Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations 51243 

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, 1985. 

The Secretary of the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 

Authority: Secs. 205(a), 221, and 702(a)(5) 

of the Social Security Act (42 U.S.C. 405(a), 

421, and 902(a)(5)). 

■ 2. Amend § 404.1615 by revising 

paragraph (c)(3) to read as follows: 

§ 404.1615 Making disability 

determinations. 

* * * * * 

(c) * * * 

(3) A State agency disability examiner 

alone if the claim is adjudicated under 

the quick disability determination 

process (see § 404.1619) or the 

compassionate allowance process (see 

§ 404.1602), and the initial or 

reconsidered determination is fully 

favorable to you. This paragraph will no 

longer be effective on November 13, 

2015 unless we terminate it earlier or 

extend it beyond that date by 

publication of a final rule in the Federal 

Register; or 

* * * * * 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

Subpart J—[Amended] 

■ 3. The authority citation for subpart J 

continues to read as follows: 

Authority: Secs. 702(a)(5), 1614, 1631, and 

1633 of the Social Security Act (42 U.S.C. 

902(a)(5), 1382c, 1383, and 1383b). 

■ 4. Amend § 416.1015 by revising 

paragraph (c)(3) to read as follows: 

§ 416.1015 Making disability 

determinations. 

* * * * * 

(c) * * * 

(3) A State agency disability examiner 

alone if you are not a child (a person 

who has not attained age 18), and the 

claim is adjudicated under the quick 

disability determination process (see 

§ 416.1019) or the compassionate 

allowance process (see § 416.1002), and 

the initial or reconsidered 

determination is fully favorable to you. 

This paragraph will no longer be 

effective on November 13, 2015 unless 

we terminate it earlier or extend it 

beyond that date by publication of a 

final rule in the Federal Register; or 

* * * * * 

[FR Doc. 2014–20535 Filed 8–27–14; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–381] 

Schedules of Controlled Substances: 

Placement of Suvorexant into 

Schedule IV 

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 [(7R)-4-(5- 

chloro-1,3-benzoxazol-2-yl)-7-methyl1,4-diazepan-1-yl][5-methyl-2-(2H-1,2,3- 

triazol-2-yl)phenyl]methanone 

(suvorexant), including its salts, 

isomers, and salts of isomers, into 

schedule IV of the Controlled 

Substances Act. This scheduling action 

is pursuant to the Controlled Substances 

Act 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 IV controlled substances on 

persons who handle (manufacture, 

distribute, dispense, import, export, 

engage in research, conduct 

instructional activities, or possess), or 

propose to handle suvorexant. 

DATES: Effective Date: September 29, 

2014. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, 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, and are collectively 

referred to as the ‘‘Controlled 

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

purpose 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, each controlled 

substance is classified into one of five 

schedules based upon its potential for 

abuse, its currently accepted medical 

use in treatment in the United States, 

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 all 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 * * *.’’ The Attorney 

General has delegated this authority to 

the Administrator of the DEA, 28 CFR 

0.100, who in turn has redelegated that 

authority to the Deputy Administrator of 

the DEA. 28 CFR part 0, appendix to 

subpart R. 

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 Health and Human Services 

(HHS); 1 or (3) on the petition of any 

interested party. 21 U.S.C. 811(a). This 

action imposes the regulatory controls 

and administrative, civil, and criminal 

sanctions of schedule IV controlled 

substances on persons who handle or 

propose to handle suvorexant. 

Background 

Suvorexant ([(7R)-4-(5-chloro-1,3- 

benzoxazol-2-yl)-7-methyl-1,4-diazepan1-yl][5-methyl-2-(2H-1,2,3-triazol-2- 

yl)phenyl]methanone), also known as 

MK–4305, is a new chemical entity 

developed for the treatment of 

insomnia. Suvorexant is a novel, first in 

class, orexin receptor antagonist with a 

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51244 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations 

2The legislative history of the CSA provides that 

a substance may have a potential for abuse if: ‘‘The 

drug or drugs containing such a substance are new 

drugs so related in their action to a drug or drugs 

already listed as having a potential for abuse to 

make it likely that the drug will have the same 

potentiality for abuse as such drugs, thus making 

it reasonable to assume that there may be significant 

diversions from legitimate channels, significant use 

contrary to or without medical advice, or that it has 

a substantial capability of creating hazards to the 

health of the user or to the safety of the 

community.’’ Comprehensive Drug Abuse 

Prevention and Control Act of 1970, H.R. Rep. No. 

91–1444 (1970); as reprinted in 1970 U.S.C.C.A.N. 

4566, 4601. 

mechanism of action distinct from any 

marketed drug. It acts via inhibition of 

the orexin 1 (OX1) and orexin 2 (OX2) 

receptors. In pharmacological activity 

studies, suvorexant functioned as an 

antagonist as demonstrated by its ability 

to block agonist-induced calcium (Ca2+) 

release. The U.S. Food and Drug 

Administration (FDA) approved the new 

drug application for suvorexant on 

August 13, 2014. 

DEA and HHS Eight Factor Analyses 

On June 27, 2013, the HHS provided 

the DEA with a scientific and medical 

evaluation document prepared by the 

FDA entitled ‘‘Basis for the 

Recommendation to Place Suvorexant in 

Schedule IV of the Controlled 

Substances Act.’’ After considering the 

eight factors in 21 U.S.C. 811(c), 

including consideration of the 

substance’s abuse potential, legitimate 

medical use, and dependence liability, 

the Assistant Secretary of the HHS 

recommended that suvorexant be 

controlled in schedule IV of the CSA 

under 21 U.S.C. 812(b). In response, the 

DEA conducted its own eightfactor 

analysis of suvorexant pursuant to 21 

U.S.C. 811(c). Both the DEA and HHS 

analyses are available in their entirety in 

the public docket for this rule (Docket 

Number DEA–381) at http://

www.regulations.gov under ‘‘Supporting 

and Related Material.’’ 

Determination to Schedule Suvorexant 

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 Suvorexant 

into Schedule IV’’ which proposed 

placement of suvorexant in schedule IV 

of the CSA. 79 FR 8639, Feb. 13, 2014. 

The proposed rule provided an 

opportunity for interested persons to file 

a request for hearing in accordance with 

DEA regulations by March 17, 2014. 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 proposal on or before March 17, 

2014. 

Comments Received 

The DEA received five comments on 

the proposed rule to schedule 

suvorexant. Two commenters supported 

controlling suvorexant as a schedule IV 

controlled substance. One commenter 

opposed the control of suvorexant, one 

commenter did not articulate an official 

position, and one commenter was in 

favor of controlling suvorexant as a 

schedule III controlled substance, rather 

than a schedule IV controlled substance. 

Support for the Proposed Rule 

Two commenters supported 

controlling suvorexant as a schedule IV 

controlled substance. These commenters 

indicated support for controlling 

suvorexant under the CSA based on the 

abuse potential of the substance. The 

commenters noted that controlling 

suvorexant as a schedule IV controlled 

substance is appropriate because it is 

similar to zolpidem (schedule IV), while 

one commenter stated that suvorexant 

produces fewer adverse effects than 

zolpidem. The commenters believe that 

controlling suvorexant as a schedule IV 

controlled substance will provide the 

necessary controls to prevent its 

diversion. 

DEA Response: The DEA appreciates 

the comments in support of this 

rulemaking. 

Opposition to the Proposed Rule 

Two commenters opposed the 

proposal to control suvorexant as a 

schedule IV controlled substance, and 

one commenter did not articulate an 

official position but expressed concern 

about the side effects of suvorexant. 

Request Not To Control Suvorexant 

One commenter opposed controlling 

suvorexant because they believed that 

there was a lack of strong scientific 

evidence that suvorexant has been 

abused, and the comparison of 

suvorexant with zolpidem (schedule IV) 

is incorrect due to each compound 

eliciting its effects via different 

mechanisms of action. The commenter 

was also concerned that controlling 

suvorexant will make it more difficult 

for patients to obtain the substance once 

it is approved by the FDA. 

DEA Response: The DEA does not 

agree. Suvorexant is a novel, first in 

class, new chemical substance and 

information on actual abuse data is not 

currently available. The legislative 

history of the CSA addresses the 

assessment of a new drug’s potential for 

abuse,2 and data from clinical studies 

investigating the abuse potential for 

suvorexant suggests that its effect is 

similar to zolpidem (schedule IV). 

Similarly, while the mechanism of 

action for suvorexant is distinct from 

any currently marketed drug for 

insomnia, human abuse potential 

studies demonstrated that suvorexant 

produced effects that were 

indistinguishable from zolpidem 

(schedule IV). 

Burdens associated with acquiring a 

substance as a result of control under 

the CSA are not relevant factors to the 

determination whether a substance 

should be controlled or under what 

schedule a substance should be placed 

if it is controlled. See 21 U.S.C. 811 and 

812. Nonetheless, the DEA disagrees 

with the unsupported statement that 

making suvorexant a controlled 

substance will make it difficult for 

ultimate users to legally acquire the 

substance once it is approved by the 

FDA. If a DEA-registered practitioner 

lawfully prescribes suvorexant to treat a 

medical condition, it may be dispensed 

on the basis of an oral or written 

prescription. 21 CFR 1306.04(a), 

1306.21. 

Request To Control Suvorexant as a 

Schedule III Substance 

One commenter had multiple 

concerns regarding the placement of 

suvorexant in schedule IV. The 

commenter believed that further studies 

on minimal levels of effective 

suvorexant doses should be conducted 

to reduce the risks of driving accidents. 

The commenter also expressed concern 

about the FDA’s statement that while 

effective, suvorexant is unsafe at various 

doses. This commenter believed that 

due to lack of conclusive findings, 

suvorexant should be categorized as a 

schedule III controlled substance for 

‘‘safety and precautionary purposes’’ 

since it is a novel, first in class, new 

substance. 

Another commenter, who did not 

articulate a specific position, expressed 

concern that the side effects produced 

by suvorexant were similar to the effects 

of sleep deprivation, including cognitive 

and psychomotor impairment. 

DEA Response: The concerns about 

the limited research on minimal levels 

of effective suvorexant doses and the 

side effects of suvorexant and sleep 

deprivation, along with the statement 

that suvorexant is unsafe at various 

doses, are outside the scope of the 

DEA’s scheduling authority. As part of 

the new drug approval process, the HHS 

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Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations 51245 

provides scientific and medical 

evaluations of a drug or other substance 

to ensure that it is safe and effective for 

its intended use. This process is 

completely separate from the DEA’s 

proceedings to control such drug or 

other substance. 21 U.S.C. 811. 

The DEA does not agree that 

suvorexant should be controlled as a 

schedule III controlled substance. 

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 * * *.’’ This scheduling 

action was initiated when the DEA 

received a scientific and medical 

evaluation and a scheduling 

recommendation to control suvorexant 

as a schedule IV controlled substance 

from the Assistant Secretary of the HHS. 

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

DEA conducted its own analysis of the 

eight factors determinative of control or 

removal: (1) Its actual or relative 

potential for abuse; (2) scientific 

evidence of its pharmacological effect, if 

known; (3) the state of current scientific 

knowledge regarding the drug or other 

substance; (4) its history and current 

pattern of abuse; (5) the scope, duration, 

and significant of abuse; (6) what, if any, 

risk there is to the public health; (7) its 

psychic or physiological dependence 

liability; and (8) whether the substance 

is an immediate precursor of a 

substance already controlled. The 

summary of each factor as analyzed by 

the DEA and the HHS, and as 

considered by the DEA in this 

scheduling action, was provided in the 

proposed rule. Both the DEA and the 

HHS analyses have been made available 

in their entirety under ‘‘Supporting and 

Related Material’’ of the public docket 

for this rule at http://

www.regulations.gov under Docket 

Number DEA–381. 

There is evidence that suvorexant has 

a potential for abuse comparable to 

zolpidem (schedule IV), and like 

zolpidem, suvorexant has a low 

potential for abuse relative to the drugs 

or other substances in schedule III. 

Suvorexant was compared to zolpidem 

in human studies of recreational 

sedative users to measure its abuse 

potential relative to that of a sedativehypnotic in schedule IV. The abuse 

potential of suvorexant (40, 80 and 150 

mg) relative to zolpidem (15 and 30 mg) 

and placebo was evaluated via a visual 

analog scale VAS, with results 

demonstrating that the effects of 

suvorexant were statistically 

indistinguishable from zolpidem. The 

results of the human abuse potential 

study suggest that suvorexant and 

zolpidem produce similar reinforcing 

effects and have a similar potential for 

abuse. In addition, preclinical studies 

demonstrated that suvorexant (10, 20, 

30 and 60 mg/kg) dose dependently 

reduced locomotor activity in rats, 

similar to other sedative drugs including 

zolpidem (schedule IV). Based on the 

review of the HHS evaluation and 

scheduling recommendation and all 

other relevant data, the DEA found that 

suvorexant has an abuse potential 

similar to other schedule IV drugs, 

including zolpidem (schedule IV). 

Scheduling Conclusion 

Based on consideration of all 

comments, the scientific and medical 

evaluation and accompanying 

recommendation of the HHS, and the 

DEA’s consideration of its own eightfactor analysis, the DEA finds that these 

facts and all other relevant data 

constitute substantial evidence of 

potential for abuse of suvorexant. As 

such, the DEA is scheduling suvorexant 

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 CSA 

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)(4), finds that: 

(1) [(7R)-4-(5-chloro-1,3-benzoxazol-2- 

yl)-7-methyl-1,4-diazepan-1-yl][5- 

methyl-2-(2H–1,2,3-triazol-2- 

yl)phenyl]methanone (suvorexant) has a 

low potential for abuse relative to the 

drugs or other substances in schedule 

III. The overall abuse potential of 

suvorexant is comparable to the 

schedule IV controlled substance 

zolpidem; 

(2) [(7R)-4-(5-chloro-1,3-benzoxazol-2- 

yl)-7-methyl-1,4-diazepan-1-yl][5- 

methyl-2-(2H–1,2,3-triazol-2- 

yl)phenyl]methanone (suvorexant) has a 

currently accepted medical use in 

treatment in the United States. 

Suvorexant was approved for marketing 

by FDA as a treatment for insomnia; and 

(3) Abuse of [(7R)-4-(5-chloro-1,3- 

benzoxazol-2-yl)-7-methyl-1,4-diazepan1-yl][5-methyl-2-(2H–1,2,3-triazol-2- 

yl)phenyl]methanone (suvorexant) may 

lead to limited physical dependence or 

psychological dependence relative to 

the drugs or other substances in 

schedule III. The potential for 

psychological dependence is similar to 

that of zolpidem (schedule IV). 

Based on these findings, the Deputy 

Administrator of the DEA concludes 

that suvorexant, including its salts, 

isomers, and salts of isomers, warrants 

control in schedule IV of the CSA. 21 

U.S.C. 812(b)(4). 

Requirements for Handling Suvorexant 

Upon the effective date of this final 

rule, any person who handles 

suvorexant is subject to the CSA’s 

schedule IV regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, dispensing, importing, 

exporting, engagement in research, and 

conduct of instructional activities, of 

schedule IV controlled substances 

including the following: 

Registration. Any person who handles 

(manufactures, distributes, dispenses, 

imports, exports, engages in research, or 

conducts instructional activities with) 

suvorexant, or who desires to handle 

suvorexant, 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 September 29, 

2014. Any person who currently 

handles suvorexant and is not registered 

with the DEA must submit an 

application for registration and may not 

continue to handle suvorexant as of 

September 29, 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. Suvorexant is subject to 

schedule III–V security requirements 

and must be handled and stored 

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

871(b) and in accordance with 21 CFR 

1301.71–1301.93, as of September 29, 

2014. 

Labeling and Packaging. All labels, 

labeling, and packaging for commercial 

containers of suvorexant must comply 

with 21 U.S.C. 825 and 958(e) and be in 

accordance with 21 CFR part 1302, as of 

September 29, 2014. 

Inventory. Every DEA registrant who 

possesses any quantity of suvorexant on 

the effective date of this final rule must 

take an inventory of all stocks of 

suvorexant on hand as of September 29, 

2014, pursuant to 21 U.S.C. 827 and 

958, 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 September 29, 2014 

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51246 Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations 

must take an initial inventory of all 

stocks of controlled substances 

(including suvorexant) on hand on the 

date the registrant first engages in the 

handling of controlled substances, 

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

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11(a) and (b). 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all stocks of controlled substances 

(including suvorexant) on hand every 

two years, pursuant to 21 U.S.C. 827 

and 958, and in accordance with 21 CFR 

1304.03, 1304.04, and 1304.11. 

Records. All DEA registrants must 

maintain records with respect to 

suvorexant pursuant to 21 U.S.C. 827 

and 958, and in accordance with 21 CFR 

parts 1304, 1307, and 1312, as of 

September 29, 2014. 

Prescriptions. All prescriptions for 

suvorexant or products containing 

suvorexant must comply with 21 U.S.C. 

829, and be issued in accordance with 

21 CFR part 1306 and subpart C of 21 

CFR part 1311 as of September 29, 2014. 

Importation and Exportation. All 

importation and exportation of 

suvorexant must be in compliance with 

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

be in accordance with 21 CFR part 1312 

as of September 29, 2014. 

Liability. Any activity involving 

suvorexant not authorized by, or in 

violation of, the CSA, occurring as of 

September 29, 2014 is unlawful, and 

may subject the person to 

administrative, civil, and/or criminal 

proceedings. 

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 done ‘‘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 criteria for 

scheduling a drug or other substance. 

Such actions are exempt from review by 

the Office of Management and Budget 

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. The rule 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 final 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 final rule is to place 

suvorexant, including its salts, isomers, 

and salts of isomers, into schedule IV of 

the CSA. No less restrictive measures 

(i.e., non-control, or control in schedule 

V) 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. 

Suvorexant is a new molecular entity 

which has not yet been marketed in the 

United States or any other country. 

Accordingly, the number of currently 

identifiable manufacturers, importers, 

and distributors for suvorexant is 

extremely small. The publicly 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 

suvorexant manufacturer/distributor/

importer was determined not to be a 

small entity. Once generic equivalents 

of suvorexant are developed and 

approved for manufacturing and 

marketing, there may be additional 

manufacturers, importers, and 

distributors of suvorexant, but whether 

they may qualify as small entities 

cannot be determined at this time. 

There are approximately 1.5 million 

controlled substance registrations that 

represent approximately 381,000 

entities (which include businesses, 

organizations, and governmental 

jurisdictions). The DEA estimates that 

371,000 (97%) of these entities are 

considered ‘‘small entities’’ in 

accordance with the RFA and SBA size 

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

632. Due to the wide variety of 

unidentifiable and unquantifiable 

variables that potentially could 

influence the dispensing rates of new 

molecular entities, the DEA is unable to 

determine what number of these 

371,000 small entities might handle 

suvorexant. 

Despite the fact that the number of 

small entities possibly impacted by this 

rule could not be determined, the DEA 

concludes that they would not 

experience a significant economic 

impact as a result of this final rule. The 

DEA estimates all anticipated 

suvorexant handlers to be DEA 

registrants and currently 98% of DEA 

registrants (most of which are small 

entities) are authorized to handle 

schedule IV controlled substances. 

Registrants that handle suvorexant are 

expected to incur nominal additional 

security, inventory, and recordkeeping 

costs. These registered entities are likely 

to have already established and 

implemented the systems and processes 

required to handle schedule IV 

controlled substances and can easily 

absorb the costs of handling suvorexant 

with nominal to no additional economic 

burden. For example, because DEA– 

registered pharmacies and institutional 

practitioners are likely to already be 

schedule IV handlers, they may secure 

schedule II–V controlled substances by 

dispersing such substances throughout 

the stock of noncontrolled substances in 

such a manner as to obstruct the theft 

or diversion of the controlled 

substances. Additionally, because other 

DEA registrants who will handle 

suvorexant are likely to already be 

schedule IV handlers, they already 

should have existing secure storage 

areas for schedule II–V controlled 

substances, which we assume would be 

able to accommodate any new stocks of 

suvorexant. See 21 CFR 1301.75(b), 

1301.72(b). Accordingly, the 

requirement to secure all controlled 

substances containing suvorexant would 

not impose a significant economic 

burden upon DEA-registered 

practitioners as the infrastructure and 

materials for doing so are already in 

place. The DEA therefore assumes that 

the cost of compliance with 21 CFR 

1301.71–1301.77 as a result of this final 

rule is nominal. 

Correspondingly, because DEAregistered manufacturers, distributors, 

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Federal Register / Vol. 79, No. 167 / Thursday, August 28, 2014 / Rules and Regulations 51247 

and importers must label and package 

all schedule II–V controlled substances 

in accordance with 21 CFR part 1302, 

the requirement to label and package all 

controlled substances containing 

suvorexant in accordance with 21 CFR 

part 1302 would not impose a 

significant economic burden upon DEAregistered manufacturers, distributors, 

and importers as the infrastructure and 

materials for doing so would already be 

in place. Accordingly, compliance with 

21 CFR part 1302 would not require 

significant additional manpower, capital 

investment, or recordkeeping burdens. 

Because of these facts, this final rule 

will not result in a 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.), 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 foreignbased 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, the DEA 

amends 21 CFR part 1308 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 § 1308.14 by redesignating 

paragraphs (c)(49) through (c)(54) as 

(c)(50) through (c)(55) and adding new 

paragraph (c)(49) to read as follows: 

§ 1308.14 Schedule IV. 

* * * * * 

(c) * * * 

(49) Suvorexant 2223 

* * * * * 

Dated: August 21, 2014. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2014–20515 Filed 8–27–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF STATE 

22 CFR Part 22 

[Public Notice: 8850] 

RIN 1400–AD47 

Schedule of Fees for Consular 

Services, Department of State and 

Overseas Embassies and 

Consulates—Visa and Citizenship 

Services Fee Changes 

AGENCY: Department of State. 

ACTION: Interim final rule. 

SUMMARY: The Department of State 

amends the Schedule of Fees for 

Consular Services (Schedule) for certain 

nonimmigrant visa application 

processing fees, certain immigrant visa 

application processing and special visa 

services fees, and certain citizenship 

services fees. More specifically, the rule 

amends the application processing fees 

for two categories of petition-based 

nonimmigrant visas and the tiered 

application processing fees for 

immigrant visas. The rule also amends 

the security surcharge for immigrant 

visa services and the fees for certain 

immigrant visa services. Lastly, the rule 

raises the application processing fee for 

renunciation of U.S. citizenship and 

lowers the hourly consular officer time 

charge. The Department of State is 

adjusting the fees in light of the findings 

of a recent Cost of Service study to 

ensure that the fees for consular services 

better align with the costs of providing 

those services. 

DATES: This interim final rule becomes 

effective September 6, 2014. Written 

comments must be received on or before 

October 21, 2014. 

ADDRESSES: Interested parties may 

submit comments to the Department by 

any of the following methods: 

• Visit the Regulations.gov Web site 

at: http://www.regulations.gov and 

search the RIN 1400–AD47or docket 

number DOS–2014–0016. 

• Mail (paper, disk, or CD–ROM): U.S. 

Department of State, Office of the 

Comptroller, Bureau of Consular Affairs 

(CA/C), SA–17 8th Floor, Washington, 

DC 20522–1707. 

• E-Mail: fees@state.gov. You must 

include the RIN (1400–AD47) in the 

subject line of your message. 

• All comments should include the 

commenter’s name, the organization the 

commenter represents, if applicable, 

and the commenter’s address. If the 

Department is unable to read your 

comment for any reason, and cannot 

contact you for clarification, the 

Department may not be able to consider 

your comment. After the conclusion of 

the comment period, the Department 

will publish a Final Rule (in which it 

will address relevant comments) as 

expeditiously as possible. 

FOR FURTHER INFORMATION CONTACT: 

Celeste Scott, Special Assistant, Office 

of the Comptroller, Bureau of Consular 

Affairs, Department of State; phone: 

202–485–6681, telefax: 202–485–6826; 

Email: fees@state.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The interim final rule makes changes 

to the Schedule of Fees for Consular 

Services of the Department of State’s 

Bureau of Consular Affairs. The 

Department sets and collects its fees 

based on the concept of full cost 

recovery. The Department completed its 

most recent review of current consular 

fees and will implement several changes 

to the Schedule of Fees based on the 

new fees calculated by the Cost of 

Service Model (CoSM). Please note that 

certain ‘‘no fee’’ consular services are 

included in the Schedule of Fees so that 

members of the public will be aware of 

significant consular services provided 

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