29506 Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Rules and Regulations 

26Regulations Implementing the National 

Environmental Policy Act of 1969, Order No. 486, 

52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs. 

¶ 30,783 (1987) (cross-referenced at 41 FERC 

¶ 61,284). 27See 18 CFR 380.4(a)(2)(ii) and (a)(5). 28 5 U.S.C. 601–612. 29 5 U.S.C. 605(b). 30Order No. 849, 164 FERC ¶ 61,031 at P 296. 31 In Order No. 849, the Commission determined 

3.9% of the total potential NGA respondents and 

5.1% of the total NGPA section 311 and Hinshaw 

pipelines could be considered a small entity. 

Eliminating the filing requirement would eliminate 

any burden and cost from FERC–501G for small and 

large entities. 32 5 U.S.C. 553(b). 

for any action that may have a 

significant adverse effect on the human 

environment.26 The actions taken here 

fall within categorical exclusions in the 

Commission’s regulations for rules 

regarding information gathering, 

analysis, and dissemination.27

Therefore, an environmental review is 

unnecessary and has not been prepared 

in this rulemaking. 

C. Regulatory Flexibility Act 

14. The Regulatory Flexibility Act of 

1980 (RFA) 28 generally requires a 

description and analysis of final rules 

that will have significant economic 

impact on a substantial number of small 

entities. The RFA mandates 

consideration of regulatory alternatives 

that accomplish the stated objectives of 

a rulemaking while minimizing any 

significant economic impact on a 

substantial number of small entities. In 

lieu of preparing a regulatory flexibility 

analysis, an agency may certify that a 

final rule will not have a significant 

economic impact on a substantial 

number of small entities.29 In Order No. 

849, the Commission found that the 

institution of the new regulations would 

not have a significant impact on a 

substantial number of small entities.30

Most of the natural gas pipelines 

regulated by the Commission do not fall 

within the RFA’s definition of a small 

entity.31 For the same reasons, removing 

these regulations will not have a 

significant impact on a substantial 

number of small entities. 

D. Document Availability 

15. In addition to publishing the full 

text of this document in the Federal 

Register, the Commission provides all 

interested persons an opportunity to 

view and/or print the contents of this 

document via the internet through the 

Commission’s Home Page (http://

www.ferc.gov). At this time, the 

Commission has suspended access to 

the Commission’s Public Reference 

Room due to the President’s March 13, 

2020 proclamation declaring a National 

Emergency concerning the Novel 

Coronavirus Disease (COVID–19). 

16. From the Commission’s Home 

Page on the internet, this information is 

available on eLibrary. The full text of 

this document is available on eLibrary 

in PDF and Microsoft Word format for 

viewing, printing, and/or downloading. 

To access this document in eLibrary, 

type the docket number excluding the 

last three digits of this document in the 

docket number field. 

17. User assistance is available for 

eLibrary and the Commission’s website 

during normal business hours from 

FERC Online Support at 202–502–6652 

(toll free at 1–866–208–3676) or email at 

ferconlinesupport@ferc.gov, or the 

Public Reference Room at (202) 502– 

8371, TTY (202) 502–8659. Email the 

Public Reference Room at 

public.referenceroom@ferc.gov. 

E. Effective Date and Congressional 

Notification 

18. These regulations are effective 

August 2, 2021. This rule does not alter 

the substantive rights or interests of any 

interested persons, and it merely 

removes certain outdated and 

nonessential natural gas regulations 

from the Commission’s body of 

regulations on a prospective basis. 

Therefore, prior notice and comment 

under section 4 of the Administrative 

Procedure Act (APA) 32 are unnecessary. 

The Commission has determined that 

this rule is not a ‘‘major rule’’ as defined 

in section 351 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996. 

List of Subjects 

18 CFR Part 154 

Natural gas, Pipelines, Reporting and 

recordkeeping requirements. 

18 CFR Part 260 

Natural gas, Reporting and 

recordkeeping requirements. 

18 CFR Part 284 

Continental shelf, Natural gas, 

Reporting and recordkeeping 

requirements. 

By the Commission. 

Issued: May 20, 2021. 

Kimberly D. Bose, 

Secretary. 

In consideration of the foregoing, the 

Commission amends parts 154, 260, & 

284, chapter I, title 18, Code of Federal 

Regulations, as follows: 

PART 154—RATE SCHEDULES AND 

TARIFFS 

■ 1. The authority citation for part 154 

continues to read as follows: 

Authority: 15 U.S.C. 717–717w; 31 U.S.C. 

9701; 42 U.S.C. 7102–7352. 

§ 154.404 [Removed] 

■ 2. Remove § 154.404. 

PART 260—STATEMENTS AND 

REPORTS (SCHEDULES) 

■ 3. The authority citation for part 260 

continues to read as follows: 

Authority: 15 U.S.C. 717–717w, 3301– 

3432; 42 U.S.C. 7101–7352. 

§ 260.402 [Removed] 

■ 4. Remove § 260.402. 

PART 284—CERTAIN SALES AND 

TRANSPORTATION OF NATURAL GAS 

UNDER THE NATURAL GAS POLICY 

ACT OF 1978 AND RELATED 

AUTHORITIES 

■ 5. The authority citation for part 284 

continues to read as follows: 

Authority: 15 U.S.C. 717–717z, 3301– 

3432; 42 U.S.C. 7101–7352; 43 U.S.C. 1331– 

1356. 

§ 284.123 [Amended] 

■ 6. In § 284.123, remove paragraph (i). 

[FR Doc. 2021–11353 Filed 6–1–21; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–658] 

Schedules of Controlled Substances: 

Placement of Remimazolam in 

Schedule IV 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: This final rule adopts, 

without change, an interim final rule 

with request for comments published in 

the Federal Register on October 6, 2020, 

placing the substance remimazolam, 

including its salts, isomers, and salts of 

isomers whenever the existence of such 

salts, isomers, and salts of isomers is 

possible, in schedule IV of the 

Controlled Substances Act. With the 

issuance of this final rule, DEA 

maintains remimazolam, including its 

salts, isomers, and salts of isomers 

whenever the existence of such salts, 


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Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Rules and Regulations 29507 

1The Department of Health and Human Services 

also referred to the substance by these chemical 

names in its April 2020 scientific and medical 

evaluation and scheduling recommendation. 

2Basis for the Recommendation to Control 

Remimazolam and Its Salts in Schedule IV of the 

Controlled Substances Act. Department of Health 

and Human Services. April 15, 2020. Received by 

DEA on July 10, 2020. 

isomers, and salts of isomers is possible, 

in schedule IV of the Controlled 

Substances Act. 

DATES: The effective date of this 

rulemaking is July 2, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Terrence L. Boos, Drug and Chemical 

Evaluation Section, Diversion Control 

Division, Drug Enforcement 

Administration; Telephone: 571–776– 

2265. 

SUPPLEMENTARY INFORMATION: 

Background and Legal Authority 

On October 6, 2020, the Drug 

Enforcement Administration (DEA), 

pursuant to 21 U.S.C. 811(j), published 

an interim final rule (IFR) [85 FR 63014] 

to make remimazolam (including its 

salts, isomers, and salts of isomers 

whenever the existence of such salts, 

isomers, and salts of isomers is 

possible), a schedule IV controlled 

substance(s). See 21 CFR 1308.14(c)(51) 

(DEA Controlled Substance Code 2846). 

Over time, alternative chemical names 

have been used to describe this same 

specific substance. In the preamble to 

the IFR, DEA provided ‘‘4Himidazol[1,2-a][1,4]benzodiazepine-4- 

propionic acid, 8-bromo-1-methyl-6-(2- 

pyridinyl)-(4S)-methyl ester, 

benzenesulfonate (1:1) and also, methyl 

3-[(4S)-8-bromo-1-methyl-6-pyridin-2- 

yl-4H-imidazo[1,2-a][1,4]benzodiazepin4yl]propanoate benzenesulfonic acid’’ 1

as the chemical names of remimazolam, 

which refer to the benzenesulfonic acid 

salt of remimazolam. Since DEA 

controlled remimazolam and its salts, 

isomers, and salts of isomers in 

schedule IV by publication of the IFR, 

DEA believes it is more appropriate to 

include chemical names consistent with 

the free base of this substance, namely 

‘‘4H-imidazol[1,2- 

a][1,4]benzodiazepine-4-propionic acid, 

8-bromo-1-methyl-6-(2-pyridinyl)-(4S)- 

methyl ester and methyl 3-[(4S)-8- 

bromo-1-methyl-6-pyridin-2-yl-4Himidazo[1,2-a][1,4]benzodiazepin4yl]propanoate’’ in the preamble of this 

final rule. It bears emphasis that the 

chemical that is the subject of this final 

rule is the same substance that was the 

subject of the IFR. DEA simply is using 

alternative chemical descriptions to 

refer to that same substance in this 

preamble. 

Remimazolam is a new molecular 

entity with central nervous system 

depressant properties, and the Food and 

Drug Administration (FDA), in July 

2020, approved the use of BYFAVO 

(Remimazolam) as an intravenous 

medication for the induction and 

maintenance of procedural sedation in 

adults undergoing procedures lasting 30 

minutes or less. The IFR to schedule 

remimazolam provided opportunity for 

interested persons to submit comments, 

as well as file a request for hearing or 

waiver of hearing, on or before 

November 5, 2020. DEA did not receive 

any requests for hearing or waiver of 

hearing. 

Comments Received 

In response to the IFR, DEA received 

three comments, from one individual 

and two anonymous sources. One 

commenter supported schedule IV 

placement; the second commenter 

suggested placement in schedule III 

instead; and the third commenter 

expressed views on a non-DEA 

rulemaking. DEA will not summarize or 

respond to this last comment as it was 

outside the scope of this rulemaking. 

Schedule IV Placement 

An anonymous commenter briefly 

expressed that schedule IV was the 

appropriate schedule for remimazolam 

based on the data from clinical trials 

conducted, limited side effects, and its 

better performance as compared to 

similar substances such as midazolam. 

DEA Response: DEA determined in 

the IFR, and re-affirms in this final rule, 

that remimazolam meets the criteria 

under 21 U.S.C. 812(b)(4) for schedule 

IV control. As described by the 

Department of Health and Human 

Services (HHS),2 and in DEA’s August 

2020 eight-factor analysis, remimazolam 

demonstrated abuse potential similar to 

midazolam, a schedule IV depressant. 

DEA appreciates the support for this 

rulemaking. 

Schedule III Placement 

One individual commenter expressed 

concerns with DEA’s placement of 

remimazolam in schedule IV and 

instead suggested placing remimazolam 

in schedule III. The commenter briefly 

discussed the pharmacology of 

remimazolam and noted that both HHS 

and DEA stated the abuse potential and 

public health risk of remimazolam is 

similar to schedule IV benzodiazepines. 

However, the commenter stated that 

remimazolam induced ‘‘positive 

euphoria related responses in [a] human 

abuse potential study leading to 

dependence to relative drugs in 

schedule III’’ and recommended 

classifying remimazolam as schedule III 

‘‘due to FDA placing a black box 

warning label on benzodiazepines and 

the numerous studies illustrating [the 

abuse and misuse of benzodiazepines] 

within the public communities.’’ The 

commenter noted that schedule III 

provided more restrictions and could 

protect the public from harm. The 

individual summarized four reference 

articles related to the historic medical 

use and abuse of prescription 

benzodiazepines, diversion and 

trafficking of licit and illicit 

benzodiazepines, and the serious 

adverse effects that may occur with 

misuse and abuse of benzodiazepines, 

including an increase in 

benzodiazepine-related deaths. Further, 

the commenter believed that the opioid 

epidemic has overshadowed the 

benzodiazepines misuse and abuse, but 

suggested that benzodiazepines and 

opioids are working ‘‘in tandem 

wreaking havoc in the lives of many’’ 

and that ‘‘creating a strong foundation 

through classification of drugs can place 

precedent in ensuring the health and 

safety of American citizens.’’ 

DEA Response: DEA considered the 

commenter’s position; however, does 

find placement in schedule IV to be 

appropriate for remimazolam. As 

discussed briefly in the background and 

legal authority section above, and in 

more detail in the IFR [85 FR 63014, 

63015–63016], FDA approved the New 

Drug Application (NDA) for BYFAVO 

(remimazolam), and HHS provided DEA 

with a scientific and medical evaluation 

and a scheduling recommendation for 

control of remimazolam in schedule IV. 

Pursuant to 21 U.S.C. 811(j), the 

scheduling recommendation by HHS 

and FDA approval of the NDA 

necessitated DEA’s review and its own 

determination for the scheduling action 

(to first issue the IFR and subsequently 

to issue this final rule) in accordance 

with 21 U.S.C. 811(b). DEA considered 

HHS’ scientific and medical evaluation 

and scheduling recommendation, and 

all other relevant data and concurred 

with HHS’ recommendation that 

remimazolam has low potential of abuse 

relative to substances in schedule III 

and therefore supported—and continues 

to support through this final rule— 

placement of remimazolam in schedule 

IV. DEA notes that under 21 U.S.C. 

811(b), HHS’s recommendation shall be 

binding on the Administrator of DEA (as 

delegated by the Attorney General) as to 

any scientific or medical considerations 

involved in three of the eight factors 

specified in 21 U.S.C. 811(c) (i.e., factors 

pertaining to the substance’s actual or 

relative potential for abuse, its history 


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and current pattern of abuse, and the 

scope, duration, and significance of 

abuse). Regarding the commenter’s 

public safety concerns with 

remimazolam’s placement in schedule 

IV, there is still significant oversight for 

schedule IV drugs. For both the IFR and 

this final rule, DEA made the findings 

required under 21 U.S.C. 812(b)(4) for 

the placement of remimazolam in 

schedule IV. 

Requirements for Handling 

Remimazolam 

As indicated above, remimazolam has 

been a schedule IV controlled substance 

by virtue of an IFR issued by DEA in 

October 2020. Thus, this final rule does 

not alter the regulatory requirements 

applicable to handlers of remimazolam 

that have been in place since that time. 

Nonetheless, for informational 

purposes, we restate here those 

requirements. Remimazolam is subject 

to the Controlled Substances Act’s 

(CSA) schedule IV regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

dispensing, importing, exporting, 

research, and conduct of instructional 

activities and chemical analysis with, 

and possession involving schedule IV 

substances, including, but not limited 

to, the following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, dispenses, imports, 

exports, engages in research, or 

conducts instructional activities or 

chemical analysis with, or possesses) 

remimazolam, or who desires to handle 

remimazolam, must be registered with 

DEA to conduct such activities pursuant 

to 21 U.S.C. 822, 823, 957, and 958 and 

in accordance with 21 CFR parts 1301 

and 1312. Any person who intends to 

handle remimazolam, and is not 

registered with DEA, must submit an 

application for registration and may not 

continue to handle remimazolam unless 

DEA has approved that application for 

registration, pursuant to 21 U.S.C. 822, 

823, 957, and 958, and in accordance 

with 21 CFR parts 1301 and 1312. These 

registration requirements, however, are 

not applicable to patients (end users) 

who possess remimazolam pursuant to 

a lawful prescription. 

2. Disposal of stocks. Any person who 

does not desire or is not able to 

maintain a schedule IV registration must 

surrender all quantities of currently 

held remimazolam or may transfer all 

quantities of remimazolam to a person 

registered with DEA in accordance with 

21 CFR part 1317, in additional to all 

other applicable Federal, State, local, 

and tribal laws. 

3. Security. Remimazolam is subject 

to schedule III–V security requirements 

for DEA registrants and it must be 

handled and stored in accordance with 

21 CFR 1301.71–1301.77. Nonpractitioners handling remimazolam 

must also comply with the employee 

screening requirements of 21 CFR 

1301.90–1301.93. 

4. Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of remimazolam must 

comply with 21 U.S.C. 825 and 958(e), 

and be in accordance with 21 CFR part 

1302. 

5. Inventory. Since October 6, 2020, 

every DEA registrant who possesses any 

quantity of remimazolam must take an 

inventory of remimazolam on hand, 

pursuant to 21 U.S.C. 827 and 958, and 

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

6. Records and Reports. DEA 

registrants must maintain records and 

submit reports for remimazolam, 

pursuant to 21 U.S.C. 827, 832(a), and 

958(e), and in accordance with 21 CFR 

1301.74(b) and (c) and parts 1304, 1312, 

and 1317. 

7. Prescriptions. All prescriptions for 

remimazolam, or products containing 

remimazolam, must comply with 21 

U.S.C. 829, and be issued in accordance 

with 21 CFR parts 1306 and 1311, 

subpart C. 

8. Manufacturing and Distributing. In 

addition to the general requirements of 

the CSA and DEA regulations that are 

applicable to manufacturers and 

distributors of schedule IV controlled 

substances, such registrants should be 

advised that (consistent with the 

foregoing considerations) any 

manufacturing or distribution of 

remimazolam may only be for the 

legitimate purposes consistent with the 

drug’s labeling, or for research activities 

authorized by the Federal Food, Drug, 

and Cosmetic Act and the CSA. 

9. Importation and Exportation. All 

importation and exportation of 

remimazolam must be in compliance 

with 21 U.S.C. 952, 953, 957, and 958, 

and in accordance with 21 CFR part 

1312. 

10. Liability. Any activity involving 

remimazolam not authorized by, or in 

violation of, the CSA or its 

implementing regulations, is unlawful, 

and may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Administrative Procedure Act 

This final rule, without change, 

affirms the amendment made by the IFR 

that is already in effect. Section 553 of 

the Administrative Procedure Act (APA) 

(5 U.S.C. 553) generally requires notice 

and comment for rulemakings. 

However, 21 U.S.C. 811(j) provides that 

in cases where a certain new drug is (1) 

approved by HHS and (2) HHS 

recommends control in CSA schedule 

II–V, DEA shall issue an IFR scheduling 

the drug within 90 days. Additionally, 

subsection (j) specifies that the 

rulemaking shall become immediately 

effective as an IFR without requiring 

DEA to demonstrate good cause. DEA 

issued an IFR on October 6, 2020, and 

solicited public comments on that rule. 

Subsection (j) further provides that after 

giving interested persons the 

opportunity to comment and to request 

a hearing, the Attorney General, as 

delegated to the Administrator of DEA, 

shall issue a final rule in accordance 

with the scheduling criteria of 21 U.S.C. 

811(b) through (d) and 812(b). DEA is 

now responding to the comments 

submitted by the public and issuing the 

final rule in accordance with subsection 

(j). 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

In accordance with 21 U.S.C. 811(a) 

and (j), this scheduling action is subject 

to formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth procedures and criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

(OMB) pursuant to section 3(d)(1) of 

Executive Order (E.O.) 12866 and the 

principles reaffirmed in E.O. 13563. 

Executive Order 12988, Civil Justice 

Reform 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of E.O. 12988 to eliminate 

drafting errors and ambiguity, minimize 

litigation, provide a clear legal standard 

for affected conduct, and promote 

simplification and burden reduction. 

Executive Order 13132, Federalism 

This rulemaking does not have 

federalism implications warranting the 

application of E.O. 13132. The rule does 

not have substantial direct effects 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. 


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Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This rule does not have tribal 

implications warranting the application 

of E.O. 13175. It does not have 

substantial direct effects on one or more 

Indian tribes, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) applies to rules that 

are subject to notice and comment 

under section 553(b) of the APA. As 

noted in the above discussion regarding 

the applicability of the APA, DEA was 

not required to publish a general notice 

of proposed rulemaking. Consequently, 

the RFA does not apply. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined that this action would not 

result in any Federal mandate that may 

result ‘‘in the expenditure by State, 

local, and tribal governments, in the 

aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any 1 year.’’ 

Therefore, neither a Small Government 

Agency Plan nor any other action is 

required under UMRA of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995. 44 U.S.C. 3501–3521. This action 

would not impose recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

Congressional Review Act (CRA) 

This rule is not a major rule as 

defined by the CRA, 5 U.S.C. 804. 

However, pursuant to the CRA, DEA is 

submitting a copy of this final rule to 

both Houses of Congress and to the 

Comptroller General. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ Accordingly, the IFR amending 21 

CFR part 1308, which published on 

October 6, 2020 (85 FR 63014), is 

adopted as final without change. 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–11512 Filed 6–1–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Parts 723, 724, 845, and 846 

[Docket ID: OSM 2021–001; S1D1S 

SS08011000 SX064A000 212S180110; 

S2D2S SS08011000 SX064A00 21XS501520] 

RIN 1029–AC79 

Civil Monetary Penalty Inflation 

Adjustments 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Final rule. 

SUMMARY: Pursuant to the Federal Civil 

Penalties Inflation Adjustment Act 

Improvements Act of 2015 (2015 Act), 

which further amended the Federal 

Civil Penalties Inflation Adjustment Act 

of 1990 (1990 Act), and Office of 

Management and Budget (OMB) 

guidance, this rule adjusts for inflation 

the level of civil monetary penalties 

assessed under the Surface Mining 

Control and Reclamation Act of 1977 

(SMCRA). 

DATES: Effective June 2, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen G. Vello, Office of Surface 

Mining Reclamation and Enforcement, 

1849 C Street NW, Mail Stop 4558, 

Washington, DC 20240; Telephone (202) 

208–1908. Email: kvello@osmre.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. The Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 

B. Calculation of Adjustments 

C. Effect of the Rule in Federal Program 

States and on Indian Lands 

D. Effect of the Rule on Approved State 

Programs 

II. Procedural Matters 

A. Regulatory Planning and Review 

(Executive Orders 12866 and 13563) 

B. Regulatory Flexibility Act 

C. Small Business Regulatory Enforcement 

Fairness Act 

D. Unfunded Mandates Reform Act 

E. Takings (Executive Order 12630) 

F. Federalism (Executive Order 13132) 

G. Civil Justice Reform (Executive Order 

12988) 

H. Consultation With Indian Tribes 

(Executive Order 13175 and 

Departmental Policy) 

I. Paperwork Reduction Act 

J. National Environmental Policy Act 

K. Effects on Energy Supply, Distribution, 

and Use (Executive Order 13211) 

L. Clarity of This Regulation 

M. Data Quality Act 

N. Administrative Procedure Act 

I. Background 

A. The Federal Civil Penalties Inflation 

Adjustment Act Improvements Act of 

2015 

Section 518 of SMCRA, 30 U.S.C. 

1268, authorizes the Secretary of the 

Interior to assess civil monetary 

penalties (CMPs) for violations of 

SMCRA. The Office of Surface Mining 

Reclamation and Enforcement’s 

(OSMRE) regulations implementing the 

CMP provisions of section 518 are 

located in 30 CFR parts 723, 724, 845, 

and 846. We are adjusting CMPs in six 

sections—30 CFR 723.14, 723.15, 

724.14, 845.14, 845.15, and 846.14. 

On November 2, 2015, the President 

signed the Federal Civil Penalties 

Inflation Adjustment Act Improvements 

Act of 2015 (Sec. 701 of Pub. L. 114–74) 

(2015 Act) into law. The 2015 Act, 

which further amended the Federal 

Civil Penalties Inflation Adjustment Act 

of 1990 (codified as amended at 28 

U.S.C. 2461 note), requires Federal 

agencies to promulgate rules to adjust 

the level of CMPs to account for 

inflation. The 2015 Act required an 

initial ‘‘catch-up’’ adjustment. OSMRE 

published the initial adjustment in the 

Federal Register on July 8, 2016 (81 FR 

44535), and the adjustment took effect 

on August 1, 2016. The 2015 Act also 

requires agencies to publish annual 

inflation adjustments in the Federal 

Register no later than January 15 of each 

year. These adjustments are aimed at 

maintaining the deterrent effect of civil 

penalties and furthering the policy goals 

of the statutes that authorize the 

penalties. Further, the 2015 Act 

provides that agencies must adjust civil 

monetary penalties ‘‘notwithstanding 

section 553 of [the Administrative 

Procedure Act (APA)].’’ Therefore, ‘‘the 

public procedure the APA generally 

requires—notice, an opportunity for 

comment, and a delay in effective 

date—is not required for agencies to 

issue regulations implementing the 

annual adjustment.’’ December 23, 2020, 

Memorandum for the Heads of 

Executive Departments and Agencies 

(M–21–10) from Russell T. Vought, 


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