Schedules of Controlled Substances: Placement of Lorcaserin Into Schedule IV, 26701-26705 [2013-10895]
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Rules and Regulations
Federal Register
Vol. 78, No. 89
Wednesday, May 8, 2013
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1. Remove the term ‘‘book’’ and add
in its place, the term ‘‘market’’ on page
23453, in the first column, line 18.
■
§ 615.5134
[Corrected]
2. On page 23456, in the first column,
line 4, in § 615.5134(e), remove the term
‘‘book’’ and add in its place, the term
‘‘market’’.
■
Dated: May 1, 2013.
Dale L. Aultman,
Secretary, Farm Credit Administration Board.
FARM CREDIT ADMINISTRATION
[FR Doc. 2013–10820 Filed 5–7–13; 8:45 am]
12 CFR Part 615
BILLING CODE 6705–01–P
RIN 3052–AC54
Funding and Fiscal Affairs, Loan
Policies and Operations, and Funding
Operations; Liquidity and Funding;
Correction
DEPARTMENT OF JUSTICE
Farm Credit Administration.
ACTION: Final rule; correction.
[Docket No. DEA–369]
AGENCY:
The Farm Credit
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2013 to strengthen liquidity risk
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SUMMARY:
The FCA
published a document in the Federal
Register on April 18, 2013, (78 FR
23438) amending part 615. In FR Doc.
2013–09166, make the following
corrections on two separate pages.
SUPPLEMENTARY INFORMATION:
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Drug Enforcement Administration
21 CFR Part 1308
Schedules of Controlled Substances:
Placement of Lorcaserin Into Schedule
IV
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
With the issuance of this final
rule, the Administrator of the Drug
Enforcement Administration (DEA)
places the substance lorcaserin,
including its salts, isomers and salts of
isomers whenever the existence of such
salts, isomers, and salts of isomers is
possible, into Schedule IV of the
Controlled Substances Act (CSA). This
action is pursuant to the CSA which
requires that such actions be made on
the record after opportunity for a
hearing through formal rulemaking.
DATES: Effective Date: June 7, 2013.
FOR FURTHER INFORMATION CONTACT: John
W. Partridge, Executive Assistant, Office
of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone, (202) 307–7165.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Legal Authority
The DEA implements and enforces
Titles II and III of the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, often referred to as the
Controlled Substances Act and the
Controlled Substances Import and
Export Act (21 U.S.C. 801–971), as
amended (hereinafter, ‘‘CSA’’). The
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implementing regulations for these
statutes are found in Title 21 of the
Code of Federal Regulations (CFR), parts
1300 to 1321. Under the CSA, controlled
substances are classified in 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 by statute are found at 21
U.S.C. 812(c) and the current list of
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 subsection (b) of
section 812 of this title 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 DEA.
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 HHS and on an evaluation
of all other relevant data by DEA. This
action imposes the regulatory controls
and criminal sanctions of Schedule IV
on the manufacture, distribution,
dispensing, importation, and
exportation of lorcaserin and products
containing lorcaserin.
Background
Lorcaserin ((R)–8–chloro–1–methyl–
2,3,4,5–tetrahydro–1H–3–benzepine
hydrochloride hemihydrate) is a new
1 As set forth in a memorandum of understanding
entered into by HHS, the Food and Drug
Administration, (FDA), and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency
within HHS in carrying out the Secretary’s
scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518. In addition,
because the Secretary of HHS has delegated to the
Assistant Secretary for Health of 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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chemical entity which has central
nervous system hallucinogenic
properties. Lorcaserin is a serotonin
receptor agonist, at the 5HT2C and
5HT2A receptor subtypes. Lorcaserin
HCl was approved by the Food and Drug
Administration (FDA) on June 27, 2012,
as an addition to a reduced-calorie diet
and exercise, for chronic weight
management and it will be marketed
under the trade name BELVIQ®.
HHS and DEA Eight-Factor Analyses
On June 25, 2012, the Department of
Human Health Service (HHS) provided
to the Drug Enforcement Administration
(DEA) a scientific and medical
evaluation and scheduling
recommendation entitled ‘‘Basis for the
Recommendation for Control of
Lorcaserin in Schedule IV of the
Controlled Substances Act.’’ Following
consideration of the eight factors and
findings related to the substance’s abuse
potential, legitimate medical use, and
dependence liability, HHS
recommended that lorcaserin be
controlled in Schedule IV of the CSA
under 21 U.S.C. 812 (b).
In response, DEA conducted an eightfactor analysis of abuse potential of
lorcaserin pursuant to 21 U.S.C. 811(c).
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Determination to Schedule Lorcaserin
After a review of the available data,
including the scientific and medical
evaluation and the scheduling
recommendation from HHS, the
Administrator of the DEA published in
the Federal Register a Notice of
Proposed Rulemaking (NPRM) entitled,
‘‘Schedules of Controlled Substances:
Placement of Lorcaserin into Schedule
IV’’ on December 19, 2012 (77 FR
75075), which proposed placement of
lorcaserin into Schedule IV of the CSA.
The proposed rule provided an
opportunity for all interested persons to
submit their written comments on or
before January 18, 2013.
Comments Received
DEA received seventy-one comments
on the proposed rule to schedule
lorcaserin. Commenters included
individual health-care providers,
national organizations, shareholders in
the company which will market
BELVIQ®, consultants, medical
researchers, and other concerned
citizens. There were 16 commenters in
favor of the proposed rule and one
opposed to it, with the remaining 54
commenters not taking a position.
Support of the Proposed Rule
Fifteen commenters supported
controlling lorcaserin as a Schedule IV
substance. Eleven commenters indicated
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support for controlling lorcaserin under
the CSA based on the abuse potential of
the substance. Most of the commenters
supported the proposal to control
lorcaserin as a Schedule IV substance.
Because lorcaserin will be indicated as
a weight loss drug, some commenters
mentioned that there will be a high
demand for the drug by the general
public upon the drug being marketed.
According to the commenters,
controlling lorcaserin as a Schedule IV
substance will therefore provide the
necessary controls to prevent its
diversion. Two commenters mentioned
that weight loss drugs are needed in the
United States.
DEA Response: DEA appreciates the
support for this rulemaking.
Opposition to the Proposed Rule
Two commenters opposed the
proposal to control lorcaserin as a
Schedule IV substance. One commenter
stated that lorcaserin should be
controlled as a Schedule V substance,
based on the commenter’s stance that
DEA is making assumptions of the abuse
potential of lorcaserin. The commenter
indicated that DEA did not include the
methodology used to determine the
abuse potential of lorcaserin. The other
commenter stated that lorcaserin should
be a non-controlled substance based on
data from a published study on the
abuse potential of lorcaserin in
recreational polydrug users.2
DEA Response: DEA does not agree.
The studies used to assess abuse
potential of lorcaserin are widely held
as the standard methods of evaluation.
Clinical studies indicated that
lorcaserin, similar to comparator drugs
zolpidem (Schedule IV) and ketamine
(Schedule III) produced significant
increases on positive subjective
measures (VAS for ‘‘high’’ and ‘‘good
drug effects’’) as well as an increase on
the VAS for ‘‘hallucinations.’’
Lorcaserin, as well as zolpidem and
ketamine, significantly increased reports
of ‘‘sedation’’ on the subjective scale of
the ARCI, compared to placebo. In a
human abuse potential study, incidence
of euphoria resulting from lorcaserin
administration is similar to the
incidence reported following zolpidem
(Schedule IV) administration (13–16%)
and lower than that following ketamine
(Schedule III) administration (50%). The
DEA did consider in its evaluation the
published article 1 cited by the
commenter. The data collectively
suggest that lorcaserin does have
sufficient abuse potential to warrant
control under the CSA. HHS
2 Shram et al. (2011) Clin Pharmacol Ther;
89(5):683–92.
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recommended control of lorcaserin in
Schedule IV of the CSA and the DEA’s
placement findings support this level of
control.
Requests To Control Lorcaserin in a
Higher Schedule Than Schedule IV
Four commenters expressed concern
that Schedule IV was not a stringent
enough schedule for lorcaserin, based
on it being an agonist at the 5–HT2A
receptors. These commenters suggested
that lorcaserin be controlled in
Schedule II or Schedule III. 5–HT2A
receptors mediate hallucinogenic
properties of other drugs, such as
lysergic acid diethylamide (LSD).
DEA Response: DEA believes that
placement in Schedule IV of the CSA
will help restrict unsafe access to
lorcaserin and reduce instances of its
abuse. Upon receiving from HHS a
scientific and medical evaluation and a
scheduling recommendation for
lorcaserin, DEA also conducted its own
analysis of the eight factors in
accordance with 21 U.S.C. 811(b). Based
on the review of HHS’ evaluation and
scheduling recommendation and other
relevant data, DEA found that lorcaserin
had a low potential for abuse relative to
ketamine, a Schedule III drug, a
currently accepted medical use for
treatment in the United States, and that
abuse of lorcaserin may lead to limited
physical or psychological dependence
relative to drugs in Schedule III. On the
basis of these findings, lorcaserin is
appropriately being controlled in
Schedule IV.
Requests To Expedite the Lorcaserin
Scheduling Action
There were thirty-two comments
which requested that DEA expedite the
scheduling action for lorcaserin.
Generally, the commenters indicated
that the scheduling action should be
expedited due to epidemic levels of
obesity in the United States and the
absence of any weight loss drugs on the
market with lorcaserin’s novel
mechanism of action. Some commenters
stated that the review conducted by
FDA was sufficient to justify that
lorcaserin be controlled expeditiously.
Of these thirty-two comments, seven
comments also requested that, ‘‘in the
interest of public health,’’ DEA waive
the 30-day comment or implementation
period in order to make lorcaserin
available immediately. One commenter
stated that the scheduling action should
be expedited because ‘‘based on
scientific evidence that is available to
date, there is no risk of this drug being
addictive, and therefore abused.’’
From the previously mentioned
thirty-two comments, eight comments
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Risk Evaluations and Mitigation
Strategy (REMS) Program for
Lorcaserin
Phentermine Being Combined With
Lorcaserin
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requested that the placement of
lorcaserin in Schedule IV become
effective on the date of the publication
of the Final Rule. One commenter
requested that the implementation
period be limited to two weeks instead
of the standard 30 days. Generally the
commenters stated that since obesity
and obesity-related illnesses are
occurring at epidemic levels, lorcaserin
should be available to health care
practitioners and patients in the
immediate future. One commenter
referenced other scheduling actions in
which the effective date was the same
as the publication date of the Final Rule
as justification of doing the same for the
lorcaserin. The scheduling actions
referenced were zopiclone (70 FR
16935), pregabalin (70 FR 43633), and
ezogabine (76 FR 77895).
DEA Response: DEA believes that
providing 30 days for this rule to
become effective is both expeditious
and sufficient to allow handlers to apply
for registration with DEA and to comply
with regulatory requirements for
handling Schedule IV controlled
substances. With regard to the comment
about lack of abuse potential for
lorcaserin, as mentioned in both HHS’
and DEA’s scientific and medical
analyses, the data collectively suggest
that lorcaserin does have sufficient
abuse potential and though the effective
dates for scheduling zopiclone,
pregabalin, and ezogabine were the date
of publication of their respective Final
Rule, DEA does not agree that
lorcaserin’s effective date should be the
date of publication of the Final Rule.
The clinical indications of above
referenced drugs are different from that
of lorcaserin. DEA believes that the
clinical indications for lorcaserin do not
support the waiver of the 30-day period.
With regard to the availability of weightloss drugs, DEA further notes that other
weight-loss drugs are currently available
on the market.
The remaining comments were
concerning various topics, not all of
them being related to lorcaserin directly.
The comments are summarized below as
follows:
Eight commenters expressed concern
about the probability that healthcare
providers would prescribe phentermine
with lorcaserin to increase weight loss
results in patients.
DEA Response: Prescriptions for
controlled substances, including
lorcaserin, must be issued for a
legitimate medical purpose by an
individual practitioner acting in the
usual course of professional practice. A
determination of the validity of a
prescription depends on an evaluation
of the particular circumstances
surrounding its issuance.
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Three commenters stated that there
should be a REMS program in place for
the prescribing and dispensing of
prescriptions of lorcaserin to minimize
the misuse of lorcaserin. Two of these
commenters also expressed concern
about the effects of direct-to-consumer
television advertisements of lorcaserin.
DEA Response: FDA is responsible for
determining whether REMS programs
should be implemented for particular
drugs. Various agencies, such as FDA
and the Federal Trade Commission
(FTC), have a role in regulating directto-consumer drug advertising.
Request for a Hearing
One commenter requested a formal
hearing prior to the finalization of the
scheduling action for lorcaserin. The
commenter expressed concern that the
potential for abuse of lorcaserin is large
since the indication is for the drug to be
taken chronically for weight loss. The
commenter requested that the hearing
include ‘‘relevant experts.’’
DEA Response: DEA regulations
provide that ‘‘[a]ny interested person’’
may request a hearing on a proposed
scheduling action. 21 CFR 1308.44(a).
DEA regulations define ‘‘interested
person’’ as ‘‘any person adversely
affected or aggrieved by any rule or
proposed rule issuable pursuant to [21
U.S.C. 811].’’ 21 CFR 1300.01(b). The
regulations further require that any
person requesting a hearing must state
‘‘with particularity’’ his interest in the
proceeding. 21 CFR 1316.47(a). Because
the commenter failed to provide
sufficient information to demonstrate
that he meets the definition of
‘‘interested person’’ as set forth in the
regulations, DEA hereby denies this
hearing request.
Other Comments
• Several commenters were critical of
DEA’s handling of the scheduling process.
The commenters did not provide specific
recommendations for action.
• One commenter expressed concern about
the abuse potential of lorcaserin. The
commenter did not indicate whether they
opposed or supported the proposal to control
lorcaserin.
• One commenter requested that DEA
extend the comment period for the NPRM by
60 additional days. The commenter indicated
that the public had not been given sufficient
time to respond to the NPRM. DEA has
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allowed 30 days for a comment period in
previous scheduling actions for new
chemical entities. A 30-day comment period
has been demonstrated to be a sufficient
period to allow the public to submit
comments to proposed scheduling actions.
• One commenter submitted information
about Combo Pilling, which is not related to
the current control action.
• One commenter discussed the side
effects experienced with taking Qsymia, a
weight loss drug. This comment was not
related to the current scheduling action.
• Two commenters stated that obesity
drugs are not needed to deal with the current
obesity epidemic. This comment was not
related to the current scheduling action.
Scheduling Conclusion
Based on consideration of all
comments, the scientific and medical
evaluation and accompanying
recommendation of HHS, and based on
DEA’s consideration of its own eightfactor analysis, DEA finds that these
facts and all relevant data constitute
substantial evidence of potential for
abuse of lorcaserin. As such, DEA will
schedule lorcaserin 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 statute
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 HHS and review
of all available data, the Administrator
of DEA, pursuant to 21 U.S.C. 812(b)(4),
finds that:
(1) Lorcaserin has a low potential for
abuse relative to the drugs or other
substances in Schedule III. The overall
abuse potential of lorcaserin is
comparable to Schedule IV substances
such as zolpidem;
(2) Lorcaserin has a currently
accepted medical use in treatment in the
United States. Lorcaserin HCL was
approved for marketing by FDA as an
addition to a reduced-calorie diet and
exercise, for chronic weight
management; and
(3) Abuse of lorcaserin may lead to
limited physical dependence or
psychological dependence relative to
the drugs or other substances in
Schedule III. This finding is based on
the ability of lorcaserin to produce
positive subjective effects at
supratherapeutic doses.
Based on these findings, the
Administrator of DEA concludes that
lorcaserin, including its salts, isomers,
and salts of isomers whenever the
existence of such salts, isomers, and
salts of isomers is possible, warrants
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control in Schedule IV of the CSA (21
U.S.C. 812(b)(4)).
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Requirements for Handling Lorcaserin
Upon the effective date of this final
rule, lorcaserin is subject to the CSA
and the Controlled Substances Import
and Export Act (CSIEA) regulatory
controls and administrative, civil, and
criminal sanctions applicable to the
manufacture, distribution, dispensing,
importing, and exporting of a Schedule
IV controlled substance, including the
following:
Registration. Any person who
manufactures, distributes, dispenses,
imports, exports, engages in research or
conducts instructional activities with
lorcaserin, or who desires to
manufacture, distribute, dispense,
import, export, engage in research or
conduct instructional activities with
lorcaserin, must be registered to conduct
such activities pursuant to 21 U.S.C. 822
and in accordance with 21 CFR Part
1301. Any person who is currently
engaged in any of the above activities
and is not registered with DEA must
submit an application for registration on
or before June 7, 2013 and may not
continue their activities until DEA has
approved that application.
Security. Lorcaserin is subject to
Schedules III–V security requirements
and must be manufactured, distributed,
and stored pursuant to 21 U.S.C. 823
and in accordance with 21 CFR 1301.71,
1301.72(b), (c), and (d), 1301.73,
1301.74, 1301.75(b) and (c), 1301.76,
and 1301.77 on or after June 7, 2013.
Labeling and Packaging. All labels
and labeling for commercial containers
of lorcaserin must be in accordance with
21 CFR 1302.03–1302.07, pursuant to 21
U.S.C. 825, on or after June 7, 2013.
Inventory. Every registrant required to
keep records and who possesses any
quantity of lorcaserin must keep an
inventory of all stocks of lorcaserin on
hand pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1304.03,
1304.04, 1304.06, and 1304.11 on or
after June 7, 2013. Every registrant who
desires registration in Schedule IV for
lorcaserin is required to conduct an
inventory of all stocks of the substance
on hand at the time of registration.
Records. All registrants must keep
records pursuant to 21 U.S.C. 827 and
in accordance with 21 CFR 1304.03,
1304.04, 1304.21, 1304.22, and 1304.23
on or after June 7, 2013.
Prescriptions. All prescriptions for
lorcaserin or prescriptions for products
containing lorcaserin must comply with
21 U.S.C. 829 and 21 CFR 1306,
including but not limited to 21 CFR
1306.03–1306.06, 1306.08, 1306.09, and
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1306.21–1306.27 on or after June 7,
2013.
Importation and Exportation. All
importation and exportation of
lorcaserin must be done in accordance
with 21 CFR Part 1312, pursuant to 21
U.S.C. 952, 953, 957, and 958, on or
after June 7, 2013.
Criminal Liability. Any activity with
lorcaserin not authorized by, or in
violation of, the Controlled Substances
Act or the Controlled Substances Import
and Export Act shall be unlawful on or
after June 7, 2013.
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 (5
U.S.C. 601–612) (RFA), has reviewed
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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
lorcaserin, including its salts, isomers
and salts of isomers, into Schedule IV of
the CSA. By this final rule, lorcaserin
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., noncontrol) enable DEA to meet its statutory
obligations under the CSA.
Lorcaserin is a new chemical entity
and is not currently available or
marketed in any country. According to
publicly available information reviewed
by DEA, lorcaserin is anticipated to
enjoy patent protection for at least a
decade before generic equivalents may
be manufactured and marketed.
Accordingly, the number of currently
identifiable manufacturers, importers,
and distributors for lorcaserin is
extremely small. The publicly available
materials also specify the readily
identifiable persons subject to direct
regulation by this final rule. Based on
guidelines utilized by the Small
Business Administration, the lorcaserin
manufacturer was identified as a small
entity and is expected to conduct
manufacturing activities at a facility
outside the United States; the
distributor/importer does not meet the
standard as a small entity. Once generic
equivalents are developed and approved
for manufacturing and marketing, there
may be additional manufacturers,
importers, and distributors of lorcaserin,
but whether they may qualify as small
entity cannot be determined at this time.
There are approximately 1.4 million
controlled substance registrants,
approximately 381,000 of which are
estimated to be businesses. DEA
estimates that 371,000 (97%) of these
businesses are considered ‘‘small
entities’’ in accordance with the RFA
and Small Business Administration
standards. 5 U.S.C. 601(6) and 15 U.S.C.
632. However, due to the wide variety
of unidentifiable and unquantifiable
variables that potentially could
influence the dispensing rates of new
chemical entities, DEA is unable to
determine the number of small entities
which might dispense (including
administer or prescribe) lorcaserin (e.g.,
pharmacies and prescribers).
Despite the fact that the number of
small businesses possibly impacted by
this rule could not be determined, DEA
concludes that they would not
experience a significant economic
impact as a result of this rule. Currently
E:\FR\FM\08MYR1.SGM
08MYR1
Federal Register / Vol. 78, No. 89 / Wednesday, May 8, 2013 / Rules and Regulations
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
(adjusted for inflation) in any one year.
Therefore, no actions were deemed
necessary under provisions of the
Unfunded Mandates Reform Act of 1995
(UMRA).
Unfunded Mandates Reform Act of 1995
For the reasons stated in the above
section titled, ‘‘Regulatory Flexibility
Act,’’ 3 this rule does not include a
Federal mandate that may result in the
expenditure by state, local, and tribal
mstockstill on DSK4VPTVN1PROD with RULES
98% of DEA registrants (most of which
are small businesses) are authorized to
handle Schedule IV controlled
substances. Even if we assume that all
of these registrants were to handle
lorcaserin (e.g., practitioners prescribe
the substance, and pharmacies dispense
those prescriptions), the costs that they
would incur as a result of lorcaserin’s
scheduling would be nominal.
Registrants that dispense (but not
prescribe) would incur nominal
additional security, inventory,
recordkeeping, and labeling costs. These
registered entities have already
established and implemented these
systems and processes required to
handle Schedule IV controlled
substances, and can easily absorb the
costs of dispensing lorcaserin with
nominal to no additional economic
burden. For example, pharmacies and
institutional practitioners may disperse
Schedule II through V controlled
substances throughout the stock of
noncontrolled substances in such a
manner as to obstruct theft or diversion
of the controlled substances. In
addition, because registered pharmacies
must label all Schedule II through V
controlled substances that they
dispense, the requirement to label all
dispensed substances containing
lorcaserin would not impose a
significant economic burden upon
registered pharmacies. Accordingly,
compliance would not require
significant additional manpower, capital
investment, or recordkeeping burdens.
The only additional requirement
imposed by this rule upon registrants
that only prescribe substances
containing lorcaserin is that they issue
an oral or written prescription to
dispense the substance. Accordingly,
registered prescribers would not incur
any additional security, inventory,
recordkeeping, or labeling costs as a
result of this rule as they would not
physically handle lorcaserin.
Because of these facts, this rule will
not result in a significant economic
impact on a substantial number of small
entities.
Authority: 21 U.S.C. 811, 812, 871(b),
unless otherwise noted.
3 UMRA and the RFA share the same definition
of ‘‘rule.’’ UMRA defines ‘‘regulation’’ or ‘‘rule’’ by
cross-referencing the RFA’s definition of ‘‘rule.’’ 2
U.S.C. 658(10)). The RFA generally defines ‘‘rule’’
as ‘‘any rule for which the agency publishes a
general notice of proposed rulemaking pursuant to
section 553(b) of [the Administrative Procedure
Act].’’ 5 U.S.C. 601(2).
VerDate Mar<15>2010
16:21 May 07, 2013
Jkt 229001
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.
Congressional Review Act
This rule is not a major rule as
defined by § 804 of the Small Business
Regulatory Enforcement Fairness Act of
1996 (Congressional Review Act). 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, 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.
Under the authority vested in the
Attorney General by Section 201(a) of
the CSA (21 U.S.C. 811(a)), and
delegated to the Administrator of DEA
by Department of Justice regulations (28
CFR 0.100) the Administrator hereby
amends 21 CFR part 1308 as follows:
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
The authority citation for 21 CFR Part
1308 continues to read as follows:
1. Section 1308.14 is amended by
redesignating paragraphs (e) and (f) as
paragraphs (f) and (g), and adding a new
paragraph (e) to read as follows:
■
§ 1308.14
Schedule IV.
*
*
*
*
*
(e) Lorcaserin. Any material,
compound, mixture, or preparation
which contains any quantity of the
following substances, including its salts,
isomers, and salts of such isomers,
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
26705
whenever the existence of such salts,
isomers, and salts of isomers is possible:
(1) Lorcaserin ...................................
*
*
*
*
1625
*
Dated: April 29, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013–10895 Filed 5–7–13; 8:45 am]
BILLING CODE 4410–09–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 54
[WC Docket Nos. 09–197; 11–42; FCC 13–
44]
Telecommunications Carriers Eligible
for Support; Lifeline and Link Up
Reform and Several Petitions for
Forbearance
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
In this order, the Federal
Communications Commission
(Commission) grants limited forbearance
from the requirement of the
Commission’s rules that the service area
of an eligible telecommunications
carrier (ETC) conform to the service area
of any rural telephone company serving
the same area. In particular, this grant
of forbearance applies to any ETC that
has been designated by a state or the
Commission, as well as pending and
future requests by telecommunications
carriers that seek limited designation, as
an ETC to participate only in the
Lifeline program (Lifeline-only ETC).
The Commission concludes that
forbearance furthers the Act’s and
Commission’s goals of ensuring the
availability of voice service to lowincome consumers.
DATES: Effective June 7, 2013, except
paragraph 19 which is effective upon
release of the Memorandum Opinion
and Order.
FOR FURTHER INFORMATION CONTACT:
Alexander Minard, Wireline
Competition Bureau, (202) 418–0428 or
TTY: (202) 418–0484.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s
Memorandum Opinion and Order
(Order) in WC Docket Nos. 09–197;11–
42; FCC 13–44, released on April 15,
2013. The full text of this document is
available for public inspection during
regular business hours in the FCC
Reference Center, Room CY–A257, 445
12th Street SW., Washington, DC 20554.
Or at the following Internet address:
SUMMARY:
E:\FR\FM\08MYR1.SGM
08MYR1
Agencies
[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Rules and Regulations]
[Pages 26701-26705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10895]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-369]
Schedules of Controlled Substances: Placement of Lorcaserin Into
Schedule IV
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: With the issuance of this final rule, the Administrator of the
Drug Enforcement Administration (DEA) places the substance lorcaserin,
including its salts, isomers and salts of isomers whenever the
existence of such salts, isomers, and salts of isomers is possible,
into Schedule IV of the Controlled Substances Act (CSA). This action is
pursuant to the CSA which requires that such actions be made on the
record after opportunity for a hearing through formal rulemaking.
DATES: Effective Date: June 7, 2013.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone, (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Legal Authority
The DEA implements and enforces Titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, often
referred to as the Controlled Substances Act and the Controlled
Substances Import and Export Act (21 U.S.C. 801-971), as amended
(hereinafter, ``CSA''). The implementing regulations for these statutes
are found in Title 21 of the Code of Federal Regulations (CFR), parts
1300 to 1321. Under the CSA, controlled substances are classified in
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 by statute are found at 21 U.S.C. 812(c) and the current
list of 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 subsection (b) of section 812 of
this title 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 DEA.
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 HHS and on an evaluation of all other relevant data by
DEA. This action imposes the regulatory controls and criminal sanctions
of Schedule IV on the manufacture, distribution, dispensing,
importation, and exportation of lorcaserin and products containing
lorcaserin.
---------------------------------------------------------------------------
\1\ As set forth in a memorandum of understanding entered into
by HHS, the Food and Drug Administration, (FDA), and the National
Institute on Drug Abuse (NIDA), FDA acts as the lead agency within
HHS in carrying out the Secretary's scheduling responsibilities
under the CSA, with the concurrence of NIDA. 50 FR 9518. In
addition, because the Secretary of HHS has delegated to the
Assistant Secretary for Health of 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.''
---------------------------------------------------------------------------
Background
Lorcaserin ((R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzepine
hydrochloride hemihydrate) is a new
[[Page 26702]]
chemical entity which has central nervous system hallucinogenic
properties. Lorcaserin is a serotonin receptor agonist, at the
5HT2C and 5HT2A receptor subtypes. Lorcaserin HCl
was approved by the Food and Drug Administration (FDA) on June 27,
2012, as an addition to a reduced-calorie diet and exercise, for
chronic weight management and it will be marketed under the trade name
BELVIQ[supreg].
HHS and DEA Eight-Factor Analyses
On June 25, 2012, the Department of Human Health Service (HHS)
provided to the Drug Enforcement Administration (DEA) a scientific and
medical evaluation and scheduling recommendation entitled ``Basis for
the Recommendation for Control of Lorcaserin in Schedule IV of the
Controlled Substances Act.'' Following consideration of the eight
factors and findings related to the substance's abuse potential,
legitimate medical use, and dependence liability, HHS recommended that
lorcaserin be controlled in Schedule IV of the CSA under 21 U.S.C. 812
(b).
In response, DEA conducted an eight-factor analysis of abuse
potential of lorcaserin pursuant to 21 U.S.C. 811(c).
Determination to Schedule Lorcaserin
After a review of the available data, including the scientific and
medical evaluation and the scheduling recommendation from HHS, the
Administrator of the DEA published in the Federal Register a Notice of
Proposed Rulemaking (NPRM) entitled, ``Schedules of Controlled
Substances: Placement of Lorcaserin into Schedule IV'' on December 19,
2012 (77 FR 75075), which proposed placement of lorcaserin into
Schedule IV of the CSA. The proposed rule provided an opportunity for
all interested persons to submit their written comments on or before
January 18, 2013.
Comments Received
DEA received seventy-one comments on the proposed rule to schedule
lorcaserin. Commenters included individual health-care providers,
national organizations, shareholders in the company which will market
BELVIQ[supreg], consultants, medical researchers, and other concerned
citizens. There were 16 commenters in favor of the proposed rule and
one opposed to it, with the remaining 54 commenters not taking a
position.
Support of the Proposed Rule
Fifteen commenters supported controlling lorcaserin as a Schedule
IV substance. Eleven commenters indicated support for controlling
lorcaserin under the CSA based on the abuse potential of the substance.
Most of the commenters supported the proposal to control lorcaserin as
a Schedule IV substance. Because lorcaserin will be indicated as a
weight loss drug, some commenters mentioned that there will be a high
demand for the drug by the general public upon the drug being marketed.
According to the commenters, controlling lorcaserin as a Schedule IV
substance will therefore provide the necessary controls to prevent its
diversion. Two commenters mentioned that weight loss drugs are needed
in the United States.
DEA Response: DEA appreciates the support for this rulemaking.
Opposition to the Proposed Rule
Two commenters opposed the proposal to control lorcaserin as a
Schedule IV substance. One commenter stated that lorcaserin should be
controlled as a Schedule V substance, based on the commenter's stance
that DEA is making assumptions of the abuse potential of lorcaserin.
The commenter indicated that DEA did not include the methodology used
to determine the abuse potential of lorcaserin. The other commenter
stated that lorcaserin should be a non-controlled substance based on
data from a published study on the abuse potential of lorcaserin in
recreational polydrug users.\2\
---------------------------------------------------------------------------
\2\ Shram et al. (2011) Clin Pharmacol Ther; 89(5):683-92.
---------------------------------------------------------------------------
DEA Response: DEA does not agree. The studies used to assess abuse
potential of lorcaserin are widely held as the standard methods of
evaluation. Clinical studies indicated that lorcaserin, similar to
comparator drugs zolpidem (Schedule IV) and ketamine (Schedule III)
produced significant increases on positive subjective measures (VAS for
``high'' and ``good drug effects'') as well as an increase on the VAS
for ``hallucinations.'' Lorcaserin, as well as zolpidem and ketamine,
significantly increased reports of ``sedation'' on the subjective scale
of the ARCI, compared to placebo. In a human abuse potential study,
incidence of euphoria resulting from lorcaserin administration is
similar to the incidence reported following zolpidem (Schedule IV)
administration (13-16%) and lower than that following ketamine
(Schedule III) administration (50%). The DEA did consider in its
evaluation the published article \1\ cited by the commenter. The data
collectively suggest that lorcaserin does have sufficient abuse
potential to warrant control under the CSA. HHS recommended control of
lorcaserin in Schedule IV of the CSA and the DEA's placement findings
support this level of control.
Requests To Control Lorcaserin in a Higher Schedule Than Schedule IV
Four commenters expressed concern that Schedule IV was not a
stringent enough schedule for lorcaserin, based on it being an agonist
at the 5-HT2A receptors. These commenters suggested that
lorcaserin be controlled in Schedule II or Schedule III. 5-
HT2A receptors mediate hallucinogenic properties of other
drugs, such as lysergic acid diethylamide (LSD).
DEA Response: DEA believes that placement in Schedule IV of the CSA
will help restrict unsafe access to lorcaserin and reduce instances of
its abuse. Upon receiving from HHS a scientific and medical evaluation
and a scheduling recommendation for lorcaserin, DEA also conducted its
own analysis of the eight factors in accordance with 21 U.S.C. 811(b).
Based on the review of HHS' evaluation and scheduling recommendation
and other relevant data, DEA found that lorcaserin had a low potential
for abuse relative to ketamine, a Schedule III drug, a currently
accepted medical use for treatment in the United States, and that abuse
of lorcaserin may lead to limited physical or psychological dependence
relative to drugs in Schedule III. On the basis of these findings,
lorcaserin is appropriately being controlled in Schedule IV.
Requests To Expedite the Lorcaserin Scheduling Action
There were thirty-two comments which requested that DEA expedite
the scheduling action for lorcaserin. Generally, the commenters
indicated that the scheduling action should be expedited due to
epidemic levels of obesity in the United States and the absence of any
weight loss drugs on the market with lorcaserin's novel mechanism of
action. Some commenters stated that the review conducted by FDA was
sufficient to justify that lorcaserin be controlled expeditiously. Of
these thirty-two comments, seven comments also requested that, ``in the
interest of public health,'' DEA waive the 30-day comment or
implementation period in order to make lorcaserin available
immediately. One commenter stated that the scheduling action should be
expedited because ``based on scientific evidence that is available to
date, there is no risk of this drug being addictive, and therefore
abused.''
From the previously mentioned thirty-two comments, eight comments
[[Page 26703]]
requested that the placement of lorcaserin in Schedule IV become
effective on the date of the publication of the Final Rule. One
commenter requested that the implementation period be limited to two
weeks instead of the standard 30 days. Generally the commenters stated
that since obesity and obesity-related illnesses are occurring at
epidemic levels, lorcaserin should be available to health care
practitioners and patients in the immediate future. One commenter
referenced other scheduling actions in which the effective date was the
same as the publication date of the Final Rule as justification of
doing the same for the lorcaserin. The scheduling actions referenced
were zopiclone (70 FR 16935), pregabalin (70 FR 43633), and ezogabine
(76 FR 77895).
DEA Response: DEA believes that providing 30 days for this rule to
become effective is both expeditious and sufficient to allow handlers
to apply for registration with DEA and to comply with regulatory
requirements for handling Schedule IV controlled substances. With
regard to the comment about lack of abuse potential for lorcaserin, as
mentioned in both HHS' and DEA's scientific and medical analyses, the
data collectively suggest that lorcaserin does have sufficient abuse
potential and though the effective dates for scheduling zopiclone,
pregabalin, and ezogabine were the date of publication of their
respective Final Rule, DEA does not agree that lorcaserin's effective
date should be the date of publication of the Final Rule. The clinical
indications of above referenced drugs are different from that of
lorcaserin. DEA believes that the clinical indications for lorcaserin
do not support the waiver of the 30-day period. With regard to the
availability of weight-loss drugs, DEA further notes that other weight-
loss drugs are currently available on the market.
Phentermine Being Combined With Lorcaserin
Eight commenters expressed concern about the probability that
healthcare providers would prescribe phentermine with lorcaserin to
increase weight loss results in patients.
DEA Response: Prescriptions for controlled substances, including
lorcaserin, must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of professional
practice. A determination of the validity of a prescription depends on
an evaluation of the particular circumstances surrounding its issuance.
Risk Evaluations and Mitigation Strategy (REMS) Program for Lorcaserin
Three commenters stated that there should be a REMS program in
place for the prescribing and dispensing of prescriptions of lorcaserin
to minimize the misuse of lorcaserin. Two of these commenters also
expressed concern about the effects of direct-to-consumer television
advertisements of lorcaserin.
DEA Response: FDA is responsible for determining whether REMS
programs should be implemented for particular drugs. Various agencies,
such as FDA and the Federal Trade Commission (FTC), have a role in
regulating direct-to-consumer drug advertising.
Request for a Hearing
One commenter requested a formal hearing prior to the finalization
of the scheduling action for lorcaserin. The commenter expressed
concern that the potential for abuse of lorcaserin is large since the
indication is for the drug to be taken chronically for weight loss. The
commenter requested that the hearing include ``relevant experts.''
DEA Response: DEA regulations provide that ``[a]ny interested
person'' may request a hearing on a proposed scheduling action. 21 CFR
1308.44(a). DEA regulations define ``interested person'' as ``any
person adversely affected or aggrieved by any rule or proposed rule
issuable pursuant to [21 U.S.C. 811].'' 21 CFR 1300.01(b). The
regulations further require that any person requesting a hearing must
state ``with particularity'' his interest in the proceeding. 21 CFR
1316.47(a). Because the commenter failed to provide sufficient
information to demonstrate that he meets the definition of ``interested
person'' as set forth in the regulations, DEA hereby denies this
hearing request.
Other Comments
The remaining comments were concerning various topics, not all of
them being related to lorcaserin directly. The comments are summarized
below as follows:
Several commenters were critical of DEA's handling of
the scheduling process. The commenters did not provide specific
recommendations for action.
One commenter expressed concern about the abuse
potential of lorcaserin. The commenter did not indicate whether they
opposed or supported the proposal to control lorcaserin.
One commenter requested that DEA extend the comment
period for the NPRM by 60 additional days. The commenter indicated
that the public had not been given sufficient time to respond to the
NPRM. DEA has allowed 30 days for a comment period in previous
scheduling actions for new chemical entities. A 30-day comment
period has been demonstrated to be a sufficient period to allow the
public to submit comments to proposed scheduling actions.
One commenter submitted information about Combo
Pilling, which is not related to the current control action.
One commenter discussed the side effects experienced
with taking Qsymia, a weight loss drug. This comment was not related
to the current scheduling action.
Two commenters stated that obesity drugs are not needed
to deal with the current obesity epidemic. This comment was not
related to the current scheduling action.
Scheduling Conclusion
Based on consideration of all comments, the scientific and medical
evaluation and accompanying recommendation of HHS, and based on DEA's
consideration of its own eight-factor analysis, DEA finds that these
facts and all relevant data constitute substantial evidence of
potential for abuse of lorcaserin. As such, DEA will schedule
lorcaserin 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 statute 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 HHS and review
of all available data, the Administrator of DEA, pursuant to 21 U.S.C.
812(b)(4), finds that:
(1) Lorcaserin has a low potential for abuse relative to the drugs
or other substances in Schedule III. The overall abuse potential of
lorcaserin is comparable to Schedule IV substances such as zolpidem;
(2) Lorcaserin has a currently accepted medical use in treatment in
the United States. Lorcaserin HCL was approved for marketing by FDA as
an addition to a reduced-calorie diet and exercise, for chronic weight
management; and
(3) Abuse of lorcaserin may lead to limited physical dependence or
psychological dependence relative to the drugs or other substances in
Schedule III. This finding is based on the ability of lorcaserin to
produce positive subjective effects at supratherapeutic doses.
Based on these findings, the Administrator of DEA concludes that
lorcaserin, including its salts, isomers, and salts of isomers whenever
the existence of such salts, isomers, and salts of isomers is possible,
warrants
[[Page 26704]]
control in Schedule IV of the CSA (21 U.S.C. 812(b)(4)).
Requirements for Handling Lorcaserin
Upon the effective date of this final rule, lorcaserin is subject
to the CSA and the Controlled Substances Import and Export Act (CSIEA)
regulatory controls and administrative, civil, and criminal sanctions
applicable to the manufacture, distribution, dispensing, importing, and
exporting of a Schedule IV controlled substance, including the
following:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with lorcaserin, or who desires to manufacture, distribute,
dispense, import, export, engage in research or conduct instructional
activities with lorcaserin, must be registered to conduct such
activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR Part
1301. Any person who is currently engaged in any of the above
activities and is not registered with DEA must submit an application
for registration on or before June 7, 2013 and may not continue their
activities until DEA has approved that application.
Security. Lorcaserin is subject to Schedules III-V security
requirements and must be manufactured, distributed, and stored pursuant
to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71, 1301.72(b),
(c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76, and
1301.77 on or after June 7, 2013.
Labeling and Packaging. All labels and labeling for commercial
containers of lorcaserin must be in accordance with 21 CFR 1302.03-
1302.07, pursuant to 21 U.S.C. 825, on or after June 7, 2013.
Inventory. Every registrant required to keep records and who
possesses any quantity of lorcaserin must keep an inventory of all
stocks of lorcaserin on hand pursuant to 21 U.S.C. 827 and in
accordance with 21 CFR 1304.03, 1304.04, 1304.06, and 1304.11 on or
after June 7, 2013. Every registrant who desires registration in
Schedule IV for lorcaserin is required to conduct an inventory of all
stocks of the substance on hand at the time of registration.
Records. All registrants must keep records pursuant to 21 U.S.C.
827 and in accordance with 21 CFR 1304.03, 1304.04, 1304.21, 1304.22,
and 1304.23 on or after June 7, 2013.
Prescriptions. All prescriptions for lorcaserin or prescriptions
for products containing lorcaserin must comply with 21 U.S.C. 829 and
21 CFR 1306, including but not limited to 21 CFR 1306.03-1306.06,
1306.08, 1306.09, and 1306.21-1306.27 on or after June 7, 2013.
Importation and Exportation. All importation and exportation of
lorcaserin must be done in accordance with 21 CFR Part 1312, pursuant
to 21 U.S.C. 952, 953, 957, and 958, on or after June 7, 2013.
Criminal Liability. Any activity with lorcaserin not authorized by,
or in violation of, the Controlled Substances Act or the Controlled
Substances Import and Export Act shall be unlawful on or after June 7,
2013.
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 (5 U.S.C. 601-612) (RFA), 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 lorcaserin, including its salts, isomers and
salts of isomers, into Schedule IV of the CSA. By this final rule,
lorcaserin 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., non-control) enable DEA to meet its
statutory obligations under the CSA.
Lorcaserin is a new chemical entity and is not currently available
or marketed in any country. According to publicly available information
reviewed by DEA, lorcaserin is anticipated to enjoy patent protection
for at least a decade before generic equivalents may be manufactured
and marketed. Accordingly, the number of currently identifiable
manufacturers, importers, and distributors for lorcaserin is extremely
small. The publicly available materials also specify the readily
identifiable persons subject to direct regulation by this final rule.
Based on guidelines utilized by the Small Business Administration, the
lorcaserin manufacturer was identified as a small entity and is
expected to conduct manufacturing activities at a facility outside the
United States; the distributor/importer does not meet the standard as a
small entity. Once generic equivalents are developed and approved for
manufacturing and marketing, there may be additional manufacturers,
importers, and distributors of lorcaserin, but whether they may qualify
as small entity cannot be determined at this time.
There are approximately 1.4 million controlled substance
registrants, approximately 381,000 of which are estimated to be
businesses. DEA estimates that 371,000 (97%) of these businesses are
considered ``small entities'' in accordance with the RFA and Small
Business Administration standards. 5 U.S.C. 601(6) and 15 U.S.C. 632.
However, due to the wide variety of unidentifiable and unquantifiable
variables that potentially could influence the dispensing rates of new
chemical entities, DEA is unable to determine the number of small
entities which might dispense (including administer or prescribe)
lorcaserin (e.g., pharmacies and prescribers).
Despite the fact that the number of small businesses possibly
impacted by this rule could not be determined, DEA concludes that they
would not experience a significant economic impact as a result of this
rule. Currently
[[Page 26705]]
98% of DEA registrants (most of which are small businesses) are
authorized to handle Schedule IV controlled substances. Even if we
assume that all of these registrants were to handle lorcaserin (e.g.,
practitioners prescribe the substance, and pharmacies dispense those
prescriptions), the costs that they would incur as a result of
lorcaserin's scheduling would be nominal. Registrants that dispense
(but not prescribe) would incur nominal additional security, inventory,
recordkeeping, and labeling costs. These registered entities have
already established and implemented these systems and processes
required to handle Schedule IV controlled substances, and can easily
absorb the costs of dispensing lorcaserin with nominal to no additional
economic burden. For example, pharmacies and institutional
practitioners may disperse Schedule II through V controlled substances
throughout the stock of noncontrolled substances in such a manner as to
obstruct theft or diversion of the controlled substances. In addition,
because registered pharmacies must label all Schedule II through V
controlled substances that they dispense, the requirement to label all
dispensed substances containing lorcaserin would not impose a
significant economic burden upon registered pharmacies. Accordingly,
compliance would not require significant additional manpower, capital
investment, or recordkeeping burdens.
The only additional requirement imposed by this rule upon
registrants that only prescribe substances containing lorcaserin is
that they issue an oral or written prescription to dispense the
substance. Accordingly, registered prescribers would not incur any
additional security, inventory, recordkeeping, or labeling costs as a
result of this rule as they would not physically handle lorcaserin.
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
For the reasons stated in the above section titled, ``Regulatory
Flexibility Act,'' \3\ this rule does not include a 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, no actions were deemed necessary under provisions of the
Unfunded Mandates Reform Act of 1995 (UMRA).
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\3\ UMRA and the RFA share the same definition of ``rule.'' UMRA
defines ``regulation'' or ``rule'' by cross-referencing the RFA's
definition of ``rule.'' 2 U.S.C. 658(10)). The RFA generally defines
``rule'' as ``any rule for which the agency publishes a general
notice of proposed rulemaking pursuant to section 553(b) of [the
Administrative Procedure Act].'' 5 U.S.C. 601(2).
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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.
Congressional Review Act
This rule is not a major rule as defined by Sec. 804 of the Small
Business Regulatory Enforcement Fairness Act of 1996 (Congressional
Review Act). 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, 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.
Under the authority vested in the Attorney General by Section
201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the
Administrator of DEA by Department of Justice regulations (28 CFR
0.100) the Administrator hereby amends 21 CFR part 1308 as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
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
1. Section 1308.14 is amended by redesignating paragraphs (e) and (f)
as paragraphs (f) and (g), and adding a new paragraph (e) to read as
follows:
Sec. 1308.14 Schedule IV.
* * * * *
(e) Lorcaserin. Any material, compound, mixture, or preparation
which contains any quantity of the following substances, including its
salts, isomers, and salts of such isomers, whenever the existence of
such salts, isomers, and salts of isomers is possible:
(1) Lorcaserin................................................. 1625
* * * * *
Dated: April 29, 2013.
Michele M. Leonhart,
Administrator.
[FR Doc. 2013-10895 Filed 5-7-13; 8:45 am]
BILLING CODE 4410-09-P