Federal Register / Vol. 88, No. 249 / Friday, December 29, 2023 / Rules and Regulations 90125 

1 85 FR 76666 (Nov. 30, 2020). 

2Pharmaceutical Care Management Association 

v. United States Department of Health & Human 

Services et al., No. 1:21–cv–00095 (D. DC. filed Jan. 

12, 2021). 

EPA-APPROVED REGULATIONS IN THE ARKANSAS SIP—Continued 

State citation Title/subject 

State 

submittal/effective 

date 

EPA approval date Explanation 

Rule 19.1504 .............. [Reserved] ..................................... 6/22/2022 12/29/2023, [Insert Federal Register citation].

Rule 19.1505 .............. Best Available Retrofit Technology 

Requirements.

6/22/2022 12/29/2023, [Insert Federal Register citation].

Rule 19.1506 .............. Compliance Provisions .................. 6/22/2022 12/29/2023, [Insert Federal Register citation].

Rule 19.1507 .............. [Reserved] ..................................... 6/22/2022 12/29/2023, [Insert Federal Register citation].

Chapter 18: Effective Date 

Rule 19.1801 .............. Effective Date ................................ 6/22/2022 12/29/2023, [Insert Federal Register citation].

Appendix A: Insignificant Activities List 

Appendix A ................. Insignificant Activities List ............. 6/22/2022 12/29/2023, [Insert Federal Register citation].

Appendix B: National Ambient Air Quality Standards List 

Appendix B ................. National Ambient Air Quality 

Standards List.

6/22/2022 12/29/2023, [Insert Federal Register citation].

* * * * * * * 

* * * * * 

■ 3. Section 52.173 is amended by 

adding paragraph (j) to read as follows: 

§ 52.173 Visibility protection. 

* * * * * 

(j) Revisions to the Arkansas Pollution 

Control and Ecology Commission’s 

(APC&EC) Rule No. 19, Chapter 15. 

Revisions to APC&EC Rule No. 19, 

Chapter 15, submitted on June 22, 2022, 

are approved. 

[FR Doc. 2023–28497 Filed 12–28–23; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1001 

RIN 0936–AA14 

Action to Delay Effective Date 

Consistent With Congressionally 

Enacted Moratorium 

AGENCY: Office of Inspector General 

(OIG), Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

SUMMARY: This action stays certain 

amendments to the safe harbors to the 

Federal anti-kickback statute that were 

promulgated in a final rule (‘‘Fraud And 

Abuse; Removal of Safe Harbor 

Protection for Rebates Involving 

Prescription Pharmaceuticals and 

Creation of New Safe Harbor Protection 

for Certain Point-of-Sale Reductions in 

Price on Prescription Pharmaceuticals 

and Certain Pharmacy Benefit Manager 

Service Fees’’) published in the Federal 

Register on November 30, 2020 (the 

2020 Final Rule). In response to a 

moratorium enacted by Congress on 

implementation of the 2020 Final Rule, 

most recently in section 11301 of the 

Inflation Reduction Act of 2022, which 

extended previous moratoria on 

implementation, administration, or 

enforcement of the 2020 Final Rule until 

January 1, 2032, the new effective date 

for the amendments set forth in the 2020 

Final Rule is January 1, 2032. 

DATES: As of December 29, 2023, 42 CFR 

1001.952(h)(5)(viii), 42 CFR 

1001.952(h)(6) through (9), 42 CFR 

1001.952(cc), and 42 CFR 1001.952(dd) 

are stayed until January 1, 2032. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Zajic, (202) 619–0335. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register published on 

November 30, 2020, the Department 

issued the 2020 Final Rule establishing 

four changes to the regulatory safe 

harbors to the Federal anti-kickback 

statute (section 1128B(b) of the Social 

Security Act).1 Specifically, the 2020 

Final Rule: (i) amended 42 CFR 

1001.952(h)(5) to remove safe harbor 

protection for reductions in price for 

prescription pharmaceutical products 

provided to plan sponsors under Part D 

by making punctuation changes to 

subparagraphs (5)(vi) and (vii) and 

adding new subparagraph paragraph 

(h)(5)(viii), (ii) added new paragraphs 

(6)–(9) to 42 CFR 1001.952(h), (iii) 

created a new safe harbor at 42 CFR 

1001.952(cc) for certain point-of-sale 

reductions in price offered by 

manufacturers on prescription 

pharmaceutical products that are 

payable under Medicare Part D or by 

Medicaid managed care organizations 

that meet certain criteria, and (iv) 

created a new safe harbor at 42 CFR 

1001.952(dd) for fixed fees that 

manufacturers pay to pharmacy benefit 

managers for services rendered to the 

manufacturers that meet specified 

criteria. The 2020 Final Rule was 

published with an effective date of 

January 29, 2021, except for the 

amendments to 42 CFR 1001.952(h)(5), 

which were to be effective on January 1, 

2022. 

On January 12, 2021, a lawsuit 

challenging the final rule was filed in 

the U.S. District Court for the District of 

Columbia.2 Because of orders in this 

lawsuit and in response to a 

Government memorandum regarding 

postponing effective dates of rules that 

had not yet taken effect, the effective 

dates of various sections of these 

amendments to the safe harbors were 

extended multiple times between 

January and March of 2021, and, 

ultimately, the effective date of the 

regulatory revisions established by the 


ddrumheller on DSK120RN23PROD with RULES1
90126 Federal Register / Vol. 88, No. 249 / Friday, December 29, 2023 / Rules and Regulations 

3See Pharmaceutical Care Management 

Association v. United States Department of Health 

& Human Services et al., No. 1:21–cv–00095 (D. 

D.C. Jan. 30, 2021) (order granting joint stipulation 

and postponing effective date), Doc. No. 19; see also 

86 FR 7815 (Feb. 2, 2021), 86 FR 10181 (Feb. 19, 

2021), and 86 FR 15132 (Mar. 22, 2021). 

2020 Final Rule was extended to 

January 1, 2023.3

Subsequently, Congress extended this 

effective date three times: (i) section 

90006 of the Infrastructure Investment 

and Jobs Act, Public Law 117–58, 

prohibited implementation, 

administration, or enforcement of the 

regulatory revisions established by the 

2020 Final Rule prior to January 1, 2026; 

(ii) section 13101 of the Bipartisan Safe 

Communities Act, Public Law 117–159, 

extended the moratorium on 

implementation, administration, or 

enforcement until January 1, 2027; and 

(iii) section 11301 of the Inflation 

Reduction Act of 2022, Public Law 117– 

169, further extended the moratorium 

on implementation, administration, or 

enforcement of the 2020 Final Rule until 

January 1, 2032. 

II. Final Rule 

This final rule stays the amendments 

made to the safe harbor regulations 

through the 2020 Final Rule, 

specifically the new paragraphs added 

at 42 CFR 1001.952(h)(5)(viii), 42 CFR 

1001.952(h)(6)–(9), 42 CFR 

1001.952(cc), and 42 CFR 1001.952(dd). 

Pursuant to the most recent 

congressional mandate in section 11301 

of the Inflation Reduction Act of 2022, 

Public Law 117–169, the 2020 Final 

Rule’s revisions to the safe harbor 

regulations will be stayed until January 

1, 2032. 

III. Regulatory Impact Statement 

As set forth below, we have examined 

the impact of this final rule as required 

by the Administrative Procedure Act, 

Executive Order 12866, the Regulatory 

Flexibility Act of 1980, the Unfunded 

Mandates Reform Act of 1995, and 

Executive Order 13132. 

A. Administrative Procedure Act 

To the extent that 5 U.S.C. 553 applies 

to this action, implementation of this 

action without opportunity for public 

comment is based on the good cause 

exception in 5 U.S.C. 553(b)(B). Seeking 

public comment is impracticable, 

unnecessary, and contrary to the public 

interest. The postponement of the 

effective date, until January 1, 2032, is 

required by law. Seeking prior public 

comment on this postponement would 

have been impracticable, as well as 

contrary to the public interest in the 

orderly issue and implementation of 

regulations. 

B. Executive Order 12866 and the 

Regulatory Flexibility Act 

Because no notice of proposed 

rulemaking is required for this rule, the 

provisions of the Regulatory Flexibility 

Act do not apply. Furthermore, this 

document does not meet the criteria for 

a significant regulatory action as 

specified in Executive Order 12866. 

C. Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995, Public 

Law 104–4, requires that agencies assess 

anticipated costs and benefits before 

issuing any rule that may result in 

expenditures in any one year by State, 

local, or Tribal Governments in the 

aggregate, or by the private sector, of 

$100 million or more (adjusted annually 

for inflation). We believe that this final 

rule will not impose any mandates on 

State, local, or Tribal Governments or 

the private sector that would result in 

an expenditure of $100 million or more 

(adjusted for inflation) in any given 

year, and that a full analysis under the 

Unfunded Mandates Reform Act is not 

necessary. 

D. Executive Order 13132 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a rule 

that imposes substantial direct 

requirements or costs on State and local 

governments, preempts State law, or 

otherwise has federalism implications. 

In reviewing this final rule under the 

threshold criteria of Executive Order 

13132, Federalism, we have determined 

that this final rule would not 

significantly limit the rights, roles, and 

responsibilities of State or local 

governments. We have determined, 

therefore, that a full analysis under 

Executive Order 13132 is not necessary. 

IV. Paperwork Reduction Act 

In accordance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we are required 

to solicit public comments, and receive 

final approval from the Office of 

Management and Budget, on any 

information collection requirements set 

forth in rulemaking. This final rule will 

not impose any information collection 

burden or affect information currently 

collected by OIG. 

List of Subjects in 42 CFR Part 1001 

Administrative practice and 

procedure, Fraud, Grant programs— 

health, Health facilities, Health 

professions, Maternal and child health, 

Medicaid, Medicare, Social Security. 

For the reasons set forth above, the 

following provisions of 42 CFR part 

1001 are stayed as set forth below: 

PART 1001—PROGRAM INTEGRITY— 

MEDICARE AND STATE HEALTH 

CARE PROGRAMS 

■ 1. The authority citation for part 1001 

continues to read as follows: 

Authority: 42 U.S.C. 1302; 1320a–7; 

1320a–7b; 1395u(j); 1395u(k); 1395w– 

104(e)(6), 1395y(d); 1395y(e); 

1395cc(b)(2)(D), (E), and (F); 1395hh; 

1842(j)(1)(D)(iv), 1842(k)(1), and sec. 2455, 

Pub. L. 103–355, 108 Stat. 3327 (31 U.S.C. 

6101 note). 

2. In § 1001.952, paragraphs 

(h)(5)(viii), (h)(6) through (9), (cc), and 

(dd) are stayed until January 1, 2032. 

Dated: December 26, 2023. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2023–28775 Filed 12–28–23; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Parts 30 and 150 

[Docket No. USCG–2022–0327] 

RIN 1625–AC73 

2022 Liquid Chemical Categorization 

Updates 

Correction 

In rule document 2023–25026, 

appearing on pages 81184 through 

81234 in the issue of Tuesday, 

November 21, 2023, make the following 

corrections: 

§ 30.25–1 Cargoes carried in vessels 

certificated under the rules of this 

subchapter. [Corrrected] 

■ 1. On page 81188, in the second 

column, on the fourth line from the 

bottom, ‘‘(≤75%)’’ should read 

‘‘(>75%)’’. 

■ 2. On the same page, in the same 

column, on the third and second lines 

from the bottom, ‘‘(≤85%)’’ should read 

‘‘(>85%)’’. 

■ 3. On page 81189, in the table, in the 

eighteenth row, ‘‘(≤75%)’’ should read 

‘‘(>75%)’’. 

■ 4. On the same page, in the same 

table, in the nineteenth row, ‘‘(≤85%)’’ 

should read ‘‘(>85%)’’. 

■ 5. On the same page, in the same 

table, following the twenty-fourth row, 


ddrumheller on DSK120RN23PROD with RULES1