Rules - 2013
[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.
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\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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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\
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\2\ Shram et al. (2011) Clin Pharmacol Ther; 89(5):683-92.
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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.
- 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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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