Rules - 2011
[Federal Register Volume 76, Number 204 (Friday, October 21, 2011)]
[Proposed Rules]
[Pages 65424-65428]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27253]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-354]
Schedules of Controlled Substances: Placement of Ezogabine Into
Schedule V
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
SUMMARY: The Drug Enforcement Administration (DEA) proposes placing the
substance ezogabine, including its salts, isomers, and salts of isomers
whenever the existence of such salts, isomers, and salts of isomers is
possible, into Schedule V of the Controlled Substances Act (CSA). This
proposed 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: DEA will permit interested persons to file written comments on
this proposal pursuant to 21 CFR 1308.43(g). Electronic comments must
be submitted and written comments must be postmarked on or before
November 21, 2011. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after
midnight Eastern Time on the last day of the comment period.
Interested persons, defined as those "adversely affected or
aggrieved by any rule or proposed rule issuable pursuant to section 201
of the Act (21 U.S.C. 811)," \1\ may file a request for hearing
pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45 and
1316.47. Requests for hearing, notices of appearance, and waivers of
participation must be received on or before November 21, 2011.
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\1\ 21 CFR 1300.01.
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ADDRESSES: To ensure proper handling of comments, please reference
"Docket No. DEA-354" on all electronic and written correspondence.
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that
site. An electronic copy of this document and supplemental information
to this proposed rule are also available at the http://www.regulations.gov Web site for easy reference. Paper comments that
duplicate the electronic submission are not necessary as all comments
submitted to http://www.regulations.gov will be posted for public
review and are part of the official docket record. Should you, however,
wish to submit written comments via regular or express mail, they
should be sent to the Drug Enforcement Administration, Attention: DEA
Federal Register Representative/OD, 8701 Morrissette Drive,
Springfield, VA 22152. All requests for hearing must be sent to Drug
Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, VA 22152.
FOR FURTHER INFORMATION CONTACT: Rhea D. Moore, Office of Diversion
Control, Drug Enforcement Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone (202) 307-7165.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov and in the DEA's public
docket. Such information includes personal identifying information
(such as your name, address, etc.) voluntarily submitted by the
commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first
paragraph of your comment. You must also place all of the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase "CONFIDENTIAL
BUSINESS INFORMATION" in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted,
and the comment, in redacted form, will be posted online and placed in
the DEA's public docket file. Please note that the Freedom of
Information Act applies to all comments received. If you wish to
inspect the agency's public docket file in person by appointment,
please see the "For Further Information" paragraph.
Request for Hearing, Notice of Appearance at or Waiver of Participation
in Hearing
In accordance with the provisions of the CSA (21 U.S.C. 811(a)),
this action is a formal rulemaking "on the record after opportunity
for a hearing." Such proceedings are conducted pursuant to the
provisions of the Administrative Procedure Act (5 U.S.C. 556 and 557)
and 21 CFR 1308.41. Pursuant to 21 CFR 1308.44(a)-(c), requests for
hearing, notices of appearance, and waivers of participation may be
submitted only by interested persons, defined as those "adversely
affected or aggrieved by any rule or proposed rule issuable pursuant to
section 201 of the Act (21 U.S.C. 811)." Such requests or notices must
conform to the requirements of 21 CFR 1308.44(a) or (b) and 1316.47 or
1316.48, as applicable. A request or notice should state, with
particularity, the interest of the person in the proceeding and the
objections or issues, if any, concerning which the person desires to be
heard. Any waiver must conform to the requirements of 21 CFR
1308.44(c), including a written statement regarding the interested
[[Page 65425]]
person's position on the matters of fact and law involved in any
hearing.
Please note that pursuant to 21 U.S.C. 811(a), the purpose and
subject matter of the hearing is restricted to "(A) find[ing] that
such drug or other substance has a potential for abuse, and (B)
mak[ing] with respect to such drug or other substance the findings
prescribed by subsection (b) of section 812 of this title for the
schedule in which such drug is to be placed * * *" Requests for
hearing, notices of appearance at the hearing, and waivers of
participation in the hearing should be submitted to DEA using the
address information provided above.
Legal Authority
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 are 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 HHS, or (3) on the petition of any
interested party. 21 U.S.C. 811(a). This proposed action is based on a
recommendation from the Assistant Secretary for Health of the
Department of Health and Human Services (HHS) and on an evaluation of
all other relevant data by DEA. If finalized, this action would impose
the regulatory controls and criminal sanctions of Schedule V on the
manufacture, distribution, dispensing, importation, and exportation of
ezogabine and products containing ezogabine.
Background
Ezogabine, known chemically as N-[2-amino-4-(4-fluorobenzylamino)-
phenyl]-carbamic acid ethyl ester, is a new chemical substance with
central nervous system depressant properties and is classified as a
sedative-hypnotic. Pharmacological studies indicate that ezogabine
primarily acts as a ligand at ion-gated channels in the brain to
enhance potassium currents mediated by neuronal KCNQ (Kv7) channels.
Additionally, ezogabine indirectly enhances the gamma-aminobutyric acid
(GABA) mediated neurotransmission. On June 10, 2011, the Food and Drug
Administration (FDA) approved a New Drug Application (NDA) for
ezogabine as an adjunct treatment of partial onset seizures, to be
marketed under the trade name Potiga.[reg] \2\
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\2\ http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm; as of July 21, 2011.
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Proposed Determination to Schedule Ezogabine
Pursuant to 21 U.S.C. 811(a), proceedings to add a drug or
substance to those controlled under the CSA may be initiated by request
of the Secretary of HHS. On January 12, 2011, HHS provided DEA with a
scientific and medical evaluation document prepared by FDA entitled
"Basis for the Recommendation for Control of Ezogabine in Schedule V
of the Controlled Substances Act." Pursuant to 21 U.S.C. 811(b), this
document contained an eight-factor analysis of the abuse potential of
ezogabine as a new drug, along with HHS' recommendation to control
ezogabine under Schedule V of the CSA.
In response, DEA conducted an eight-factor analysis of ezogabine's
abuse potential pursuant to 21 U.S.C. 811(c). Included below is a brief
summary of each factor as analyzed by HHS and DEA, and as considered by
DEA in the scheduling decision. Please note that both the DEA and HHS
analyses are available in their entirety under "Supporting and Related
Material" of the public docket for this rule at www.regulations.gov
under docket number DEA-354.
1. The Drug's Actual or Relative Potential for Abuse: Ezogabine is
a new chemical substance that has not been marketed in the U.S. or in
any other country. As such, there is no information available which
details actual abuse of ezogabine. However, the legislative history of
the CSA offers another methodology for assessing a drug or substance's
potential for abuse:
The drug or drugs containing such a substance are new drugs so
related in their action to a drug or drugs already listed as having
a potential for abuse to make it likely that the drug will have the
same potentiality for abuse as such drugs, thus making it reasonable
to assume that there may be significant diversions from legitimate
channels, significant use contrary to or without medical advice, or
that it has a substantial capability of creating hazards to the
health of the user or to the safety of the community.\3\
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\3\ Comprehensive Drug Abuse Prevention and Control Act of 1970,
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); 1970 U.S.C.C.A.N.
4566, 4601.
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Ezogabine acts as a ligand at ion-gated channels in the brain,
similar to the Schedule V substances pregabalin and lacosamide, and,
like those drugs, ezogabine is indicated for the treatment of epileptic
conditions in humans. There is strong evidence, described below, that
ezogabine produces behavioral effects in humans and in animals that are
similar to those produced by pregabalin and lacosamide.
Phase 1 clinical studies indicate that the rate of euphoria-related
adverse events (AEs) resulting from administration of ezogabine was 6-
9%. This is similar to the AE rates for administration of pregabalin
(10%) and lacosamide (>7%), while Phase \2/3\ clinical studies
indicated similar AE rates between ezogabine (<1%) and lacosamide
(<2%). Animal studies involving administration of ezogabine to animals
produced a sedative behavioral profile similar to that produced from
administration of pregabalin and lacosamide, including decreased
locomotion, decreased muscle tone, and an increase in ataxia. Further,
in abuse potential studies conducted with sedative-hypnotic abusers,
ezogabine, pregabalin, and lacosamide, when compared to placebos, are
similar in their ability to produce statistically significant increases
in subjective responses including "Drug Liking," "Euphoria,"
"Overall Drug Liking," "Good Drug Effects," and "High."
Because of the similarities between ezogabine, pregabalin, and
lacosamide, it is very likely that ezogabine will have an abuse
potential similar to those Schedule V substances. Currently there is a
lack of evidence regarding the diversion, illicit manufacturing or
deliberate misuse of ezogabine due to its commercial unavailability in
any country, but since ezogabine is not readily synthesized from
available substances, any diversion would be from legitimate channels.
The above referenced studies, which include demonstration of the
significant euphoric effects produced by ezogabine in humans, predict
that there will be significant use of ezogabine contrary to or without
medical advice.
2. Scientific Evidence of the Drug's Pharmacological Effects, If
Known:
[[Page 65426]]
Ezogabine acts to enhance potassium currents mediated by neuronal KCNQ
(Kv7) channels with a secondary action through the augmentation of
GABA-mediated neurotransmission without direct GABA receptor
stimulation. In individuals with histories of recreational sedative-
hypnotic abuse, ezogabine (300 and 600 mg orally) produced increased
ratings on the primary positive subjective scales [VAS-Drug-liking,
VAS-Overall Drug Liking, ARCI-MBG (Euphoria), VAS-Take Drug Again] for
peak responses (Emax for the first eight hours after drug
administration) that were significantly different from the placebo.
This effect is similar to that produced by alprazolam (1.5 and 3.0 mg
orally; Schedule IV). On secondary positive subjective scales [VAS-
High, VAS-Good Effects, ARCI-Amphetamine (Activation)] for peak
responses, both ezogabine and alprazolam produced significant increases
compared to the placebo, while there were no differences between
ezogabine and alprazolam on those measures.
In human abuse potential studies, ezogabine (300 and 600 mg), upon
oral administration, increased ratings on negative and sedating
subjective measures [VAS-Bad Effects, ARCI-LSD (dysphoria) and ARCI-
PCAG (sedation)] compared to the placebo, but these increases were
lower than those produced by 1.5 and 3.0 mg alprazolam. These data for
ezogabine are similar to those produced by lacosamide. A 900 mg dose of
ezogabine produced VAS-Drug Liking and VAS-Good Effects that were
higher than those produced by the two lower doses of ezogabine and
either dose of alprazolam. However, the changes in VAS-Bad Effects and
ARCI-LSD (dysphoria) following 900 mg ezogabine were less than or
similar to those produced by lower doses of ezogabine and either dose
of alprazolam. The adverse events following 900 mg ezogabine are
similar to those described in the NDA for the human abuse potential
study conducted with lacosamide. These included euphoria, somnolence,
visual disturbances, and altered auditory perception.
In human abuse potential studies, ezogabine, similar to pregabalin
and lacosamide, also produced ratings on each of the positive
subjective responses that were statistically similar to those produced
by Schedule IV benzodiazepines (alprazolam or diazepam). Although this
appears to suggest that these drugs have an abuse potential similar to
that of Schedule IV substances, the other data from human abuse
potential studies, the adverse effect profile data from safety and
efficacy studies, and the data from the preclinical animal behavioral
studies demonstrate that ezogabine has abuse potential less than that
of Schedule IV drugs but similar to that of Schedule V drugs.
3. The State of Current Scientific Knowledge Regarding the Drug or
Other Substance: The chemical name of ezogabine is N-[2-amino-4-(4-
fluorobenzylamino)-phenyl]-carbamic acid ethyl ester. It is an achiral
molecule with a molecular formula of
C16H18FN3O2 and a molecular
weight of 303.3 g/mol. Ezogabine is a non-hygroscopic white to slightly
colored powder with a melting point of 140-143\0\C. It is soluble in
0.9% saline, methanol, chloroform, but only sparingly soluble in
ethanol and 0.1N HCL.
Ezogabine in humans has a Tmax (time required for
ezogabine to reach maximum plasma concentration) ranging from 1-4 hours
following both acute and multiple dosing, and, without the involvement
of cytochrome P450, undergoes an extensive and almost exclusively phase
2 metabolic biotransformation. Ezogabine is predominantly metabolized
by N-glucuronidation, resulting in the formation of two distinct N-
glucuronides of the unchanged parent drug and to a lesser extent by N-
acetylation to form N-acetyl-retigabine, the major bioactive metabolite
of ezogabine. The half-life of both ezogabine and N-acetyl-retigabine
is approximately eight hours and the Cmax (maximum plasma
concentration) of both components is dose proportional after both acute
and multiple dosing, suggesting a lack of accumulation with repeated
administration.
4. Its History and Current Pattern of Abuse: As stated in the
summary of Factor 1, information on ezogabine's history and current
pattern of abuse is unavailable as it has not been marketed in any
country. As such, evaluation of abuse potential for ezogabine derives
from positive indicators in clinical studies which are believed to be
predictive of drug abuse and which are discussed in Factors 1 and 2
above.
5. The Scope, Duration, and Significance of Abuse: Because
ezogabine has not been marketed in any country, information on the
scope, duration, and significance of abuse of ezogabine is unavailable.
However, epidemiological data on pregabalin, a Schedule V drug with an
abuse potential similar to that of ezogabine, is available from the
Drug Abuse Warning Network (DAWN) database.
The "abuse frequency ratio," calculated as the ratio of
nonmedical use related annual emergency department visits (as reported
in DAWN) to the total number of annual prescriptions for pregabalin is
less than that for the Schedule IV drug, alprazolam. Further, because
ezogabine has abuse-related human and animal data in its NDA similar to
data generated for pregabalin, ezogabine is likely to have an abuse
potential similar to pregabalin. The "abuse frequency ratios" for
pregabalin range from 29 to 47, while those for alprazolam are
approximately three to six times higher, ranging from 160 to 235. Thus,
pregabalin was placed into Schedule V based both on abuse-related human
and animal data submitted in its NDA and by epidemiological data which
justified placement relative to drugs in Schedule IV. Given that
ezogabine has abuse-related human and animal data in its NDA similar to
the data generated by pregabalin, it is likely that ezogabine will have
an abuse potential similar to this Schedule V drug.
6. What, if any, Risk There is to the Public Health: The data
indicates that ezogabine may present a serious safety risk to the
public health, and the predicted level of risk is similar to that
observed with pregabalin and lacosamide but less than that produced by
Schedule IV benzodiazepines. In Phase 1 clinical safety studies, the
overall adverse event profile following ezogabine administration was
similar to those from pregabalin and lacosamide and includes not only
euphoria, but also somnolence, and feeling or thinking abnormally.
Further, the human abuse potential study showed that the majority of
subjects receiving the 900 mg dose of ezogabine experienced multiple
adverse events such as euphoria, somnolence, visual disturbance,
amnesia, hypo-aesthesia, paranoia, fear, confusion and hallucination.
Although the 900 mg dose is three times greater than the recommended
therapeutic dose, individuals who abuse drugs typically do so at supra-
therapeutic doses.
7. Its Psychic or Physiological Dependence Liability: Ezogabine may
produce limited psychic or physiological dependence liability following
extended administration. Since there are no studies detailing abrupt
discontinuation of ezogabine, there are minimal adequate data to
evaluate the ability of ezogabine to induce withdrawal symptoms that
are indicative of physical dependence. Many of the adverse events
reported from the discontinuation of ezogabine were also reported prior
to its discontinuation, including dizziness,
[[Page 65427]]
somnolence, and a state of confusion. By comparison, abrupt or rapid
discontinuation of pregabalin in human studies resulted in patient-
reported symptoms of nausea, headache or diarrhea, which are suggestive
of physical dependence, while abrupt termination of lacosamide produced
no signs or symptoms of withdrawal in diabetic neuropathic pain
patients.
Unlike ezogabine and pregabalin, the withdrawal syndrome following
discontinuation of Schedule IV substances such as alprazolam can range
from mild dysphoria and insomnia to a major syndrome including
abdominal pain, muscle cramps, vomiting, sweating, tremors and
convulsions. These are similar in character to those associated with
other sedative-hypnotics.
The study of ezogabine abuse potential in humans with histories of
recreational abuse of sedative-hypnotics found that ezogabine produces
euphoria (18-33%) in these individuals. Additionally, ezogabine
produced euphoria (8.5%) in Phase 1 studies in healthy individuals.
These euphoria-related adverse events following administration of
ezogabine are suggestive of its ability to produce psychic dependence,
and the adverse events appear to be less severe and occur less
frequently than Schedule IV drugs (diazepam and alprazolam) and are
more similar to those of Schedule V drugs, pregabalin and lacosamide.
8. Whether the Substance is an Immediate Precursor of a Substance
Already Controlled Under the CSA: Ezogabine is not an immediate
precursor of any controlled substance.
Conclusion: Based on consideration of 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 ezogabine. As such, DEA hereby proposes to
schedule ezogabine as a controlled substance under the CSA.
Proposed 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 to place 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)(5), finds that:
(1) Ezogabine has a low potential for abuse relative to the drugs
or other substances in Schedule IV. The overall abuse potential of
ezogabine is comparable to the Schedule V substances such as pregabalin
and lacosamide;
(2) Ezogabine has a currently accepted medical use in treatment in
the United States. Ezogabine was approved for marketing by FDA as an
adjunct treatment of partial onset seizures; and
(3) Abuse of ezogabine may lead to limited physical dependence or
psychological dependence relative to the drugs or other substances in
Schedule IV.
Based on these findings, the Administrator of DEA concludes that
ezogabine, including its salts, isomers and salts of isomers, whenever
the existence of such salts, isomers, and salts of isomers is possible,
warrants control in Schedule V of the CSA (21 U.S.C. 812(b)(5)).
Requirements for Handling Ezogabine
If this rule is finalized as proposed, ezogabine would be 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 V controlled substance, including the
following:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with ezogabine, or who desires to manufacture, distribute,
dispense, import, export, engage in research or conduct instructional
activities with ezogabine, would need to be registered to conduct such
activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR part
1301.
Security. Ezogabine would be subject to Schedules III-V security
requirements and would need to 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.
Labeling and Packaging. All labels and labeling for commercial
containers of ezogabine which are distributed on or after finalization
of this rule would need to be in accordance with 21 CFR 1302.03-
1302.07, pursuant to 21 U.S.C. 825.
Inventory. Every registrant required to keep records and who
possesses any quantity of ezogabine would be required to keep an
inventory of all stocks of ezogabine on hand pursuant to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Every
registrant who desires registration in Schedule V for ezogabine would
be required to conduct an inventory of all stocks of the substance on
hand at the time of registration.
Records. All registrants would be required to keep records pursuant
to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04,
1304.06, 1304.21, 1304.22, and 1304.23.
Prescriptions. Ezogabine or products containing ezogabine would be
required to be distributed or dispensed pursuant to 21 U.S.C. 829 and
in accordance with 21 CFR 1306.03-1306.06, 1306.08, 1306.21, and
1306.23-1306.27.
Importation and Exportation. All importation and exportation of
ezogabine would need to be done in accordance with 21 CFR part 1312,
pursuant to 21 U.S.C. 952, 953, 957, and 958.
Criminal Liability. Any activity with ezogabine not authorized by,
or in violation of, Subchapter I Part D and Subchapter II of the CSA or
the CSIEA occurring on or after finalization of this proposed rule
would be unlawful.
Regulatory Analyses
Executive Orders 12866 and 13563
In accordance with 21 U.S.C. 811(a), this proposed 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 proposed regulation meets the applicable standards set forth
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform to eliminate ambiguity, minimize litigation, establish clear
legal standards, and reduce burden.
Executive Order 13132
This proposed rulemaking does not preempt or modify any provision
of State law; nor does it impose enforcement responsibilities on any
State; nor does it diminish the power of any State to enforce its own
laws. Accordingly, this rulemaking does not have federalism
implications warranting the application of Executive Order 13132.
[[Page 65428]]
Executive Order 13175
This proposed rule will not have Tribal implications and will not
impose substantial direct compliance costs on Indian Tribal
governments.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information under
the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is proposed to be
amended to read as follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
2. Section 1308.15 is amended by redesignating paragraphs (e)(1)
and (2) as paragraphs (e)(2) and (3), and adding a new paragraph (e)(1)
to read as follows:
Sec. 1308.15 Schedule V.
* * * * *
(e) * * *
(1) Ezogabine--2779
* * * * *
Dated: October 14, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-27253 Filed 10-20-11; 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). |
