Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Rules and Regulations 469 

1Though DEA has used the term ‘‘final order’’ 

with respect to temporary scheduling orders in the 

past, this document adheres to the statutory 

language of 21 U.S.C. 811(h), which refers to a 

‘‘temporary scheduling order.’’ No substantive 

change is intended. 

2As discussed in a memorandum of 

understanding entered into by 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. 58 FR 35460, July 1, 1993. 

List of Subjects in 18 CFR Part 381 

Electric power plants, Electric 

utilities, Natural gas, reporting and 

recordkeeping requirements. 

Anton C. Porter, 

Executive Director. 

In consideration of the foregoing, the 

Commission amends Part 381, Chapter I, 

Title 18, Code of Federal Regulations, as 

set forth below. 

PART 381—FEES 

■ 1. The authority citation for Part 381 

continues to read as follows: 

Authority: 15 U.S.C. 717–717w; 16 U.S.C. 

791–828c, 2601–2645; 31 U.S.C. 9701; 42 

U.S.C. 7101–7352; 49 U.S.C. 60502; 49 App. 

U.S.C. 1–85. 

§ 381.302 [Amended] 

■ 2. In 381.302, paragraph (a) is 

amended by removing ‘‘$25,640’’ and 

adding ‘‘$27,130’’ in its place. 

§ 381.303 [Amended] 

■ 3. In 381.303, paragraph (a) is 

amended by removing ‘‘$37,430’’ and 

adding ‘‘$39,610’’ in its place. 

§ 381.304 [Amended] 

■ 4. In 381.304, paragraph (a) is 

amended by removing ‘‘$19,630’’ and 

adding ‘‘$20,770’’ in its place. 

§ 381.305 [Amended] 

■ 5. In 381.305, paragraph (a) is 

amended by removing ‘‘$7,350’’ and 

adding ‘‘$7,780’’ in its place. 

§ 381.403 [Amended] 

■ 6. Section 381.403 is amended by 

removing ‘‘$12,760’’ and adding 

‘‘$13,500’’ in its place. 

§ 381.505 [Amended] 

■ 7. In 381.505, paragraph (a) is 

amended by removing ‘‘$22,050’’ and 

adding ‘‘$23,330’’ in its place and by 

removing ‘‘$24,960’’ and adding 

‘‘$26,410’’ in its place. 

[FR Doc. 2017–28466 Filed 1–3–18; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–474] 

Schedules of Controlled Substances: 

Temporary Placement of Cyclopropyl 

Fentanyl in Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Temporary amendment; 

temporary scheduling order. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this temporary scheduling order to 

schedule the synthetic opioid, N-(1- 

phenethylpiperidin-4-yl)-Nphenylcyclopropanecarboxamide 

(cyclopropyl fentanyl), and its isomers, 

esters, ethers, salts, and salts of isomers, 

esters, and ethers in schedule I. This 

action is based on a finding by the 

Administrator that the placement of 

cyclopropyl fentanyl in schedule I of the 

Controlled Substances Act is necessary 

to avoid an imminent hazard to the 

public safety. As a result of this order, 

the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to schedule I 

controlled substances will be imposed 

on persons who handle (manufacture, 

distribute, reverse distribute, import, 

export, engage in research, conduct 

instructional activities or chemical 

analysis, or possess), or propose to 

handle, cyclopropyl fentanyl. 

DATES: This temporary scheduling order 

is effective January 4, 2018, until 

January 4, 2020. If this order is extended 

or made permanent, the DEA will 

publish a document in the Federal 

Register. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Lewis, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

Section 201 of the Controlled 

Substances Act (CSA), 21 U.S.C. 811, 

provides the Attorney General with the 

authority to temporarily place a 

substance in schedule I of the CSA for 

two years without regard to the 

requirements of 21 U.S.C. 811(b) if he 

finds that such action is necessary to 

avoid an imminent hazard to the public 

safety. 21 U.S.C. 811(h)(1). In addition, 

if proceedings to control a substance are 

initiated under 21 U.S.C. 811(a)(1), the 

Attorney General may extend the 

temporary scheduling 1 for up to one 

year. 21 U.S.C. 811(h)(2). 

Where the necessary findings are 

made, a substance may be temporarily 

scheduled if it is not listed in any other 

schedule under section 202 of the CSA, 

21 U.S.C. 812, or if there is no 

exemption or approval in effect for the 

substance under section 505 of the 

Federal Food, Drug, and Cosmetic Act 

(FDCA), 21 U.S.C. 355. 21 U.S.C. 

811(h)(1). The Attorney General has 

delegated scheduling authority under 21 

U.S.C. 811 to the Administrator of the 

DEA. 28 CFR 0.100. 

Background 

Section 201(h)(4) of the CSA, 21 

U.S.C. 811(h)(4), requires the 

Administrator to notify the Secretary of 

the Department of Health and Human 

Services (HHS) of his intention to 

temporarily place a substance in 

schedule I of the CSA.2 The 

Administrator transmitted notice of his 

intent to place cyclopropyl fentanyl in 

schedule I on a temporary basis to the 

Assistant Secretary for Health of HHS by 

letter dated August 28, 2017. The 

Assistant Secretary responded by letter 

dated September 6, 2017, and advised 

that based on review by the Food and 

Drug Administration (FDA), there are 

currently no investigational new drug 

applications or approved new drug 

applications for cyclopropyl fentanyl. 

The Assistant Secretary also stated that 

the HHS has no objection to the 

temporary placement of cyclopropyl 

fentanyl in schedule I of the CSA. The 

DEA has taken into consideration the 

Assistant Secretary’s comments as 

required by 21 U.S.C. 811(h)(4). 

Cyclopropyl fentanyl is not currently 

listed in any schedule under the CSA, 

and no exemptions or approvals are in 

effect for cyclopropyl fentanyl under 

section 505 of the FDCA, 21 U.S.C. 355. 

The DEA has found that the control of 

cyclopropyl fentanyl in schedule I on a 

temporary basis is necessary to avoid an 

imminent hazard to the public safety, 

and as required by 21 U.S.C. 

811(h)(1)(A), a notice of intent to 

temporarily schedule cyclopropyl 

fentanyl was published in the Federal 

Register on November 21, 2017. 82 FR 

55333. 

To find that placing a substance 

temporarily in schedule I of the CSA is 

necessary to avoid an imminent hazard 

to the public safety, the Administrator is 

required to consider three of the eight 

factors set forth in section 201(c) of the 

CSA, 21 U.S.C. 811(c): The substance’s 


rmajette on DSKBCKNHB2PROD with RULES
470 Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Rules and Regulations 

3 Data are still being collected for May 2017– 

August 2017 due to the normal lag period for labs 

reporting to NFLIS. 

4Email from Philadelphia Police DepartmentOffice of Forensic Science, to DEA (August 18, 2017 

11:09 a.m.) (on file with DEA). 

5Laboratory report obtained from Division of 

Forensic Science, Georgia Bureau of Investigation. 

history and current pattern of abuse; the 

scope, duration and significance of 

abuse; and what, if any, risk there is to 

the public health. 21 U.S.C. 811(h)(3). 

Consideration of these factors includes 

actual abuse, diversion from legitimate 

channels, and clandestine importation, 

manufacture, or distribution. 21 U.S.C. 

811(h)(3). 

A substance meeting the statutory 

requirements for temporary scheduling 

may only be placed in schedule I. 21 

U.S.C. 811(h)(1). Substances in schedule 

I are those that have a high potential for 

abuse, no currently accepted medical 

use in treatment in the United States, 

and a lack of accepted safety for use 

under medical supervision. 21 U.S.C. 

812(b)(1). 

Available data and information for 

cyclopropyl fentanyl, summarized 

below, indicate that this synthetic 

opioid has a high potential for abuse, no 

currently accepted medical use in 

treatment in the United States, and a 

lack of accepted safety for use under 

medical supervision. The DEA’s threefactor analysis and the Assistant 

Secretary’s September 6, 2017 letter are 

available in their entirety under the tab 

‘‘Supporting Documents’’ of the public 

docket of this action at 

www.regulations.gov under FDMS 

Docket ID: DEA–2017–0005 (Docket 

Number DEA–474). 

Factor 4. History and Current Pattern of 

Abuse 

The recreational abuse of fentanyl-like 

substances continues to be a significant 

concern. These substances are 

distributed to users, often with 

unpredictable outcomes. Cyclopropyl 

fentanyl has been encountered by law 

enforcement and public health officials 

beginning as early as May 2017. The 

DEA is not aware of any laboratory 

identifications of this substance prior to 

2017. Adverse health effects and 

outcomes of cyclopropyl fentanyl abuse 

are consistent with those of other 

opioids and are demonstrated by fatal 

overdose cases involving this substance. 

On October 1, 2014, the DEA 

implemented STARLiMS (a web-based, 

commercial laboratory information 

management system) to replace the 

System to Retrieve Information from 

Drug Evidence (STRIDE) as its 

laboratory drug evidence data system of 

record. DEA laboratory data submitted 

after September 30, 2014, are reposited 

in STARLiMS. Data from STRIDE and 

STARLiMS were queried on August 25, 

2017. STARLiMS registered a total of 

three reports containing cyclopropyl 

fentanyl from California, Connecticut, 

and New York. Of these three exhibits, 

one had a net weight of approximately 

one kilogram. According to STARLiMS, 

the first laboratory submission of 

cyclopropyl fentanyl occurred in 

Connecticut in June 2017. 

The National Forensic Laboratory 

Information System (NFLIS) is a 

national drug forensic laboratory 

reporting system that systematically 

collects results from drug chemistry 

analyses conducted by other federal, 

state and local forensic laboratories 

across the country. NFLIS registered 10 

reports containing cyclopropyl fentanyl 

from state or local forensic laboratories 

in Oklahoma in July 2017 (query date: 

August 29, 2017).3

In addition to data recorded in NFLIS 

and STARLiMS, cyclopropyl fentanyl 

was identified in drug evidence 

submitted to state and local forensic 

laboratories in Georgia and 

Pennsylvania. Cyclopropyl fentanyl was 

confirmed in combination with U– 

47700, another synthetic opioid 

temporarily controlled in schedule I of 

the CSA, in 24 glassine paper packets 

submitted to a law enforcement forensic 

laboratory in Pennsylvania.4 A law 

enforcement forensic laboratory in 

Georgia confirmed 5 the presence of 

cyclopropyl fentanyl in counterfeit 

oxycodone tablets which also contained 

U–47700. The distribution of 

cyclopropyl fentanyl in these forms, and 

in combination with another synthetic 

opioid, suggests that this substance was 

marketed as heroin or prescription 

opioids in the illicit market. 

Evidence suggests that the pattern of 

abuse of fentanyl analogues, including 

cyclopropyl fentanyl, parallels that of 

heroin and prescription opioid 

analgesics. Seizures of cyclopropyl 

fentanyl have been encountered in 

powder form, similar to fentanyl and 

heroin, and in counterfeit prescription 

opioid analgesics (i.e. counterfeit 

oxycodone tablets). Cyclopropyl 

fentanyl was also confirmed in 

toxicology samples from fatal overdose 

cases. 

Factor 5. Scope, Duration and 

Significance of Abuse 

Reports collected by the DEA 

demonstrate that cyclopropyl fentanyl is 

being abused for its opioid effects. 

Abuse of cyclopropyl fentanyl has 

resulted in mortality (see DEA 3-Factor 

Analysis for full discussion). The DEA 

collected post-mortem toxicology and 

medical examiner reports on 115 

confirmed fatalities associated with 

cyclopropyl fentanyl which occurred in 

Georgia (1), Maryland (24), Mississippi 

(1), North Carolina (75), and Wisconsin 

(14). It is likely that the prevalence of 

this substance in opioid related 

emergency room admissions and deaths 

is underreported as standard 

immunoassays may not differentiate this 

fentanyl analogue from fentanyl. 

NFLIS and STARLiMS have a total of 

13 drug reports in which cyclopropyl 

fentanyl was identified in drug exhibits 

submitted to forensic laboratories in 

2017 from law enforcement encounters 

in California, Connecticut, New York, 

and Oklahoma. In addition to the data 

collected in these databases, 

cyclopropyl fentanyl was identified in 

drug evidence submitted to forensic 

laboratories in Georgia (counterfeit 

oxycodone preparation) and 

Pennsylvania (24 glassine paper 

packets). 

The population likely to abuse 

cyclopropyl fentanyl overlaps with the 

population abusing prescription opioid 

analgesics, heroin, fentanyl and other 

fentanyl-related substances. This is 

supported by cyclopropyl fentanyl being 

identified in powder contained within 

glassine paper packets and counterfeit 

prescription opioid products. This is 

also demonstrated by routes of drug 

administration and drug use history 

documented in cyclopropyl fentanyl 

fatal overdose cases. Because abusers of 

cyclopropyl fentanyl obtain this 

substance through unregulated sources, 

the identity, purity, and quantity are 

uncertain and inconsistent, thus posing 

significant adverse health risks to the 

end user. Individuals who initiate (i.e. 

use a drug for the first time) cyclopropyl 

fentanyl abuse are likely to be at risk of 

developing substance use disorder, 

overdose, and death similar to that of 

other opioid analgesics (e.g., fentanyl, 

morphine, etc.). 

Factor 6. What, if Any, Risk There Is to 

the Public Health 

With no legitimate medical use, 

cyclopropyl fentanyl has emerged on 

the illicit drug market and is being 

misused and abused for its opioid 

properties. Cyclopropyl fentanyl 

exhibits pharmacological profiles 

similar to that of fentanyl and other mopioid receptor agonists. The abuse of 

cyclopropyl fentanyl poses significant 

adverse health risks when compared to 

abuse of pharmaceutical preparations of 

opioid analgesics, such as morphine and 

oxycodone. The toxic effects of 

cyclopropyl fentanyl in humans are 

demonstrated by overdose fatalities 

involving this substance. 


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Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Rules and Regulations 471 

Based on information received by the 

DEA, the misuse and abuse of 

cyclopropyl fentanyl lead to, at least, 

the same qualitative public health risks 

as heroin, fentanyl, and other opioid 

analgesic substances. As with any nonmedically approved opioid agonist, the 

health and safety risks for users are 

high. The public health risks attendant 

to the abuse of heroin and opioid 

analgesics are well established and have 

resulted in large numbers of drug 

treatment admissions, emergency 

department visits, and fatal overdoses. 

Cyclopropyl fentanyl has been 

associated with numerous fatalities. At 

least 115 confirmed overdose deaths 

involving cyclopropyl fentanyl abuse 

have been reported from Georgia (1), 

Maryland (24), Mississippi (1), North 

Carolina (75), and Wisconsin (14) in 

2017. As the data demonstrate, the 

potential for fatal and non-fatal 

overdoses exists for cyclopropyl 

fentanyl and this substance poses an 

imminent hazard to the public safety. 

Finding of Necessity of Schedule I 

Placement To Avoid Imminent Hazard 

to Public Safety 

In accordance with 21 U.S.C. 

811(h)(3), based on the available data 

and information, summarized above, the 

continued uncontrolled manufacture, 

distribution, reverse distribution, 

importation, exportation, conduct of 

research and chemical analysis, 

possession, and abuse of cyclopropyl 

fentanyl pose an imminent hazard to the 

public safety. The DEA is not aware of 

any currently accepted medical uses for 

cyclopropyl fentanyl in the United 

States. A substance meeting the 

statutory requirements for temporary 

scheduling, 21 U.S.C. 811(h)(1), may 

only be placed in schedule I. Substances 

in schedule I are those that have a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. Available data and 

information for cyclopropyl fentanyl 

indicate that this substance has a high 

potential for abuse, no currently 

accepted medical use in treatment in the 

United States, and a lack of accepted 

safety for use under medical 

supervision. As required by section 

201(h)(4) of the CSA, 21 U.S.C. 

811(h)(4), the Administrator, by letter 

dated August 28, 2017, notified the 

Assistant Secretary of the DEA’s 

intention to temporarily place this 

substance in schedule I. A notice of 

intent was subsequently published in 

the Federal Register on November 21, 

2017. 82 FR 55333. 

Conclusion 

In accordance with the provisions of 

section 201(h) of the CSA, 21 U.S.C. 

811(h), the Administrator considered 

available data and information, and 

herein sets forth the grounds for his 

determination that it is necessary to 

temporarily schedule cyclopropyl 

fentanyl in schedule I of the CSA to 

avoid an imminent hazard to the public 

safety. 

Because the Administrator hereby 

finds it necessary to temporarily place 

this synthetic opioid in schedule I to 

avoid an imminent hazard to the public 

safety, this temporary order scheduling 

cyclopropyl fentanyl is effective on the 

date of publication in the Federal 

Register, and is in effect for a period of 

two years, with a possible extension of 

one additional year, pending 

completion of the regular (permanent) 

scheduling process. 21 U.S.C. 811(h)(1) 

and (2). 

The CSA sets forth specific criteria for 

scheduling a drug or other substance. 

Permanent scheduling actions in 

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

subject to formal rulemaking procedures 

done ‘‘on the record after opportunity 

for a hearing’’ conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557. 

21 U.S.C. 811. The permanent 

scheduling process of formal 

rulemaking affords interested parties 

with appropriate process and the 

government with any additional 

relevant information needed to make a 

determination. Final decisions that 

conclude the permanent scheduling 

process of formal rulemaking are subject 

to judicial review. 21 U.S.C. 877. 

Temporary scheduling orders are not 

subject to judicial review. 21 U.S.C. 

811(h)(6). 

Requirements for Handling 

Upon the effective date of this 

temporary order, cyclopropyl fentanyl 

will be subject to the regulatory controls 

and administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

importation, exportation, engagement in 

research, and conduct of instructional 

activities or chemical analysis with, and 

possession of schedule I controlled 

substances including the following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

reverse distributes, imports, exports, 

engages in research, or conducts 

instructional activities or chemical 

analysis with, or possesses), or who 

desires to handle, cyclopropyl fentanyl 

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 4, 2018. Any person 

who currently handles cyclopropyl 

fentanyl, and is not registered with the 

DEA, must submit an application for 

registration and may not continue to 

handle cyclopropyl fentanyl as of 

January 4, 2018, unless the DEA has 

approved that application for 

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

823, 957, 958, and in accordance with 

21 CFR parts 1301 and 1312. Retail sales 

of schedule I controlled substances to 

the general public are not allowed under 

the CSA. Possession of any quantity of 

this substance in a manner not 

authorized by the CSA on or after 

January 4, 2018 is unlawful and those in 

possession of any quantity of this 

substance may be subject to prosecution 

pursuant to the CSA. 

2. Disposal of stocks. Any person who 

does not desire or is not able to obtain 

a schedule I registration to handle 

cyclopropyl fentanyl must surrender all 

currently held quantities of cyclopropyl 

fentanyl. 

3. Security. Cyclopropyl fentanyl is 

subject to schedule I security 

requirements and must be handled and 

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

871(b), and in accordance with 21 CFR 

1301.71–1301.93, as of January 4, 2018. 

4. Labeling and packaging. All labels, 

labeling, and packaging for commercial 

containers of cyclopropyl fentanyl must 

be in compliance with 21 U.S.C. 825, 

958(e), and be in accordance with 21 

CFR part 1302. Current DEA registrants 

shall have 30 calendar days from 

January 4, 2018, to comply with all 

labeling and packaging requirements. 

5. Inventory. Every DEA registrant 

who possesses any quantity of 

cyclopropyl fentanyl on the effective 

date of this order must take an inventory 

of all stocks of this substance on hand, 

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

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. Current DEA 

registrants shall have 30 calendar days 

from the effective date of this order to 

be in compliance with all inventory 

requirements. After the initial 

inventory, every DEA registrant must 

take an inventory of all controlled 

substances (including cyclopropyl 

fentanyl) on hand on a biennial basis, 

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

in accordance with 21 CFR 1304.03, 

1304.04, and 1304.11. 

6. Records. All DEA registrants must 

maintain records with respect to 

cyclopropyl fentanyl pursuant to 21 

U.S.C. 827 and 958, and in accordance 

with 21 CFR parts 1304, 1312, 1317, and 

§ 1307.11. Current DEA registrants shall 

have 30 calendar days from the effective 


rmajette on DSKBCKNHB2PROD with RULES
472 Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Rules and Regulations 

date of this order to be in compliance 

with all recordkeeping requirements. 

7. Reports. All DEA registrants who 

manufacture or distribute cyclopropyl 

fentanyl must submit reports pursuant 

to 21 U.S.C. 827 and in accordance with 

21 CFR parts 1304 and 1312 as of 

January 4, 2018. 

8. Order Forms. All DEA registrants 

who distribute cyclopropyl fentanyl 

must comply with order form 

requirements pursuant to 21 U.S.C. 828 

and in accordance with 21 CFR part 

1305 as of January 4, 2018. 

9. Importation and Exportation. All 

importation and exportation of 

cyclopropyl fentanyl must be in 

compliance with 21 U.S.C. 952, 953, 

957, 958, and in accordance with 21 

CFR part 1312 as of January 4, 2018. 

10. Quota. Only DEA registered 

manufacturers may manufacture 

cyclopropyl fentanyl in accordance with 

a quota assigned pursuant to 21 U.S.C. 

826 and in accordance with 21 CFR part 

1303 as of January 4, 2018. 

11. Liability. Any activity involving 

cyclopropyl fentanyl not authorized by, 

or in violation of, the CSA, occurring as 

of January 4, 2018, is unlawful, and may 

subject the person to administrative, 

civil, and/or criminal sanctions. 

Regulatory Matters 

Section 201(h) of the CSA, 21 U.S.C. 

811(h), provides for a temporary 

scheduling action where such action is 

necessary to avoid an imminent hazard 

to the public safety. As provided in this 

subsection, the Attorney General may, 

by order, schedule a substance in 

schedule I on a temporary basis. Such 

an order may not be issued before the 

expiration of 30 days from (1) the 

publication of a notice in the Federal 

Register of the intention to issue such 

order and the grounds upon which such 

order is to be issued, and (2) the date 

that notice of the proposed temporary 

scheduling order is transmitted to the 

Assistant Secretary. 21 U.S.C. 811(h)(1). 

Inasmuch as section 201(h) of the 

CSA directs that temporary scheduling 

actions be issued by order and sets forth 

the procedures by which such orders are 

to be issued, the DEA believes that the 

notice and comment requirements of the 

Administrative Procedure Act (APA) at 

5 U.S.C. 553, do not apply to this 

temporary scheduling action. In the 

alternative, even assuming that this 

action might be subject to 5 U.S.C. 553, 

the Administrator finds that there is 

good cause to forgo the notice and 

comment requirements of 5 U.S.C. 553, 

as any further delays in the process for 

issuance of temporary scheduling orders 

would be contrary to the public interest 

in view of the manifest urgency to avoid 

an imminent hazard to the public safety. 

Further, the DEA believes that this 

temporary scheduling action is not a 

‘‘rule’’ as defined by 5 U.S.C. 601(2), 

and, accordingly, is not subject to the 

requirements of the Regulatory 

Flexibility Act. The requirements for the 

preparation of an initial regulatory 

flexibility analysis in 5 U.S.C. 603(a) are 

not applicable where, as here, the DEA 

is not required by the APA or any other 

law to publish a general notice of 

proposed rulemaking. 

Additionally, this action is not a 

significant regulatory action as defined 

by Executive Order 12866 (Regulatory 

Planning and Review), section 3(f), and, 

accordingly, this action has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This action will 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. Therefore, in 

accordance with Executive Order 13132 

(Federalism) it is determined that this 

action does not have sufficient 

federalism implications to warrant the 

preparation of a Federalism Assessment. 

As noted above, this action is an 

order, not a rule. Accordingly, the 

Congressional Review Act (CRA) is 

inapplicable, as it applies only to rules. 

However, if this were a rule, pursuant 

to the Congressional Review Act, ‘‘any 

rule for which an agency for good cause 

finds that notice and public procedure 

thereon are impracticable, unnecessary, 

or contrary to the public interest, shall 

take effect at such time as the federal 

agency promulgating the rule 

determines.’’ 5 U.S.C. 808(2). It is in the 

public interest to schedule this 

substance immediately to avoid an 

imminent hazard to the public safety. 

This temporary scheduling action is 

taken pursuant to 21 U.S.C. 811(h), 

which is specifically designed to enable 

the DEA to act in an expeditious manner 

to avoid an imminent hazard to the 

public safety. 21 U.S.C. 811(h) exempts 

the temporary scheduling order from 

standard notice and comment 

rulemaking procedures to ensure that 

the process moves swiftly. For the same 

reasons that underlie 21 U.S.C. 811(h), 

that is, the DEA’s need to move quickly 

to place this substance in schedule I 

because it poses an imminent hazard to 

the public safety, it would be contrary 

to the public interest to delay 

implementation of the temporary 

scheduling order. Therefore, this order 

shall take effect immediately upon its 

publication. The DEA has submitted a 

copy of this temporary order to both 

Houses of Congress and to the 

Comptroller General, although such 

filing is not required under the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act), 5 U.S.C. 801–808 because, 

as noted above, this action is an order, 

not a rule. 

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 part 1308 

continues to read as follows: 

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

956(b), unless otherwise noted. 

■ 2. In § 1308.11, add paragraph (h)(22) 

to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(22) N-(1-phenethylpiperidin-4-yl)-Nphenylcyclopropanecarboxamide, its 

isomers, esters, ethers, salts and salts of 

isomers, esters and ethers (Other name: 

cyclopropyl fentanyl)........... .(9845) 

Dated: December 28, 2017. 

Robert W. Patterson, 

Acting Administrator. 

[FR Doc. 2017–28470 Filed 1–3–18; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Chapter I 

[Docket ID FEMA–2016–0022] 

Revisions to the Public Assistance 

Program and Policy Guide 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notification of availability. 

SUMMARY: This document provides 

notice of the availability of the final 

policy Public Assistance Program and 

Policy Guide (PAPPG). 

DATES: FEMA applies the revisions in 

this policy to incidents declared on or 

after August 23, 2017, or to any 

application for assistance that, as of 

January 1, 2018 is pending before 


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