Schedules of Controlled Substances: Temporary Placement of Furanyl Fentanyl Into Schedule I, 85873-85877 [2016-28693]
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Rules and Regulations
§ 1.90
Notice of sampling.
When a sample of an article offered
for import has been requested by the
district director, FDA shall provide to
the owner or consignee prompt notice of
delivery of, or intention to deliver, such
sample. Upon receipt of the notice, the
owner or consignee shall hold such
article and not distribute it until further
notice from the district director or U.S.
Customs and Border Protection of the
results of examination of the sample.
■ 5. In § 1.94, revise the first sentence of
paragraphs (a) and (c) to read as follows:
§ 1.94 Hearing on refusal of admission or
destruction.
(a) If it appears that the article may be
subject to refusal of admission, or that
the article is a drug that may be subject
to destruction under section 801(a) of
the Federal Food, Drug, and Cosmetic
Act, the district director shall give the
owner or consignee a written or
electronic notice to that effect, stating
the reasons therefor. * * *
*
*
*
*
*
(c) If the article is a drug that may be
subject to destruction under section
801(a) of the Federal Food, Drug, and
Cosmetic Act, the district director may
give the owner or consignee a single
written or electronic notice that
provides the notice of refusal of
admission and the notice of destruction
of an article described in paragraph (a)
of this section. * * *
HCT/P is offered for import, the
importer of record must notify, either
before or at the time of importation, the
director of the district of the Food and
Drug Administration (FDA) having
jurisdiction over the port of entry
through which the HCT/P is imported or
offered for import, or such officer of the
district as the director may designate to
act in his or her behalf in administering
and enforcing this part, and must
provide sufficient information,
including information submitted in the
Automated Commercial Environment
(ACE) system or any other electronic
data interchange system authorized by
the U.S. Customs and Border Protection
Agency as required in part 1, subpart D
of this chapter, for FDA to make an
admissibility decision.
*
*
*
*
*
Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and
Drug Administration.
In concurrence with FDA:
Dated: November 21, 2016.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and
Tariff Policy), Department of the Treasury.
85873
FOR FURTHER INFORMATION CONTACT:
David Edwards, Center for Veterinary
Medicine (HFV–220), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6205.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 24, 2016 (81
FR 57796), FDA solicited comments
concerning the direct final rule for a 75day period ending November 7, 2016.
FDA stated that the effective date of the
direct final rule would be on December
1, 2016, unless any significant adverse
comment was submitted to FDA during
the comment period. FDA did not
receive any significant adverse
comments.
Authority: Therefore, under the animal
drug provisions of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 354, 360b,
360ccc, 360ccc–1, and 371), and under
authority delegated to the Commissioner of
Food and Drugs, 21 CFR part 558 is
amended. Accordingly, the amendments
issued thereby are effective.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–28607 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
[FR Doc. 2016–28582 Filed 11–28–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Drug Enforcement Administration
21 CFR Part 1308
PART 1005—IMPORTATION OF
ELECTRONIC PRODUCTS
Food and Drug Administration
[Docket No. DEA–448]
21 CFR Part 558
6. The authority citation for part 1005
continues to read as follows:
[Docket No. FDA–2016–N–1896]
Schedules of Controlled Substances:
Temporary Placement of Furanyl
Fentanyl Into Schedule I
■
New Animal Drugs for Use in Animal
Feed; Category Definitions;
Confirmation of Effective Date
Authority: 21 U.S.C. 360ii, 360mm.
■
7. Revise § 1005.2 to read as follows:
§ 1005.2
Definitions.
AGENCY:
As used in this part:
The term owner or consignee means
the person who makes entry under the
provisions of section 484 of the Tariff
Act of 1930, as amended (19 U.S.C.
1484), namely, the ‘‘importer of record.’’
PART 1271—HUMAN CELLS, TISSUES,
AND CELLULAR AND TISSUE–BASED
PRODUCTS
8. The authority citation for part 1271
continues to read as follows:
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■
Authority: 42 U.S.C. 216, 243, 263a, 264,
271.
9. In § 1271.420, revise paragraph (a)
to read as follows:
■
§ 1271.420
HCT/Ps offered for import.
(a) Except as provided in paragraphs
(c) and (d) of this section, when an
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Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of December 1, 2016, for
the final rule that appeared in the
Federal Register of August 24, 2016.
The direct final rule amends the animal
drug regulations by revising the
definitions of the two categories of new
animal drugs used in medicated feeds to
base category assignment only on
approved uses in major animal species.
This document confirms the effective
date of the direct final rule.
DATES: Effective date of final rule
published in the Federal Register of
August 24, 2016 (81 FR 57796)
confirmed: December 1, 2016.
SUMMARY:
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Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
The Administrator of the Drug
Enforcement Administration is issuing
this final order to temporarily schedule
the synthetic opioid, N-(1phenethylpiperidin-4-yl)-Nphenylfuran-2-carboxamide (furanyl
fentanyl), and its isomers, esters, ethers,
salts and salts of isomers, esters and
ethers, 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
furanyl 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
SUMMARY:
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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, furanyl fentanyl.
DATES: This final order is effective on
November 29, 2016.
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
The Drug Enforcement
Administration (DEA) implements and
enforces titles II and III of the
Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended. 21
U.S.C. 801–971. Titles II and III are
referred to as the ‘‘Controlled
Substances Act’’ and the ‘‘Controlled
Substances Import and Export Act,’’
respectively, and are collectively
referred to as the ‘‘Controlled
Substances Act’’ or the ‘‘CSA’’ for the
purpose of this action. The DEA
publishes the implementing regulations
for these statutes in title 21 of the Code
of Federal Regulations (CFR), chapter II.
The CSA and its implementing
regulations are designed to prevent,
detect, and eliminate the diversion of
controlled substances and listed
chemicals into the illicit market while
ensuring an adequate supply is available
for the legitimate medical, scientific,
research, and industrial needs of the
United States. Controlled substances
have the potential for abuse and
dependence and are controlled to
protect the public health and safety.
Under the CSA, every controlled
substance is classified into one of five
schedules based upon its potential for
abuse, its currently accepted medical
use in treatment in the United States,
and the degree of dependence the drug
or other substance may cause. 21 U.S.C.
812. The initial schedules of controlled
substances established by Congress are
found at 21 U.S.C. 812(c), and the
current list of all scheduled substances
is published at 21 CFR part 1308.
Section 201 of the 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 she
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
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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). The Attorney General has
delegated her 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.1 The
Administrator transmitted the notice of
intent to place furanyl fentanyl into
schedule I on a temporary basis to the
Assistant Secretary by letter dated June
22, 2016. The Assistant Secretary
responded to this notice by letter dated
July 8, 2016, 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 furanyl fentanyl. The
Assistant Secretary also stated that the
HHS has no objection to the temporary
placement of furanyl 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). Furanyl fentanyl is not
currently listed in any schedule under
the CSA, and no exemptions or
approvals are in effect for furanyl
fentanyl under section 505 of the FDCA,
21 U.S.C. 355. The DEA has found that
the control of furanyl fentanyl in
schedule I on a temporary basis is
necessary to avoid an imminent hazard
to the public safety, and as required by
21 U.S.C. 811(h)(1)(A), a notice of intent
to temporarily schedule furanyl fentanyl
was published in the Federal Register
on September 27, 2016. 81 FR 66224.
1 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.
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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 furanyl 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
updated three-factor analysis, and the
Assistant Secretary’s July 8, 2016, letter,
are available in their entirety under the
tab ‘‘Supporting Documents’’ of the
public docket of this action at
www.regulations.gov under FDMS
Docket ID: DEA–2016–0018 (Docket
Number DEA–448).
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 with often
unpredictable outcomes. Furanyl
fentanyl has recently been encountered
by law enforcement and public health
officials and the adverse health effects
and outcomes are documented in the
scientific literature. The documented
negative effects of furanyl 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 November
2, 2016. STARLiMS registered 113
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reports containing furanyl fentanyl, all
reported in 2016, from Alabama,
California, Connecticut, Delaware,
Florida, Georgia, Illinois, Maryland,
Mississippi, Missouri, Montana, New
Jersey, New York, North Carolina, North
Dakota, Rhode Island, Tennessee, Texas,
Utah, Virginia, Wisconsin, West
Virginia, and the District of Columbia.
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 participating
Federal, State and local forensic
laboratories across the country.
According to NFLIS, the first report of
furanyl fentanyl was recorded in
December 2015 in Oregon. From
December 2015 through September
2016, a total of 494 submissions to state
and local forensic laboratories
identifying furanyl fentanyl were
reported in NFLIS as a result of law
enforcement encounters in California,
Connecticut, Florida, Iowa, Kentucky,
Massachusetts, Minnesota, Missouri,
New Jersey, North Dakota, Ohio,
Oklahoma, Oregon, Pennsylvania,
Virginia, and Wisconsin (query date:
November 2, 2016). The DEA is not
aware of any laboratory identifications
of furanyl fentanyl prior to 2015.
Evidence suggests that the pattern of
abuse of fentanyl analogues, including
furanyl fentanyl, parallels that of heroin
and prescription opioid analgesics.
Seizures of furanyl fentanyl have been
encountered in powder form. Furanyl
fentanyl has also been encountered in
drug paraphernalia commonly
associated with heroin or other opioid
abuse including glassine bags, and as a
residue on spoons and bottle caps.
Furanyl fentanyl has been encountered
as a single substance as well as in
combination with other substances of
abuse, including heroin, fentanyl,
butyryl fentanyl, and U–47700. Furanyl
fentanyl has been connected to fatal
overdoses, in which intravenous routes
of administration are documented.
Factor 5. Scope, Duration and
Significance of Abuse
The scientific literature and reports
collected by the DEA demonstrate
furanyl fentanyl is being abused for its
opioid properties. This abuse of furanyl
fentanyl has resulted in morbidity and
mortality (see updated DEA 3-Factor
Analysis for full discussion). The DEA
has received reports for at least 128
confirmed fatalities associated with
furanyl fentanyl. The information on
these deaths occurring in 2015 and 2016
was collected from email
communications or toxicology and
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medical examiner reports received by
the DEA. These deaths were reported
from five states—Illinois (36), Maryland
(41), New Jersey (1), North Carolina (49),
and Ohio (1). The scientific literature
notes additional fatal overdoses
connected to furanyl fentanyl.
STARLiMS and NFLIS have a total of
607 drug reports in which furanyl
fentanyl was identified in drug exhibits
submitted to forensic laboratories from
December 2015 through September 2016
from law enforcement encounters. It is
likely that the prevalence of furanyl
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 furanyl
fentanyl overlaps with the population
abusing prescription opioid analgesics
and heroin. This is evidenced by the
routes of drug administration and drug
use history documented in furanyl
fentanyl fatal overdose cases. Because
abusers of furanyl fentanyl are likely to
obtain this substance through
unregulated sources (i.e. on-line
purchases or drug dealers), 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) furanyl 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
Furanyl fentanyl exhibits
pharmacological profiles similar to that
of fentanyl and other m-opioid receptor
agonists. The toxic effects of furanyl
fentanyl in humans are demonstrated by
overdose fatalities involving this
substance. Abusers of furanyl 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 reports in the scientific
literature and information received by
the DEA, the abuse of furanyl 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 great. The public health risks
attendant to the abuse of heroin and
opioid analgesics are well established
and have resulted in large numbers of
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drug treatment admissions, emergency
department visits, and fatal overdoses.
Furanyl fentanyl has been associated
with a number of fatalities and non-fatal
overdoses as detailed in the scientific
literature. The DEA has received
information connecting furanyl fentanyl
to at least 128 confirmed overdose
deaths occurring in 2015 and 2016 in
Illinois (36), Maryland (41), New Jersey
(1), North Carolina (49), and Ohio (1).
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 data and
information summarized above, the
continued uncontrolled manufacture,
distribution, importation, exportation,
and abuse of furanyl fentanyl pose an
imminent hazard to the public safety.
The DEA is not aware of any currently
accepted medical uses for this substance
in treatment in the United States. A
substance meeting the statutory
requirements for temporary scheduling,
21 U.S.C. 811(h)(1), may only be placed
into 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 furanyl
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 June 22, 2016, notified the
Assistant Secretary of the DEA’s
intention to temporarily place this
substance into schedule I.
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 furanyl fentanyl
into schedule I of the CSA, and finds
that placement of this synthetic opioid
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 this synthetic opioid into
schedule I to avoid an imminent hazard
to the public safety, this final order
temporarily scheduling furanyl fentanyl
will be effective on the date of
publication in the Federal Register, and
will be in effect for a period of two
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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 final
order, furanyl 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:
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, furanyl 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 November 29, 2016. Any
person who currently handles furanyl
fentanyl, and is not registered with the
DEA, must submit an application for
registration and may not continue to
handle furanyl fentanyl as of November
29, 2016, unless the DEA has approved
that application for registration
pursuant to 21 U.S.C. 822, 823, 957,
958, and in accordance with 21 CFR
parts 1301 and 1312. Retail sales of
schedule I controlled substances to the
general public are not allowed under the
CSA. Possession of any quantity of this
substance in a manner not authorized by
the CSA on or after November 29, 2016
is unlawful and those in possession of
any quantity of this substance may be
subject to prosecution pursuant to the
CSA.
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2. Disposal of stocks. Any person who
does not desire or is not able to obtain
a schedule I registration to handle
furanyl fentanyl, must surrender all
quantities of currently held furanyl
fentanyl.
3. Security. Furanyl fentanyl is subject
to schedule I security requirements and
must be handled and stored pursuant to
21 U.S.C. 821, 823, 871(b), and in
accordance with 21 CFR 1301.71–
1301.93, as of November 29, 2016.
4. Labeling and packaging. All labels,
labeling, and packaging for commercial
containers of furanyl 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
November 29, 2016, to comply with all
labeling and packaging requirements.
5. Inventory. Every DEA registrant
who possesses any quantity of furanyl
fentanyl on the effective date of this
order must take an inventory of all
stocks of this substance on hand,
pursuant to 21 U.S.C. 827 and 958, and
in accordance with 21 CFR 1304.03,
1304.04, and 1304.11. Current DEA
registrants shall have 30 calendar days
from the effective date of this order to
be in compliance with all inventory
requirements. After the initial
inventory, every DEA registrant must
take an inventory of all controlled
substances (including furanyl 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 furanyl
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 furanyl
fentanyl must submit reports pursuant
to 21 U.S.C. 827 and in accordance with
21 CFR parts 1304, and 1312 as of
November 29, 2016.
8. Order Forms. All DEA registrants
who distribute furanyl fentanyl must
comply with order form requirements
pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of
November 29, 2016.
9. Importation and Exportation. All
importation and exportation of furanyl
fentanyl must be in compliance with 21
U.S.C. 952, 953, 957, 958, and in
accordance with 21 CFR part 1312 as of
November 29, 2016.
10. Quota. Only DEA registered
manufacturers may manufacture furanyl
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fentanyl in accordance with a quota
assigned pursuant to 21 U.S.C. 826 and
in accordance with 21 CFR part 1303 as
of November 29, 2016.
11. Liability. Any activity involving
furanyl fentanyl not authorized by, or in
violation of the CSA, occurring as of
November 29, 2016, 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 (OMB).
E:\FR\FM\29NOR1.SGM
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Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Rules and Regulations
This action will not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with Executive Order 13132
(Federalism) it is determined that this
action does not have sufficient
federalism implications to warrant the
preparation of a Federalism Assessment.
As noted above, this action is an
order, not a rule. Accordingly, the
Congressional Review Act (CRA) is
inapplicable, as it applies only to rules.
However, if this were a rule, pursuant
to the Congressional Review Act, ‘‘any
rule for which an agency for good cause
finds that notice and public procedure
thereon are impracticable, unnecessary,
or contrary to the public interest, shall
take effect at such time as the federal
agency promulgating the rule
determines.’’ 5 U.S.C. 808(2). It is in the
public interest to schedule this
substance immediately to avoid an
imminent hazard to the public safety.
This temporary scheduling action is
taken pursuant to 21 U.S.C. 811(h),
which is specifically designed to enable
the DEA to act in an expeditious manner
to avoid an imminent hazard to the
public safety. 21 U.S.C. 811(h) exempts
the temporary scheduling order from
standard notice and comment
rulemaking procedures to ensure that
the process moves swiftly. For the same
reasons that underlie 21 U.S.C. 811(h),
that is, the DEA’s need to move quickly
to place this substance 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 final 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.
jstallworth on DSK7TPTVN1PROD with RULES
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:
VerDate Sep<11>2014
14:25 Nov 28, 2016
Jkt 241001
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. Amend § 1308.11 by adding
paragraph (h)(19) to read as follows:
■
§ 1308.11
Schedule I.
*
*
*
*
*
(h) * * *
(19) N-(1-phenethylpiperidin-4-yl)-Nphenylfuran-2-carboxamide, its isomers,
esters, ethers, salts and salts of isomers,
esters and ethers (Other name: Furanyl
fentanyl) (9834).
Dated: November 22, 2016
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–28693 Filed 11–28–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
28 CFR Part 90
[OVW Docket No. 120]
RIN 1105–AB46
Conforming STOP Violence Against
Women Formula Grant Program
Regulations to Statutory Change;
Definitions and Confidentiality
Requirements Applicable to All OVW
Grant Programs
Office on Violence Against
Women, Justice.
ACTION: Final rule.
AGENCY:
This rule amends the
regulations for the STOP (Services
•Training•Officers•Prosecutors)
Violence Against Women Formula Grant
Program (STOP Program) and the
general provisions governing Office on
Violence Against Women (OVW)
programs to comply with statutory
changes and reduce repetition of
statutory language. Also, this rule
implements statutory requirements for
nondisclosure of confidential or private
information relating to all OVW grant
programs.
SUMMARY:
This rule is effective December
29, 2016.
FOR FURTHER INFORMATION CONTACT:
Marnie Shiels, Office on Violence
Against Women, 145 N Street NE., Suite
10W.100, Washington, DC 20530, by
telephone (202) 307–6026 or by email at
marnie.shiels@usdoj.gov.
SUPPLEMENTARY INFORMATION:
DATES:
List of Subjects in 21 CFR Part 1308
■
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
85877
I. Executive Summary
The Violence Against Women Act
(VAWA) was enacted on September 13,
1994, by title IV of the Violent Crime
Control and Law Enforcement Act of
1994, Public Law 103–322, 108 Stat.
1796. The STOP Program is codified at
42 U.S.C. 3796gg through 3796gg–5 and
3796gg–8. The final rule for this
program, found at 28 CFR part 90,
subpart B, was promulgated on April 18,
1995. General provisions affecting all
OVW grant programs are found at 28
CFR part 90, subpart A.
This rule amends the general
provisions applicable to all OVW grant
programs and the regulations governing
the STOP Program to comply with the
amendments to these programs enacted
by the Violence Against Women Act of
2000 (VAWA 2000), Division B of the
Victims of Trafficking and Violence
Protection Act of 2000, Public Law 106–
386, 114 Stat. 1464 (Oct. 28, 2000), the
Violence Against Women and
Department of Justice Reauthorization
Act of 2005 (VAWA 2005), Public Law
109–162, 119 Stat. 2960 (Jan. 5, 2006),
and the Violence Against Women
Reauthorization Act of 2013 (VAWA
2013), Public Law 113–4, 127 Stat. 54
(Mar. 7, 2013). These changes to the
regulations incorporate the statutory
changes, make minor technical
corrections, implement enhanced
administrative and planning practices
for formula grantees, and streamline
existing regulations to reduce repetition
of statutory language.
In addition, this rule amends an
existing regulatory provision, § 90.2,
that sets forth certain definitions that
apply to all OVW grant programs.
Furthermore, the rule adds a new
regulatory provision, § 90.4, that is
applicable to all OVW grant programs to
implement statutory amendments
requiring nondisclosure of confidential
or private information pertaining to
victims of domestic violence, dating
violence, sexual assault and stalking.
II. Background
A. Overview of the Violence Against
Women Act and Subsequent
Reauthorizations
In 1994, Congress passed the Violence
Against Women Act (VAWA), a
comprehensive legislative package
aimed at ending violence against
women. VAWA was enacted on
September 13, 1994, as title IV of the
Violent Crime Control and Law
Enforcement Act of 1994, Public Law
103–322, 108 Stat. 1796. VAWA was
designed to improve criminal justice
system responses to domestic violence,
sexual assault, and stalking, and to
E:\FR\FM\29NOR1.SGM
29NOR1
]]>Agencies
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Rules and Regulations]
[Pages 85873-85877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28693]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-448]
Schedules of Controlled Substances: Temporary Placement of
Furanyl Fentanyl Into Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Administrator of the Drug Enforcement Administration is
issuing this final order to temporarily schedule the synthetic opioid,
N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide (furanyl
fentanyl), and its isomers, esters, ethers, salts and salts of isomers,
esters and ethers, 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 furanyl 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
[[Page 85874]]
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, furanyl fentanyl.
DATES: This final order is effective on November 29, 2016.
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
The Drug Enforcement Administration (DEA) implements and enforces
titles II and III of the Comprehensive Drug Abuse Prevention and
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III
are referred to as the ``Controlled Substances Act'' and the
``Controlled Substances Import and Export Act,'' respectively, and are
collectively referred to as the ``Controlled Substances Act'' or the
``CSA'' for the purpose of this action. The DEA publishes the
implementing regulations for these statutes in title 21 of the Code of
Federal Regulations (CFR), chapter II. The CSA and its implementing
regulations are designed to prevent, detect, and eliminate the
diversion of controlled substances and listed chemicals into the
illicit market while ensuring an adequate supply is available for the
legitimate medical, scientific, research, and industrial needs of the
United States. Controlled substances have the potential for abuse and
dependence and are controlled to protect the public health and safety.
Under the CSA, every controlled substance is classified into one of
five schedules based upon its potential for abuse, its currently
accepted medical use in treatment in the United States, and the degree
of dependence the drug or other substance may cause. 21 U.S.C. 812. The
initial schedules of controlled substances established by Congress are
found at 21 U.S.C. 812(c), and the current list of all scheduled
substances is published at 21 CFR part 1308.
Section 201 of the 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 she 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 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 her 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.\1\ The Administrator transmitted the notice
of intent to place furanyl fentanyl into schedule I on a temporary
basis to the Assistant Secretary by letter dated June 22, 2016. The
Assistant Secretary responded to this notice by letter dated July 8,
2016, 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 furanyl fentanyl.
The Assistant Secretary also stated that the HHS has no objection to
the temporary placement of furanyl 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). Furanyl fentanyl is not currently
listed in any schedule under the CSA, and no exemptions or approvals
are in effect for furanyl fentanyl under section 505 of the FDCA, 21
U.S.C. 355. The DEA has found that the control of furanyl fentanyl in
schedule I on a temporary basis is necessary to avoid an imminent
hazard to the public safety, and as required by 21 U.S.C. 811(h)(1)(A),
a notice of intent to temporarily schedule furanyl fentanyl was
published in the Federal Register on September 27, 2016. 81 FR 66224.
---------------------------------------------------------------------------
\1\ 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 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
furanyl 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 updated three-factor analysis, and
the Assistant Secretary's July 8, 2016, letter, are available in their
entirety under the tab ``Supporting Documents'' of the public docket of
this action at www.regulations.gov under FDMS Docket ID: DEA-2016-0018
(Docket Number DEA-448).
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 with
often unpredictable outcomes. Furanyl fentanyl has recently been
encountered by law enforcement and public health officials and the
adverse health effects and outcomes are documented in the scientific
literature. The documented negative effects of furanyl 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
November 2, 2016. STARLiMS registered 113
[[Page 85875]]
reports containing furanyl fentanyl, all reported in 2016, from
Alabama, California, Connecticut, Delaware, Florida, Georgia, Illinois,
Maryland, Mississippi, Missouri, Montana, New Jersey, New York, North
Carolina, North Dakota, Rhode Island, Tennessee, Texas, Utah, Virginia,
Wisconsin, West Virginia, and the District of Columbia.
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
participating Federal, State and local forensic laboratories across the
country. According to NFLIS, the first report of furanyl fentanyl was
recorded in December 2015 in Oregon. From December 2015 through
September 2016, a total of 494 submissions to state and local forensic
laboratories identifying furanyl fentanyl were reported in NFLIS as a
result of law enforcement encounters in California, Connecticut,
Florida, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, New
Jersey, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Virginia,
and Wisconsin (query date: November 2, 2016). The DEA is not aware of
any laboratory identifications of furanyl fentanyl prior to 2015.
Evidence suggests that the pattern of abuse of fentanyl analogues,
including furanyl fentanyl, parallels that of heroin and prescription
opioid analgesics. Seizures of furanyl fentanyl have been encountered
in powder form. Furanyl fentanyl has also been encountered in drug
paraphernalia commonly associated with heroin or other opioid abuse
including glassine bags, and as a residue on spoons and bottle caps.
Furanyl fentanyl has been encountered as a single substance as well as
in combination with other substances of abuse, including heroin,
fentanyl, butyryl fentanyl, and U-47700. Furanyl fentanyl has been
connected to fatal overdoses, in which intravenous routes of
administration are documented.
Factor 5. Scope, Duration and Significance of Abuse
The scientific literature and reports collected by the DEA
demonstrate furanyl fentanyl is being abused for its opioid properties.
This abuse of furanyl fentanyl has resulted in morbidity and mortality
(see updated DEA 3-Factor Analysis for full discussion). The DEA has
received reports for at least 128 confirmed fatalities associated with
furanyl fentanyl. The information on these deaths occurring in 2015 and
2016 was collected from email communications or toxicology and medical
examiner reports received by the DEA. These deaths were reported from
five states--Illinois (36), Maryland (41), New Jersey (1), North
Carolina (49), and Ohio (1). The scientific literature notes additional
fatal overdoses connected to furanyl fentanyl. STARLiMS and NFLIS have
a total of 607 drug reports in which furanyl fentanyl was identified in
drug exhibits submitted to forensic laboratories from December 2015
through September 2016 from law enforcement encounters. It is likely
that the prevalence of furanyl 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 furanyl fentanyl overlaps with the
population abusing prescription opioid analgesics and heroin. This is
evidenced by the routes of drug administration and drug use history
documented in furanyl fentanyl fatal overdose cases. Because abusers of
furanyl fentanyl are likely to obtain this substance through
unregulated sources (i.e. on-line purchases or drug dealers), 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) furanyl 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
Furanyl fentanyl exhibits pharmacological profiles similar to that
of fentanyl and other [micro]-opioid receptor agonists. The toxic
effects of furanyl fentanyl in humans are demonstrated by overdose
fatalities involving this substance. Abusers of furanyl 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 reports in the scientific literature and information
received by the DEA, the abuse of furanyl 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 great. 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.
Furanyl fentanyl has been associated with a number of fatalities
and non-fatal overdoses as detailed in the scientific literature. The
DEA has received information connecting furanyl fentanyl to at least
128 confirmed overdose deaths occurring in 2015 and 2016 in Illinois
(36), Maryland (41), New Jersey (1), North Carolina (49), and Ohio (1).
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 data and
information summarized above, the continued uncontrolled manufacture,
distribution, importation, exportation, and abuse of furanyl fentanyl
pose an imminent hazard to the public safety. The DEA is not aware of
any currently accepted medical uses for this substance in treatment in
the United States. A substance meeting the statutory requirements for
temporary scheduling, 21 U.S.C. 811(h)(1), may only be placed into
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 furanyl 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 June 22, 2016, notified the
Assistant Secretary of the DEA's intention to temporarily place this
substance into schedule I.
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 furanyl fentanyl into schedule
I of the CSA, and finds that placement of this synthetic opioid 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 this synthetic opioid into schedule I to avoid an
imminent hazard to the public safety, this final order temporarily
scheduling furanyl fentanyl will be effective on the date of
publication in the Federal Register, and will be in effect for a period
of two
[[Page 85876]]
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 final order, furanyl 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:
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, furanyl 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 November 29,
2016. Any person who currently handles furanyl fentanyl, and is not
registered with the DEA, must submit an application for registration
and may not continue to handle furanyl fentanyl as of November 29,
2016, unless the DEA has approved that application for registration
pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR
parts 1301 and 1312. Retail sales of schedule I controlled substances
to the general public are not allowed under the CSA. Possession of any
quantity of this substance in a manner not authorized by the CSA on or
after November 29, 2016 is unlawful and those in possession of any
quantity of this substance may be subject to prosecution pursuant to
the CSA.
2. Disposal of stocks. Any person who does not desire or is not
able to obtain a schedule I registration to handle furanyl fentanyl,
must surrender all quantities of currently held furanyl fentanyl.
3. Security. Furanyl fentanyl is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821,
823, 871(b), and in accordance with 21 CFR 1301.71-1301.93, as of
November 29, 2016.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of furanyl 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 November 29, 2016, to
comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of
furanyl fentanyl on the effective date of this order must take an
inventory of all stocks of this substance on hand, pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11. Current DEA registrants shall have 30 calendar days from the
effective date of this order to be in compliance with all inventory
requirements. After the initial inventory, every DEA registrant must
take an inventory of all controlled substances (including furanyl
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 furanyl fentanyl pursuant to 21 U.S.C. 827 and 958, and in
accordance with 21 CFR parts 1304, and 1312, 1317 and Sec. 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
furanyl fentanyl must submit reports pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR parts 1304, and 1312 as of November 29, 2016.
8. Order Forms. All DEA registrants who distribute furanyl fentanyl
must comply with order form requirements pursuant to 21 U.S.C. 828 and
in accordance with 21 CFR part 1305 as of November 29, 2016.
9. Importation and Exportation. All importation and exportation of
furanyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957,
958, and in accordance with 21 CFR part 1312 as of November 29, 2016.
10. Quota. Only DEA registered manufacturers may manufacture
furanyl fentanyl in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21 CFR part 1303 as of November 29,
2016.
11. Liability. Any activity involving furanyl fentanyl not
authorized by, or in violation of the CSA, occurring as of November 29,
2016, 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 (OMB).
[[Page 85877]]
This action will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Therefore, in accordance with Executive Order
13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.
As noted above, this action is an order, not a rule. Accordingly,
the Congressional Review Act (CRA) is inapplicable, as it applies only
to rules. However, if this were a rule, pursuant to the Congressional
Review Act, ``any rule for which an agency for good cause finds that
notice and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest, shall take effect at such time as the
federal agency promulgating the rule determines.'' 5 U.S.C. 808(2). It
is in the public interest to schedule this substance immediately to
avoid an imminent hazard to the public safety. This temporary
scheduling action is taken pursuant to 21 U.S.C. 811(h), which is
specifically designed to enable the DEA to act in an expeditious manner
to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)
exempts the temporary scheduling order from standard notice and comment
rulemaking procedures to ensure that the process moves swiftly. For the
same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to
move quickly to place this substance 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 final 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.
0
For the reasons set out above, the DEA amends 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. Amend Sec. 1308.11 by adding paragraph (h)(19) to read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(h) * * *
(19) N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide, its
isomers, esters, ethers, salts and salts of isomers, esters and ethers
(Other name: Furanyl fentanyl) (9834).
Dated: November 22, 2016
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-28693 Filed 11-28-16; 8:45 am]
BILLING CODE 4410-09-P
