49504 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations 

21See, e.g., Idaho Power Co., 132 FERC ¶ 62,001 

(2010) (10-year extension of the license term due to 

the costs of replacing the project’s existing 

powerhouse and increasing generating capacity); 

PPL Holtwood, LLC, 129 FERC ¶ 62,092 (2009) (16- 

year extension of license term due to costs 

associated with the constructing a new powerhouse, 

installing two turbine generating units at the 

existing powerhouse, and various environmental 

measures). 

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. 

years, must justify such requests, for 

example by proposing development, 

environmental, and recreation 

enhancements in a license amendment 

application accompanied by a request 

that the Commission extend their 

license term.21

III. Document Availability 

21. In addition to publishing the full 

text of this document in the Federal 

Register, the Commission provides all 

interested persons an opportunity to 

view and/or print the contents of this 

document via the Internet through 

FERC’s Home Page (http://

www.ferc.gov) and in FERC’s Public 

Reference Room during normal business 

hours (8:30 a.m. to 5:00 p.m. Eastern 

time) at 888 First Street NE., Room 2A, 

Washington, DC 20426. 

22. From FERC’s Home Page on the 

Internet, this information is available on 

eLibrary. The full text of this document 

is available on eLibrary in PDF and 

Microsoft Word format for viewing, 

printing, and/or downloading. To access 

this document in eLibrary, type the 

docket number excluding the last three 

digits of this document in the docket 

number field. User assistance is 

available for eLibrary and the 

Commission’s Web site during normal 

business hours from FERC Online 

Support at 202–502–6652 (toll free at 

1–866–208–3676) or email at 

ferconlinesupport@ferc.gov, or the 

Public Reference Room at (202) 502– 

8371, TTY (202)502–8659. Email the 

Public Reference Room at 

public.referenceroom@ferc.gov. 

By the Commission. 

Issued: October 19, 2017. 

Nathaniel J. Davis, Sr., 

Deputy Secretary. 

[FR Doc. 2017–23286 Filed 10–25–17; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–473] 

Schedules of Controlled Substances: 

Temporary Placement of orthoFluorofentanyl, Tetrahydrofuranyl 

Fentanyl, and Methoxyacetyl Fentanyl 

Into 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 opioids, N-(2- 

fluorophenyl)-N-(1-phenethylpiperidin4-yl)propionamide (ortho-fluorofentanyl 

or 2-fluorofentanyl), N-(1- 

phenethylpiperidin-4-yl)-Nphenyltetrahydrofuran-2-carboxamide 

(tetrahydrofuranyl fentanyl), and 2- 

methoxy-N-(1-phenethylpiperidin-4-yl)- 

N-phenylacetamide (methoxyacetyl 

fentanyl), into Schedule I. This action is 

based on a finding by the Administrator 

that the placement of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

into 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, orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl. 

DATES: This temporary scheduling order 

is effective October 26, 2017, until 

October 28, 2019. 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 into 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 into 

Schedule I of the CSA.2 The 

Administrator transmitted notice of his 

intent to place ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl in Schedule I on 

a temporary basis to the Assistant 

Secretary for Health of HHS by letter. 

Notice for these actions was transmitted 

on the following dates: May 19, 2017 

(ortho-fluorofentanyl) and July 5, 2017 

(tetrahydrofuranyl fentanyl and 

methoxyacetyl fentanyl). The Assistant 

Secretary responded by letters dated 

June 9, 2017 (ortho-fluorofentanyl) and 

July 14, 2017 (tetrahydrofuranyl 

fentanyl and methoxyacetyl fentanyl), 

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 orthoVerDate Sep<11>2014 18:08 Oct 25, 2017 Jkt 244001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\26OCR1.SGM 26OCR1

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3 Data are still being collected for March 2017– 

June 2017 due to the normal lag period for labs 

reporting to NFLIS. 

4Email from Cuyahoga County Medical 

Examiner’s Office, to DEA (May 8, 2017 02:29 p.m. 

EST) (on file with DEA). 

fluorofentanyl, tetrahydrofuranyl 

fentanyl, or methoxyacetyl fentanyl. The 

Assistant Secretary also stated that the 

HHS has no objection to the temporary 

placement of ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, or 

methoxyacetyl fentanyl into 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). ortho-Fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl are not 

currently listed in any schedule under 

the CSA, and no exemptions or 

approvals are in effect for orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

under section 505 of the FDCA, 21 

U.S.C. 355. The DEA has found that the 

control of ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl 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 issue 

a temporary order to schedule orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

was published in the Federal Register 

on September 12, 2017. 82 FR 42754. 

To find that placing a substance 

temporarily into 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 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 into 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 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl, 

summarized below, indicate that these 

synthetic opioids 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. The DEA’s 

three-factor analysis, and the Assistant 

Secretary’s June 9, 2017 and July 14, 

2017 letters 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–473). 

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. orthoFluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

have recently been encountered by law 

enforcement and public health officials. 

Adverse health effects and outcomes are 

demonstrated by fatal overdose cases 

involving these substances. The 

documented adverse health effects of 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

are consistent with those of other 

opioids. 

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 June 19, 

2017. STARLiMS registered four reports 

containing ortho-fluorofentanyl from 

California and five reports containing 

tetrahydrofuranyl fentanyl from Florida 

and Missouri. According to STARLiMS, 

the first laboratory submissions of orthofluorofentanyl and tetrahydrofuranyl 

fentanyl occurred in April 2016, and 

March 2017, respectively. 

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. Data from NFLIS 

was queried on June 20, 2017. NFLIS 

registered three reports containing 

ortho-fluorofentanyl from state or local 

forensic laboratories in Virginia.3

According to NFLIS, the first report of 

ortho-fluorofentanyl was reported in 

September 2016. NFLIS registered two 

reports containing tetrahydrofuranyl 

fentanyl from state or local forensic 

laboratories in New Jersey and was first 

reported in January 2017. The 

identification of methoxyacetyl fentanyl 

in drug evidence submitted in April 

2017 was reported to DEA from a local 

laboratory in Ohio.4 The DEA is not 

aware of any laboratory identifications 

of ortho-fluorofentanyl prior to 2016 or 

identifications of tetrahydrofuranyl 

fentanyl or methoxyacetyl fentanyl prior 

to 2017. 

Evidence suggests that the pattern of 

abuse of fentanyl analogues, including 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl, 

parallels that of heroin and prescription 

opioid analgesics. Seizures of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

have been encountered in powder form 

similar to fentanyl and heroin and have 

been connected to fatal overdoses. 

Factor 5. Scope, Duration and 

Significance of Abuse 

Reports collected by the DEA 

demonstrate ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl are being 

abused for their opioid properties. 

Abuse of ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl have resulted in 

mortality (see DEA 3-Factor Analysis for 

full discussion). The DEA collected 

post-mortem toxicology and medical 

examiner reports on 13 confirmed 

fatalities associated with orthofluorofentanyl which occurred in 

Georgia (1), North Carolina (11), and 

Texas (1), two confirmed fatalities 

associated with tetrahydrofuranyl 

fentanyl which occurred in New Jersey 

(1) and Wisconsin (1), and two 

confirmed fatalities associated with 

methoxyacetyl fentanyl which occurred 

in Pennsylvania. It is likely that the 

prevalence of these substances in opioid 

related emergency room admissions and 

deaths is underreported as standard 

immunoassays may not differentiate 

fentanyl analogues from fentanyl. 

ortho-Fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl have been 

identified in drug evidence collected by 

law enforcement. NFLIS and STARLiMS 

have a total of seven drug reports in 

which ortho-fluorofentanyl was 

identified in drug exhibits submitted to 

forensic laboratories in 2016 from law 

enforcement encounters in California 

and Virginia and seven drug reports in 

which tetrahydrofuranyl fentanyl was 

identified in drug exhibits submitted to 

forensic laboratories in 2017 from law 


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enforcement encounters in Florida, 

Missouri, and New Jersey. The 

identification of methoxyacetyl fentanyl 

in drug evidence submitted in April 

2017 was reported to DEA from Ohio. 

The population likely to abuse orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

overlaps with the population abusing 

prescription opioid analgesics, heroin, 

fentanyl, and other fentanyl-related 

substances. This is evidenced by the 

routes of drug administration and drug 

use history documented in orthofluorofentanyl and tetrahydrofuranyl 

fentanyl fatal overdose cases. Because 

abusers of ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl are likely to 

obtain these substances 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) ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, or 

methoxyacetyl 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 

ortho-Fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl exhibit 

pharmacological profiles similar to that 

of fentanyl and other m-opioid receptor 

agonists. The toxic effects of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl in 

humans are demonstrated by overdose 

fatalities involving these substances. 

Abusers of ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl may not know 

the origin, identity, or purity of these 

substances, thus posing significant 

adverse health risks when compared to 

abuse of pharmaceutical preparations of 

opioid analgesics, such as morphine and 

oxycodone. 

Based on information received by the 

DEA, the misuse and abuse of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

lead to the same qualitative public 

health risks as heroin, fentanyl and 

other opioid analgesic substances. As 

with any non-medically approved 

opioid, 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. 

ortho-Fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl have been 

associated with numerous fatalities. At 

least 13 confirmed overdose deaths 

involving ortho-fluorofentanyl abuse 

have been reported from Georgia (1), 

North Carolina (11), and Texas (1). At 

least two confirmed overdose deaths 

involving tetrahydrofuranyl fentanyl 

have been reported from New Jersey (1) 

and Wisconsin (1). At least two 

confirmed overdose deaths involving 

methoxyacetyl fentanyl have been 

repored from Pennsylvania. As the data 

demonstrate, the potential for fatal and 

non-fatal overdoses exists for orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

and these substances pose 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 orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

poses an imminent hazard to the public 

safety. The DEA is not aware of any 

currently accepted medical uses for 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, or methoxyacetyl 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 ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl indicate that 

these substances 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. As required 

by section 201(h)(4) of the CSA, 21 

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

through letters dated May 19, 2017 

(ortho-fluorofentanyl) and July 5, 2017 

(tetrahydrofuranyl fentanyl and 

methoxyacetyl fentanyl), notified the 

Assistant Secretary of the DEA’s 

intention to temporarily place these 

substances in Schedule I. A notice of 

intent was subsequently published in 

the Federal Register on September 12, 

2017. 82 FR 42754. 

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, herein 

sets forth the grounds for his 

determination that it is necessary to 

temporarily schedule orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

into Schedule I of the CSA, and finds 

that placement of these synthetic 

opioids into Schedule I of the CSA is 

necessary to avoid an imminent hazard 

to the public safety. 

Because the Administrator hereby 

finds it necessary to temporarily place 

these synthetic opioids into Schedule I 

to avoid an imminent hazard to the 

public safety, this temporary order 

scheduling ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl 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, ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl will become 

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: 


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Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations 49507 

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, ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl 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 

October 26, 2017. Any person who 

currently handles ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl, and is not 

registered with the DEA, must submit an 

application for registration and may not 

continue to handle ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl as of October 

26, 2017, 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 these 

substances in a manner not authorized 

by the CSA on or after October 26, 2017 

is unlawful and those in possession of 

any quantity of these substances 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 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl, 

must surrender all quantities of 

currently held ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl. 

3. Security. ortho-Fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl are 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 October 26, 2017. 

4. Labeling and packaging. All labels, 

labeling, and packaging for commercial 

containers of ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl 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 October 26, 2017, 

to comply with all labeling and 

packaging requirements. 

5. Inventory. Every DEA registrant 

who possesses any quantity of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl on 

the effective date of this order must take 

an inventory of all stocks of these 

substances 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 orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl 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 orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

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

in accordance with 21 CFR parts 1304, 

and 1312, 1317 and § 1307.11. Current 

DEA registrants shall have 30 calendar 

days from the effective date of this order 

to be in compliance with all 

recordkeeping requirements. 

7. Reports. All DEA registrants who 

manufacture or distribute orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

must submit reports pursuant to 21 

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

CFR parts 1304 and 1312 as of October 

26, 2017. 

8. Order Forms. All DEA registrants 

who distribute ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl must comply 

with order form requirements pursuant 

to 21 U.S.C. 828 and in accordance with 

21 CFR part 1305 as of October 26, 2017. 

9. Importation and Exportation. All 

importation and exportation of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

must be in compliance with 21 U.S.C. 

952, 953, 957, 958, and in accordance 

with 21 CFR part 1312 as of October 26, 

2017. 

10. Quota. Only DEA registered 

manufacturers may manufacture orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl in 

accordance with a quota assigned 

pursuant to 21 U.S.C. 826 and in 

accordance with 21 CFR part 1303 as of 

October 26, 2017. 

11. Liability. Any activity involving 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

not authorized by, or in violation of the 

CSA, occurring as of October 26, 2017, 

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 impracticable and 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. 

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 


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49508 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Rules and Regulations 

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 these 

substances 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 these substances into 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 reserved 

paragraphs (h)(15) through (18) and 

paragraphs (h)(19), (20), and (21) to read 

as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(h) * * * 

(19) N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide, its isomers, esters, ethers, salts and salts of isomers, esters 

and ethers (Other names: ortho-fluorofentanyl, 2-fluorofentanyl) ..................................................................................................... (9816) 

(20) N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other name: tetrahydrofuranyl fentanyl) .................................................................................................... (9843) 

(21) 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its isomers, esters, ethers, salts and salts of isomers, esters 

and ethers (Other name: methoxyacetyl fentanyl) .............................................................................................................................. (9825) 

Dated: October 17, 2017. 

Robert W. Patterson, 

Acting Administrator. 

[FR Doc. 2017–23206 Filed 10–25–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9815] 

RIN 1545–BM33 

Dividend Equivalents From Sources 

Within the United States; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations and temporary 

regulations; Correcting amendments. 

SUMMARY: This document contains 

corrections to final and temporary 

regulations (TD TD 9815), which were 

published in the Federal Register on 

Tuesday, January 24, 2017. 

DATES: Effective Date: These corrections 

are effective October 26, 2017. 

Applicability Date: The corrections to 

§§ 1.1.871–15, 1.871–15T, 1.1441– 

1(e)(5)(v)(B)(4), (e)(6), and (f)(5), 1.1441– 

2, 1.1441–7, and 1.1461–1 are 

applicable on January 19, 2017. 

FOR FURTHER INFORMATION CONTACT: D. 

Peter Merkel or Karen Walny at 202– 

317–6938 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final and temporary regulations 

that are the subject of these corrections 

are §§ 1.871–15, 1.871–15T, 1.1441–1, 

1.1441–2, 1.1441–7, and 1.1461–1, 

promulgated under sections 871(m) and 

7805 of the Internal Revenue Code. 

These regulations affect foreign persons 

that hold certain financial products 

providing for payments that are 

contingent upon or determined by 

reference to U.S. source dividends, as 

well withholding agents with respect to 

dividend equivalents and certain other 

parties to section 871(m) transactions 

and their agents. 

Need for Correction 

As published, TD 9815 contains errors 

that may prove to be misleading and are 

in need of clarification. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Correction of Publication 

Accordingly, 26 CFR part 1 is 

corrected by making the following 

correcting amendments: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

§ 1.871–15 [Amended] 

■ Par. 2. Section 1.871–15 is amended 

by: 

■ 1. Removing paragraph (r)(2). 

■ 2. Redesignating paragraphs (r)(3), (4), 

and (5), as (r)(2), (3), and (4), 

respectively. 

§ 1.871–15 [Amended] 

■ Par. 3. For each section listed in the 

table, remove the language in the 

‘‘Remove’’ column and add in its place 

the language in the ‘‘Add’’ column as set 

forth below: 

Section Remove Add 

§ 1.871–15(a)(14)(ii)(B) ...................................... ELI.More ........................................................... ELI. More 

§ 1.871–15(l)(1), second sentence ..................... described in this paragraph (l) ......................... described in this paragraph (l)(1) 

§ 1.871–15(q)(1) qualified intermediary agreement .................... qualified intermediary withholding agreement 


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