345 to subpart C to read as follows: ■ khammond on DSKJM1Z7X2PROD with RULES § 870.2345 Electrocardiograph software for over-the-counter use. 16:23 Jan 14, 2022 Jkt 256001 National Indian Gaming Commission 25 CFR Part 575 (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. VerDate Sep<11>2014 DEPARTMENT OF THE INTERIOR Annual Adjustment of Civil Monetary Penalty To Reflect Inflation National Indian Gaming Commission. ACTION: Final rule. AGENCY: 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: SUMMARY: 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. PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 2549 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 E:\FR\FM\18JAR1.SGM 18JAR1 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. Effects on the Energy Supply Clarity of This Regulation [Docket No. USCG–2022–0006] Takings 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. RIN 1625–AA00 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 khammond on DSKJM1Z7X2PROD with RULES 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: ■ [Amended] 2. Amend the introductory text of § 575.4 by removing ‘‘$54,157’’ and adding in its place ‘‘$57,527’’. ■ 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). Jkt 256001 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. § 575.4 National Environmental Policy Act 16:23 Jan 14, 2022 Required Determinations Under the Administrative Procedure Act Authority: 25 U.S.C. 2705(a), 2706, 2713, 2715; and Sec. 701, Pub. L. 114–74, 129 Stat. 599. This final rule does not affect any information collections under the Paperwork Reduction Act. VerDate Sep<11>2014 This final rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required. 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 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 Safety Zone; St. Clair Icy Bazaar Fireworks, St. Clair River, MI Coast Guard, Department of Homeland Security (DHS). ACTION: Temporary final rule. AGENCY: 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: SUMMARY: 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 E:\FR\FM\18JAR1.SGM 18JAR1

Agencies

[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Rules and Regulations]
[Pages 2549-2550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00835]


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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 toll-free 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 x 
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

[[Page 2550]]

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

0
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.


Sec.  575.4   [Amended]

0
2. Amend the introductory text of Sec.  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