81 FR 58834 - Schedules of Controlled Substances: Placement of Thiafentanil Into Schedule II

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 166 (August 26, 2016)

Page Range		58834-58840
FR Document		2016-20463

The Drug Enforcement Administration is placing the substance thiafentanil (4-(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1-[2- (thienyl)ethyl]piperidine), including its isomers, esters, ethers, salts and salts of isomers, esters and ethers as possible, into schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015.

Federal Register, Volume 81 Issue 166 (Friday, August 26, 2016)

[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Rules and Regulations]
[Pages 58834-58840]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-20463]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301, 1305, and 1308

[Docket No. DEA-375]

Schedules of Controlled Substances: Placement of Thiafentanil
Into Schedule II

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Interim final rule with request for comments.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration is placing the substance
thiafentanil (4-(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1-[2-
(thienyl)ethyl]piperidine), including its isomers, esters, ethers,
salts and salts of isomers, esters and ethers as possible, into
schedule II of the Controlled Substances Act. This scheduling action is
pursuant to the Controlled Substances Act, as revised by the Improving
Regulatory Transparency for New Medical Therapies Act which was signed
into law on November 25, 2015.

DATES: The effective date of this rule is August 26, 2016. Interested
persons may file written comments on this rule in accordance with 21
U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be
submitted, and written comments must be postmarked, on or before
September 26, 2016. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after 11:59
p.m. Eastern Time on the last day of the comment period.
Interested persons, defined at 21 CFR 1300.01 as those ``adversely
affected or aggrieved by any rule or proposed rule issuable pursuant to
section 201 of the Act (21 U.S.C. 811),'' may file a request for
hearing or waiver of hearing pursuant to 21 CFR 1308.44 and in
accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests
for hearing and waivers of an opportunity for a hearing or to
participate in a hearing must be received on or before September 26,
2016.

ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-375'' on all correspondence, including any
attachments.
Electronic comments: The Drug Enforcement Administration
encourages that all comments be submitted electronically through the
Federal eRulemaking Portal, which provides the ability to type short
comments directly into the comment field on the Web page or attach a
file for lengthier comments. Please go to http://www.regulations.gov
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number for your comment. Please be aware that
submitted comments are not instantaneously available for public view on
Regulations.gov. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments that duplicate the
electronic submission are not necessary and are discouraged. Should you
wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attn: DEA Federal Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia 22152.
Hearing requests: All requests for hearing and waivers of
participation must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing and waivers of participation should also be sent
to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug
Enforcement Administration, Attn: DEA Federal Register Representative/
ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received are considered part of the
public record. They will, unless reasonable cause is given, be made
available by the Drug Enforcement

[[Page 58835]]

Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter. The Freedom of Information Act (FOIA) applies to all
comments received. If you want to submit personal identifying
information (such as your name, address, etc.) as part of your comment,
but do not want it to be made publicly available, you must include the
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of
your comment. You must also place all of the personal identifying
information you do not want made publicly available in the first
paragraph of your comment and identify what information you want
redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
Comments containing personal identifying information and
confidential business information identified as directed above will
generally be made publicly available in redacted form. If a comment has
so much confidential business information or personal identifying
information that it cannot be effectively redacted, all or part of that
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information
(such as name, address, and phone number) included in the text of your
electronic submission that is not identified as directed above as
confidential.
An electronic copy of this document and supplemental information,
including the complete Department of Health and Human Services and Drug
Enforcement Administration eight-factor analyses, to this interim final
rule are available at http://www.regulations.gov for easy reference.

Request for Hearing, Notice of Appearance at Hearing, or Waiver of
Participation in Hearing

Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking
``on the record after opportunity for a hearing.'' Such proceedings are
conducted pursuant to the provisions of the Administrative Procedure
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316,
subpart D. In accordance with 21 CFR 1308.44(a)-(c), requests for a
hearing, notices of appearance, and waivers of an opportunity for a
hearing or to participate in a hearing may be submitted only by
interested persons, defined as those ``adversely affected or aggrieved
by any rule or proposed rule issuable pursuant to section 201 of the
Act (21 U.S.C. 811).'' 21 CFR 1300.01. Requests for a hearing and
notices of participation must conform to the requirements of 21 CFR
1308.44(a) or (b), as applicable, and include a statement of the
interest of the person in the proceeding and the objections or issues,
if any, concerning which the person desires to be heard. Any waiver of
an opportunity for a hearing must conform to the requirements of 21 CFR
1308.44(c), including a written statement regarding the interested
person's position on the matters of fact and law involved in any
hearing.
Please note that pursuant to 21 U.S.C. 811(a), the purpose and
subject matter of the hearing are restricted to ``(A) find[ing] that
such drug or other substance has a potential for abuse, and (B)
mak[ing] with respect to such drug or other substance the findings
prescribed by subsection (b) of section 812 of this title for the
schedule in which such drug is to be placed . . . .'' Requests for a
hearing and waivers of participation in the hearing should be submitted
to the DEA on or before the deadline specified above, using the address
information provided therein.

Background, Legal Authority, and Basis for This Scheduling Action

Thiafentanil, known chemically as 4-(methoxycarbonyl)-4-(N-
phenylmethoxyacetamido)-1-[2-(2-thienyl)ethyl]piperidine, a potent
opioid, is an analogue of fentanyl. The product Thianil (thiafentanil
oxalate, a salt form of thiafentanil) was reviewed by the Food and Drug
Administration (FDA) to determine whether it meets the requirements for
addition to the Index of Legally Marketed Unapproved New Animal Drugs
for Minor Species (the Index) (21 U.S.C. 360ccc-1) as set forth by the
Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act, 2004).
The MUMS Act amended the Federal Food, Drug, and Cosmetic Act (FDCA) to
allow for the legal marketing of unapproved new animal drugs intended
for use in minor species. In a letter from the Department of Health and
Human Services (HHS) dated June 20, 2016, the DEA received notification
that HHS/FDA added Thianil (thiafentanil oxalate) to the Index under
section 572 of the FDCA. In this same notification, HHS/FDA stated that
on June 16, 2016, HHS/FDA granted the request for the addition of
Thianil to the Index under Minor Species Index File (MIF) 900000.
Thianil is indicated for use in the immobilization of non-domestic,
non-food-producing minor species hoofstock.
Thiafentanil will be marketed as thiafentanil oxalate, 4-
(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-
thienyl)ethyl]piperidinium oxalate. Thiafentanil should not be confused
with thiofentanyl (N-phenyl-N-(1-(2-(thiophen-2-yl)ethyl)piperidin-4-
yl)propionamide), which is currently listed as a controlled schedule I
substance.
Under the Controlled Substances Act (CSA), as amended in 2015 by
the Improving Regulatory Transparency for New Medical Therapies Act
(Pub. L. 114-89), where the DEA receives notification from HHS that the
Secretary has indexed a drug under section 572 of the FDCA, the DEA is
required to issue an interim final rule controlling the drug not later
than 90 days after receiving such notification from HHS. 21 U.S.C.
811(j). Accordingly, the DEA is issuing this interim final rule
controlling thiafentanil.
When controlling a drug pursuant to section 811(j), the DEA must
apply the scheduling criteria of subsections 811(b), (c), and (d) and
section 812(b). 21 U.S.C. 811(j)(3). In accordance with these criteria,
the DEA has reviewed the scientific and medical evaluation and
scheduling recommendation provided by the HHS, along with all other
relevant data, and completed its own eight-factor review document on
thiafentanil pursuant to 21 U.S.C. 811(c). As explained below, based on
these considerations, the DEA concludes that thiafentanil meets the
criteria for placement in schedule II of the CSA.
On November 28, 2011, the HHS provided the DEA with its initial
scientific and medical evaluation and scheduling recommendation
regarding thiafentanil. Pursuant to 21 U.S.C. 811(b), this document
contained an eight-factor analysis of the abuse potential of
thiafentanil as a new drug, along with the HHS' recommendation to
control thiafentanil and its salts under schedule II of the CSA.
Subsequently, on March 23, 2016, the HHS provided the DEA with a
supplement to its 2011 analysis, which indicated that the HHS/FDA
planned to add Thianil (thiafentanil oxalate) to the Index for use in
the immobilization of non-domestic, non-food-producing minor species
hoofstock and reiterated their recommendation that thiafentanil be
placed in schedule II of the CSA. By

[[Page 58836]]

letter dated June 20, 2016, the DEA received notification from the HHS
that the FDA had granted the request on June 16, 2016, for Thianil
(thiafentanil oxalate) to be added to the Index.
Pursuant to 21 U.S.C. 811(j), and based on the HHS recommendation,
MUMS Act indication by the HHS/FDA, and the DEA's determination, the
DEA finds that thiafentanil has a high potential for abuse, a currently
accepted medical use with severe restrictions, and that abuse of
thiafentanil may lead to severe psychological or physical dependence.
Accordingly, the DEA is issuing this interim final rule to add
thiafentanil (4-(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-
thienyl)ethyl]piperidine) and its isomers, esters, ethers, salts and
salts of isomers, esters and ethers, whenever the existence of such, to
schedule II of the CSA.
Included below is a brief summary of each factor as analyzed by the
HHS and the DEA, and as considered by the DEA in its scheduling action.
Please note that the DEA and HHS analyses, along with the HHS
supplement, are available in their entirety under ``Supporting
Documents'' in the public docket for this interim final rule at http://www.regulations.gov, under Docket Number ``DEA-375.'' Full analysis of,
and citations to, the information referenced in the summary may also be
found in the supporting and related material.
1. The Drug's Actual or Relative Potential for Abuse: Thiafentanil
is a chemical substance that has not been marketed in the United
States, however, it is approved and marketed in the Republic of South
Africa as a salt form under the brand name Thianil (thiafentanil
oxalate). There is no information available which details actual abuse
of thiafentanil.
According to the HHS, thiafentanil is a synthetic analogue of
fentanyl and is structurally related to other fentanyl-like opioids
such as sufentanil (schedule II) and carfentanil (schedule II). It acts
as a potent [micro]-opioid receptor agonist and produces strong
morphine-like effects in animals. It is only intended for the
immobilization of non-domestic, non-food-producing minor species
hoofstock. Thiafentanil has been used in a manner similar to other
opioid immobilizing agents such as etorphine hydrochloride (schedule
II) and carfentanil (schedule II), which are approved only for
veterinary use as animal immobilization agents. The abuse potential of
thiafentanil has not been evaluated in humans or in animal behavioral
models that are predictors of abuse by humans. Because thiafentanil
shares chemical and pharmacological similarities with schedule II
fentanyl and its analogues, the abuse potential of thiafentanil is
considered similar to that of schedule II opioid substances such as
sufentanil and carfentanil.
Pharmacologically, as a potent [micro] opioid receptor agonist,
thiafentanil is slightly less potent than carfentanil, which is 100
times more potent than fentanyl and 10,000 times more potent than
morphine. Thiafentanil is a potent fentanyl analogue. Thus, it is
reasonable to assume that there will be potentially significant
diversion of thiafentanil from legitimate channels by people who have
access to it, and that thiafentanil would be used without medical
advice, therefore causing substantial hazards to the users or to the
safety of the community if not controlled. The chemical and potent
opioid-like pharmacological properties of thiafentanil predict that its
risk to the public health is likely to be similar to fentanyl (schedule
II) and its analogues such as carfentanil (schedule II), sufentanil
(schedule II) and alpha-methylfentanyl (schedule I).
2. Scientific Evidence of the Drug's Pharmacological Effects, if
Known: According to HHS' scientific and medical review, there are no
data on the effects of thiafentanil in humans. Thiafentanil's effects
in humans are predicted from its effects in animals and its chemical
and pharmacological similarity to other schedule II potent opioids such
as fentanyl and carfentanil.
The HHS eight-factor review document described a study directly
comparing the immobilizing effects of thiafentanil (15 mg) and
carfentanil (2 or 4 mg) in elk in which thiafentanil produced a faster
immobilization effect (0.7 to 2.2 minutes) than carfentanil. In
addition, the elk returned to standing 0.9 to 1.4 minutes faster under
the thiafentanil condition. This study appears to support a faster
immobilization and recovery time with thiafentanil relative to
carfentanil. However, the authors stated that the role of the increased
dose of thiafentanil is unknown.
Animal studies described by the HHS demonstrated that the effects
of thiafentanil and carfentanil are completely reversed by naltrexone.
As a [micro]-opioid receptor antagonist, naltrexone can reverse the
effects of a variety of opioid drugs including thiafentanil and
carfentanil. Those studies suggest that thiafentanil possesses a neuro-
pharmacological mechanism of action similar to other schedule II opioid
drugs with a high abuse potential.
According to HHS' review, Thianil (thiafentanil) is currently
approved and registered for use in the Republic of South Africa.
Thiafentanil oxalate is suggested as a drug of choice in the capture of
exotic and ungulate wildlife species.
3. The State of Current Scientific Knowledge Regarding
Thiafentanil: The chemical name of free base thiafentanil is 4-
(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-
thienyl)ethyl]piperidine. It has a molecular formula of
C22H28N2O4S and a molecular
weight of 416.52 g/mol with a Chemical Abstract Registry Number (CAS)
of 101345-60-2. Thiafentanil oxalate is also known as A3080 with a CAS
number of 101365-73-5 and has a molecular formula of
C24H30N2O8S with a
molecular weight of 506.57 g/mol. Thiafentanil oxalate is a white
crystalline powder with a melting point of 190-192 [deg]C and its salt
crystalizes from absolute alcohol. Thiafentanil should not be confused
with thiofentanyl (N-phenyl-N-(1-(2-(thiophen-2-yl)ethyl)piperidin-4-
yl)propionamide), which is currently listed as a schedule I substance.
4. Its History and Current Pattern of Abuse: According to the HHS'
review, there are no reports of actual abuse and misuse of
thiafentanil. This may be due to the limited use of thiafentanil as an
immobilizing agent by trained veterinarians.
Current data from the National Forensic Laboratory System
(NFLIS),\1\ the System to Retrieve Information from Drug Evidence
(STRIDE),\2\ and the STARLiMS databases show that there is no evidence
of law enforcement encounters of thiafentanil in the United States.
However, thiafentanil's pharmacological and structural properties
suggest that its pattern of abuse would be similar to other potent

[[Page 58837]]

schedule II [micro]-opioid receptor agonists such as fentanyl and
carfentanil.
---------------------------------------------------------------------------

\1\ The National Forensic Laboratory System (NFLIS) is a program
of the DEA, Office of Diversion Control. NFLIS systematically
collects drug identification results and associated information from
drug cases submitted to and analyzed by State and local forensic
laboratories. NFLIS represents an important resource in monitoring
illicit drug abuse and trafficking, including the diversion of
legally manufactured pharmaceuticals into illegal markets. NFLIS is
a comprehensive information system that includes data from forensic
laboratories that handle approximately 90% of an estimated 1.0
million distinct annual State and local drug analysis cases. NFLIS
includes drug chemistry results from completed analyses only. While
NFLIS data is not direct evidence of abuse, it can lead to an
inference that a drug has been diverted and abused. See 76 FR 77330,
77332, Dec. 12, 2011.
\2\ The System to Retrieve Information from Drug Evidence
(STRIDE) is a database of drug exhibits sent to DEA laboratories for
analysis. Exhibits from the database are from the DEA, other federal
agencies, and local law enforcement agencies. Reporting via STRIDE
ceased on September 30, 2014. STRIDE was succeeded by STARLiMS.
---------------------------------------------------------------------------

5. The Scope, Duration, and Significance of Abuse: An assessment of
the scope, duration, and significance of thiafentanil abuse is not
available since it has only been used in a limited market. However, as
stated in the HHS review, the structural and pharmacological properties
of thiafentanil suggest that it could lead to an abuse pattern with a
scope, duration, and significance of abuse similar to that observed
with other opioid drugs and opioid analogues if it were marketed in a
non-controlled status or were the subject of clandestine synthesis. The
HHS and DEA note that thiafentanil is not known to be or to have been
the subject of abuse in the United States.
6. What, if any, Risk There is to the Public Health: The HHS review
indicates that thiafentanil presents a significant risk to the public
health and, in this vein, that thiafentanil should only be used in
certain animals for very limited purposes and with extreme caution.
Based on the review of the structural and pharmacological properties of
thiafentanil, the HHS concluded that the abuse of thiafentanil is
likely to pose a similar risk to public health as that of other potent
opioid drugs such as sufentanil (schedule II), fentanyl (schedule II),
carfentanil (schedule II) and clandestinely synthesized alpha-
methylfentanyl (schedule I). Thus, inappropriate use of thiafentanil
poses a high risk to the public health. Among other things, HHS noted
that as a fentanyl derivative, and assuming that thiafentanil can be
aerosolized, the use of thiafentanil presents a significant risk to the
public health.
HHS described that thiafentanil's labeling indicates that it is
solely intended for use by zoologic, wildlife, or exotic animal
veterinarians or field biologists who have received training and are
supervised by veterinarians. The sponsor recommends the use of handling
protocols similar to those in place for other scheduled potent opioids
such as carfentanil. HHS further indicated that thiafentanil should be
handled in teams consisting of at least two individuals knowledgeable
about the hazards of working with potent [mu]-opioid agonist
substances. Personal protective equipment such as latex gloves and
protective eyewear should be used and syringes must be disposed of
properly. If exposure to thiafentanil occurs in a remote or distant
environment, veterinary naltrexone is recommended for use as a reversal
agent. The label information will further state that thiafentanil must
never be used unless an adequate amount of reversal agent (naltrexone
hydrochloride) is immediately available.
HHS also describes the risk of thiafentanil intoxication upon
ingestion of animals immobilized with thiafentanil. The label
information states that thiafentanil is not intended for human or
animal consumption or in non-food producing minor species that become
eligible for consumption by humans or food-producing animals. Because
thiafentanil, similar to carfentanil, etorphine hydrochloride and
diprenorphine, is a potent [mu]-opioid receptor agonist, it will be
subject to specialized handling, distribution and storage procedures
similar to those applicable for carfentanil, etorphine hydrochloride
and diprenorphine as set forth in 21 CFR parts 1301 and 1305. As a
result, this interim final rule revises 21 CFR 1301.74(g), 1301.75(e),
1305.07 introductory text and paragraph (a), and 1305.17(d) to include
``thiafentanil.''
7. Its Psychic or Physiological Dependence Liability: HHS' review
states that the structural and pharmacological properties of
thiafentanil suggest that it possesses a psychic and physiological
dependence liability that is similar to other schedule II related
[micro]-opioid receptor agonist drugs such as sufentanil, fentanyl and
carfentanil.
As cited by the HHS review, a double-blind abuse liability study
examining intravenous fentanyl, buprenorphine, heroin, morphine, and
oxycodone in methadone-maintained patients reported that fentanyl
produced subjective effects similar to heroin (schedule I) on several
outcome measures indicating that the two drugs produce similar
subjective effects. It also demonstrates the psychic dependence
liability of fentanyl, and thiafentanil is expected to produce effects
similar to fentanyl and to present a similar risk of psychic and
physiological dependence. There has been a major increase in abuse of
opioids analgesics in the United States (HHS review document, 2011;
Compton and Volkow, 2006). Thiafentanil, similar to these opioid
analgesics, presents a risk of severe psychic and physiological
dependence.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled under the CSA: Thiafentanil is not considered an
immediate precursor of any controlled substance.

Determination of Appropriate Schedule

The CSA lists the findings required to place a drug or other
substance in any particular schedule (I, II, III, IV, or V). 21 U.S.C.
812(b). After consideration of the analysis and recommendation of the
Assistant Secretary for Health of the HHS and review of all available
data, the Acting Administrator of the DEA, pursuant to 21 U.S.C.
812(b)(2), finds that:
1. Thiafentanil has a high potential for abuse. Based on its
structural and pharmacological properties, thiafentanil has an abuse
potential that is comparable to other schedule II opioid drugs such as
fentanyl, carfentanil, and sufentanil;
2. FDA determined that Thianil (thiafentanil oxalate) meets the
requirements for addition to the Index as set forth by the MUMS Act,
2004 and accordingly added Thianil (thiafentanil oxalate) to the Index
of Legally Marketed Unapproved New Animal Drugs for Minor Species (the
Index) under section 572 of the Federal Food, Drug, and Cosmetic Act.
Thianil (thiafentanil oxalate) will be legally marketed in the United
States and will have an accepted medical use with severe restrictions;
\3\ and
---------------------------------------------------------------------------

\3\ According to the HHS analysis, ``[u]se of a new animal
indexed drug is subject to significant restrictions. For example,
use of an indexed new animal drug for minor species is limited to a
minor species for which there is a reasonable certainty that the
animal or edible products from the animal will not be consumed by
humans or food producing animals. 21 U.S.C. Sec. 360ccc-l(a)(1).
The requester must label, distribute, and promote the new animal
drug in accordance with the Index entry, and the FDA may remove a
new animal drug from the Index if the conditions and limitations of
use have not been followed. 21 U.S.C. 360ccc-l(d)(l)(G); (f)(l)(F).
The labeling of an indexed new animal drug must prominently state
that the extra-label use of the product is prohibited. 21 U.S.C.
360ccc-l(h). Such restrictions are not imposed upon approved human
or animal drugs.''
---------------------------------------------------------------------------

3. Due to the chemical and pharmacological similarities of
thiafentanil to other schedule II fentanyl derivatives, abuse of
thiafentanil may lead to severe psychological or physical dependence.
Based on these findings, the Acting Administrator of the DEA
concludes that thiafentanil, including its isomers, esters, ethers,
salts and salts of isomers, esters and ethers whenever the existences
of such isomers, esters, ethers, and salts is possible warrants control
in schedule II of the CSA. 21 U.S.C. 812(b)(2).

Requirements for Handling Thiafentanil

Thiafentanil is subject to the CSA's schedule II regulatory
controls and administrative, civil, and criminal sanctions applicable
to the manufacture, distribution, reverse distribution, dispensing,
importing, exporting, research, and conduct of instructional

[[Page 58838]]

activities and chemical analysis with, and possession involving
schedule II substances, including the following:
1. Registration. Any person who desires to handle thiafentanil
(manufacture, distribute, reverse distribute, dispense, import, export,
engage in research, or conduct instructional activities or chemical
analysis with, or possess), 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.
2. Quota. Only registered manufacturers are permitted to
manufacture thiafentanil in accordance with a quota assigned pursuant
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
3. Disposal of stocks. Upon obtaining a schedule II registration to
handle thiafentanil, and if subsequently, any person who does not
desire or is not able to maintain a schedule II registration must
surrender all quantities of currently held thiafentanil, or may
transfer all quantities of currently held thiafentanil to a person
registered with the DEA in accordance with 21 CFR part 1317, in
addition to all other applicable federal, state, local, and tribal
laws.
4. Security. Thiafentanil is subject to schedule II security
requirements and must be handled and stored pursuant to 21 U.S.C. 821
and 823, and in accordance with 21 CFR 1301.71-1301.93.
5. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of thiafentanil must comply with 21 U.S.C. 825
and 958(e), and be in accordance with 21 CFR part 1302. In addition,
thiafentanil is subject to additional labeling requirements provided by
FDA. Thiafentanil must be labeled, distributed, and promoted in
accordance with the Index entry of the new animal drug and the FDA may
remove a new animal drug from the Index if the conditions and
limitations of use have not been followed. 21 U.S.C. 360ccc-l(d)(l)(G);
(f)(l)(F). The labeling of an indexed new animal drug must prominently
state that the extra-label use of the product is prohibited. 21 U.S.C.
360ccc-l(h).
6. Inventory. Every DEA registrant who desires to possess any
quantity of thiafentanil must take an inventory of thiafentanil on
hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
Any person who becomes registered with the DEA to handle
thiafentanil must take an initial inventory of all stocks of controlled
substances (including thiafentanil) on hand on the date the registrant
first engages in the handling of controlled substances, pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of controlled substances (including
thiafentanil) on hand every two years, pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant must maintain records
and submit reports for thiafentanil, or products containing
thiafentanil, pursuant to 21 U.S.C. 827 and 958(e), and in accordance
with 21 CFR parts 1304, 1312, and 1317.
8. Orders for thiafentanil. Every DEA registrant who distributes
thiafentanil is required to comply with order form requirements,
pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.
9. Prescriptions and other dispensing. All prescriptions for
thiafentanil or products containing thiafentanil must comply with 21
U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and
1311, subpart C. Moreover, given that thiafentanil is not the subject
of an approved new drug application under the FDCA, and that it is only
allowed under the MUMS Act amendments to the FDCA to be marketed for
extremely limited use in minor species, DEA would not consider any
dispensing of thiafentanil for human use to be for a legitimate medical
purpose within the meaning of the CSA. Likewise, DEA would not consider
any dispensing of thiafentanil for animal use beyond the scope of the
drug's labeling authorized under the MUMS Act amendments to the FDCA to
be for a legitimate medical purpose within the meaning of the CSA.
10. Manufacturing and Distributing. In addition to the general
requirements of the CSA and DEA regulations that are applicable to
manufacturers and distributors of schedule II controlled substances,
such registrants should be advised that (consistent with the foregoing
considerations) any manufacturing or distribution of thiafentanil may
only be for the legitimate purposes consistent with the drug's labeling
authorized under the MUMS Act, or for research activities authorized by
the FDCA and CSA.
11. Importation and Exportation. All importation and exportation of
thiafentanil must be in compliance with 21 U.S.C. 952, 953, 957, and
958, and in accordance with 21 CFR part 1312.
12. Liability. Any activity involving thiafentanil not authorized
by, or in violation of, the CSA or its implementing regulations, is
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.

Regulatory Analyses

Administrative Procedure Act

Public Law 114-89 was signed into law, amending 21 U.S.C. 811. This
amendment provides that in cases where a new drug is (1) approved or
indexed by the Department of Health and Human Services (HHS) and (2)
HHS recommends control in CSA schedule II-V, the DEA shall issue an
interim final rule scheduling the drug within 90 days. Additionally,
the law specifies that the rulemaking shall become immediately
effective as an interim final rule without requiring the DEA to
demonstrate good cause. Therefore, the DEA has determined that the
notice and comment requirements of section 553 of the APA, 5 U.S.C.
553, do not apply to this scheduling action.

Executive Orders 12866, Regulatory Planning and Review, and 13563,
Improving Regulation and Regulatory Review

In accordance with Public Law 114-89, this scheduling action is
subject to formal rulemaking procedures performed ``on the record after
opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures
and criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order 12866 and the principles
reaffirmed in Executive Order 13563.

Executive Order 12988, Civil Justice Reform

This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate
drafting errors and ambiguity, minimize litigation, provide a clear
legal standard for affected conduct, and promote simplification and
burden reduction.

Executive Order 13132, Federalism

This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does 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

[[Page 58839]]

responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments

This rule does not have tribal implications warranting the
application of Executive Order 13175. It does not have substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes.

Regulatory Flexibility Act

In accordance with 5 U.S.C. 603(a), ``[w]henever an agency is
required by [5 U.S.C. 553], or any other law, to publish general notice
of proposed rulemaking for any proposed rule, or publishes a notice of
proposed rulemaking for an interpretive rule involving the internal
revenue laws of the United States, the agency shall prepare and make
available for public comment an initial regulatory flexibility
analysis.'' As noted in the above discussion regarding applicability of
the Administrative Procedure Act, the DEA has determined that the
notice and comment requirements of section 553 of the APA, 5 U.S.C.
553, do not apply to this scheduling action. Consequently, the RFA does
not apply to this interim final rule.

Unfunded Mandates Reform Act of 1995

In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., the DEA has determined and certifies that this
action would not result in any Federal mandate that may result ``in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted for
inflation) in any one year.'' Therefore, neither a Small Government
Agency Plan nor any other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action would not impose recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number.

Congressional Review Act

This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act (CRA)). This rule will not result in: An
annual effect on the economy of $100,000,000 or more; a major increase
in costs or prices for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of U.S.-based companies to
compete with foreign based companies in domestic and export markets.
However, pursuant to the CRA, the DEA has submitted a copy of this
interim final rule to both Houses of Congress and to the Comptroller
General.

List of Subjects

21 CFR Part 1301

Administrative practice and procedure, Drug traffic control,
Security measures.

21 CFR Part 1305

Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1308

Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.

For the reasons set out above, the DEA amends 21 CFR parts 1301,
1305 and 1308 as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1301 continues to read as
follows:

Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 953, 956, 957, 958, 965.

0
2. In Sec. 1301.74, revise paragraph (g) to read as follows:

Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs.

* * * * *
(g) Before the initial distribution of thiafentanil, carfentanil,
etorphine hydrochloride and/or diprenorphine to any person, the
registrant must verify that the person is authorized to handle the
substance(s) by contacting the Drug Enforcement Administration.
* * * * *

0
3. In Sec. 1301.75, revise paragraph (e) to read as follows:

Sec. 1301.75 Physical security controls for practitioners.

* * * * *
(e) Thiafentanil, carfentanil, etorphine hydrochloride and
diprenorphine shall be stored in a safe or steel cabinet equivalent to
a U.S. Government Class V security container.

PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

0
4. The authority citation for 21 CFR part 1305 continues to read as
follows:

Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.

0
5. In Sec. 1305.07, revise the introductory text and paragraph (a) to
read as follows:

Sec. 1305.07 Special procedure for filling certain orders.

A supplier of thiafentanil, carfentanil, etorphine hydrochloride,
or diprenorphine, if he or she determines that the purchaser is a
veterinarian engaged in zoo and exotic animal practice, wildlife
management programs, or research, and is authorized by the
Administrator to handle these substances, may fill the order in
accordance with the procedures set forth in Sec. 1305.17 except that:
(a) A DEA Form 222 or an electronic order for thiafentanil,
carfentanil, etorphine hydrochloride, and diprenorphine must contain
only these substances in reasonable quantities.
* * * * *

0
6. In Sec. 1305.17, revise paragraph (d) to read as follows:

Sec. 1305.17 Preservation of DEA Forms 222.

* * * * *
(d) The supplier of thiafentanil, carfentanil, etorphine
hydrochloride, and diprenorphine must maintain DEA Forms 222 for these
substances separately from all other DEA Forms 222 and records required
to be maintained by the registrant.

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
7. The authority citation for 21 CFR part 1308 continues to read as
follows:

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

0
8. In Sec. 1308.12, add paragraph (c)(29) to read as follows:

Sec. 1308.12 Schedule II.

* * * * *
(c) * * *

(29) Thiafentanil............................................... 9729

* * * * *

[[Page 58840]]

Dated: August 18, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-20463 Filed 8-25-16; 8:45 am]
BILLING CODE 4410-09-P

58834 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations

■ 10. Amend § 143.23 by revising § 145.31 [Amended] for a hearing or to participate in a
paragraph (j) and adding paragraph (k) ■ 13. Amend § 145.31 by removing the hearing must be received on or before
to read as follows: figure ‘‘$200’’ and adding in its place September 26, 2016.
‘‘$800’’ in the section heading and text. ADDRESSES: To ensure proper handling
§ 143.23 Form of entry.
of comments, please reference ‘‘Docket
* * * * * R. Gil Kerlikowske, No. DEA–375’’ on all correspondence,
(j) Except for mail importations (see Commissioner, U.S. Customs and Border including any attachments.
§§ 145.31 and 145.32 of this chapter), or Protection. • Electronic comments: The Drug
in the case of personal written or oral Approved: August 23, 2016. Enforcement Administration encourages
declarations (see §§ 148.12, 148.13, and Timothy E. Skud, that all comments be submitted
148.62 of this chapter), a shipment of Assistant Secretary of the Treasury. electronically through the Federal
merchandise that qualifies for informal [FR Doc. 2016–20581 Filed 8–25–16; 8:45 am] eRulemaking Portal, which provides the
entry under 19 U.S.C. 1498 may be BILLING CODE 9111–14–P ability to type short comments directly
entered, including the information into the comment field on the Web page
listed in paragraph (k) of this section, by or attach a file for lengthier comments.
presenting the bill of lading or a DEPARTMENT OF JUSTICE Please go to http://www.regulations.gov
manifest listing each bill of lading and follow the online instructions at
when: Drug Enforcement Administration that site for submitting comments. Upon
(1) The value of the shipment does completion of your submission, you will
not exceed $100 in the case of a bona 21 CFR Parts 1301, 1305, and 1308 receive a Comment Tracking Number for
fide gift from a person in a foreign your comment. Please be aware that
[Docket No. DEA–375]
country to a person in the United States submitted comments are not
and the shipment meets the Schedules of Controlled Substances: instantaneously available for public
requirements in § 10.152 of this chapter Placement of Thiafentanil Into view on Regulations.gov. If you have
(see § 10.152 of this chapter); Schedule II received a Comment Tracking Number,
your comment has been successfully
(2) The value of the shipment does AGENCY: Drug Enforcement submitted and there is no need to
not exceed $200 in the case of articles Administration, Department of Justice. resubmit the same comment.
(including bona fide gifts) from the • Paper comments: Paper comments
ACTION: Interim final rule with request
Virgin Islands, Guam, and American that duplicate the electronic submission
for comments.
Samoa and the shipment meets the are not necessary and are discouraged.
requirements in § 10.152 of this chapter SUMMARY: The Drug Enforcement Should you wish to mail a paper
(see § 10.152 of this chapter); or Administration is placing the substance comment in lieu of an electronic
(3) The value of the shipment does thiafentanil (4-(methoxycarbonyl)-4-(N- comment, it should be sent via regular
not exceed $800 and the shipment phenmethoxyacetamido)-1-[2- or express mail to: Drug Enforcement
satisfies the requirements in § 10.151 of (thienyl)ethyl]piperidine), including its Administration, Attn: DEA Federal
this chapter (see §§ 10.151 and 128.24(e) isomers, esters, ethers, salts and salts of Register Representative/ODW, 8701
of this chapter). isomers, esters and ethers as possible, Morrissette Drive, Springfield, Virginia
(k) The following information is into schedule II of the Controlled 22152.
required to be filed as a part of entry Substances Act. This scheduling action • Hearing requests: All requests for
made under paragraph (j) of this section: is pursuant to the Controlled Substances hearing and waivers of participation
Act, as revised by the Improving must be sent to: Drug Enforcement
(1) Country of origin of the Regulatory Transparency for New Administration, Attn: Administrator,
merchandise; Medical Therapies Act which was 8701 Morrissette Drive, Springfield,
(2) Shipper name, address and signed into law on November 25, 2015. Virginia 22152. All requests for hearing
country; DATES: The effective date of this rule is and waivers of participation should also
(3) Ultimate consignee name and August 26, 2016. Interested persons may be sent to: (1) Drug Enforcement
address; file written comments on this rule in Administration, Attn: Hearing Clerk/LJ,
accordance with 21 U.S.C. 811(j)(3) and 8701 Morrissette Drive, Springfield,
(4) Specific description of the Virginia 22152; and (2) Drug
merchandise; 21 CFR 1308.43(g). Electronic comments
must be submitted, and written Enforcement Administration, Attn: DEA
(5) Quantity; comments must be postmarked, on or Federal Register Representative/ODW,
(6) Shipping weight; and before September 26, 2016. Commenters 8701 Morrissette Drive, Springfield,
should be aware that the electronic Virginia 22152.
(7) Value.
Federal Docket Management System FOR FURTHER INFORMATION CONTACT:
■ 11. Amend § 143.26 by removing the will not accept comments after 11:59 Michael J. Lewis, Office of Diversion
figure ‘‘$200’’ and adding in its place p.m. Eastern Time on the last day of the Control, Drug Enforcement
‘‘$800’’ in two places each in paragraphs comment period. Administration; Mailing Address: 8701
(a) and (b). Interested persons, defined at 21 CFR Morrissette Drive, Springfield, Virginia
1300.01 as those ‘‘adversely affected or 22152; Telephone: (202) 598–6812.
PART 145—MAIL IMPORTATIONS aggrieved by any rule or proposed rule SUPPLEMENTARY INFORMATION:
issuable pursuant to section 201 of the
ehiers on DSK5VPTVN1PROD with RULES

■ 12. The general authority citation for Act (21 U.S.C. 811),’’ may file a request Posting of Public Comments
part 145 continues to read as follows: for hearing or waiver of hearing Please note that all comments
Authority: 19 U.S.C. 66, 1202 (General pursuant to 21 CFR 1308.44 and in received are considered part of the
Note 3(i), Harmonized Tariff Schedule of the accordance with 21 CFR 1316.45 and/or public record. They will, unless
United States), 1624. 1316.47, as applicable. Requests for reasonable cause is given, be made
* * * * * hearing and waivers of an opportunity available by the Drug Enforcement

VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1

Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations 58835

Administration (DEA) for public (c), requests for a hearing, notices of request for the addition of Thianil to the
inspection online at http:// appearance, and waivers of an Index under Minor Species Index File
www.regulations.gov. Such information opportunity for a hearing or to (MIF) 900000. Thianil is indicated for
includes personal identifying participate in a hearing may be use in the immobilization of non-
information (such as your name, submitted only by interested persons, domestic, non-food-producing minor
address, etc.) voluntarily submitted by defined as those ‘‘adversely affected or species hoofstock.
the commenter. The Freedom of aggrieved by any rule or proposed rule Thiafentanil will be marketed as
Information Act (FOIA) applies to all issuable pursuant to section 201 of the thiafentanil oxalate, 4-
comments received. If you want to Act (21 U.S.C. 811).’’ 21 CFR 1300.01. (methoxycarbonyl)-4-(N-
submit personal identifying information Requests for a hearing and notices of phenylmethoxyacetamido)-1-[2-(2-
(such as your name, address, etc.) as participation must conform to the thienyl)ethyl]piperidinium oxalate.
part of your comment, but do not want requirements of 21 CFR 1308.44(a) or Thiafentanil should not be confused
it to be made publicly available, you (b), as applicable, and include a with thiofentanyl (N-phenyl-N-(1-(2-
must include the phrase ‘‘PERSONAL statement of the interest of the person in (thiophen-2-yl)ethyl)piperidin-4-
IDENTIFYING INFORMATION’’ in the the proceeding and the objections or yl)propionamide), which is currently
first paragraph of your comment. You issues, if any, concerning which the listed as a controlled schedule I
must also place all of the personal person desires to be heard. Any waiver substance.
identifying information you do not want of an opportunity for a hearing must Under the Controlled Substances Act
made publicly available in the first conform to the requirements of 21 CFR (CSA), as amended in 2015 by the
paragraph of your comment and identify 1308.44(c), including a written Improving Regulatory Transparency for
what information you want redacted. statement regarding the interested New Medical Therapies Act (Pub. L.
If you want to submit confidential person’s position on the matters of fact 114–89), where the DEA receives
business information as part of your and law involved in any hearing. notification from HHS that the Secretary
comment, but do not want it to be made Please note that pursuant to 21 U.S.C. has indexed a drug under section 572 of
publicly available, you must include the 811(a), the purpose and subject matter the FDCA, the DEA is required to issue
phrase ‘‘CONFIDENTIAL BUSINESS of the hearing are restricted to ‘‘(A) an interim final rule controlling the
INFORMATION’’ in the first paragraph find[ing] that such drug or other drug not later than 90 days after
of your comment. You must also substance has a potential for abuse, and receiving such notification from HHS.
prominently identify the confidential (B) mak[ing] with respect to such drug 21 U.S.C. 811(j). Accordingly, the DEA
business information to be redacted or other substance the findings is issuing this interim final rule
within the comment. prescribed by subsection (b) of section controlling thiafentanil.
Comments containing personal 812 of this title for the schedule in When controlling a drug pursuant to
identifying information and confidential which such drug is to be placed . . . .’’ section 811(j), the DEA must apply the
business information identified as Requests for a hearing and waivers of scheduling criteria of subsections
directed above will generally be made participation in the hearing should be 811(b), (c), and (d) and section 812(b).
publicly available in redacted form. If a submitted to the DEA on or before the 21 U.S.C. 811(j)(3). In accordance with
comment has so much confidential deadline specified above, using the these criteria, the DEA has reviewed the
business information or personal address information provided therein. scientific and medical evaluation and
identifying information that it cannot be scheduling recommendation provided
effectively redacted, all or part of that Background, Legal Authority, and Basis by the HHS, along with all other
for This Scheduling Action relevant data, and completed its own
comment may not be made publicly
available. Comments posted to http:// Thiafentanil, known chemically as 4- eight-factor review document on
www.regulations.gov may include any (methoxycarbonyl)-4-(N- thiafentanil pursuant to 21 U.S.C.
personal identifying information (such phenylmethoxyacetamido)-1-[2-(2- 811(c). As explained below, based on
as name, address, and phone number) thienyl)ethyl]piperidine, a potent these considerations, the DEA
included in the text of your electronic opioid, is an analogue of fentanyl. The concludes that thiafentanil meets the
submission that is not identified as product Thianil (thiafentanil oxalate, a criteria for placement in schedule II of
directed above as confidential. salt form of thiafentanil) was reviewed the CSA.
An electronic copy of this document by the Food and Drug Administration On November 28, 2011, the HHS
and supplemental information, (FDA) to determine whether it meets the provided the DEA with its initial
including the complete Department of requirements for addition to the Index scientific and medical evaluation and
Health and Human Services and Drug of Legally Marketed Unapproved New scheduling recommendation regarding
Enforcement Administration eight-factor Animal Drugs for Minor Species (the thiafentanil. Pursuant to 21 U.S.C.
analyses, to this interim final rule are Index) (21 U.S.C. 360ccc–1) as set forth 811(b), this document contained an
available at http://www.regulations.gov by the Minor Use and Minor Species eight-factor analysis of the abuse
for easy reference. Animal Health Act of 2004 (MUMS Act, potential of thiafentanil as a new drug,
2004). The MUMS Act amended the along with the HHS’ recommendation to
Request for Hearing, Notice of Federal Food, Drug, and Cosmetic Act control thiafentanil and its salts under
Appearance at Hearing, or Waiver of (FDCA) to allow for the legal marketing schedule II of the CSA. Subsequently,
Participation in Hearing of unapproved new animal drugs on March 23, 2016, the HHS provided
Pursuant to 21 U.S.C. 811(a), this intended for use in minor species. In a the DEA with a supplement to its 2011
action is a formal rulemaking ‘‘on the letter from the Department of Health analysis, which indicated that the HHS/
record after opportunity for a hearing.’’ and Human Services (HHS) dated June FDA planned to add Thianil
ehiers on DSK5VPTVN1PROD with RULES

Such proceedings are conducted 20, 2016, the DEA received notification (thiafentanil oxalate) to the Index for
pursuant to the provisions of the that HHS/FDA added Thianil use in the immobilization of non-
Administrative Procedure Act (APA), 5 (thiafentanil oxalate) to the Index under domestic, non-food-producing minor
U.S.C. 551–559. 21 CFR 1308.41– section 572 of the FDCA. In this same species hoofstock and reiterated their
1308.45; 21 CFR part 1316, subpart D. notification, HHS/FDA stated that on recommendation that thiafentanil be
In accordance with 21 CFR 1308.44(a)– June 16, 2016, HHS/FDA granted the placed in schedule II of the CSA. By

VerDate Sep<11>2014 16:25 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1

Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations 58837

schedule II m-opioid receptor agonists used unless an adequate amount of 21 U.S.C. 812(b). After consideration of
such as fentanyl and carfentanil. reversal agent (naltrexone the analysis and recommendation of the
5. The Scope, Duration, and hydrochloride) is immediately available. Assistant Secretary for Health of the
Significance of Abuse: An assessment of HHS also describes the risk of HHS and review of all available data,
the scope, duration, and significance of thiafentanil intoxication upon ingestion the Acting Administrator of the DEA,
thiafentanil abuse is not available since of animals immobilized with pursuant to 21 U.S.C. 812(b)(2), finds
it has only been used in a limited thiafentanil. The label information that:
market. However, as stated in the HHS states that thiafentanil is not intended 1. Thiafentanil has a high potential for
review, the structural and for human or animal consumption or in abuse. Based on its structural and
pharmacological properties of non-food producing minor species that pharmacological properties, thiafentanil
thiafentanil suggest that it could lead to become eligible for consumption by has an abuse potential that is
an abuse pattern with a scope, duration, humans or food-producing animals. comparable to other schedule II opioid
and significance of abuse similar to that Because thiafentanil, similar to drugs such as fentanyl, carfentanil, and
observed with other opioid drugs and carfentanil, etorphine hydrochloride sufentanil;
opioid analogues if it were marketed in and diprenorphine, is a potent m-opioid 2. FDA determined that Thianil
a non-controlled status or were the receptor agonist, it will be subject to (thiafentanil oxalate) meets the
subject of clandestine synthesis. The specialized handling, distribution and requirements for addition to the Index
HHS and DEA note that thiafentanil is storage procedures similar to those as set forth by the MUMS Act, 2004 and
not known to be or to have been the applicable for carfentanil, etorphine accordingly added Thianil (thiafentanil
subject of abuse in the United States. hydrochloride and diprenorphine as set oxalate) to the Index of Legally
6. What, if any, Risk There is to the forth in 21 CFR parts 1301 and 1305. As Marketed Unapproved New Animal
Public Health: The HHS review a result, this interim final rule revises 21 Drugs for Minor Species (the Index)
indicates that thiafentanil presents a CFR 1301.74(g), 1301.75(e), 1305.07 under section 572 of the Federal Food,
significant risk to the public health and, introductory text and paragraph (a), and Drug, and Cosmetic Act. Thianil
in this vein, that thiafentanil should 1305.17(d) to include ‘‘thiafentanil.’’ (thiafentanil oxalate) will be legally
only be used in certain animals for very 7. Its Psychic or Physiological marketed in the United States and will
limited purposes and with extreme Dependence Liability: HHS’ review have an accepted medical use with
caution. Based on the review of the states that the structural and severe restrictions; 3 and
structural and pharmacological pharmacological properties of 3. Due to the chemical and
properties of thiafentanil, the HHS thiafentanil suggest that it possesses a pharmacological similarities of
concluded that the abuse of thiafentanil psychic and physiological dependence thiafentanil to other schedule II fentanyl
is likely to pose a similar risk to public liability that is similar to other schedule derivatives, abuse of thiafentanil may
health as that of other potent opioid II related m-opioid receptor agonist lead to severe psychological or physical
drugs such as sufentanil (schedule II), drugs such as sufentanil, fentanyl and dependence.
fentanyl (schedule II), carfentanil carfentanil. Based on these findings, the Acting
(schedule II) and clandestinely As cited by the HHS review, a double- Administrator of the DEA concludes
synthesized alpha-methylfentanyl blind abuse liability study examining that thiafentanil, including its isomers,
(schedule I). Thus, inappropriate use of intravenous fentanyl, buprenorphine, esters, ethers, salts and salts of isomers,
thiafentanil poses a high risk to the heroin, morphine, and oxycodone in esters and ethers whenever the
public health. Among other things, HHS methadone-maintained patients existences of such isomers, esters,
noted that as a fentanyl derivative, and reported that fentanyl produced ethers, and salts is possible warrants
assuming that thiafentanil can be subjective effects similar to heroin control in schedule II of the CSA. 21
aerosolized, the use of thiafentanil (schedule I) on several outcome U.S.C. 812(b)(2).
presents a significant risk to the public measures indicating that the two drugs
health. produce similar subjective effects. It Requirements for Handling
HHS described that thiafentanil’s also demonstrates the psychic Thiafentanil
labeling indicates that it is solely dependence liability of fentanyl, and Thiafentanil is subject to the CSA’s
intended for use by zoologic, wildlife, or thiafentanil is expected to produce schedule II regulatory controls and
exotic animal veterinarians or field effects similar to fentanyl and to present administrative, civil, and criminal
biologists who have received training a similar risk of psychic and sanctions applicable to the manufacture,
and are supervised by veterinarians. The physiological dependence. There has distribution, reverse distribution,
sponsor recommends the use of been a major increase in abuse of dispensing, importing, exporting,
handling protocols similar to those in opioids analgesics in the United States research, and conduct of instructional
place for other scheduled potent opioids (HHS review document, 2011; Compton
such as carfentanil. HHS further and Volkow, 2006). Thiafentanil, similar 3 According to the HHS analysis, ‘‘[u]se of a new
indicated that thiafentanil should be to these opioid analgesics, presents a animal indexed drug is subject to significant
handled in teams consisting of at least risk of severe psychic and physiological restrictions. For example, use of an indexed new
two individuals knowledgeable about animal drug for minor species is limited to a minor
dependence. species for which there is a reasonable certainty
the hazards of working with potent m- 8. Whether the Substance is an that the animal or edible products from the animal
opioid agonist substances. Personal Immediate Precursor of a Substance will not be consumed by humans or food producing
protective equipment such as latex Already Controlled under the CSA: animals. 21 U.S.C. § 360ccc–l(a)(1). The requester
gloves and protective eyewear should be must label, distribute, and promote the new animal
Thiafentanil is not considered an drug in accordance with the Index entry, and the
used and syringes must be disposed of immediate precursor of any controlled
ehiers on DSK5VPTVN1PROD with RULES

FDA may remove a new animal drug from the Index
properly. If exposure to thiafentanil substance. if the conditions and limitations of use have not
occurs in a remote or distant been followed. 21 U.S.C. 360ccc–l(d)(l)(G); (f)(l)(F).
environment, veterinary naltrexone is Determination of Appropriate Schedule The labeling of an indexed new animal drug must
prominently state that the extra-label use of the
recommended for use as a reversal The CSA lists the findings required to product is prohibited. 21 U.S.C. 360ccc–l(h). Such
agent. The label information will further place a drug or other substance in any restrictions are not imposed upon approved human
state that thiafentanil must never be particular schedule (I, II, III, IV, or V). or animal drugs.’’

VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1

58838 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations

activities and chemical analysis with, (including thiafentanil) on hand on the 12. Liability. Any activity involving
and possession involving schedule II date the registrant first engages in the thiafentanil not authorized by, or in
substances, including the following: handling of controlled substances, violation of, the CSA or its
1. Registration. Any person who pursuant to 21 U.S.C. 827 and 958, and implementing regulations, is unlawful,
desires to handle thiafentanil in accordance with 21 CFR 1304.03, and may subject the person to
(manufacture, distribute, reverse 1304.04, and 1304.11. administrative, civil, and/or criminal
distribute, dispense, import, export, After the initial inventory, every DEA sanctions.
engage in research, or conduct registrant must take a new inventory of
instructional activities or chemical Regulatory Analyses
all stocks of controlled substances
analysis with, or possess), must be (including thiafentanil) on hand every Administrative Procedure Act
registered with the DEA to conduct such two years, pursuant to 21 U.S.C. 827 Public Law 114–89 was signed into
activities pursuant to 21 U.S.C. 822, and 958, and in accordance with 21 CFR law, amending 21 U.S.C. 811. This
823, 957, and 958 and in accordance 1304.03, 1304.04, and 1304.11. amendment provides that in cases
with 21 CFR parts 1301 and 1312. 7. Records and Reports. Every DEA where a new drug is (1) approved or
2. Quota. Only registered registrant must maintain records and indexed by the Department of Health
manufacturers are permitted to submit reports for thiafentanil, or and Human Services (HHS) and (2) HHS
manufacture thiafentanil in accordance products containing thiafentanil, recommends control in CSA schedule
with a quota assigned pursuant to 21 pursuant to 21 U.S.C. 827 and 958(e), II–V, the DEA shall issue an interim
U.S.C. 826 and in accordance with 21 and in accordance with 21 CFR parts final rule scheduling the drug within 90
CFR part 1303. 1304, 1312, and 1317. days. Additionally, the law specifies
3. Disposal of stocks. Upon obtaining
8. Orders for thiafentanil. Every DEA that the rulemaking shall become
a schedule II registration to handle
registrant who distributes thiafentanil is immediately effective as an interim final
thiafentanil, and if subsequently, any
required to comply with order form rule without requiring the DEA to
person who does not desire or is not
requirements, pursuant to 21 U.S.C. 828, demonstrate good cause. Therefore, the
able to maintain a schedule II
and in accordance with 21 CFR part DEA has determined that the notice and
registration must surrender all
1305. comment requirements of section 553 of
quantities of currently held thiafentanil,
9. Prescriptions and other dispensing. the APA, 5 U.S.C. 553, do not apply to
or may transfer all quantities of
All prescriptions for thiafentanil or this scheduling action.
currently held thiafentanil to a person
registered with the DEA in accordance products containing thiafentanil must Executive Orders 12866, Regulatory
with 21 CFR part 1317, in addition to comply with 21 U.S.C. 829, and be Planning and Review, and 13563,
all other applicable federal, state, local, issued in accordance with 21 CFR parts Improving Regulation and Regulatory
and tribal laws. 1306 and 1311, subpart C. Moreover, Review
4. Security. Thiafentanil is subject to given that thiafentanil is not the subject
of an approved new drug application In accordance with Public Law 114–
schedule II security requirements and 89, this scheduling action is subject to
must be handled and stored pursuant to under the FDCA, and that it is only
allowed under the MUMS Act formal rulemaking procedures
21 U.S.C. 821 and 823, and in performed ‘‘on the record after
accordance with 21 CFR 1301.71– amendments to the FDCA to be
marketed for extremely limited use in opportunity for a hearing,’’ which are
1301.93. conducted pursuant to the provisions of
5. Labeling and Packaging. All labels, minor species, DEA would not consider
any dispensing of thiafentanil for 5 U.S.C. 556 and 557. The CSA sets
labeling, and packaging for commercial forth the procedures and criteria for
containers of thiafentanil must comply human use to be for a legitimate medical
purpose within the meaning of the CSA. scheduling a drug or other substance.
with 21 U.S.C. 825 and 958(e), and be Such actions are exempt from review by
in accordance with 21 CFR part 1302. In Likewise, DEA would not consider any
dispensing of thiafentanil for animal use the Office of Management and Budget
addition, thiafentanil is subject to (OMB) pursuant to section 3(d)(1) of
additional labeling requirements beyond the scope of the drug’s labeling
authorized under the MUMS Act Executive Order 12866 and the
provided by FDA. Thiafentanil must be principles reaffirmed in Executive Order
labeled, distributed, and promoted in amendments to the FDCA to be for a
13563.
accordance with the Index entry of the legitimate medical purpose within the
new animal drug and the FDA may meaning of the CSA. Executive Order 12988, Civil Justice
remove a new animal drug from the 10. Manufacturing and Distributing. Reform
Index if the conditions and limitations In addition to the general requirements This regulation meets the applicable
of use have not been followed. 21 U.S.C. of the CSA and DEA regulations that are standards set forth in sections 3(a) and
360ccc–l(d)(l)(G); (f)(l)(F). The labeling applicable to manufacturers and 3(b)(2) of Executive Order 12988 to
of an indexed new animal drug must distributors of schedule II controlled eliminate drafting errors and ambiguity,
prominently state that the extra-label substances, such registrants should be minimize litigation, provide a clear legal
use of the product is prohibited. 21 advised that (consistent with the standard for affected conduct, and
U.S.C. 360ccc–l(h). foregoing considerations) any promote simplification and burden
6. Inventory. Every DEA registrant manufacturing or distribution of reduction.
who desires to possess any quantity of thiafentanil may only be for the
thiafentanil must take an inventory of legitimate purposes consistent with the Executive Order 13132, Federalism
thiafentanil on hand, pursuant to 21 drug’s labeling authorized under the This rulemaking does not have
U.S.C. 827 and 958, and in accordance MUMS Act, or for research activities federalism implications warranting the
ehiers on DSK5VPTVN1PROD with RULES

with 21 CFR 1304.03, 1304.04, and authorized by the FDCA and CSA. application of Executive Order 13132.
1304.11. 11. Importation and Exportation. All The rule does not have substantial
Any person who becomes registered importation and exportation of direct effects on the States, on the
with the DEA to handle thiafentanil thiafentanil must be in compliance with relationship between the national
must take an initial inventory of all 21 U.S.C. 952, 953, 957, and 958, and government and the States, or on the
stocks of controlled substances in accordance with 21 CFR part 1312. distribution of power and

VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1

Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations 58839

responsibilities among the various Business Regulatory Enforcement § 1301.75 Physical security controls for
levels of government. Fairness Act of 1996 (Congressional practitioners.
Review Act (CRA)). This rule will not * * * * *
Executive Order 13175, Consultation
result in: An annual effect on the (e) Thiafentanil, carfentanil, etorphine
and Coordination With Indian Tribal
economy of $100,000,000 or more; a hydrochloride and diprenorphine shall
Governments
major increase in costs or prices for be stored in a safe or steel cabinet
This rule does not have tribal consumers, individual industries, equivalent to a U.S. Government Class
implications warranting the application Federal, State, or local government V security container.
of Executive Order 13175. It does not agencies, or geographic regions; or
have substantial direct effects on one or significant adverse effects on PART 1305—ORDERS FOR SCHEDULE
more Indian tribes, on the relationship competition, employment, investment, I AND II CONTROLLED SUBSTANCES
between the Federal government and productivity, innovation, or on the
Indian tribes, or on the distribution of ability of U.S.-based companies to ■ 4. The authority citation for 21 CFR
power and responsibilities between the compete with foreign based companies part 1305 continues to read as follows:
Federal government and Indian tribes. in domestic and export markets. Authority: 21 U.S.C. 821, 828, 871(b),
Regulatory Flexibility Act However, pursuant to the CRA, the DEA unless otherwise noted.
has submitted a copy of this interim
In accordance with 5 U.S.C. 603(a), final rule to both Houses of Congress ■ 5. In § 1305.07, revise the introductory
‘‘[w]henever an agency is required by [5 and to the Comptroller General. text and paragraph (a) to read as follows:
U.S.C. 553], or any other law, to publish
general notice of proposed rulemaking List of Subjects § 1305.07 Special procedure for filling
certain orders.
for any proposed rule, or publishes a 21 CFR Part 1301
notice of proposed rulemaking for an A supplier of thiafentanil, carfentanil,
interpretive rule involving the internal Administrative practice and etorphine hydrochloride, or
revenue laws of the United States, the procedure, Drug traffic control, Security diprenorphine, if he or she determines
agency shall prepare and make available measures. that the purchaser is a veterinarian
for public comment an initial regulatory engaged in zoo and exotic animal
21 CFR Part 1305
flexibility analysis.’’ As noted in the practice, wildlife management
above discussion regarding applicability Drug traffic control, Reporting and programs, or research, and is authorized
of the Administrative Procedure Act, the recordkeeping requirements. by the Administrator to handle these
DEA has determined that the notice and substances, may fill the order in
21 CFR Part 1308
comment requirements of section 553 of accordance with the procedures set
the APA, 5 U.S.C. 553, do not apply to Administrative practice and forth in § 1305.17 except that:
this scheduling action. Consequently, procedure, Drug traffic control, (a) A DEA Form 222 or an electronic
the RFA does not apply to this interim Reporting and recordkeeping order for thiafentanil, carfentanil,
final rule. requirements. etorphine hydrochloride, and
For the reasons set out above, the DEA diprenorphine must contain only these
Unfunded Mandates Reform Act of 1995
amends 21 CFR parts 1301, 1305 and substances in reasonable quantities.
In accordance with the Unfunded 1308 as follows: * * * * *
Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., the DEA has PART 1301—REGISTRATION OF ■ 6. In § 1305.17, revise paragraph (d) to
determined and certifies that this action MANUFACTURERS, DISTRIBUTORS, read as follows:
would not result in any Federal AND DISPENSERS OF CONTROLLED § 1305.17 Preservation of DEA Forms 222.
mandate that may result ‘‘in the SUBSTANCES
* * * * *
expenditure by State, local, and tribal
governments, in the aggregate, or by the ■ 1. The authority citation for 21 CFR (d) The supplier of thiafentanil,
private sector, of $100,000,000 or more part 1301 continues to read as follows: carfentanil, etorphine hydrochloride,
(adjusted for inflation) in any one year.’’ and diprenorphine must maintain DEA
Authority: 21 U.S.C. 821, 822, 823, 824,
Therefore, neither a Small Government Forms 222 for these substances
831, 871(b), 875, 877, 886a, 951, 952, 953,
Agency Plan nor any other action is 956, 957, 958, 965. separately from all other DEA Forms
required under UMRA of 1995. 222 and records required to be
■ 2. In § 1301.74, revise paragraph (g) to maintained by the registrant.
Paperwork Reduction Act of 1995 read as follows:
This action does not impose a new PART 1308—SCHEDULES OF
§ 1301.74 Other security controls for non- CONTROLLED SUBSTANCES
collection of information requirement practitioners; narcotic treatment programs
under the Paperwork Reduction Act of and compounders for narcotic treatment
1995. 44 U.S.C. 3501–3521. This action programs.
■ 7. The authority citation for 21 CFR
would not impose recordkeeping or part 1308 continues to read as follows:
* * * * *
reporting requirements on State or local Authority: 21 U.S.C. 811, 812, 871(b),
(g) Before the initial distribution of
governments, individuals, businesses, or unless otherwise noted.
thiafentanil, carfentanil, etorphine
organizations. An agency may not hydrochloride and/or diprenorphine to ■ 8. In § 1308.12, add paragraph (c)(29)
conduct or sponsor, and a person is not any person, the registrant must verify to read as follows:
required to respond to, a collection of
ehiers on DSK5VPTVN1PROD with RULES

that the person is authorized to handle
information unless it displays a the substance(s) by contacting the Drug § 1308.12 Schedule II.
currently valid OMB control number. Enforcement Administration. * * * * *
Congressional Review Act * * * * * (c) * * *
This rule is not a major rule as (29) Thiafentanil ................................ 9729
■ 3. In § 1301.75, revise paragraph (e) to
defined by section 804 of the Small read as follows: * * * * *

VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1

58840 Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Rules and Regulations

Dated: August 18, 2016. other amendments, the July 2015 Final supplementary information to the July
Chuck Rosenberg, Rule modified provisions relating to the 2015 Final Rule discusses coverage of
Acting Administrator. optional mechanism a creditor may use overdraft products.
[FR Doc. 2016–20463 Filed 8–25–16; 8:45 am] when assessing whether a consumer is The MLA regulation defines
BILLING CODE 4410–09–P
a ‘‘covered borrower,’’ modified the ‘‘consumer credit’’ as credit offered or
disclosures that a creditor must provide extended to a covered borrower
to a covered borrower, and implemented primarily for personal, family or
the enforcement provisions of the MLA. household purposes that is either
DEPARTMENT OF DEFENSE
Subsequently, the Department subject to a finance charge or payable by
Office of the Secretary received requests to clarify its a written agreement in more than four
interpretation of points raised in the installments, with some exceptions. The
32 CFR Part 232 July 2015 Final Rule. The Department is exceptions include: Residential
issuing this interpretive rule to inform mortgage transactions; purchase money
[Docket ID: DOD–2013–OS–0133] the public of its views. The Department credit for a vehicle or personal property
RIN 0790–ZA11 has chosen to provide this guidance in that is secured by the purchased vehicle
the form of a question and answer or personal property; certain
Military Lending Act Limitations on document to assist industry in transactions exempt from Regulation Z
Terms of Consumer Credit Extended to complying with the July 2015 Final (not including transactions exempt
Service Members and Dependents Rule. This interpretive rule does not under 12 CFR 1026.29); and credit
substantively change the regulation extended to non-covered borrowers
AGENCY: Under Secretary of Defense for implementing the MLA, but rather consistent with 32 CFR 232.5(b).
Personnel and Readiness, Department of merely states the Department’s Although coverage by the MLA and the
Defense. preexisting interpretations of an existing MLA regulation is not completely
ACTION: Interpretive rule. regulation. Therefore, under 5 U.S.C. identical to that of TILA and Regulation
553(b)(A), this rulemaking is exempt Z, the July 2015 Final Rule amends the
SUMMARY: The Department of Defense
from the notice and comment definition of consumer credit under the
(Department) is interpreting its
requirements of the Administrative MLA to be more consistent with how
regulation implementing the Military
Procedure Act, and, pursuant to 5 U.S.C. credit is defined under TILA. The
Lending Act (the MLA). The MLA as
553(d)(2), this rule is effective supplementary information to the July
implemented by the Department, limits
immediately upon publication in the 2015 Final Rule states:
the military annual percentage rate Federal Register.
(MAPR) that a creditor may charge to a As proposed, the Department is amending
maximum of 36 percent, requires certain II. Interpretations of the Department its regulation so that, in general, consumer
disclosures, and provides other The following questions and answers credit covered under the MLA would be
substantive consumer protections on defined consistently with credit that for
represent official interpretations of the decades has been subject to TILA, namely:
‘‘consumer credit’’ extended to Service Department on issues related to 32 CFR Credit offered or extended to a covered
members and their families. On July 22, part 232. For ease of reference, the borrower primarily for personal, family, or
2015, the Department amended its following terms are used throughout household purposes, and that is (i) subject to
regulation primarily for the purpose of this document: MLA refers to the a finance charge or (ii) payable by a written
extending the protections of the MLA to Military Lending Act (codified at 10 agreement in more than four installments.5
a broader range of closed-end and open- U.S.C. 987); MAPR refers to the military The MLA regulation also defines
end credit products (the July 2015 Final annual percentage rate, as defined in 32 ‘‘closed-end credit’’ and ‘‘open-end
Rule). This interpretive rule provides CFR 232.3(p); TILA refers to the Truth credit’’ with express references to the
guidance on certain questions the in Lending Act (codified at 15 U.S.C. definitions of the same terms in
Department has received regarding 1601 et seq.); Regulation Z refers to the Regulation Z.
compliance with the July 2015 Final regulation, and interpretations thereof, The supplementary information to the
Rule. issued by the Consumer Financial July 2015 Final Rule illustrates how to
DATES: Effective Date: August 26, 2016. Protection Bureau (or the Board of apply these standards specifically with
FOR FURTHER INFORMATION CONTACT: Governors of the Federal Reserve respect to overdraft products and
Marcus Beauregard, 571–372–5357. System, as applicable) to implement services.6 It states that consistent with
TILA, as defined in 32 CFR 232.3(s); Regulation Z, an overdraft line of credit
SUPPLEMENTARY INFORMATION:
DMDC refers to the Defense Manpower with a finance charge is a covered
I. Background and Purpose Data Center. consumer credit product when: It is
In July, 2015, the Department of 1. What types of overdraft products are offered to a covered borrower; the credit
Defense (Department) issued a final within the scope of 32 CFR 232.3(f) extended by the creditor is primarily for
rule 1 (the July 2015 Final Rule) defining ‘‘consumer credit’’? personal, family, or household
amending its regulation implementing Answer: The MLA regulation purposes; it is used to pay an item that
the Military Lending Act (MLA) 2 generally directs creditors to look to overdraws an asset account and results
primarily for the purpose of extending provisions of TILA and its in a fee or charge to the covered
the protections of the MLA to a broader implementing regulation, Regulation Z, borrower; and, the extension of credit
range of closed-end and open-end credit in determining whether a product or
products, rather than the limited credit service is considered ‘‘consumer credit’’
connection with certain credit features offered in
conjunction with prepaid card accounts). It is the
ehiers on DSK5VPTVN1PROD with RULES

products that had been defined as for purposes of the MLA.4 Also, the Department’s intention that this part should
‘‘consumer credit.’’ 3 Moreover, among wherever possible be interpreted consistently with
4 The Department notes that the Consumer Regulation Z as it evolves in order to harmonize the
1 80 FR 435560. two regulations and thereby minimize compliance
Financial Protection Bureau may from time to time
2 10 U.S.C. 987.
revise Regulation Z. See, e.g., 79 FR 77102 (Dec. 23, burden.
3 32 CFR 232.3(b) as implemented in a final rule 5 80 FR 43563 (footnotes omitted).
2014) (proposing to revise the definition of finance
published at 72 FR 50580 (Aug. 31, 2007). charge with respect to charges imposed in 6 80 FR 43579–43580.

VerDate Sep<11>2014 14:39 Aug 25, 2016 Jkt 238001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\26AUR1.SGM 26AUR1

Document Created: 2016-08-26 10:40:23
Document Modified: 2016-08-26 10:40:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Interim final rule with request for comments.
Dates		The effective date of this rule is August 26, 2016. Interested persons may file written comments on this rule in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before September 26, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
Contact		Michael J. Lewis, Office of Diversion
FR Citation		81 FR 58834
CFR Citation		21 CFR 1301 21 CFR 1305 21 CFR 1308
CFR Associated		Administrative Practice and Procedure; Drug Traffic Control; Security Measures and Reporting and Recordkeeping Requirements

81 FR 58834 - Schedules of Controlled Substances: Placement of Thiafentanil Into Schedule II

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 166 (August 26, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration