Rules - 2011
[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Rules and Regulations]
[Pages 77895-77899]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32172]
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: Final rule.
SUMMARY: With the issuance of this final rule, the Administrator of the
Drug Enforcement Administration (DEA) places 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 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: December 15, 2011.
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:
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 HHS, 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 for Health of the
Department of Health and Human Services (HHS) and on an evaluation of
all other relevant data by DEA. This action imposes the regulatory
controls and criminal sanctions of Schedule V on the manufacture,
distribution, dispensing, importation, and exportation of ezogabine and
products containing ezogabine.
Pursuant to 21 CFR 1308.44(e), the Administrator of DEA may issue
her final order "[I]f all interested persons waive or are deemed to
waive their opportunity for the hearing or to participate in the
hearing." As no requests for a hearing were filed on this proposed
scheduling action, all interested persons are deemed to have waived
their opportunity for a hearing pursuant to 21 CFR 1308.44(d), and the
Administrator may issue her final order without a hearing.
Ezogabine is a new drug with a novel mechanism of action for the
treatment of partial onset seizures. Because ezogabine is a new drug
with possible immediate medical application to a life-threatening
illness not always treatable with medications currently available and
because it may not be prescribed in the United States until this final
rulemaking action is in effect and the subsequent requirements that
result from this final action are satisfied, the Administrator hereby
finds that it is in the interest of public health to forego the 30 day
period prior to this final rule taking effect. This will impose no
hardship on any interested party and is responsive to comments intended
to facilitate the availability of ezogabine as soon as possible for
that population of people suffering from seizures that may benefit from
treatment with ezogabine. Therefore, in accordance with this finding of
conditions of public health and of good cause to waive the 30 day
period and pursuant to 21 CFR 1308.45 and 5 U.S.C. 553(d)(3), this
final rule is effective upon publication.
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[supreg].\1\
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\1\ http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm; as of July 21, 2011.
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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
[[Page 77896]]
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).
Following analysis, the Administrator of DEA published a Notice of
Proposed Rulemaking entitled "Schedules of Controlled Substances:
Placement of Ezogabine into Schedule V" on October 21, 2011 (76 FR
65424), which proposed placement of ezogabine into Schedule V of the
CSA. The proposed rule provided an opportunity for all interested
persons to request a hearing or to submit comments on or before
November 21, 2011.
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 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. 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.\2\
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\2\ 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: 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 file 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 [deg]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
[[Page 77897]]
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 yet been marketed, 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 file
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 file
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, 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.
Requests for a Hearing and Comments
DEA received no requests for a hearing on this scheduling action.
DEA received two comments on the NPRM to schedule ezogabine.
Comment: The first comment requested that ezogabine be placed into
Schedule IV of the CSA instead of Schedule V as proposed. While the
commenter stated that ezogabine may help those who have not had success
with current epilepsy treatments, the commenter believed that
ezogabine's new mechanism of action, including its effect on the
central nervous system as an anticonvulsant and the potential side
effects of the drug therein, warrant closer scrutiny and supervision
under Schedule IV.
DEA Response: DEA disagrees. That ezogabine has an effect on the
central nervous system is alone not enough to merit its inclusion into
Schedule IV of the CSA, nor is the possibility that persons to whom
ezogabine is prescribed would need to monitor their medications
closely. Instead, as detailed in the HHS and DEA analyses and the HHS
recommendation, studies indicate that the abuse potential and likely
effects of ezogabine are similar to those of the Schedule V drugs
pregabalin and lacosamide, and, therefore, merit ezogabine's inclusion
into Schedule V of the CSA.
Comment: The second comment stated that because epilepsy is a
serious and potentially life-threatening illness that may not be
adequately treated with currently available medicines, conditions of
public health necessitate an early effective date for the final rule
pursuant to 21 CFR 1308.45. As such, the commenter requested an
effective date for the rule concurrent with its publication in the
Federal Register.
DEA Response: As stated under "Legal Authority," DEA agrees that
this rule should become effective upon publication. Ezogabine, unlike
the currently available anticonvulsant
[[Page 77898]]
medications, may act as an anticonvulsant through a novel mechanism of
action. Because some patients with epilepsy do not achieve satisfactory
seizure control from treatments currently in use, the availability of
ezogabine becomes an important and potentially life-saving option for
such patients. Thus, for public health reasons pursuant to 21 CFR
1308.45 and based on finding good cause pursuant to 5 U.S.C. 553(d)(3)
as outlined, this final rule is effective upon publication in the
Federal Register.
Scheduling 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 will schedule ezogabine 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 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
Upon the effective date of this final rule, ezogabine 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 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, must be registered to conduct such
activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR Part
1301.
Security. Ezogabine 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.
Labeling and Packaging. All labels and labeling for commercial
containers of ezogabine which are distributed on or after the effective
date of this final rule must 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 must 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 must 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, 1304.06, 1304.21,
1304.22, and 1304.23.
Prescriptions. Ezogabine or products containing ezogabine must 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 must 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 the effective date of this final rule
is unlawful.
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 ambiguity, minimize litigation, establish clear legal
standards, and reduce burden.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law or impose enforcement responsibilities on any state or 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.
Executive Order 13175
This 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.
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,
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.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
[[Page 77899]]
For the reasons set out above, 21 CFR Part 1308 is amended 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 [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-
carbamic acid ethyl ester]-2779
* * * * *
Dated: December 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-32172 Filed 12-14-11; 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). |
