Schedules of Controlled Substances: Temporary Placement of Acryl Fentanyl Into Schedule I, 25564-25567 [2017-11215]
Download as PDF
25564
Federal Register / Vol. 82, No. 105 / Friday, June 2, 2017 / Proposed Rules
dated August 3, 2016, and effective
September 15, 2016. FAA Order
7400.11A is publicly available as listed
in the ADDRESSES section of this
document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting
points.
The Proposal
The FAA is proposing an amendment
to Title 14 Code of Federal Regulations
(14 CFR) part 71 by establishing Class E
airspace extending upward from 700
feet above the surface at Dixon Airport,
Dixon, WY. Class E airspace would be
established within a 7-mile radius of
Dixon Airport with a segment 8 miles
wide (4 miles each side of a 045°
bearing from the airport) extending to
15.5 miles northeast of the airport. This
airspace is necessary to support IFR
operations in standard instrument
approach and departure procedures at
the airport.
Class E airspace designations are
published in paragraph 6005 of FAA
Order 7400.11A, dated August 3, 2016,
and effective September 15, 2016, which
is incorporated by reference in 14 CFR
71.1. The Class E airspace designations
listed in this document will be
published subsequently in the Order.
Regulatory Notices and Analyses
nlaroche on DSK30NT082PROD with PROPOSALS
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current, and is non-controversial and
unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this rule, when
promulgated, would not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
This proposal would be subject to an
environmental analysis in accordance
with FAA Order 1050.1F,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action.
13:14 Jun 01, 2017
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
Accordingly, pursuant to the
authority delegated to me, the Federal
Aviation Administration proposes to
amend 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting
Points, dated August 3, 2016, and
effective September 15, 2016, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
ANM WY E5 Dixon, WY [New]
Dixon Airport
(Lat. 41°02′15″ N., long. 107°29′33″ W.)
That airspace extending upward from 700
feet above the surface within a 7-miles radius
of the Dixon Airport, and within 4 miles each
side of a 045° bearing from the airport
extending from the 7-mile radius to 15.5
miles northeast of the airport.
Issued in Seattle, Washington, on May 22,
2017.
Sam S.L. Shrimpton,
Acting Group Manager, Operations Support
Group, Western Service Center.
order to schedule the synthetic opioid,
N-(1-phenethylpiperidin-4-yl)-Nphenylacrylamide (acryl fentanyl or
acryloylfentanyl), into Schedule I
pursuant to the temporary scheduling
provisions of the Controlled Substances
Act. This action is based on a finding by
the Administrator that the placement of
this synthetic opioid 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 this synthetic opioid.
DATES: The date of this notice of intent
is June 2, 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 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 order to add acryl fentanyl to
Schedule I under the Controlled
Substances Act.1 The temporary
scheduling order will be published in
the Federal Register, but that order will
not be issued before July 3, 2017.
AGENCY:
Environmental Review
VerDate Sep<11>2014
List of Subjects in 14 CFR Part 71
Jkt 241001
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
The Administrator of the Drug
Enforcement Administration is issuing
this notice of intent to issue a temporary
1 Though 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.
[FR Doc. 2017–11078 Filed 6–1–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–460]
Schedules of Controlled Substances:
Temporary Placement of Acryl
Fentanyl Into Schedule I
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of intent.
SUMMARY:
PO 00000
Frm 00026
Fmt 4702
Sfmt 4702
E:\FR\FM\02JNP1.SGM
02JNP1
Federal Register / Vol. 82, No. 105 / Friday, June 2, 2017 / Proposed Rules
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.
nlaroche on DSK30NT082PROD with PROPOSALS
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 acryl fentanyl in
Schedule I on a temporary basis to the
Assistant Secretary for Health of HHS by
letter dated April 17, 2017. The
Assistant Secretary responded to this
notice by letter dated May 2, 2017, 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 acryl fentanyl. The
Assistant Secretary also stated that the
HHS has no objection to the temporary
placement of acryl fentanyl into
Schedule I of the CSA. Acryl fentanyl is
not currently listed in any schedule
under the CSA, and no exemptions or
approvals are in effect for acryl fentanyl
under section 505 of the FDCA, 21
U.S.C. 355. The DEA has found that the
control of acryl fentanyl in Schedule I
on a temporary basis is necessary to
avoid an imminent hazard to the public
safety.
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,
2 As 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.
VerDate Sep<11>2014
13:14 Jun 01, 2017
Jkt 241001
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).
Acryl Fentanyl
Acryl fentanyl was first described in
1981 in the scientific literature where its
chemical structure and its in vivo
antinociceptive effects were reported.
No approved medical use has been
identified for acryl fentanyl, nor has it
been approved by the FDA for human
consumption. The recent identification
of acryl fentanyl in drug evidence and
the identification of this substance in
association with fatal overdose events
indicate that this substance is being
abused for its opioid properties.
Available data and information for
acryl 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 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–460.
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. Acryl fentanyl
has recently been encountered by law
enforcement and public health officials
and the adverse health effects and
outcomes are demonstrated by fatal
overdose cases. The documented
negative effects of acryl 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 May 5,
2017. STARLiMS registered 36 reports
containing acryl fentanyl, from
Alabama, Connecticut, Illinois, Indiana,
PO 00000
Frm 00027
Fmt 4702
Sfmt 4702
25565
Kentucky, Louisiana, Minnesota,
Missouri, North Carolina, South
Carolina, Tennessee, Texas, and West
Virginia. According to STARLiMS, the
first laboratory submission of acryl
fentanyl occurred in July 2016 in Texas.
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 74
reports containing acryl fentanyl from
state or local forensic laboratories in
Arkansas, California, Connecticut, Iowa,
Kentucky, Ohio, Pennsylvania, South
Carolina, Texas, and Wisconsin (query
date: May 5, 2017).3 The first report of
acryl fentanyl was reported in
Wisconsin in May 2016. The DEA is not
aware of any laboratory identifications
of acryl fentanyl prior to 2016.
Evidence suggests that the pattern of
abuse of fentanyl analogues, including
acryl fentanyl, parallels that of heroin
and prescription opioid analgesics.
Seizures of acryl fentanyl have been
encountered in powder form, in
solution, and packaged similar to that of
heroin. Acryl fentanyl has been
encountered as a single substance as
well as in combination with other
substances of abuse, including heroin,
fentanyl, 4-fluoroisobutyryl fentanyl,
and furanyl fentanyl. Acryl fentanyl has
been connected to fatal overdoses, in
which insufflation and intravenous
routes of administration are
documented.
Factor 5. Scope, Duration and
Significance of Abuse
Reports collected by the DEA
demonstrate acryl fentanyl is being
abused for its opioid properties. This
abuse of acryl fentanyl has resulted in
morbidity and mortality (see DEA 3Factor Analysis for full discussion). The
DEA has received reports for at least 83
confirmed fatalities associated with
acryl fentanyl. Information on these
deaths, occurring as early as September
2016, was collected by the DEA from
post-mortem toxicology and medical
examiner reports. These deaths were
reported from, and occurred in, Illinois
(27), Maryland (22), New Jersey (1),
Ohio (31), and Pennsylvania (2). NFLIS
and STARLiMS have a total of 110 drug
reports in which acryl fentanyl was
identified in drug exhibits submitted to
forensic laboratories in 2016 and 2017
from law enforcement encounters in
3 Data are still being collected for February 2017–
April 2017 due to the normal lag period for labs
reporting to NFLIS.
E:\FR\FM\02JNP1.SGM
02JNP1
25566
Federal Register / Vol. 82, No. 105 / Friday, June 2, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS
Alabama, Arkansas, California,
Connecticut, Illinois, Indiana, Iowa,
Kentucky, Louisiana, Minnesota,
Missouri, North Carolina, Ohio,
Pennsylvania, South Carolina,
Tennessee, Texas, West Virginia, and
Wisconsin. It is likely that the
prevalence of acryl fentanyl in opioid
analgesic-related emergency room
admissions and deaths is underreported
as standard immunoassays may not
differentiate this substance from
fentanyl.
The population likely to abuse acryl
fentanyl overlaps with the population
abusing prescription opioid analgesics,
heroin, fentanyl, and other fentanylrelated substances. This is evidenced by
the routes of drug administration and
drug use history documented in acryl
fentanyl fatal overdose cases and
encounters of the substance by law
enforcement officials. Because abusers
of acryl fentanyl are likely to 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) acryl
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
Acryl fentanyl exhibits
pharmacological profiles similar to that
of fentanyl and other m-opioid receptor
agonists. The toxic effects of acryl
fentanyl in humans are demonstrated by
overdose fatalities involving this
substance. Abusers of acryl fentanyl
may not know the origin, identity, or
purity of this substance, thus posing
significant adverse health risks when
compared to abuse of pharmaceutical
preparations of opioid analgesics, such
as morphine and oxycodone.
Based on information reviewed by the
DEA, the misuse and abuse of acryl
fentanyl leads 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.
Acryl fentanyl has been associated
with numerous fatalities. At least 83
confirmed overdose deaths involving
acryl fentanyl abuse have been reported
from Illinois, Maryland, New Jersey,
VerDate Sep<11>2014
13:14 Jun 01, 2017
Jkt 241001
Ohio, and Pennsylvania in 2016 and
2017. As the data demonstrates, the
potential for fatal and non-fatal
overdoses exists for acryl fentanyl and
acryl fentanyl 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 acryl fentanyl
poses an imminent hazard to the public
safety. The DEA is not aware of any
currently accepted medical uses for
acryl 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 acryl 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, through a
letter dated April 17, 2017, notified the
Assistant Secretary of the DEA’s
intention to temporarily place this
substance in Schedule I.
Conclusion
This notice of intent initiates a
temporary scheduling process and
provides the 30-day notice pursuant to
section 201(h) of the CSA, 21 U.S.C.
811(h), of DEA’s intent to issue a
temporary scheduling order. 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
set forth the grounds for his
determination that it is necessary to
temporarily schedule acryl fentanyl in
Schedule I of the CSA, and finds that
placement of this synthetic opioid
substance into Schedule I of the CSA is
necessary in order to avoid an imminent
hazard to the public safety.
The temporary placement of acryl
fentanyl into Schedule I of the CSA will
take effect pursuant to a temporary
scheduling order, which will not be
issued before July 3, 2017. Because the
PO 00000
Frm 00028
Fmt 4702
Sfmt 4702
Administrator hereby finds that it is
necessary to temporarily place acryl
fentanyl into Schedule I to avoid an
imminent hazard to the public safety,
the temporary order scheduling this
substance 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
notice. Upon publication of the
temporary order, acryl 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
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).
E:\FR\FM\02JNP1.SGM
02JNP1
25567
Federal Register / Vol. 82, No. 105 / Friday, June 2, 2017 / Proposed Rules
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 will take
into consideration any comments
submitted by the Assistant Secretary
with regard to the proposed temporary
scheduling order.
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 (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
proposes to 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 paragraph (h)(17)
to read as follows:
■
§ 1308.11
*
Schedule I.
*
*
(h) * * *
*
*
(17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its isomers, esters, ethers, salts and salts of isomers, esters and ethers
(Other names: acryl fentanyl, acryloylfentanyl) ...................................................................................................................................
*
*
*
*
United States Department of Agriculture
(USDA) and the Secretary of the United
States Department of Health and Human
Services (HHS) a draft regulatory
document concerning Pesticides;
Technical Amendment to Data
Requirements for Antimicrobial
Pesticides. The draft regulatory
document is not available to the public
until after it has been signed and made
available by EPA.
*
Dated: May 24, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017–11215 Filed 6–1–17; 8:45 am]
BILLING CODE 4410–09–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 158
[EPA–HQ–OPP–2015–0683; FRL–9962–67]
RIN 2070–AK00
Notification of Submission to the
Secretaries of Agriculture and Health
and Human Services; Pesticides;
Technical Amendment to Data
Requirements for Antimicrobial
Pesticides
Environmental Protection
Agency (EPA).
ACTION: Notification of submission to
the Secretaries of Agriculture and
Health and Human Services.
nlaroche on DSK30NT082PROD with PROPOSALS
AGENCY:
This document notifies the
public as required by the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) that the EPA Administrator
has forwarded to the Secretary of the
SUMMARY:
VerDate Sep<11>2014
13:14 Jun 01, 2017
Jkt 241001
DATES: See Unit
INFORMATION.
I. under SUPPLEMENTARY
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0683, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Docket (OPP Docket) in the
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
ADDRESSES:
PO 00000
Frm 00029
Fmt 4702
Sfmt 4702
(9811)
FOR FURTHER INFORMATION CONTACT:
Cameo Smoot, Field and External
Affairs Division (7506P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington DC 20460–0001;
telephone number: (703) 305–5454;
email address: smoot.cameo@epa.gov.
SUPPLEMENTARY INFORMATION:
I. What action is EPA taking?
Section 25(a)(2)(A) of FIFRA requires
the EPA Administrator to provide the
Secretary of USDA with a copy of any
draft proposed rule at least 60 days
before signing it in proposed form for
publication in the Federal Register.
Similarly, FIFRA section 21(b) requires
the EPA Administrator to provide the
Secretary of HHS with a copy of any
draft proposed rule pertaining to a
public health pesticide at least 60 days
before publishing it in the Federal
Register. The draft proposed rule is not
available to the public until after it has
been signed by EPA. If either Secretary
comments in writing regarding the draft
proposed rule within 30 days after
receiving it, the EPA Administrator
shall include the comments of the
Secretary and the EPA Administrator’s
response to those comments with the
proposed rule that publishes in the
Federal Register. If either Secretary
E:\FR\FM\02JNP1.SGM
02JNP1
Agencies
[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Proposed Rules]
[Pages 25564-25567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11215]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-460]
Schedules of Controlled Substances: Temporary Placement of Acryl
Fentanyl Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of intent.
-----------------------------------------------------------------------
SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this notice of intent to issue a temporary order to schedule
the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide
(acryl fentanyl or acryloylfentanyl), into Schedule I pursuant to the
temporary scheduling provisions of the Controlled Substances Act. This
action is based on a finding by the Administrator that the placement of
this synthetic opioid 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 this synthetic
opioid.
DATES: The date of this notice of intent is June 2, 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 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 order to
add acryl fentanyl to Schedule I under the Controlled Substances
Act.\1\ The temporary scheduling order will be published in the Federal
Register, but that order will not be issued before July 3, 2017.
---------------------------------------------------------------------------
\1\ Though 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.
---------------------------------------------------------------------------
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
[[Page 25565]]
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 acryl fentanyl in Schedule I on a temporary basis
to the Assistant Secretary for Health of HHS by letter dated April 17,
2017. The Assistant Secretary responded to this notice by letter dated
May 2, 2017, 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 acryl fentanyl. The
Assistant Secretary also stated that the HHS has no objection to the
temporary placement of acryl fentanyl into Schedule I of the CSA. Acryl
fentanyl is not currently listed in any schedule under the CSA, and no
exemptions or approvals are in effect for acryl fentanyl under section
505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of
acryl fentanyl in Schedule I on a temporary basis is necessary to avoid
an imminent hazard to the public safety.
---------------------------------------------------------------------------
\2\ As 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.
---------------------------------------------------------------------------
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).
Acryl Fentanyl
Acryl fentanyl was first described in 1981 in the scientific
literature where its chemical structure and its in vivo antinociceptive
effects were reported. No approved medical use has been identified for
acryl fentanyl, nor has it been approved by the FDA for human
consumption. The recent identification of acryl fentanyl in drug
evidence and the identification of this substance in association with
fatal overdose events indicate that this substance is being abused for
its opioid properties.
Available data and information for acryl 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 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-460.
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. Acryl fentanyl has recently been
encountered by law enforcement and public health officials and the
adverse health effects and outcomes are demonstrated by fatal overdose
cases. The documented negative effects of acryl 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 May 5, 2017. STARLiMS
registered 36 reports containing acryl fentanyl, from Alabama,
Connecticut, Illinois, Indiana, Kentucky, Louisiana, Minnesota,
Missouri, North Carolina, South Carolina, Tennessee, Texas, and West
Virginia. According to STARLiMS, the first laboratory submission of
acryl fentanyl occurred in July 2016 in Texas.
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 74 reports containing acryl fentanyl from state or
local forensic laboratories in Arkansas, California, Connecticut, Iowa,
Kentucky, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin
(query date: May 5, 2017).\3\ The first report of acryl fentanyl was
reported in Wisconsin in May 2016. The DEA is not aware of any
laboratory identifications of acryl fentanyl prior to 2016.
---------------------------------------------------------------------------
\3\ Data are still being collected for February 2017-April 2017
due to the normal lag period for labs reporting to NFLIS.
---------------------------------------------------------------------------
Evidence suggests that the pattern of abuse of fentanyl analogues,
including acryl fentanyl, parallels that of heroin and prescription
opioid analgesics. Seizures of acryl fentanyl have been encountered in
powder form, in solution, and packaged similar to that of heroin. Acryl
fentanyl has been encountered as a single substance as well as in
combination with other substances of abuse, including heroin, fentanyl,
4-fluoroisobutyryl fentanyl, and furanyl fentanyl. Acryl fentanyl has
been connected to fatal overdoses, in which insufflation and
intravenous routes of administration are documented.
Factor 5. Scope, Duration and Significance of Abuse
Reports collected by the DEA demonstrate acryl fentanyl is being
abused for its opioid properties. This abuse of acryl fentanyl has
resulted in morbidity and mortality (see DEA 3-Factor Analysis for full
discussion). The DEA has received reports for at least 83 confirmed
fatalities associated with acryl fentanyl. Information on these deaths,
occurring as early as September 2016, was collected by the DEA from
post-mortem toxicology and medical examiner reports. These deaths were
reported from, and occurred in, Illinois (27), Maryland (22), New
Jersey (1), Ohio (31), and Pennsylvania (2). NFLIS and STARLiMS have a
total of 110 drug reports in which acryl fentanyl was identified in
drug exhibits submitted to forensic laboratories in 2016 and 2017 from
law enforcement encounters in
[[Page 25566]]
Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Iowa,
Kentucky, Louisiana, Minnesota, Missouri, North Carolina, Ohio,
Pennsylvania, South Carolina, Tennessee, Texas, West Virginia, and
Wisconsin. It is likely that the prevalence of acryl fentanyl in opioid
analgesic-related emergency room admissions and deaths is underreported
as standard immunoassays may not differentiate this substance from
fentanyl.
The population likely to abuse acryl 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 acryl
fentanyl fatal overdose cases and encounters of the substance by law
enforcement officials. Because abusers of acryl fentanyl are likely to
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) acryl 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
Acryl fentanyl exhibits pharmacological profiles similar to that of
fentanyl and other [micro]-opioid receptor agonists. The toxic effects
of acryl fentanyl in humans are demonstrated by overdose fatalities
involving this substance. Abusers of acryl fentanyl may not know the
origin, identity, or purity of this substance, thus posing significant
adverse health risks when compared to abuse of pharmaceutical
preparations of opioid analgesics, such as morphine and oxycodone.
Based on information reviewed by the DEA, the misuse and abuse of
acryl fentanyl leads 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.
Acryl fentanyl has been associated with numerous fatalities. At
least 83 confirmed overdose deaths involving acryl fentanyl abuse have
been reported from Illinois, Maryland, New Jersey, Ohio, and
Pennsylvania in 2016 and 2017. As the data demonstrates, the potential
for fatal and non-fatal overdoses exists for acryl fentanyl and acryl
fentanyl 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 acryl fentanyl poses an imminent hazard to the public safety.
The DEA is not aware of any currently accepted medical uses for acryl
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 acryl
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, through a letter dated April 17, 2017, notified the
Assistant Secretary of the DEA's intention to temporarily place this
substance in Schedule I.
Conclusion
This notice of intent initiates a temporary scheduling process and
provides the 30-day notice pursuant to section 201(h) of the CSA, 21
U.S.C. 811(h), of DEA's intent to issue a temporary scheduling order.
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 set forth the grounds for his determination that it
is necessary to temporarily schedule acryl fentanyl in Schedule I of
the CSA, and finds that placement of this synthetic opioid substance
into Schedule I of the CSA is necessary in order to avoid an imminent
hazard to the public safety.
The temporary placement of acryl fentanyl into Schedule I of the
CSA will take effect pursuant to a temporary scheduling order, which
will not be issued before July 3, 2017. Because the Administrator
hereby finds that it is necessary to temporarily place acryl fentanyl
into Schedule I to avoid an imminent hazard to the public safety, the
temporary order scheduling this substance 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 notice. Upon
publication of the temporary order, acryl 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 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).
[[Page 25567]]
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 will take into
consideration any comments submitted by the Assistant Secretary with
regard to the proposed temporary scheduling order.
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 (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 proposes to amend 21 CFR
part 1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
2. In Sec. 1308.11, add paragraph (h)(17) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
(17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its (9811)
isomers, esters, ethers, salts and salts of isomers,
esters and ethers (Other names: acryl fentanyl,
acryloylfentanyl).........................................
------------------------------------------------------------------------
* * * * *
Dated: May 24, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-11215 Filed 6-1-17; 8:45 am]
BILLING CODE 4410-09-P