Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Rules and Regulations 72013 

1As set forth in a memorandum of understanding 

entered into by the HHS, the Food and Drug 

Administration (FDA), and the National Institute on 

Drug Abuse (NIDA), the FDA acts as the lead agency 

within the HHS in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1995. In 

addition, because the Secretary of the HHS has 

delegated to the Assistant Secretary for Health of 

the HHS the authority to make domestic drug 

scheduling recommendations, for purposes of this 

document, all subsequent references to ‘‘Secretary’’ 

have been replaced with ‘‘Assistant Secretary.’’ 

exercised sufficient operational control 

to carry out the launch or reentry, 

§ 50919(g) would serve as a bar to FAA 

licensing the activity. 

In the scenarios described above, as 

currently under development by launch 

and reentry operators, the NASA 

astronaut would likely not affect the 

flight path of the vehicle during a 

nominal launch. During a launch, the 

astronaut would likely only manipulate 

the flight path of the vehicle if an 

emergency arose. Accordingly, section 

50919(g) would not limit a NASA 

astronaut’s ability to engage in 

operational functions during launch. 

Most of the conduct or operations 

would simply constitute the execution 

of emergency training required of space 

flight participants by § 460.51. 

The analysis for a reentry is similar to 

that of a launch, with some additional 

consideration for the possible manual 

operation of the reentry vehicle by a 

NASA astronaut. Specifically, a NASA 

astronaut could initiate reentry 

manually, but because the scenarios 

have the reentry operator’s flight 

computer directing the reentry, the 

NASA astronaut’s interaction would not 

be sufficient to constitute NASA 

carrying out the reentry. Additionally, 

the NASA astronaut’s exercise of 

manual control over the vehicle in an 

off-nominal situation would also not 

rise to NASA carrying out the reentry 

because, as discussed above, in an offnominal situation, the astronaut would 

largely be implementing procedures 

created by a commercial launch or 

reentry operator for purposes of safety 

or mission success. 

In conclusion, Chapter 509 and the 

FAA’s regulations impose no 

operational constraints on NASA 

astronauts for the scenarios envisioned 

here. 

Issued in Washington, DC, on November 

21, 2013. 

Mark W. Bury, 

Assistant Chief Counsel for International Law, 

Legislation and Regulations. 

[FR Doc. 2013–28405 Filed 11–29–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–374] 

Schedules of Controlled Substances: 

Placement of Perampanel into 

Schedule III 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Deputy Administrator of the 

Drug Enforcement Administration 

(DEA) places the substance perampanel 

[2-(2-oxo-1-phenyl-5-pyridin-2-yl-1,2- 

dihydropyridin-3-yl) benzonitrile], 

including its salts, isomers, and salts of 

isomers, into schedule III of the 

Controlled Substances Act (CSA). This 

scheduling action is pursuant to the 

CSA which requires that such actions be 

made on the record after opportunity for 

a hearing through formal rulemaking. 

This action imposes the regulatory 

controls and administrative, civil, and 

criminal sanctions applicable to 

schedule III controlled substances on 

persons who handle (manufacture, 

distribute, dispense, import, export, 

engage in research, conduct 

instructional activities with, or possess) 

or propose to handle perampanel. 

DATES: Effective Date: January 2, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Ruth A. Carter, Chief, Policy Evaluation 

and Analysis Section, Office of 

Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The DEA implements and enforces 

titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, as amended. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, but they are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purposes of this action. 21 U.S.C. 801– 

971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR) parts 1300 to 1321. 

The CSA and its implementing 

regulations are designed to prevent, 

detect, and eliminate the diversion of 

controlled substances and listed 

chemicals into the illicit market while 

providing for the legitimate medical, 

scientific, research, and industrial needs 

of the United States. Controlled 

substances have the potential for abuse 

and dependence and are controlled to 

protect the public health and safety. 

Under the CSA, controlled substances 

are classified in one of five schedules 

based upon their potential for abuse, 

their currently accepted medical use, 

and the degree of dependence the 

substance may cause. 21 U.S.C. 812. The 

initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c) and the 

current list of scheduled substances is 

published at 21 CFR part 1308. 

Pursuant to 21 U.S.C. 811(a)(1), the 

Attorney General may, by rule, ‘‘add to 

such a schedule or transfer between 

such schedules any drug or other 

substance if he (A) finds that such drug 

or other substance has a potential for 

abuse, and (B) makes with respect to 

such drug or other substance the 

findings prescribed by [21 U.S.C. 812(b)] 

for the schedule in which such drug is 

to be placed. . . .’’ Pursuant to 28 CFR 

0.100(b), the Attorney General has 

delegated this scheduling authority to 

the Administrator of the DEA, who has 

further delegated this authority to the 

Deputy Administrator of the DEA. 28 

CFR 0.104. 

The CSA provides that scheduling of 

any drug or other substance may be 

initiated by the Attorney General (1) on 

his own motion; (2) at the request of the 

Secretary of the Department of Health 

and Human Services (HHS),1 or (3) on 

the petition of any interested party. 21 

U.S.C. 811(a). This action is based on a 

recommendation from the Assistant 

Secretary of the HHS and on an 

evaluation of all other relevant data by 

the DEA. This action imposes the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to schedule III controlled substances on 

persons who handle or propose to 

handle perampanel. 

Background 

Perampanel [2-(2-oxo-1-phenyl-5- 

pyridin-2-yl-1,2-dihydropyridin-3-yl) 

benzonitrile] is a new chemical entity 

with central nervous system (CNS) 


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depressant and hallucinogenic 

properties. On October 22, 2012, the 

Food and Drug Administration (FDA) 

approved a new drug application for 

perampanel as an adjunctive therapy for 

the treatment of partial-onset seizures 

with or without secondarily generalized 

seizures in patients with epilepsy aged 

12 years and older. Perampanel will be 

marketed in the United States under the 

trade name FYCOMPA®. Perampanel is 

a non-competitive AMPA (a-amino-3- 

hydroxy-5-methyl-4-isoxazolepropionic 

acid)-type glutamate receptor 

antagonist. Perampanel was approved in 

Europe in May 2012 and has been 

marketed there since July 2012. 

HHS and DEA Eight-Factor Analyses 

On January 22, 2013, the Assistant 

Secretary of the HHS provided to the 

DEA a scientific and medical evaluation 

and scheduling recommendation 

entitled ‘‘Basis for the Recommendation 

for Control of Perampanel and its Salts 

in Schedule III of the Controlled 

Substances Act.’’ Following 

consideration of the eight factors and 

findings related to the substance’s abuse 

potential, legitimate medical use, and 

dependence liability, the Assistant 

Secretary of the HHS recommended that 

perampanel be controlled in schedule III 

of the CSA under 21 U.S.C. 812(b). In 

response, the DEA conducted its own 

eight-factor analysis of perampanel 

pursuant to 21 U.S.C. 811(c). Electronic 

copies of these documents are available 

at www.regulations.gov for easy 

reference. 

Determination to Schedule Perampanel 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation from the HHS, the 

Deputy Administrator of the DEA 

published in the Federal Register a 

notice of proposed rulemaking (NPRM) 

entitled ‘‘Schedules of Controlled 

Substances: Placement of Perampanel 

into Schedule III’’ on October 22, 2013 

(78 FR 62500), which proposed 

placement of perampanel in schedule III 

of the CSA. The NPRM provided an 

opportunity for interested persons to file 

a request for hearing in accordance with 

DEA regulations on or before November 

21, 2013. No requests for such a hearing 

were received by the DEA. The NPRM 

also provided an opportunity for 

interested persons to submit written 

comments on the proposed rule on or 

before November 21, 2013. 

Comments Received 

The DEA received two comments on 

the proposed rule to schedule 

perampanel. One commenter was in 

favor of controlling perampanel as a 

schedule III controlled substance. 

Another commenter requested that the 

DEA make the rule effective on the same 

date as the publication of the final rule. 

Support for the Proposed Rule: One 

commenter supported controlling 

perampanel as a schedule III controlled 

substance, as opposed to a schedule II 

controlled substance, but expressed 

concern about the unknown effects and 

abuse potential of this new drug at 

higher doses. However, the commenter 

indicated that the controls applicable to 

schedule III controlled substances are 

appropriate until there is more available 

data on perampanel’s effects. 

DEA Response: The DEA appreciates 

the comment in support of this 

rulemaking. 

Request to Change Effective Date: One 

commenter requested that the DEA 

make this rule effective on the same 

date as publication to enable physicians 

and their patients to have access to 

perampanel as soon as possible and 

pointed out that the DEA has included 

an earlier effective date in the final rule 

for other drugs including zopiclone, 

pregablin, and ezogabine. 

DEA Response: The DEA appreciates 

the commenter’s request, but does not 

believe an earlier effective date is 

warranted. As provided in 21 CFR 

1308.45, final orders shall not have an 

effective date of ‘‘less than 30 days from 

the date of publication in the Federal 

Register unless the Administrator finds 

that the conditions of public health or 

safety necessitate an earlier effective 

date . . . .’’ The Administrator finds 

that the conditions of public health or 

safety do not necessitate such an earlier 

effective date in this instance. There are 

other anti-seizure medications currently 

available, specifically lacosamide, an 

anti-epileptic medication that has a 

similar clinical indication to 

perampanel. Though the mechanisms of 

actions of perampanel and lacosamide 

are different, the indications are very 

similar. Like perampanel, lacosamide is 

indicated as an adjunctive therapy for 

the treatment of partial-onset seizures, 

and did not have its 30-day 

implementation period waived. 

Furthermore, the DEA believes that 

providing 30 days for this Final Rule to 

become effective is expeditious and 

sufficient to allow handlers to obtain the 

appropriate registration with the DEA 

and to comply with regulatory 

requirements for handling schedule III 

controlled substances. 

Scheduling Conclusion 

Based on consideration of all 

comments, the scientific and medical 

evaluation and accompanying 

recommendation of the HHS, and based 

on the DEA’s consideration of its own 

eight-factor analysis, the DEA finds that 

these facts and all relevant data 

constitute substantial evidence of 

potential for abuse of perampanel. As 

such, the DEA is scheduling perampanel 

as a controlled substance under the 

CSA. 

Determination of Appropriate Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The statute 

outlines the findings required for 

placing a drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analysis and 

recommendation of the Assistant 

Secretary for Health of the HHS and 

review of all available data, the Deputy 

Administrator of the DEA, pursuant to 

21 U.S.C. 812(b)(3), finds that: 

1. Perampanel has a potential for 

abuse less than the drugs or other 

substances in schedules I and II; 

2. Perampanel has a currently 

accepted medical use in treatment in the 

United States. Perampanel was 

approved for marketing by the FDA as 

an adjunctive treatment of partial-onset 

seizures with or without secondarily 

generalized seizures in patients with 

epilepsy aged 12 years and older; and 

3. Abuse of perampanel may lead to 

moderate or low physical dependence 

or high psychological dependence. 

Based on these findings, the Deputy 

Administrator of the DEA concludes 

that perampanel, including its salts, 

isomers, and salts of isomers, warrants 

control in schedule III of the CSA. 21 

U.S.C. 812(b)(3). 

Requirements for Handling Perampanel 

Upon the effective date of this final 

rule, any person who handles 

perampanel is subject to the CSA’s 

schedule III regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, dispensing, importing, 

exporting, engagement of research, and 

conduct of instructional activities, of 

schedule III controlled substances 

including the following: 

Registration. Any person who handles 

(manufactures, distributes, dispenses, 

imports, exports, engages in research, or 

conducts instructional activities with) 

perampanel, or who desires to handle 

perampanel, must be registered with the 

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 as of January 2, 

2014. Any person who is currently 

engaged in any of the above activities 

and is not registered with the DEA must 


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Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Rules and Regulations 72015 

submit an application for registration 

and may not continue their activities as 

of January 2, 2014 unless the DEA has 

approved that application, pursuant to 

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

in accordance with 21 CFR parts 1301 

and 1312. 

Security. Perampanel is subject to 

schedule III–V security requirements 

and must be handled and stored in 

accordance with 21 CFR 1301.71– 

1301.93, pursuant to 21 U.S.C. 823, 821, 

871(b) as of January 2, 2014. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of perampanel must be in accordance 

with 21 CFR 1302.03–1302.07, pursuant 

to 21 U.S.C. 825, 958(e) as of January 2, 

2014. 

Inventory. Every DEA registrant who 

possesses any quantity of perampanel 

on the effective date of this final rule is 

required to take an inventory of all 

stocks of perampanel on hand as of 

January 2, 2014, pursuant to 21 U.S.C. 

827, 958(e), and in accordance with 21 

CFR 1304.03, 1304.04, and 1304.11(a) 

and (d). Any person who becomes 

registered with the DEA after January 2, 

2014 is required to take an initial 

inventory of all controlled substances 

(including perampanel) on hand at the 

time of registration, pursuant to 21 

U.S.C. 827, 958(e) and in accordance 

with 21 CFR 1304.03, 1304.04, and 

1304.11(a) and (b). After the initial 

inventory, every DEA registrant is 

required to take a biennial inventory of 

all controlled substances (including 

perampanel), on hand pursuant to 21 

U.S.C. 827, 958(e) and in accordance 

with 21 CFR 1304.03, 1304.04 and 

1304.11. 

Records. All DEA registrants must 

keep records with respect to perampanel 

pursuant to 21 U.S.C. 827, 958(e) and in 

accordance with 21 CFR parts 1304, 

1307, and 1312, as of January 2, 2014. 

Prescriptions. All prescriptions for 

perampanel or prescriptions for 

products containing perampanel must 

comply with 21 U.S.C. 829 and must be 

issued in accordance with 21 CFR part 

1306 as of January 2, 2014. 

Importation and Exportation. All 

importation and exportation of 

perampanel must be done in accordance 

with 21 CFR part 1312, pursuant to 21 

U.S.C. 952, 953, 957, and 958 as of 

January 2, 2014. 

Criminal Liability. Any activity 

involving perampanel not authorized 

by, or in violation of, the CSA, occurring 

as of January 2, 2014 is unlawful, and 

may subject the person to 

administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

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

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 the 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 12866 and the 

principles reaffirmed in Executive Order 

13563. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform 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 

This rulemaking does not have 

federalism implications warranting the 

application of Executive Order 13132. 

The rule does not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175 

This rule does not have tribal 

implications warranting the application 

of Executive Order 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 Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601– 

612), has reviewed this rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

The purpose of this rule is to place 

perampanel, including its salts, isomers, 

and salts of isomers, into schedule III of 

the CSA. No less restrictive measures 

(i.e., non-control or control in a lower 

schedule) enable the DEA to meet its 

statutory obligations under the CSA. In 

preparing this certification, the DEA has 

assessed economic impact by size 

category and has considered costs with 

respect to the various DEA registrant 

business activity classes. 

Perampanel is a new molecular entity, 

approved by the FDA on October 22, 

2012. It was approved in Europe in May 

2012, and has been marketed in Europe 

since July 2012. According to publically 

available information reviewed by the 

DEA, perampanel is currently 

anticipated to enjoy patent protection 

for at least a decade before generic 

equivalents may be manufactured and 

marketed. Accordingly, the number of 

currently identifiable manufacturers, 

importers, and distributors for 

perampanel is extremely small. The 

publically available materials also 

specify the readily identifiable persons 

subject to direct regulation by this final 

rule. Based on guidelines utilized by the 

Small Business Administration (SBA), 

the perampanel manufacturer/ 

distributor/importer was determined not 

to be a small entity. Once generic 

equivalents are developed and approved 

for manufacturing and marketing, there 

may be additional manufacturers, 

importers, and distributors of 

perampanel, but whether they may 

qualify as small entities cannot be 

determined at this time. 

There are approximately 1.5 million 

controlled substance registrants, who 

represent approximately 381,000 

entities. The DEA estimates that 371,000 

(97 percent) of these businesses are 

considered ‘‘small entities’’ in 

accordance with the RFA and SBA 

standards. 5 U.S.C. 601(6) and 15 U.S.C. 

632. Due to the wide variety of 

unidentifiable and unquantifiable 

variables that could potentially 

influence the dispensing rates of new 

chemical entities, the DEA is unable to 

determine the number of small entities 

that might dispense (including 

administer and prescribe) perampanel 

(e.g., pharmacies and prescribers). 

Despite the fact that the number of 

small businesses potentially impacted 

by this final rule could not be 

determined at this time, the DEA 

concludes that they would not 

experience a significant economic 

impact as a result of this rule. The DEA 

estimates all anticipated perampanel 

handlers to be DEA registrants and 

currently 98 percent of DEA registrants 

(most of which are small businesses) are 

authorized to handle schedule III 

controlled substances. Even if we 

assume that all of the DEA registrants 

were to dispense perampanel, (e.g., 

practitioners prescribe, administer, or 

dispense the substance, and pharmacies 

dispense the prescriptions), the costs 

that they would incur as a result of 

perampanel scheduling would be 


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72016 Federal Register / Vol. 78, No. 231 / Monday, December 2, 2013 / Rules and Regulations 

minimal. Registrants that dispense (but 

not prescribe) would incur nominal 

additional security, inventory, 

recordkeeping, and labeling costs, as 

they have already established and 

implemented the required systems and 

processes to handle schedule III 

controlled substances. For example, 

pharmacies and institutional 

practitioners may disperse schedule II– 

V controlled substances throughout 

their stock of non-controlled substances 

in such a manner as to obstruct theft or 

diversion of the controlled substances. 

The inclusion of one additional 

substance to this system would result in 

little or no additional burden to such 

practitioners. In addition, because DEAregistered dispensers must label all 

schedule II–V controlled substances 

dispensed, the requirement to label all 

controlled substances containing 

perampanel would not impose a 

significant economic burden upon DEAregistered dispensers (as the 

infrastructure and materials for doing so 

would already be in place). 

Accordingly, compliance would not 

require significant manpower, capital 

investments, or recordkeeping burdens. 

Registrants who only prescribe 

perampanel by oral or written 

prescription would not incur any 

additional security, inventory, 

recordkeeping, or labeling costs as a 

result of this rule, as they would not 

physically handle perampanel. 

Because of these facts, this rule will 

not result in significant economic 

impact on a substantial number of small 

entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995 

(2 U.S.C. 1501 et seq.), on the basis of 

information contained in the 

‘‘Regulatory Flexibility Act’’ section 

above, the DEA has determined and 

certifies pursuant to UMRA 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 for inflation) in any one year 

. . . .’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under provisions of 

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 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act (CRA)). This rule will not 

result in: an annual effect on the 

economy of $100,000,000 or more; a 

major increase in costs or prices for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. However, pursuant to 

the CRA, the DEA has submitted 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. 

For the reasons set out above, 21 CFR 

part 1308 is amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 2. Amend § 1308.13 by redesignating 

paragraphs (c)(11) through (c)(14) as 

paragraphs (c)(12) through (c)(15) and 

adding new paragraph (c)(11) to read as 

follows: 

§ 1308.13 Schedule III. 

* * * * * 

(c) * * * 

(11) Perampanel, and its salts, isomers, and salts of isomers ........... 2261 

* * * * * 

Dated: November 25, 2013. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2013–28778 Filed 11–29–13; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 300 

[TD 9647] 

RIN 1545–BL37 

User Fees for Processing Installment 

Agreements and Offers in Compromise 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains final 

regulations that provide user fees 

charged for processing installment 

agreements and offers in compromise. 

The final regulations affect taxpayers 

who wish to pay their federal tax 

liabilities through installment 

agreements and offers in compromise. 

DATES: Effective date: These regulations 

are effective on December 2, 2013. 

Applicability Date: These regulations 

apply to installment agreements entered 

into, restructured, or reinstated and 

offers in compromise processed on or 

after January 1, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Concerning cost methodology, Eva 

Williams, at (202) 803–9728; concerning 

the regulations, Girish Prasad, at (202) 

317–5429 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

This document contains amendments 

to 26 CFR part 300. On August 30, 2013, 

a notice of proposed rulemaking (REG– 

144990–12) relating to the user fees 

charged for processing installment 

agreements and offers in compromise 

was published in the Federal Register 

(78 FR 53702). The charging of user fees 

for services provided by agencies is 

authorized by the Independent Offices 

Appropriations Act (IOAA), which is 

codified at 31 U.S.C. 9701. Under the 

IOAA and OMB Circular A–25, 58 FR 

38142 (July 15, 1993) (the OMB 

Circular), the charges must be fair and 

must be based on the costs to the 

government, the value of the service to 

the recipient, the public policy or 

interest served, and other relevant facts. 

In general, the amount of a user fee 

should recover the cost of providing the 

service, unless the Office of 

Management and Budget (OMB) grants 

an exception under the OMB Circular. 

The notice of proposed rulemaking 

proposed to increase the fee under 

§ 300.1 for entering into an installment 

agreement from $105 to $120 and to 

increase the fee under § 300.2 for 


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