42754 Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Proposed Rules 

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

with respect to temporary scheduling orders in the 

past, this notice of intent 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. 

(h) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, FAA, ECO Branch, 

Compliance and Airworthiness Division, has 

the authority to approve AMOCs for this AD, 

if requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ECO Branch, send it to 

the attention of the person identified in 

paragraph (i)(1) of this AD. You may email 

your request to: ANE-AD-AMOC@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(i) Related Information 

(1) For more information about this AD, 

contact Herman Mak, Aerospace Engineer, 

FAA, ECO Branch, Compliance and 

Airworthiness Division, 1200 District 

Avenue, Burlington, MA 01803; phone: 781– 

238–7147; fax: 781–238–7199; email: 

herman.mak@faa.gov. 

(2) GE CF6–80A Service Bulletin 72–0749, 

Revision 2, dated August 31, 2016; can be 

obtained from GE using the contact 

information in paragraph (i)(3) of this AD. 

(3) For service information identified in 

this proposed AD, contact General Electric 

Company, GE-Aviation, Room 285, 1 

Neumann Way, Cincinnati, OH 45215, 

phone: 513–552–3272; fax: 513–552–3329; 

email: geae.aoc@ge.com. 

(4) You may view this service information 

at the FAA, Engine and Propeller Standards 

Branch, Policy and Innovation Division, 1200 

District Avenue, Burlington, MA. For 

information on the availability of this 

material at the FAA, call 781–238–7125. 

Issued in Burlington, Massachusetts, on 

September 6, 2017. 

Robert J. Ganley, 

Manager, Engine and Propeller Standards 

Branch, Aircraft Certification Service. 

[FR Doc. 2017–19250 Filed 9–11–17; 8:45 am] 

BILLING CODE 4910–13–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: Proposed amendment; notice of 

intent. 

SUMMARY: The Administrator of the Drug 

Enforcement Administration is issuing 

this notice of intent to publish a 

temporary order to schedule the 

synthetic opioids, N-(2-fluorophenyl)-N- 

(1-phenethylpiperidin-4- 

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 these synthetic 

opioids into Schedule I of the 

Controlled Substances Act is necessary 

to avoid an imminent hazard to the 

public safety. When it is issued, the 

temporary scheduling order will impose 

the administrative, civil, and criminal 

sanctions and regulatory controls 

applicable to Schedule I controlled 

substances under the Controlled 

Substances Act on the manufacture, 

distribution, reverse distribution, 

possession, importation, exportation, 

research, and conduct of instructional 

activities, and chemical analysis of 

these synthetic opioids. 

DATES: September 12, 2017. 

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: This 

notice of intent contained in this 

document is issued pursuant to the 

temporary scheduling provisions of 21 

U.S.C. 811(h). The Drug Enforcement 

Administration (DEA) intends to issue a 

temporary scheduling order (in the form 

of a temporary amendment) to add 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl to 

Schedule I under the Controlled 

Substances Act.1 The temporary 

scheduling order will be published in 

the Federal Register, but will not be 

issued before October 12, 2017. 

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 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 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); 21 CFR part 1308. 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 letter dated June 

9, 2017 (ortho-fluorofentanyl) and July 

14, 2017 (tetrahydrofuranyl fentanyl and 

methoxyacetyl fentanyl), and advised 

that based on a review by the Food and 

Drug Administration (FDA), there are 

currently no investigational new drug 

applications or approved new drug 

applications for ortho-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, and 

methoxyacetyl fentanyl into Schedule I 

of the CSA. ortho-Fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl are not 


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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). 

currently listed in any schedule under 

the CSA, and no exemptions or 

approvals are in effect for orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, or methoxyacetyl fentanyl 

under section 505 of the FDCA, 21 

U.S.C. 355. 

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 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 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). 

Ortho-Fluorofentanyl, 

Tetrahydrofuranyl Fentanyl, and 

Methoxyacetyl Fentanyl 

The recent identification of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl in 

drug evidence and the identification of 

these substances in association with 

fatal overdose events indicate that these 

substances are being abused for their 

opioid properties. No approved medical 

use has been identified for orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, or methoxyacetyl fentanyl, nor 

have they been approved by the FDA for 

human consumption. 

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 is available in its 

entirety under ‘‘Supporting and Related 

Material’’ of the public docket for this 

action at www.regulations.gov under 

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 negative effects of orthofluorofentanyl, 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 2 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 

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 


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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 repored from New Jersey (1) 

and Wisconsin (1). At least two 

confirmed overdose deaths involving 

methoxyacetyl fentanyl have been 

reported from Pennsylvania. As the data 

demonstrates, 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 

pose 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. 

Conclusion 

This notice of intent provides the 30- 

day notice pursuant to section 201(h)(1) 

of the CSA, 21 U.S.C. 811(h)(1), of 

DEA’s intent to issue a temporary 

scheduling order. In accordance with 

the provisions of section 201(h)(3) of the 

CSA, 21 U.S.C. 811(h)(3), the 

Administrator considered available data 

and information, herein set forth the 

grounds for his determination that it is 

necessary to temporarily schedule 

ortho-fluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl in 

Schedule I of the CSA, and finds that 

placement of these synthetic opioids 

into Schedule I of the CSA is necessary 

in order to avoid an imminent hazard to 

the public safety. 

The temporary placement of orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

into Schedule I of the CSA will take 

effect pursuant to a temporary 

scheduling order, which will not be 

issued before October 12, 2017. Because 

the Administrator hereby finds that it is 

necessary to temporarily place orthofluorofentanyl, tetrahydrofuranyl 

fentanyl, and methoxyacetyl fentanyl 

into Schedule I to avoid an imminent 

hazard to the public safety, the 

temporary order scheduling these 

substances will be effective on the date 

that order is published in the Federal 

Register, and will be 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). It is the 

intention of the Administrator to issue 

a temporary scheduling order as soon as 

possible after the expiration of 30 days 

from the date of publication of this 

document. Upon publication of the 

temporary order, ortho-fluorofentanyl, 

tetrahydrofuranyl fentanyl, and 

methoxyacetyl fentanyl will then be 

subject to the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, reverse distribution, 

importation, exportation, research, 

conduct of instructional activities and 

chemical analysis, and possession of a 

Schedule I controlled substance. 

The CSA sets forth specific criteria for 

scheduling a drug or other substance. 

Regular 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 regular 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 regular 

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). 

Regulatory Matters 

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

811(h), provides for a temporary 

scheduling action where such action is 


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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 of HHS. 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 

section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 553, do 

not apply to this notice of intent. In the 

alternative, even assuming that this 

notice of intent might be subject to 

section 553 of the APA, the 

Administrator finds that there is good 

cause to forgo the notice and comment 

requirements of section 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. 

Although the DEA believes this notice 

of intent to issue a temporary 

scheduling order is not subject to the 

notice and comment requirements of 

section 553 of the APA, the DEA notes 

that in accordance with 21 U.S.C. 

811(h)(4), the Administrator took into 

consideration comments submitted by 

the Assistant Secretary in response to 

notice that DEA transmitted to the 

Assistant Secretary pursuant to section 

811(h)(4). 

Further, the DEA believes that this 

notice of intent 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 (RFA). 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 section 553 

of 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 

federalism implications to warrant the 

preparation of a Federalism Assessment. 

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 

hereby provides notice of its intent to 

temporarily amend 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), 

unless otherwise noted. 

■ 2. In § 1308.11, add paragraphs (h)(19) 

through (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)-Nphenyltetrahydrofuran-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)-Nphenylacetamide, its isomers, esters, 

ethers, salts and salts of isomers, esters 

and ethers (Other name: methoxyacetyl 

fentanyl)—(9825) 

Dated: August 26, 2017. 

Chuck Rosenberg, 

Acting Administrator. 

[FR Doc. 2017–19283 Filed 9–11–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Mine Safety and Health Administration 

30 CFR Parts 56 and 57 

[Docket No. MSHA–2014–0030] 

RIN 1219–AB87 

Examinations of Working Places in 

Metal and Nonmetal Mines 

AGENCY: Mine Safety and Health 

Administration, Labor. 

ACTION: Proposed rule, limited 

reopening of the rulemaking record; 

notice of public hearings; close of 

comment period. 

SUMMARY: The Mine Safety and Health 

Administration (MSHA) proposes to 

amend the Agency’s final rule on 

examinations of working places in metal 

and nonmetal mines that was published 

in January 2017. The proposed changes 

would require that an examination of 

the working place be conducted before 

work begins or as miners begin work in 

that place, and that the examination 

record include descriptions of adverse 

conditions that are not corrected 

promptly and the dates of corrective 

action for these conditions. The 

proposed rule would provide mine 

operators additional flexibility in 

managing their safety and health 

programs and reduce regulatory burdens 

without reducing the protections 

afforded miners. 

DATES: MSHA is reopening the comment 

period to solicit comments on limited 

changes to the final rule published on 

January 23, 2017 (82 FR 7695), effective 

May 23, 2017, and delayed on May 22, 

2017 (82 FR 23139), until October 2, 

2017 (82 FR 23139). 

Comment date: Comments must be 

received or postmarked by midnight 

Eastern Standard Time (EST) on 

November 13, 2017. 

Hearing dates: October 24, 2017, 

October 26, 2017, October 31, 2017, and 

November 2, 2017. The locations are 

listed in the Public Hearings section in 

the SUPPLEMENTARY INFORMATION section 

of this document. 

ADDRESSES: Submit comments and 

informational materials, identified by 

RIN 1219–AB87 or Docket No. MSHA– 

2014–0030, by one of the following 

methods: 

• Federal E-Rulemaking Portal: 

https://www.regulations.gov. Follow the 

online instructions for submitting 

comments. 

• Email: zzMSHA-comments@

dol.gov. 

• Mail: MSHA, Office of Standards, 

Regulations, and Variances, 201 12th 


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