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[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10985-10989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04332]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-370]

Schedules of Controlled Substances: Placement of Alfaxalone into 
Schedule IV

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Administrator of the 
Drug Enforcement Administration (DEA) places the substance 5[alpha]-
pregnan-3[alpha]-ol-11,20-dione (alfaxalone), including its salts, 
isomers, and salts of isomers, into schedule IV of the Controlled 
Substances Act (CSA). This scheduling action is pursuant to the CSA 
which requires that such actions be made on the record after 
opportunity for a hearing through formal rulemaking. This action 
imposes the regulatory controls and administrative, civil, and criminal 
sanctions applicable to schedule IV controlled substances on persons 
who handle (manufacture, distribute, dispense, import, export, engage 
in research, conduct instructional activities with, or possess) or 
propose to handle alfaxalone and substances containing alfaxalone.

DATES: Effective Date: March 31, 2014.

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

SUPPLEMENTARY INFORMATION:

Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. 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. 21 U.S.C. 801-971. The DEA publishes the implementing 
regulations for these statutes in title 21 of the Code of Federal 
Regulations (CFR), parts 1300 to 1321. 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 providing 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, controlled substances are classified into one of 
five schedules based upon their potential for abuse, their currently 
accepted medical use, and the degree of dependence the 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.
    Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, 
``add to such a schedule or transfer between such schedules any drug or 
other substance if he (A) finds that such drug or other substance has a 
potential for abuse, and (B) makes with respect to such drug or other 
substance the findings prescribed by [21 U.S.C. 812(b)] for the 
schedule in which such drug is to be placed . . ..'' Pursuant to 28 CFR 
0.100(b), the Attorney General has delegated this scheduling authority 
to the Administrator of the DEA. 28 CFR 0.104.
    The CSA provides that scheduling of any drug or other substance may 
be initiated by the Attorney General (1) on his own motion; (2) at the 
request of the Secretary of the Department of Health and Human Services 
(HHS),\1\ or (3) on the petition of any interested party. 21 U.S.C. 
811(a). This action is based on a recommendation from the Assistant 
Secretary of the HHS and on an evaluation of all other relevant data by 
the DEA. This action imposes the regulatory controls and 
administrative, civil, and criminal sanctions applicable to schedule IV 
controlled substances on persons who handle or propose to handle 
alfaxalone.
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    \1\ As set forth in a memorandum of understanding entered into 
by the HHS, 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, 1995. In addition, because the Secretary of the HHS 
has delegated to the Assistant Secretary for Health of the HHS the 
authority to make domestic drug scheduling recommendations, for 
purposes of this document, all subsequent references to 
``Secretary'' have been replaced with ``Assistant Secretary.''
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Background

    Alfaxalone (5[alpha]-pregnan-3[alpha]-ol-11,20-dione, previously 
spelled ``alphaxalone''), a substance with central nervous system (CNS) 
depressant properties, is a neurosteroid that is a derivative of 11-
alpha-hydroxy-progesterone. On October 23, 2012, the Food and Drug 
Administration (FDA) published a final rule to approve a New Animal 
Drug Application (NADA, 141-342) for alfaxalone (Alfaxan[supreg]), as 
an intravenous injectable anesthetic, for the induction and maintenance 
of anesthesia and for induction of anesthesia followed by maintenance 
of anesthesia with an inhalant anesthetic, in cats and dogs (77 FR 
64715). Alfaxalone primarily acts as an agonist at the gamma-
aminobutyric acid (GABA) receptor-channel complex, with a mechanism of 
action at this site similar to that of barbiturates like phenobarbital 
(schedule IV) and methohexital (schedule IV), benzodiazepines such as 
diazepam (schedule IV) and midazolam (schedule IV), as well as the 
anesthetic agents

[[Page 10986]]

propofol (proposed to be controlled as a schedule IV substance, 75 FR 
66195, Oct. 27, 2010) and fospropofol (schedule IV).

HHS and DEA Eight-Factor Analyses

    On July 17, 2012, the Assistant Secretary of the HHS provided to 
the DEA a scientific and medical evaluation and scheduling 
recommendation entitled ``Basis for the Recommendation to Control 
Alfaxalone in Schedule IV of the Controlled Substances Act.'' After 
considering the eight factors in 21 U.S.C. 811(c), including 
consideration of the substance's abuse potential, legitimate medical 
use, and dependence liability, the Assistant Secretary of the HHS 
recommended that alfaxalone be controlled in schedule IV of the CSA 
under 21 U.S.C. 812(b). In response, the DEA conducted its own eight-
factor analysis of alfaxalone pursuant to 21 U.S.C. 811(c). Both the 
DEA and HHS analyses are available in their entirety in the public 
docket for this rule (Docket Number DEA-370) at www.regulations.gov 
under ``Supporting and Related Material.''

Determination to Schedule Alfaxalone

    After a review of the available data, including the scientific and 
medical evaluation and the scheduling recommendation from the HHS, the 
Administrator of the DEA published in the Federal Register a notice of 
proposed rulemaking (NPRM) entitled ``Schedules of Controlled 
Substances: Placement of Alfaxalone into Schedule IV'' which proposed 
placement of alfaxalone in schedule IV of the CSA. 78 FR 17895, March 
25, 2013. The proposed rule provided an opportunity for interested 
persons to file a request for hearing in accordance with DEA 
regulations by April 24, 2013. No requests for such a hearing were 
received by the DEA. The NPRM also provided an opportunity for 
interested persons to submit written comments on the proposal on or 
before April 24, 2013.

Comments Received

    The DEA received four comments on the proposed rule to schedule 
alfaxalone. Two commenters were in favor of controlling alfaxalone as a 
schedule IV controlled substance. One commenter was in favor of 
controlling alfaxalone as a schedule V controlled substance rather than 
a schedule IV controlled substance, and one commenter opposed the 
control of alfaxalone.
    Support of the Proposed Rule:
    Two commenters supported controlling alfaxalone as a schedule IV 
controlled substance. These commenters indicated support for 
controlling alfaxalone under the CSA based on the abuse potential of 
the substance. Because alfaxalone is indicated for use as a pre-
anesthetic and anesthetic in cats and dogs, these commenters felt that 
the abuse potential was particularly high for persons with access to 
the substance in the medical field. One commenter noted that 
controlling alfaxalone as a schedule IV controlled substance is 
appropriate because it could be abused in a manner similar to other 
schedule IV CNS depressants. The commenters believe that controlling 
alfaxalone as a schedule IV controlled substance will provide the 
necessary controls to prevent its diversion.
    DEA Response: The DEA appreciates the comments in support of this 
rulemaking.
    Opposition to the Proposed Rule:
    Two commenters opposed the proposal to control alfaxalone as a 
schedule IV controlled substance.
    Request Not to Control Alfaxalone:
    One commenter opposed controlling alfaxalone at all and stated that 
alfaxalone does not have the same abuse potential as Xanax[supreg] 
(alprazolam) (schedule IV), Valium[supreg] (diazepam) (schedule IV), 
and other benzodiazepines. The commenter also stated that controlling 
alfaxalone under the CSA would make it difficult for veterinarians and 
animal surgeons to acquire the drug. Lastly, this commenter stated that 
alfaxalone is ``unheard of outside of the veterinary community and does 
not have a `black market' as do the other schedule IV drugs.''
    DEA Response: The DEA does not agree. Pursuant to 21 U.S.C. 
811(a)(1), the Attorney General may, by rule, ``add to such a schedule 
or transfer between such schedules any drug or other substance if he 
(A) finds that such drug or other substance has a potential for abuse, 
and (B) makes with respect to such drug or other substance the findings 
prescribed by [21 U.S.C. 812(b)] for the schedule in which such drug is 
to be placed * * *.'' This scheduling action was initiated when the DEA 
received a scientific and medical evaluation and a scheduling 
recommendation to control alfaxalone as a schedule IV controlled 
substance from the Assistant Secretary of the HHS. In accordance with 
21 U.S.C. 811(c), the DEA conducted its own analysis of the eight 
factors determinative of control or removal: (1) Its actual or relative 
potential for abuse; (2) scientific evidence of its pharmacological 
effect, if known; (3) the state of current scientific knowledge 
regarding the drug or other substance; (4) its history and current 
pattern of abuse; (5) the scope, duration, and significant of abuse; 
(6) what, if any, risk there is to the public health; (7) its psychic 
or physiological dependence liability; and (8) whether the substance is 
an immediate precursor of a substance already controlled. The summary 
of each factor as analyzed by the HHS and the DEA, and as considered by 
the DEA in this scheduling action, was provided in the proposed rule. 
Both the DEA and the HHS analyses have been made available in their 
entirety under ``Supporting and Related Material'' of the public docket 
for this rule at www.regulations.gov under Docket Number DEA-370.
    Based on the review of the HHS evaluation and scheduling 
recommendation and all other relevant data, the DEA found that 
alfaxalone has an abuse potential similar to other schedule IV drugs, 
including the benzodiazepines diazepam and midazolam, the barbiturates 
phenobarbital and methohexital, and also the anesthetic agents propofol 
(proposed to be controlled as a schedule IV substance, 75 FR 66195, 
Oct. 27, 2010) and fospropofol. Alfaxalone also acts as an agonist at 
the gamma-aminobutyric acid (GABA) receptor-channel complex, with a 
mechanism of action at the site similar to that of benzodiazepines like 
diazepam(schedule IV) and midazolam (schedule IV). This mechanism of 
action is also similar to that of other schedule IV controlled 
substances, including barbiturates like phenobarbital and methohexital, 
and also anesthetic agents like propofol (proposed to be controlled as 
a schedule IV substance, 75 FR 66195, Oct. 27, 2010) and fospropofol. 
It should be noted that alfaxalone's current exclusive use as a 
veterinary anesthetic drug and the asserted conclusion that there is no 
``black market'' for the substance, do not negate its abuse potential 
and associated risk of diversion. The DEA and HHS analyses demonstrate 
that alfaxalone does have the potential for abuse and meets the 
necessary findings on potential for abuse, currently accepted medical 
use, and physical or psychological dependence for placement in schedule 
IV.
    Burdens associated with acquiring a substance as a result of 
control under the CSA are not relevant factors to the determination 
whether a substance should be controlled or under what schedule a 
substance should be placed if it is controlled. See 21 U.S.C. 811 and 
812. Nonetheless, the DEA disagrees with the unsupported statement that 
making alfaxalone a controlled substance would make it difficult for 
veterinarians and animal surgeons to

[[Page 10987]]

acquire the drug. Several other anesthetic substances used by 
veterinarians and other practitioners are controlled under the CSA. All 
veterinarians and animal surgeons who are authorized by the State in 
which they practice to handle alfaxalone and who are registered with 
the DEA to dispense controlled substances may acquire alfaxalone once 
it is controlled. As discussed in the Regulatory Flexibility Analysis 
section of this document, currently 98% of DEA registrants (most of 
which are small businesses) are already authorized to handle schedule 
IV controlled substances.
    Request to Control Alfaxalone as a Schedule V Substance:
    One commenter stated that alfaxalone should be controlled as a 
schedule V controlled substance. This commenter stated that there was 
limited information available regarding alfaxalone's abuse. The 
commenter also stated that alfaxalone is a new introduction to the 
United States veterinary market, and controlling it in the least 
stringent schedule, schedule V, would minimize burdens on practitioners 
using it for legitimate purposes, while also imposing controls to 
account for its abuse potential.
    DEA Response: The DEA does not agree. The DEA thoroughly reviewed 
the scientific and medical evaluation and the scheduling recommendation 
to control alfaxalone as a schedule IV controlled substance from the 
HHS.
    Additionally, the DEA conducted its own analysis of the eight 
factors in accordance with 21 U.S.C. 811(b) and made the findings 
required under 21 U.S.C. 812(b) for the placement of alfaxalone in 
schedule IV. Based on the review of the HHS's evaluation and scheduling 
recommendation and all other relevant and available data, the DEA found 
that alfaxalone has an abuse potential similar to other schedule IV 
controlled substances, including the benzodiazepines diazepam and 
midazolam, barbiturates phenobarbital and methohexital, and also the 
anesthetic agents propofol (proposed to be controlled as a schedule IV 
substance, 75 FR 66195, Oct. 27, 2010) and fospropofol.
    While not relevant to the substance's schedule placement, the DEA 
does not agree with this commenter's concern that the requirements 
applicable to schedule IV controlled substances are more burdensome 
than the requirements applicable to schedule V controlled substances. 
There are only very minimal differences in handling requirements 
between schedule IV and schedule V controlled substances. Most 
importantly for purposes of responding to this comment, the physical 
security requirements for schedule IV and V controlled substances are 
the same. Also, under the CSA, schedule V controlled substances may be 
dispensed without a prescription, while schedule IV controlled 
substances may only be dispensed pursuant to a prescription. However, 
this distinction is of no consequence with regard to alfaxalone because 
alfaxalone cannot be prescribed by a veterinarian, nor may alfaxalone 
be dispensed by a pharmacist pursuant to a prescription. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian (i.e., it may only be administered). 21 CFR 522.52; see 
also 21 CFR 514.8.

Scheduling Conclusion

    Based on consideration of all comments, the scientific and medical 
evaluation and accompanying recommendation of the HHS, and based on the 
DEA's consideration of its own eight-factor analysis, the DEA finds 
that these facts and all other relevant data constitute substantial 
evidence of potential for abuse of alfaxalone. As such, the DEA is 
scheduling alfaxalone as a controlled substance under the CSA.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA outlines the findings 
required for placing a drug or other substance in any particular 
schedule. 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 Administrator of the DEA, pursuant to 
21 U.S.C. 812(b)(4), finds that:
    (1) 5[alpha]-pregnan-3[alpha]-ol-11,20-dione (alfaxalone) has a low 
potential for abuse relative to the drugs or other substances in 
schedule III; the overall abuse potential of alfaxalone is comparable 
to the schedule IV controlled substances diazepam, midazolam, 
phenobarbital, methohexital, propofol (proposed to be controlled as a 
schedule IV substance, 75 FR 66195, Oct. 27, 2010), and fospropofol;
    (2) 5[alpha]-pregnan-3[alpha]-ol-11,20-dione (alfaxalone) has a 
currently accepted medical use in treatment in the United States; 
alfaxalone was approved for marketing by the FDA as a veterinary 
anesthetic product for the induction and maintenance of anesthesia in 
cats and in dogs; and
    (3) Abuse of 5[alpha]-pregnan-3[alpha]-ol-11,20-dione (alfaxalone) 
may lead to limited physical dependence or psychological dependence 
relative to the drugs or other substances in schedule III.
    Based on these findings, the Administrator of the DEA concludes 
that alfaxalone, including its salts, isomers, and salts of isomers, 
warrants control in schedule IV of the CSA. 21 U.S.C. 812(b)(4).

Requirements for Handling Alfaxalone

    Upon the effective date of this final rule, any person who handles 
alfaxalone is subject to the CSA's schedule IV regulatory controls and 
administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, engagement 
in research, and conduct of instructional activities, of schedule IV 
controlled substances including the following:
    Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities with) alfaxalone, or who desires to handle 
alfaxalone, 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 March 31, 2014. Any person who currently 
handles alfaxalone and is not registered with the DEA must submit an 
application for registration and may not continue to handle alfaxalone 
as of March 31, 2014 unless the DEA has approved that application, 
pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 
CFR parts 1301 and 1312.
    Security. Alfaxalone is subject to schedule III-V security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, and 871(b) and in accordance with 21 CFR 1301.71-1301.93, as of 
March 31, 2014.
    Labeling and Packaging. All labels and labeling for commercial 
containers of alfaxalone must comply with 21 U.S.C. 825 and 958(e) and 
be in accordance with 21 CFR part 1302, as of March 31, 2014.
    Inventory. Every DEA registrant who possesses any quantity of 
alfaxalone on the effective date of this final rule must to take an 
inventory of all stocks of alfaxalone on hand as of March 31, 2014, 
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 
1304.03, 1304.04, and 1304.11(a) and (d).
    Any person who becomes registered with the DEA after March 31, 2014 
must take an initial inventory of all stocks of controlled substances 
(including alfaxalone) on hand on the date the registrant first engages 
in the handling

[[Page 10988]]

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(a) and (b).
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including alfaxalone) 
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.
    Records. All DEA registrants must maintain records with respect to 
alfaxalone pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR parts 1304, 1307, and 1312, as of March 31, 2014.
    Prescriptions. The DEA recognizes that alfaxalone is currently only 
approved as an injectable anesthetic that is administered to patients. 
The DEA also acknowledges that Federal law currently restricts 
alfaxalone to use by or on the order of a licensed veterinarian, and it 
may not be dispensed pursuant to a prescription. 21 CFR 522.52; see 
also 21 CFR 514.8. A ``prescription'' is defined as an order for 
medication which is dispensed to or for an ultimate user but does not 
include an order for medication which is dispensed for immediate 
administration to the ultimate user (e.g., an order to dispense a drug 
to a bed patient for immediate administration in a hospital is not a 
prescription). 21 CFR 1300.01(b). However, any lawful prescriptions for 
alfaxalone or prescriptions for products containing alfaxalone must 
comply with 21 U.S.C. 829 and must be issued in accordance with 21 CFR 
parts 1306 and 1311 subpart C as of March 31, 2014.
    Importation and Exportation. All importation and exportation of 
alfaxalone must be in compliance with 21 U.S.C. 952, 953, 957, and 958, 
and be in accordance with 21 CFR part 1312 as of March 31, 2014.
    Criminal Liability. Any activity involving alfaxalone not 
authorized by, or in violation of, the CSA, occurring as of March 31, 
2014 is unlawful, and may subject the person to administrative, civil, 
and/or criminal sanctions.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this scheduling action is 
subject to formal rulemaking procedures done ``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 criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget pursuant to section 
3(d)(1) of Executive Order 12866 and the principles reaffirmed in 
Executive Order 13563.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform 
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

    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 the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. The rule 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

    The Administrator, in accordance with the Regulatory Flexibility 
Act (RFA) (5 U.S.C. 601-612), has reviewed this final rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. The purpose of this 
final rule is to place alfaxalone, including its salts, isomers, and 
salts of isomers, into schedule IV of the CSA. By this final rule, 
alfaxalone will remain in schedule IV unless and until additional 
scheduling action is taken to either transfer it between the schedules 
or to remove it from the list of schedules. See 21 U.S.C. 811 and 812. 
No less restrictive measures (i.e., no control or control in schedule 
V) enable the DEA to meet its statutory obligations under the CSA.
    On September 6, 2012, the FDA approved for use in the United States 
one product containing alfaxalone, which will have FDA marketing 
exclusivity and patent protection for several years. Accordingly, the 
number of currently identifiable manufacturers, distributors, 
importers, and exporters for alfaxalone is extremely small. The 
manufacturer who obtained FDA approval for the sale of alfaxalone 
product in the United States is not considered a ``small entity'' in 
accordance with the RFA and Small Business Administration (SBA) size 
standards. Upon expiration of the exclusivity period, and more likely, 
the related patent, additional products containing alfaxalone may 
receive approvals from the FDA, and thus additional manufacturers, 
distributors, importers, and exporters will handle alfaxalone. Whether 
such manufacturers, distributors, importers, or exporters may qualify 
as small entities cannot be determined at this time.
    There are currently approximately 1.5 million controlled substance 
registrations, representing approximately 381,000 entities. The DEA 
estimates that 371,000 (97%) of these entities are considered ``small 
entities'' in accordance with the RFA and SBA size standards. 5 U.S.C. 
601(6) and 15 U.S.C. 632. Due to the wide variety of unidentifiable and 
unquantifiable variables that potentially could influence the 
dispensing rates of new chemical entities, the DEA is unable to 
determine the number of small entities which might handle alfaxalone. 
However, because alfaxalone is a new chemical entity that is a 
veterinary anesthetic administered in veterinary settings and is not 
prescribed to ultimate users, the number of entities affected by the 
rule would be far fewer than the 381,000 entities represented by all 
DEA registrants. There are approximately 66,361 veterinarian 
practitioners and 23 veterinarian distributors (schedules III-V) 
registered with the DEA.
    Despite the fact that the number of small entities possibly 
impacted by this rule could not be determined, the DEA concludes that 
they would not experience a significant economic impact as a result of 
this rule. The DEA estimates all anticipated alfaxalone handlers to be 
DEA registrants, and currently 98% of DEA registrants (most of which 
are small entities) are authorized to handle schedule IV controlled 
substances. Even assuming that all of these registrants were to handle 
alfaxalone (e.g., practitioners administer the substance), the costs 
that they would incur as a result of alfaxalone's scheduling would be 
nominal.
    Registrants that dispense (e.g., administer) alfaxalone are 
expected to incur nominal additional security, inventory, and 
recordkeeping costs. These registered entities have already established 
and implemented the systems and processes required to handle schedule 
IV controlled

[[Page 10989]]

substances and can easily absorb the costs of administering alfaxalone 
with nominal to no additional economic burden. For example, because 
DEA-veterinary practitioners are likely to already be schedule IV 
handlers, they already secure schedule II-V controlled substances in a 
securely locked, substantially constructed cabinet. See 21 CFR 
1301.75(b). Accordingly, the requirement to secure all controlled 
substances containing alfaxalone would not impose a significant 
economic burden upon DEA-registered practitioners as the infrastructure 
and materials for doing so are already in place. Labeling their 
products is routine and in the normal course of business of 
manufacturers. The DEA therefore assumes that the cost of compliance 
with 21 CFR part 1302 as a result of this final rule is nominal. 
Correspondingly, the DEA estimates that the cost of the labeling and 
packaging requirements of this final rule is nominal for the authorized 
manufacturer. Accordingly, compliance would not require significant 
additional manpower, capital investment, or recordkeeping burdens.
    Because of these facts, this rule will not result in a significant 
economic impact on a substantial number of small entities.

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 pursuant 
to UMRA 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 provisions of 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 United States-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 final rule to both Houses of Congress and to the 
Comptroller General.

List of Subjects in 21 CFR Part 1308

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

    For the reasons set out above, 21 CFR part 1308 is amended as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. 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
2. Amend Sec.  1308.14 by redesignating paragraphs (c)(1) through 
(c)(53) as paragraphs (c)(2) through (c)(54) and adding new paragraph 
(c)(1) to read as follows:

Sec.  1308.14  Schedule IV.

* * * * *
    (c) * * *
    (1) Alfaxalone--(2731)
* * * * *

    Dated: February 21, 2014.
Michele M. Leonhart,
Administrator.
[FR Doc. 2014-04332 Filed 2-26-14; 8:45 am]
BILLING CODE 4410-09-P
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