Serenity Café; Decision and Order, 35027-35028 [2012-14291]
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Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
on January 29, 2011, eight months
earlier than scheduled. (Tr. 41, 59.)
In addition to the foregoing, there is
no other credible evidence of record that
Respondent’s registration would be
inconsistent with the public interest, to
include issues with his prescribing
practices, making unnecessary any
recommendation that the registration be
subject to conditions. The Government’s
argument that ‘‘Respondent cannot be
trusted to tell the truth’’ because of his
fraud conviction, (Gov’t Br., at 6), is
inconsistent with the evidence of
record. Such an argument might be
persuasive in a case where a respondent
does not testify at all or testifies
untruthfully, but Respondent did
credibly testify at length. There is also
no evidence that Respondent impeded
the criminal investigation or was
untruthful at any stage of the sentencing
process, which was required by
Respondent’s plea agreement with the
United States. (Gov’t Ex. 3 at 10–11.)
This is not to minimize the seriousness
of Respondent’s criminal misconduct,
but the Government’s argument that
Respondent cannot be trusted to tell the
truth based solely on his fraud
conviction ignores the significant recent
positive evidence to the contrary. I find
by substantial evidence of record that
Respondent’s post-offense conduct and
testimony at hearing demonstrate that
he has been truthful, and can continue
to be entrusted to tell the truth.
Respondent has also fulfilled the
requirements of discipline related to his
Illinois medical license, to include
serving a four-month suspension,
payment of a $1,000 fine, and
completion of a continuing medical
education requirement. (Tr. 60–61;
Resp’t Ex. D.) Respondent is also in
compliance with the terms of his
medical license probation. (Tr. 61.) In
light of the foregoing, and consistent
with DEA precedent, I find that
revocation of Respondent’s registration
is not an appropriate sanction in this
case.
srobinson on DSK4SPTVN1PROD with NOTICES
Conclusion And Recommendation
I recommend continuation of
Respondent’s DEA COR and approval of
any pending applications for renewal or
modification on the grounds that
Respondent’s continued registration
would be fully consistent with the
public interest as that term is used in 21
U.S.C. 823(f).
Dated: October 13, 2011.
Timothy D. Wing
Administrative Law Judge
[FR Doc. 2012–14319 Filed 6–11–12; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
´
Serenity Cafe; Decision and Order
On December 2, 2011, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
´
Show Cause to Serenity Cafe
(Applicant), of Chicago, Illinois. The
Show Cause Order proposed the denial
´
of Serenity Cafe’s application for a DEA
Certificate of Registration as a
Maintenance Narcotic Treatment
Program, on the grounds that the
Applicant does ‘‘not have authority to
handle controlled substances in the
state of Illinois,’’ and because its
registration would be inconsistent with
the public interest. Show Cause Order,
at 1 (citing 21 U.S.C. 824(a)(3) and 21
U.S.C. 823(f)).
Specifically, the Show Cause Order
alleged that on January 26, 2011,
Applicant, while doing business as
´
Recovery Cafe, had voluntarily
surrendered its DEA Certificate of
Registration for cause. Id. at 1. The
Order alleged that an investigation of
´
Recovery Cafe found that it ‘‘failed to
maintain the mandatory records
required to be kept for controlled
substances, had an unexplained
shortage of approximately 199,476 mg of
methadone, and left controlled
substances in an open safe unattended.’’
Id.
The Show Cause Order further alleged
that Applicant had failed to disclose on
´
its application that Recovery Cafe had
voluntarily surrendered for cause its
DEA registration. Id. at 2 (citing 21
U.S.C. 824(a)(1)). Next, the Order
alleged that Applicant does not have a
valid Illinois Department of Human
Services Alcoholism and Substance
Abuse Treatment and Intervention
License as required by state law. Id.
(citing 20 Ill. Comp. Stat. 301/15–5; Ill.
Admin. Code tit. 77, 2060.201). Finally,
the Order also notified Applicant of its
right to request a hearing on the
allegations or to submit a written
statement in lieu of a hearing, the
procedure for doing either, and the
consequence for failing to do either. Id.
(citing 21 CFR 1301.43).
On December 8, 2011, Diversion
Investigators (DIs) personally served the
Show Cause Order on Mr. Derrick Arna,
who, according to the affidavit of a DI,
is the Chief Executive Officer and owner
´
of Serenity Cafe. GX 1, at 3; GX 6. Since
the date of service of the Order, thirty
days have now passed and neither
Applicant, nor anyone purporting to
represent it, has requested a hearing or
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Frm 00095
Fmt 4703
Sfmt 4703
35027
submitted a written statement in lieu of
a hearing. I therefore find that Applicant
has waived its right to a hearing or to
submit a written statement in lieu of a
hearing, and issue this Decision and
Final Order based on relevant evidence
contained in the record submitted by
the Government. 21 CFR 1301.43(d) &
(e). I make the following findings of fact.
Findings
´
Serenity Cafe is owned by Mr. Derrick
Arna. GX 1, at 3. Mr. Arna is also the
´
authorized agent of Recovery Cafe, a
former Opioid Treatment Program in
Chicago, Illinois, which, on January 26,
2011, voluntarily surrendered its DEA
Registration for cause following a
January 6, 2001 on-site inspection
which found numerous violations. Id. at
1; GX 3. More specifically, during the
on-site inspection, DEA DIs found that
´
Recovery Cafe had multiple recordkeeping violations. Id. at 2. These
included, inter alia, that it: (1) Failed to
record on DEA Form 222s, the date of
receipt and quantity of schedule II
controlled substances it received; (2)
failed to maintain accurate and
complete controlled substance records;
and (3) failed to maintain dispensing
records for the methadone it dispensed,
including the date of the dispensing and
the name of the patient receiving the
drug. Id.
In addition, the DIs performed an
audit of its handling of methadone hcl
(5mg & 40mg) for the period from
October 19, 2009 to January 6, 2011. Id.
The audit found that the clinic was
short approximately 199,476 mg of
methadone. Id. Finally, on January 25,
2011, the DIs found that controlled
substances were left unattended in an
open safe. Id. The next day, Mr. Arna
executed a voluntary surrender of
´
Recovery Cafe’s DEA registration.
On February 14, 2011, Mr. Arna filed
an application under the name of
´
Serenity Cafe for registration as a
Narcotic Treatment Program—
Maintenance, at the proposed address of
110 E. 78th Street, Chicago, Illinois. GX
2, at 1. Mr. Arna sought authorization to
handle methadone, a schedule II
narcotic controlled substance, and
buprenorphine, a schedule III narcotic
controlled substance. Id.
In Section 4 of the application, Mr.
Arna was required to list Applicant’s
state of licensure, license number and
its expiration date. GX 2, at 2. Mr. Arna
completed only the state of licensure
block, writing ‘‘Illinois’’ and the word
‘‘pending.’’ Id. at 2.
In Section 5 of the application, Mr.
Arna was required to answer four
liability questions. Among them was
question 2, which asked: ‘‘Has the
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35028
Federal Register / Vol. 77, No. 113 / Tuesday, June 12, 2012 / Notices
applicant ever surrendered (for cause) or
had a federal controlled substance
registration revoked, suspended,
restricted, or denied, or is any such
action pending?’’ Mr. Arna marked
‘‘NO,’’ and in the area provided for
explaining any ‘‘YES’’ answer, wrote
‘‘None.’’ Id.
On February 17, 2012, following a
hearing before a state Administrative
Law Judge (ALJ), the Secretary of the
Illinois Department of Human Services
issued a Final Order on Applicant’s
application for state licensure. See In
´
the Matter of Serenity Cafe at 1, 11
DASA 001 (Ill. Dep’t Hum. Servs., Feb.
17, 2012). Adopting the ALJ’s findings
and report, the Final Order denied
Applicant’s application for a state
license to provide both Level I Adult
and Adolescent Outpatient Treatment
and Level II Adult and Adolescent
Intensive Outpatient Treatment, DUI
Evaluation, DUI Risk Education, and
Methadone as Adjunct Services. Id.
Accordingly, because Applicant does
not possess a valid Illinois license to
provide substance abuse treatment, I
find that Applicant is not currently
authorized to dispense controlled
substances in the State of Illinois, the
State in which it seeks registration. See
20 Ill. Comp. Stat. 301/15–5 (it is
‘‘unlawful for any person to provide
treatment for alcoholism and other drug
abuse or dependency . . . unless the
person is licensed to do so by the
Department’’); Ill. Admin. Code tit. 77,
2060.201 (‘‘Substance abuse treatment
and intervention services * * * shall be
licensed by the Department.’’).
srobinson on DSK4SPTVN1PROD with NOTICES
Discussion
Under section 303(g) of the Controlled
Substances Act (CSA), ‘‘practitioners
who dispense narcotic drugs [in
schedule II] to individuals for
maintenance treatment * * * shall
obtain annually a separate registration
for that purpose.’’ 21 U.S.C. 823(g)(1)
(emphasis added). Moreover, this
provision imposes as a requirement of
registration, that the applicant meet
three conditions, including that ‘‘the
applicant is a practitioner who is
determined by the Secretary to be
qualified * * * to engage in the
treatment with respect to which
registration is sought.’’ Id. 823(g)(1)(A)
(emphasis added). Thus, it is clear that
in order to obtain a registration
authorizing the dispensing of schedule
II narcotics such as methadone for
maintenance treatment, the applicant
must be (among other things), a
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practitioner within the meaning of the
CSA.1
The CSA defines the term
‘‘practitioner’ to mean ‘‘a physician
* * * pharmacy, hospital or other
person licensed, registered, or otherwise
permitted, by * * * the jurisdiction in
which he practices * * * to distribute,
dispense, [or] administer * * * a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Likewise, in the case of
practitioners, the CSA imposes, as a
condition of registration, that it be
currently authorized to dispense
controlled substances under the laws of
the State in which it engages in
professional practice. See id. 823(f)
(‘‘The Attorney General shall register
practitioners * * * if the applicant is
authorized to dispense * * * controlled
substances under the laws of the State
in which he practices.’’). Thus, DEA has
long held that the possession of
authority under state law to dispense
controlled substances is an essential
condition for obtaining and maintaining
a DEA registration. See David W. Wang,
72 FR 54297, 54298 (2007); Sheran
Arden Yeates, 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104,
51105 (1993); Bobby Watts, 53 FR
11919, 11920 (1988).
As found above, the Illinois
Department of Human Services has
issued a final order denying Applicant’s
application for the state licenses
required to dispense controlled
substances for the purpose of providing
maintenance treatment. Therefore,
Applicant is not a ‘‘practitioner’’ within
the meaning of the CSA, and thus, it is
not entitled to be registered. See 21
U.S.C. 802(21); 823(f); 823(g).
Accordingly, its application will be
denied.2
1 Likewise, the requirements of section 303(g)(1)
‘‘are waived in the case of the dispensing (including
the prescribing), by a practitioner, of narcotic drugs
in schedule III, IV, or V or combinations of such
drugs if the practitioner meets the conditions
specified in subparagraph (B). 21 U.S.C.
823(g)(2)(A) (emphasis added). This provision
requires that the ‘‘the practitioner submit to the
Secretary [of HHS] a notification of the intent of the
practitioner to begin dispensing the drugs or
combinations for’’ maintenance or detoxification
treatment, ‘‘as well as to certify that ‘‘[t]he
practitioner is a qualifying physician,’’ that ‘‘the
practitioner has the capacity to refer the patients for
appropriate counseling and other appropriate
ancillary services,’’ and that ‘‘[t]he total number of
such patients of the practitioner at any one time
will not exceed the applicable number.’’ Id.
823(g)(2)(B) (emphasis added). Moreover, a
practitioner’s notification to the Secretary must
‘‘identif[y] the registration issued for the
practitioner pursuant to subsection (f) of this
section.’’ Id. 823(g)(2)(D)(i)(II). See also 21 CFR
1301.28.
2 Because it is clear that Applicant is not entitled
to be registered, it is not necessary to decide
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Fmt 4703
Sfmt 4703
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 823(g)(1) & (2),
as well as 28 CFR 0.100(b), I order that
´
the application of Serenity Cafe for a
DEA Certificate of Registration as a
Narcotic Treatment Program, be, and it
hereby is, denied. This Order is effective
July 12, 2012.
Dated: June 4, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–14291 Filed 6–11–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bill Alexander, M.D.; Decision and
Order
On September 22, 2011, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order To
Show Cause to Bill Alexander, M.D.
(Applicant), of Porter, Texas. The Show
Cause Order proposed the denial of
Applicant’s application for a DEA
Certificate of Registration as a
practitioner in schedules II through V,
on the ground that his ‘‘registration
would be inconsistent with the public
interest.’’ Show Cause Order at 1 (citing
21 U.S.C. 823(f) and 824(a)(4)).
The Show Cause Order alleged that on
December 3, 2010, Applicant applied for
a practitioner’s registration in schedules
II–V at the location of 24420 FM 1314,
Suite 101, Porter, Texas. Id. The Show
Cause Order then alleged that on or
about June 18, 2009, Applicant
unlawfully possessed 64 kilograms of
marijuana, a schedule I controlled
substance, in violation of both federal
and state law. Id. at 2 (citing 21 U.S.C.
841(a)(1) and Texas Health & Safety
Code Ann. 481.121(b)(5)).
Next, the Show Cause Order alleged
that on or about June 18, 2009,
Applicant told law enforcement agents
that he was transporting the marijuana
for a drug dealer, and that he had
transported over a dozen such loads of
marijuana in the past. Id. The Order
further alleged that Applicant told the
agents that he was addicted to and used
crack cocaine, a schedule I controlled
substance.1 Id.
The Show Cause Order also alleged
that on or about February 4, 2011, the
Texas Medical Board entered a
Corrective Order against Applicant’s
medical license. Id. According to the
whether denial of its application is warranted under
the public interest standard of 21 U.S.C. 823(f).
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[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 35027-35028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14291]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Serenity Caf[eacute]; Decision and Order
On December 2, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Serenity Caf[eacute] (Applicant), of Chicago, Illinois.
The Show Cause Order proposed the denial of Serenity Caf[eacute]'s
application for a DEA Certificate of Registration as a Maintenance
Narcotic Treatment Program, on the grounds that the Applicant does
``not have authority to handle controlled substances in the state of
Illinois,'' and because its registration would be inconsistent with the
public interest. Show Cause Order, at 1 (citing 21 U.S.C. 824(a)(3) and
21 U.S.C. 823(f)).
Specifically, the Show Cause Order alleged that on January 26,
2011, Applicant, while doing business as Recovery Caf[eacute], had
voluntarily surrendered its DEA Certificate of Registration for cause.
Id. at 1. The Order alleged that an investigation of Recovery
Caf[eacute] found that it ``failed to maintain the mandatory records
required to be kept for controlled substances, had an unexplained
shortage of approximately 199,476 mg of methadone, and left controlled
substances in an open safe unattended.'' Id.
The Show Cause Order further alleged that Applicant had failed to
disclose on its application that Recovery Caf[eacute] had voluntarily
surrendered for cause its DEA registration. Id. at 2 (citing 21 U.S.C.
824(a)(1)). Next, the Order alleged that Applicant does not have a
valid Illinois Department of Human Services Alcoholism and Substance
Abuse Treatment and Intervention License as required by state law. Id.
(citing 20 Ill. Comp. Stat. 301/15-5; Ill. Admin. Code tit. 77,
2060.201). Finally, the Order also notified Applicant of its right to
request a hearing on the allegations or to submit a written statement
in lieu of a hearing, the procedure for doing either, and the
consequence for failing to do either. Id. (citing 21 CFR 1301.43).
On December 8, 2011, Diversion Investigators (DIs) personally
served the Show Cause Order on Mr. Derrick Arna, who, according to the
affidavit of a DI, is the Chief Executive Officer and owner of Serenity
Caf[eacute]. GX 1, at 3; GX 6. Since the date of service of the Order,
thirty days have now passed and neither Applicant, nor anyone
purporting to represent it, has requested a hearing or submitted a
written statement in lieu of a hearing. I therefore find that Applicant
has waived its right to a hearing or to submit a written statement in
lieu of a hearing, and issue this Decision and Final Order based on
relevant evidence contained in the record submitted by the Government.
21 CFR 1301.43(d) & (e). I make the following findings of fact.
Findings
Serenity Caf[eacute] is owned by Mr. Derrick Arna. GX 1, at 3. Mr.
Arna is also the authorized agent of Recovery Caf[eacute], a former
Opioid Treatment Program in Chicago, Illinois, which, on January 26,
2011, voluntarily surrendered its DEA Registration for cause following
a January 6, 2001 on-site inspection which found numerous violations.
Id. at 1; GX 3. More specifically, during the on-site inspection, DEA
DIs found that Recovery Caf[eacute] had multiple record-keeping
violations. Id. at 2. These included, inter alia, that it: (1) Failed
to record on DEA Form 222s, the date of receipt and quantity of
schedule II controlled substances it received; (2) failed to maintain
accurate and complete controlled substance records; and (3) failed to
maintain dispensing records for the methadone it dispensed, including
the date of the dispensing and the name of the patient receiving the
drug. Id.
In addition, the DIs performed an audit of its handling of
methadone hcl (5mg & 40mg) for the period from October 19, 2009 to
January 6, 2011. Id. The audit found that the clinic was short
approximately 199,476 mg of methadone. Id. Finally, on January 25,
2011, the DIs found that controlled substances were left unattended in
an open safe. Id. The next day, Mr. Arna executed a voluntary surrender
of Recovery Caf[eacute]'s DEA registration.
On February 14, 2011, Mr. Arna filed an application under the name
of Serenity Caf[eacute] for registration as a Narcotic Treatment
Program--Maintenance, at the proposed address of 110 E. 78th Street,
Chicago, Illinois. GX 2, at 1. Mr. Arna sought authorization to handle
methadone, a schedule II narcotic controlled substance, and
buprenorphine, a schedule III narcotic controlled substance. Id.
In Section 4 of the application, Mr. Arna was required to list
Applicant's state of licensure, license number and its expiration date.
GX 2, at 2. Mr. Arna completed only the state of licensure block,
writing ``Illinois'' and the word ``pending.'' Id. at 2.
In Section 5 of the application, Mr. Arna was required to answer
four liability questions. Among them was question 2, which asked: ``Has
the
[[Page 35028]]
applicant ever surrendered (for cause) or had a federal controlled
substance registration revoked, suspended, restricted, or denied, or is
any such action pending?'' Mr. Arna marked ``NO,'' and in the area
provided for explaining any ``YES'' answer, wrote ``None.'' Id.
On February 17, 2012, following a hearing before a state
Administrative Law Judge (ALJ), the Secretary of the Illinois
Department of Human Services issued a Final Order on Applicant's
application for state licensure. See In the Matter of Serenity
Caf[eacute] at 1, 11 DASA 001 (Ill. Dep't Hum. Servs., Feb. 17, 2012).
Adopting the ALJ's findings and report, the Final Order denied
Applicant's application for a state license to provide both Level I
Adult and Adolescent Outpatient Treatment and Level II Adult and
Adolescent Intensive Outpatient Treatment, DUI Evaluation, DUI Risk
Education, and Methadone as Adjunct Services. Id.
Accordingly, because Applicant does not possess a valid Illinois
license to provide substance abuse treatment, I find that Applicant is
not currently authorized to dispense controlled substances in the State
of Illinois, the State in which it seeks registration. See 20 Ill.
Comp. Stat. 301/15-5 (it is ``unlawful for any person to provide
treatment for alcoholism and other drug abuse or dependency . . .
unless the person is licensed to do so by the Department''); Ill.
Admin. Code tit. 77, 2060.201 (``Substance abuse treatment and
intervention services * * * shall be licensed by the Department.'').
Discussion
Under section 303(g) of the Controlled Substances Act (CSA),
``practitioners who dispense narcotic drugs [in schedule II] to
individuals for maintenance treatment * * * shall obtain annually a
separate registration for that purpose.'' 21 U.S.C. 823(g)(1) (emphasis
added). Moreover, this provision imposes as a requirement of
registration, that the applicant meet three conditions, including that
``the applicant is a practitioner who is determined by the Secretary to
be qualified * * * to engage in the treatment with respect to which
registration is sought.'' Id. 823(g)(1)(A) (emphasis added). Thus, it
is clear that in order to obtain a registration authorizing the
dispensing of schedule II narcotics such as methadone for maintenance
treatment, the applicant must be (among other things), a practitioner
within the meaning of the CSA.\1\
---------------------------------------------------------------------------
\1\ Likewise, the requirements of section 303(g)(1) ``are waived
in the case of the dispensing (including the prescribing), by a
practitioner, of narcotic drugs in schedule III, IV, or V or
combinations of such drugs if the practitioner meets the conditions
specified in subparagraph (B). 21 U.S.C. 823(g)(2)(A) (emphasis
added). This provision requires that the ``the practitioner submit
to the Secretary [of HHS] a notification of the intent of the
practitioner to begin dispensing the drugs or combinations for''
maintenance or detoxification treatment, ``as well as to certify
that ``[t]he practitioner is a qualifying physician,'' that ``the
practitioner has the capacity to refer the patients for appropriate
counseling and other appropriate ancillary services,'' and that
``[t]he total number of such patients of the practitioner at any one
time will not exceed the applicable number.'' Id. 823(g)(2)(B)
(emphasis added). Moreover, a practitioner's notification to the
Secretary must ``identif[y] the registration issued for the
practitioner pursuant to subsection (f) of this section.'' Id.
823(g)(2)(D)(i)(II). See also 21 CFR 1301.28.
---------------------------------------------------------------------------
The CSA defines the term ``practitioner' to mean ``a physician * *
* pharmacy, hospital or other person licensed, registered, or otherwise
permitted, by * * * the jurisdiction in which he practices * * * to
distribute, dispense, [or] administer * * * a controlled substance in
the course of professional practice.'' 21 U.S.C. 802(21). Likewise, in
the case of practitioners, the CSA imposes, as a condition of
registration, that it be currently authorized to dispense controlled
substances under the laws of the State in which it engages in
professional practice. See id. 823(f) (``The Attorney General shall
register practitioners * * * if the applicant is authorized to dispense
* * * controlled substances under the laws of the State in which he
practices.''). Thus, DEA has long held that the possession of authority
under state law to dispense controlled substances is an essential
condition for obtaining and maintaining a DEA registration. See David
W. Wang, 72 FR 54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130,
39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988).
As found above, the Illinois Department of Human Services has
issued a final order denying Applicant's application for the state
licenses required to dispense controlled substances for the purpose of
providing maintenance treatment. Therefore, Applicant is not a
``practitioner'' within the meaning of the CSA, and thus, it is not
entitled to be registered. See 21 U.S.C. 802(21); 823(f); 823(g).
Accordingly, its application will be denied.\2\
---------------------------------------------------------------------------
\2\ Because it is clear that Applicant is not entitled to be
registered, it is not necessary to decide whether denial of its
application is warranted under the public interest standard of 21
U.S.C. 823(f).
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
823(g)(1) & (2), as well as 28 CFR 0.100(b), I order that the
application of Serenity Caf[eacute] for a DEA Certificate of
Registration as a Narcotic Treatment Program, be, and it hereby is,
denied. This Order is effective July 12, 2012.
Dated: June 4, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-14291 Filed 6-11-12; 8:45 am]
BILLING CODE 4410-09-P