Stephen R. Kovacs, D.O.; Decision and Order, 66747-66750 [2018-28072]
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Shenzhen Yibo Technology Co., Ltd.,
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St., Guangming New District, Shenzhen
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Vapor 4 Life Holdings, Inc., 4080
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shall designate the presiding
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notice of investigation must be
submitted by the named respondents in
accordance with section 210.13 of the
Commission’s Rules of Practice and
Procedure, 19 CFR 210.13. Pursuant to
19 CFR 201.16(e) and 210.13(a), such
responses will be considered by the
Commission if received not later than 20
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Commission of the complaint and the
notice of investigation. Extensions of
time for submitting responses to the
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investigation will not be granted unless
good cause therefor is shown.
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response to each allegation in the
complaint and in this notice may be
deemed to constitute a waiver of the
right to appear and contest the
allegations of the complaint and this
notice, and to authorize the
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and to enter an initial determination
and a final determination containing
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issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
By order of the Commission.
Issued: December 20, 2018.
Lisa Barton,
Secretary to the Commission.
66747
Act on September 4, 2018 (83 FR
44903).
Suzanne Morris,
Chief, Premerger and Division Statistics Unit,
Antitrust Division.
[FR Doc. 2018–28041 Filed 12–26–18; 8:45 am]
BILLING CODE 4410–11–P
[FR Doc. 2018–28068 Filed 12–26–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 2018–48]
DEPARTMENT OF JUSTICE
Stephen R. Kovacs, D.O.; Decision and
Order
Antitrust Division
Notice Pursuant to the National
Cooperative Research and Production
Act of 1993—DVD Copy Control
Association
Notice is hereby given that, on
December 5, 2018, pursuant to Section
6(a) of the National Cooperative
Research and Production Act of 1993,
15 U.S.C. 4301 et seq. (‘‘the Act’’), the
DVD Copy Control Association (‘‘DVD
CCA’’) has filed written notifications
simultaneously with the Attorney
General and the Federal Trade
Commission disclosing changes in its
membership. The notifications were
filed for the purpose of extending the
Act’s provisions limiting the recovery of
antitrust plaintiffs to actual damages
under specified circumstances.
Specifically, Shenzhen Soling Industrial
Co., Ltd., Shenzhen City, Guangdong,
PEOPLE’S REPUBLIC OF CHINA, has
been added as a party to this venture.
Also, Fujitsu Limited, Nakahara-ku,
Kawasaki, JAPAN; and Koninklijke
Philips Electronics N.V., Eindhoven,
NETHERLANDS, have withdrawn as
parties to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and DVD CCA
intends to file additional written
notifications disclosing all changes in
membership.
On April 11, 2001, DVD CCA filed its
original notification pursuant to Section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on August 3, 2001 (66 FR 40727).
The last notification was filed with
the Department on August 14, 2018. A
notice was published in the Federal
Register pursuant to Section 6(b) of the
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On August 2, 2018, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Stephen R. Kovacs, D.O.
(hereinafter, Respondent), of Owasso
and Claremore, Oklahoma. Order to
Show Cause (hereinafter, OSC), at 1.
The Show Cause Order proposes the
revocation of Respondent’s Certificates
of Registration on the ground that he has
‘‘no state authority to handle controlled
substances’’ in Oklahoma, the State in
which he is registered with the DEA. Id.
(citing 21 U.S.C. 824(a)(3)). It also
proposes the denial of ‘‘any applications
for renewal or modification of such
registrations and any applications for
any other DEA registrations.’’ OSC, at 1
(citing 21 U.S.C. 824(a)(3)).
Regarding jurisdiction, the Show
Cause Order alleges that Respondent
holds DEA Certificate of Registration
No. BK9173840 at the registered address
of 10314 N 138th E Ave., Suite 101,
Owasso, Oklahoma 74055. OSC, at 2.
This registration, the OSC alleges,
authorizes Respondent to dispense
controlled substances in schedules II
through V as a practitioner-DW/275. Id.
The Show Cause Order alleges that this
registration expires on December 31,
2019. Id.
The Show Cause Order further alleges
that Respondent holds DEA Certificate
of Registration No. BK7370492 at the
registered address of 985 West Will
Rogers Blvd., Claremore, OK 74017,
with a mailing address of 13616 E 103rd
St. N, Ste. A, Owasso, Oklahoma 74055.
Id. This registration, the OSC alleges,
authorizes Respondent to dispense
controlled substances in schedules II
through V as a practitioner. Id. The
Show Cause Order alleges that this
registration expires on December 31,
2018. Id.
The substantive ground for the
proceeding, as alleged in the Show
Cause Order, is that Respondent is
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‘‘currently without authority to handle
controlled substances in the State of
Oklahoma, the state in which . . . [he
is] registered with DEA.’’ Id.
Specifically, the Show Cause Order
alleges that, on May 31, 2018, the
Oklahoma State Bureau of Narcotics and
Dangerous Drugs Control immediately
suspended Respondent’s Oklahoma
controlled substances registration
OBN#29222, and that this registration is
associated with Respondent’s practice
location at 10314 N 138th E Ave., Suite
101, Owasso, Oklahoma 74055. Id. The
Show Cause Order further alleges that
Respondent’s Oklahoma controlled
substances registration OBN#33269,
associated with Respondent’s practice
location at 985 West Will Rogers Blvd.,
Claremore, Oklahoma 74017, expired on
October 31, 2017 and is listed as
‘‘INACTIVE.’’ Id.
The Show Cause Order notifies
Respondent of his right to request a
hearing on the allegations or to submit
a written statement while waiving his
right to a hearing, the procedures for
electing each option, and the
consequences for failing to elect either
option. Id. at 2–3 (citing 21 CFR
1301.43). The Show Cause Order also
notifies Respondent of the opportunity
to submit a corrective action plan. OSC,
at 3–4 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated September 7, 2018,
Respondent timely requested a hearing.1
Hearing Request, at 1. According to the
Hearing Request, the Oklahoma Bureau
of Narcotics & Dangerous Drugs Control
(hereinafter, OBNDDC) immediately
suspended ‘‘for imminent
endangerment’’ Respondent’s State
controlled substances registration based
on ‘‘allegations of professional
misconduct.’’ Id. Respondent contests
the OBNDDC allegations. Id. The
Hearing Request admits that Respondent
‘‘is currently suspended under the State
order from prescribing medications.’’ Id.
at 2. It states that, ‘‘upon a full and fair
hearing of the facts,’’ Respondent
‘‘should not have his State or Federal
Certificates of Registration revoked or
modified.’’ Id.
The Office of Administrative Law
Judges put the matter on the docket and
1 Attached to the Government’s Motion for
Summary Disposition is a DEA–12 (Receipt for Cash
or Other Items) that, according to the Government’s
allegations, Respondent executed when the
Government served the OSC on August 8, 2018.
Respondent does not challenge the Government’s
service-related allegations. The Government does
not contest the timeliness of Respondent’s request
for a hearing. Government’s Motion for Summary
Disposition dated September 19, 2018 (hereinafter
‘‘Summary Disposition Motion’’), at 2. Thus, I find
that Respondent’s Hearing Request was timely since
it was filed within 30 days of service of the OSC.
21 CFR 1301.43(a).
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assigned it to Chief Administrative Law
Judge John J. Mulrooney, II (hereinafter,
CALJ). On September 10, 2018, the CALJ
issued an Order directing the filing of
evidence of lack of State authority and
a briefing schedule.
The Government filed a timely
Summary Disposition Motion ‘‘based on
Respondent’s lack of state authority to
handle controlled substances.’’
Summary Disposition Motion, at 1. The
Government attached to its Summary
Disposition Motion a certified copy of
the OBNDDC’s letter to Respondent
notifying him of his ‘‘Immediate
Suspension Due to Imminent Danger’’
dated May 31, 2018. Id. at Exh. 4.
According to the Summary Disposition
Motion, Respondent ‘‘is not authorized
to possess a DEA registration’’ in
Oklahoma ‘‘[a]bsent authority by the
State of Oklahoma to dispense
controlled substances.’’ Id. at 4. Citing
Agency precedent, the Government
argues that ‘‘even if the period of
suspension is temporary or if there is
the potential that Respondent’s state
controlled substances privileges will be
reinstated, summary disposition is
warranted.’’ Id.
On September 27, 2018, Respondent
timely filed a Response to the Summary
Disposition Motion. Attached to the
Response is an email from the Deputy
General Counsel of the Oklahoma
Bureau of Narcotics dated September
13, 2018. The email asks Respondent’s
attorney if he ‘‘[w]ould . . . be opposed
to continuing . . . [Respondent’s]
hearing until October 25, 2018.’’
Response, Exh. 1, at 1. Counsel for
Respondent did not object to the
continuance. Id. at 1. According to the
Response, ‘‘Respondent’s rights have
been severely prejudiced by delaying
the state hearing.’’ Id. at 2.
Respondent ‘‘admits that the
OBNDDC filed the Notice of Immediate
Suspension of Respondent’s Oklahoma
controlled substances registration on
May 31, 2018.’’ Id. at 1. He states,
however, that he ‘‘has had no
opportunity to present evidence or
cross-examine witnesses, defenses to
which he is absolutely entitled under
Oklahoma law’’ and that ‘‘but for’’ the
continuance, he ‘‘would have had that
opportunity today.’’ Id. at 3. Respondent
argues that the Agency precedent on
which the Government relies ‘‘allowed
some form of process with the state . .
. before the Government’s motion for
summary disposition was granted.’’ Id.
at 2. He states that the ‘‘state
administrative hearing will be
concluded in less than one month . . .
[at which] time both sides will have a
much more complete understanding of
the facts, and the ALJ will be able to
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more effectively rule on the status of
Respondent’s DEA registration.’’ Id. at 3.
Respondent asks that the Summary
Disposition Motion be denied or, in the
alternative, that the deadline for his
response be ‘‘extended . . . beyond the
date of his state administrative hearing.’’
Id.
The CALJ granted the Summary
Disposition Motion and recommended
that Respondent’s registration be
revoked. Order Denying the
Respondent’s Request for Extension,
Granting the Government’s Motion for
Summary Disposition, and
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge dated
September 28, 2018 (hereinafter, R.D.).
The CALJ notes Respondent’s
concession that his Oklahoma
registration was suspended on May 31,
2018. Id. at 3. Citing Agency precedent
about stay requests, the CALJ denied
Respondent’s request for an extended
response deadline. Id. After
summarizing Agency precedent
concerning a registrant’s loss of State
authority to dispense controlled
substances, the CALJ recommended that
Respondent’s registration be revoked
and that pending applications for
renewal be denied. Id. at 4–7.
By letter dated October 18, 2018, the
CALJ certified and transmitted the
record to me for final Agency action. In
that letter, the CALJ advises that neither
party filed exceptions.
I issue this Decision and Order based
on the entire record before me. 21 CFR
1301.43(e). I make the following
findings of fact.
Findings of Fact
Respondent’s DEA Registrations
Respondent holds two DEA
Certificates of Registration. First,
Respondent holds DEA Certificate of
Registration No. BK9173840, pursuant
to which he is authorized to dispense
controlled substances in schedules II
through V as a practitioner DW/275, at
the registered address of 10314 N 138th
E Ave., Suite 101, Owasso, Oklahoma
74055. Summary Disposition Motion,
Exh. 1 (Certification of Registration
Status), at 1. This registration expires on
December 31, 2019. Id.
Second, Respondent holds DEA
Certificate of Registration No.
BK7370492, pursuant to which he is
authorized to dispense controlled
substances in schedules II through V as
a practitioner, at the registered address
of 985 West Will Rogers Blvd.,
Claremore, Oklahoma 74017. Id. at Exh.
2 (Certification of Registration Status), at
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1. This registration expires on December
31, 2018. Id.
The Status of Respondent’s State
License
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On May 31, 2018, the OBNDDC
immediately suspended due to
imminent danger Respondent’s
‘‘privileges to possess, administer,
dispense, prescribe and/or distribute
scheduled controlled dangerous
substances.’’ Id. at Exh. 4, at 1.
According to the immediate suspension,
the OBNDDC found ‘‘by clear and
convincing evidence . . . [that
Respondent’s] continuing status as an
Oklahoma Bureau of Narcotics registrant
represents an imminent danger to the
public health, safety and welfare of the
citizens of Oklahoma.’’ Id. at Exh. 4, at
3. The OBNDDC’s action was based on
information that Respondent wrote false
Oxycodone (30mg) prescriptions for a
patient with the intention of diverting
the narcotics back to himself; that
Respondent urged a patient to include a
false report of stolen Oxycodone on a
police report with the intention of
getting another refill; that Respondent
deleted messages pertaining to his
illegal activity from a patient’s
electronic device; that a patient
witnessed Respondent snort Oxycodone
between meetings with patients; and
that Respondent was opioid dependent.
Id. at Exh. 4, at 2–3.
Respondent admits that the OBNDDC
filed the Notice of Immediate
Suspension on May 31, 2018. Response,
at 1. There is no evidence in the record
that the OBNDDC lifted this Immediate
Suspension. Further, according to the
online records of the State of Oklahoma,
of which I take official notice, I find that
this Immediate Suspension is still in
effect today and that no Oklahoma
controlled substances registration ever
assigned to Respondent is currently
active.2 OBNDDC Registration Search
Lookup, https://pay.apps.ok.gov/obndd/
_app/search/index.php (last visited
December 11, 2018).
2 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an
agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Respondent may dispute my finding by filing a
properly supported motion for reconsideration
within 15 calendar days of the date of this Order.
Any such motion shall be filed with the Office of
the Administrator and a copy shall be served on the
Government; in the event Respondent files a
motion, the Government shall have 15 calendar
days to file a response.
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Accordingly, I find that Respondent
currently is without authority to
dispense controlled substances in
Oklahoma, the State in which he is
registered.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (hereinafter, CSA),
‘‘upon a finding that the registrant . . .
has had his State license or registration
suspended . . . [or] revoked . . . by
competent State authority and is no
longer authorized by State law to engage
in the . . . dispensing of controlled
substances.’’ With respect to a
practitioner, the DEA has long held that
the possession of authority to dispense
controlled substances under the laws of
the State in which a practitioner engages
in professional practice is a
fundamental condition for obtaining
and maintaining a practitioner’s
registration. See, e.g., James L. Hooper,
M.D., 76 FR 71,371 (2011), pet. for rev.
denied, 481 Fed. Appx. 826 (4th Cir.
2012); Frederick Marsh Blanton, M.D.,
43 FR 27,616, 27,617 (1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘practitioner’’ to mean
‘‘a physician . . . 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). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess State authority in order to be
deemed a practitioner under the CSA,
the DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever he
is no longer authorized to dispense
controlled substances under the laws of
the State in which he practices. See,
e.g., Hooper, supra, 76 FR at 71,371–72;
Sheran Arden Yeates, M.D., 71 FR
39,130, 39,131 (2006); Dominick A.
Ricci, M.D., 58 FR 51,104, 51,105 (1993);
Bobby Watts, M.D., 53 FR 11,919, 11,920
(1988), Blanton, supra, 43 FR at 27,617.
Under longstanding Agency
precedent, DEA revokes the registration
of a practitioner who lacks State
authority to handle controlled
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66749
substances even when the practitioner’s
State authority was suspended
summarily or pending a final decision
on the merits. See, e.g., Bourne
Pharmacy, Inc., 72 FR 18,273, 18,274
(2007). Similarly, as the CALJ made
clear, the facts that a State immediately
suspended a respondent’s registration
and that the respondent may, some day,
regain his State registration to dispense
controlled substances do not change the
salient fact—the respondent is not
currently authorized to handle
controlled substances in the State in
which he is registered.3 Mehdi
Nikparvarfard, M.D., 83 FR 14,503,
14,504 (2018).
Here, Respondent admits that the
OBNDDC suspended his Oklahoma
controlled substances registration.
Further, there is no evidence in the
record that Respondent holds any active
Oklahoma registration to handle
controlled substances. As such,
according to Oklahoma law, Respondent
currently does not have authority to
handle controlled substances in
Oklahoma. Okla. Stat. tit. 63, § 2–302
(Westlaw, current with legislation of the
Second Regular Session of the 56th
Legislature (2018)) (Every person who
dispenses any controlled dangerous
substance within Oklahoma shall obtain
a registration issued by OBNDDC.).
Respondent, therefore, is not eligible for
a DEA registration. Accordingly, I will
order that Respondent’s DEA
registrations be revoked and that any
pending application for the renewal or
modification of those registrations be
denied. 21 U.S.C. 824(a)(3).
Order
Pursuant to 28 CFR 0.100(b) and the
authority thus vested in me by 21 U.S.C.
824(a), I order that DEA Certificate of
Registration Nos. BK9173840 and
BK7370492 issued to Stephen R.
Kovacs, D.O., be, and they hereby are,
revoked. I further order that any
pending application of Stephen R.
Kovacs, D.O., to renew or modify these
registration, as well as any other
pending application by him for
registration in the State of Oklahoma,
be, and it hereby is, denied. This Order
is effective immediately.4
3 The CALJ’s denial of Respondent’s request for
an enlargement of time is the correct result. Also,
as already discussed, Oklahoma’s online records
still indicate that Respondent’s Oklahoma
controlled substances registrations are inactive or
inactivated.
4 For the same reasons the OBNDDC found by
clear and convincing evidence that Respondent’s
continuing status as an Oklahoma Bureau of
Narcotics registrant represents an imminent danger
to the public health, safety and welfare of the
citizens of Oklahoma, I find that the public interest
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Dated: December 11, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018–28072 Filed 12–26–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Johnson Matthey Inc.
ACTION:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007)
ADDRESSES:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before January 28, 2019. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2019.
DATES:
SUPPLEMENTARY INFORMATION:
The Attorney General has delegated
his authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated to the Assistant
Administrator of the DEA Diversion
Control Division (‘‘Assistant
Administrator’’) pursuant to section 7 of
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR
1301.34(a), this is notice that on October
15, 2018, Johnson Matthey Inc., 2003
Nolte Drive, West Deptford, New Jersey
08066 applied to be registered as an
importer of the following basic classes
of controlled substances:
Controlled substance
Drug code
Coca Leaves ............................................................................................................................................................
Thebaine ..................................................................................................................................................................
Opium, raw ..............................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Poppy Straw Concentrate ........................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to import coca
leaves (9040), raw opium (9600), and
poppy straw concentrate (9670) in order
to bulk manufacture active
pharmaceutical ingredients (API) for
distribution to its customers. The
company plans to also import thebaine
(9333), noroxymorophone (9668), and
fentanyl (9801) to use as analytical
reference standards, both internally and
to be sold to their customers to support
testing of Johnson Matthey Inc.’s API’s
only.
Dated: December 8, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–28073 Filed 12–26–18; 8:45 am]
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BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Company
17:14 Dec 26, 2018
Jkt 247001
II
II
II
II
II
II
FR docket
Published
83 FR
49580.
October
2, 2018.
Drug Enforcement Administration
R & D Systems, Inc.
[Docket No. DEA–392]
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the
registration of the listed registrant to
import the applicable basic classes of
schedule I or II controlled substances is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
DEA investigated the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I or II controlled substances to
the above listed company.
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
The registrant listed below
has applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as an importer of
various classes of schedule I or II
controlled substances.
SUMMARY:
The
company listed below applied to be
registered as an importer of various
basic classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for this notice.
SUPPLEMENTARY INFORMATION:
necessitates that this Order be effective
immediately. 21 CFR 1316.67.
VerDate Sep<11>2014
9040
9333
9600
9668
9670
9801
Schedule
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[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Pages 66747-66750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28072]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 2018-48]
Stephen R. Kovacs, D.O.; Decision and Order
On August 2, 2018, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause to Stephen R. Kovacs, D.O.
(hereinafter, Respondent), of Owasso and Claremore, Oklahoma. Order to
Show Cause (hereinafter, OSC), at 1. The Show Cause Order proposes the
revocation of Respondent's Certificates of Registration on the ground
that he has ``no state authority to handle controlled substances'' in
Oklahoma, the State in which he is registered with the DEA. Id. (citing
21 U.S.C. 824(a)(3)). It also proposes the denial of ``any applications
for renewal or modification of such registrations and any applications
for any other DEA registrations.'' OSC, at 1 (citing 21 U.S.C.
824(a)(3)).
Regarding jurisdiction, the Show Cause Order alleges that
Respondent holds DEA Certificate of Registration No. BK9173840 at the
registered address of 10314 N 138th E Ave., Suite 101, Owasso, Oklahoma
74055. OSC, at 2. This registration, the OSC alleges, authorizes
Respondent to dispense controlled substances in schedules II through V
as a practitioner-DW/275. Id. The Show Cause Order alleges that this
registration expires on December 31, 2019. Id.
The Show Cause Order further alleges that Respondent holds DEA
Certificate of Registration No. BK7370492 at the registered address of
985 West Will Rogers Blvd., Claremore, OK 74017, with a mailing address
of 13616 E 103rd St. N, Ste. A, Owasso, Oklahoma 74055. Id. This
registration, the OSC alleges, authorizes Respondent to dispense
controlled substances in schedules II through V as a practitioner. Id.
The Show Cause Order alleges that this registration expires on December
31, 2018. Id.
The substantive ground for the proceeding, as alleged in the Show
Cause Order, is that Respondent is
[[Page 66748]]
``currently without authority to handle controlled substances in the
State of Oklahoma, the state in which . . . [he is] registered with
DEA.'' Id. Specifically, the Show Cause Order alleges that, on May 31,
2018, the Oklahoma State Bureau of Narcotics and Dangerous Drugs
Control immediately suspended Respondent's Oklahoma controlled
substances registration OBN#29222, and that this registration is
associated with Respondent's practice location at 10314 N 138th E Ave.,
Suite 101, Owasso, Oklahoma 74055. Id. The Show Cause Order further
alleges that Respondent's Oklahoma controlled substances registration
OBN#33269, associated with Respondent's practice location at 985 West
Will Rogers Blvd., Claremore, Oklahoma 74017, expired on October 31,
2017 and is listed as ``INACTIVE.'' Id.
The Show Cause Order notifies Respondent of his right to request a
hearing on the allegations or to submit a written statement while
waiving his right to a hearing, the procedures for electing each
option, and the consequences for failing to elect either option. Id. at
2-3 (citing 21 CFR 1301.43). The Show Cause Order also notifies
Respondent of the opportunity to submit a corrective action plan. OSC,
at 3-4 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated September 7, 2018, Respondent timely requested a
hearing.\1\ Hearing Request, at 1. According to the Hearing Request,
the Oklahoma Bureau of Narcotics & Dangerous Drugs Control
(hereinafter, OBNDDC) immediately suspended ``for imminent
endangerment'' Respondent's State controlled substances registration
based on ``allegations of professional misconduct.'' Id. Respondent
contests the OBNDDC allegations. Id. The Hearing Request admits that
Respondent ``is currently suspended under the State order from
prescribing medications.'' Id. at 2. It states that, ``upon a full and
fair hearing of the facts,'' Respondent ``should not have his State or
Federal Certificates of Registration revoked or modified.'' Id.
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\1\ Attached to the Government's Motion for Summary Disposition
is a DEA-12 (Receipt for Cash or Other Items) that, according to the
Government's allegations, Respondent executed when the Government
served the OSC on August 8, 2018. Respondent does not challenge the
Government's service-related allegations. The Government does not
contest the timeliness of Respondent's request for a hearing.
Government's Motion for Summary Disposition dated September 19, 2018
(hereinafter ``Summary Disposition Motion''), at 2. Thus, I find
that Respondent's Hearing Request was timely since it was filed
within 30 days of service of the OSC. 21 CFR 1301.43(a).
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The Office of Administrative Law Judges put the matter on the
docket and assigned it to Chief Administrative Law Judge John J.
Mulrooney, II (hereinafter, CALJ). On September 10, 2018, the CALJ
issued an Order directing the filing of evidence of lack of State
authority and a briefing schedule.
The Government filed a timely Summary Disposition Motion ``based on
Respondent's lack of state authority to handle controlled substances.''
Summary Disposition Motion, at 1. The Government attached to its
Summary Disposition Motion a certified copy of the OBNDDC's letter to
Respondent notifying him of his ``Immediate Suspension Due to Imminent
Danger'' dated May 31, 2018. Id. at Exh. 4. According to the Summary
Disposition Motion, Respondent ``is not authorized to possess a DEA
registration'' in Oklahoma ``[a]bsent authority by the State of
Oklahoma to dispense controlled substances.'' Id. at 4. Citing Agency
precedent, the Government argues that ``even if the period of
suspension is temporary or if there is the potential that Respondent's
state controlled substances privileges will be reinstated, summary
disposition is warranted.'' Id.
On September 27, 2018, Respondent timely filed a Response to the
Summary Disposition Motion. Attached to the Response is an email from
the Deputy General Counsel of the Oklahoma Bureau of Narcotics dated
September 13, 2018. The email asks Respondent's attorney if he
``[w]ould . . . be opposed to continuing . . . [Respondent's] hearing
until October 25, 2018.'' Response, Exh. 1, at 1. Counsel for
Respondent did not object to the continuance. Id. at 1. According to
the Response, ``Respondent's rights have been severely prejudiced by
delaying the state hearing.'' Id. at 2.
Respondent ``admits that the OBNDDC filed the Notice of Immediate
Suspension of Respondent's Oklahoma controlled substances registration
on May 31, 2018.'' Id. at 1. He states, however, that he ``has had no
opportunity to present evidence or cross-examine witnesses, defenses to
which he is absolutely entitled under Oklahoma law'' and that ``but
for'' the continuance, he ``would have had that opportunity today.''
Id. at 3. Respondent argues that the Agency precedent on which the
Government relies ``allowed some form of process with the state . . .
before the Government's motion for summary disposition was granted.''
Id. at 2. He states that the ``state administrative hearing will be
concluded in less than one month . . . [at which] time both sides will
have a much more complete understanding of the facts, and the ALJ will
be able to more effectively rule on the status of Respondent's DEA
registration.'' Id. at 3. Respondent asks that the Summary Disposition
Motion be denied or, in the alternative, that the deadline for his
response be ``extended . . . beyond the date of his state
administrative hearing.'' Id.
The CALJ granted the Summary Disposition Motion and recommended
that Respondent's registration be revoked. Order Denying the
Respondent's Request for Extension, Granting the Government's Motion
for Summary Disposition, and Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision of the Administrative Law Judge dated
September 28, 2018 (hereinafter, R.D.). The CALJ notes Respondent's
concession that his Oklahoma registration was suspended on May 31,
2018. Id. at 3. Citing Agency precedent about stay requests, the CALJ
denied Respondent's request for an extended response deadline. Id.
After summarizing Agency precedent concerning a registrant's loss of
State authority to dispense controlled substances, the CALJ recommended
that Respondent's registration be revoked and that pending applications
for renewal be denied. Id. at 4-7.
By letter dated October 18, 2018, the CALJ certified and
transmitted the record to me for final Agency action. In that letter,
the CALJ advises that neither party filed exceptions.
I issue this Decision and Order based on the entire record before
me. 21 CFR 1301.43(e). I make the following findings of fact.
Findings of Fact
Respondent's DEA Registrations
Respondent holds two DEA Certificates of Registration. First,
Respondent holds DEA Certificate of Registration No. BK9173840,
pursuant to which he is authorized to dispense controlled substances in
schedules II through V as a practitioner DW/275, at the registered
address of 10314 N 138th E Ave., Suite 101, Owasso, Oklahoma 74055.
Summary Disposition Motion, Exh. 1 (Certification of Registration
Status), at 1. This registration expires on December 31, 2019. Id.
Second, Respondent holds DEA Certificate of Registration No.
BK7370492, pursuant to which he is authorized to dispense controlled
substances in schedules II through V as a practitioner, at the
registered address of 985 West Will Rogers Blvd., Claremore, Oklahoma
74017. Id. at Exh. 2 (Certification of Registration Status), at
[[Page 66749]]
1. This registration expires on December 31, 2018. Id.
The Status of Respondent's State License
On May 31, 2018, the OBNDDC immediately suspended due to imminent
danger Respondent's ``privileges to possess, administer, dispense,
prescribe and/or distribute scheduled controlled dangerous
substances.'' Id. at Exh. 4, at 1. According to the immediate
suspension, the OBNDDC found ``by clear and convincing evidence . . .
[that Respondent's] continuing status as an Oklahoma Bureau of
Narcotics registrant represents an imminent danger to the public
health, safety and welfare of the citizens of Oklahoma.'' Id. at Exh.
4, at 3. The OBNDDC's action was based on information that Respondent
wrote false Oxycodone (30mg) prescriptions for a patient with the
intention of diverting the narcotics back to himself; that Respondent
urged a patient to include a false report of stolen Oxycodone on a
police report with the intention of getting another refill; that
Respondent deleted messages pertaining to his illegal activity from a
patient's electronic device; that a patient witnessed Respondent snort
Oxycodone between meetings with patients; and that Respondent was
opioid dependent. Id. at Exh. 4, at 2-3.
Respondent admits that the OBNDDC filed the Notice of Immediate
Suspension on May 31, 2018. Response, at 1. There is no evidence in the
record that the OBNDDC lifted this Immediate Suspension. Further,
according to the online records of the State of Oklahoma, of which I
take official notice, I find that this Immediate Suspension is still in
effect today and that no Oklahoma controlled substances registration
ever assigned to Respondent is currently active.\2\ OBNDDC Registration
Search Lookup, https://pay.apps.ok.gov/obndd/_app/search/index.php
(last visited December 11, 2018).
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\2\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e),
``[w]hen an agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Respondent may dispute my finding by filing
a properly supported motion for reconsideration within 15 calendar
days of the date of this Order. Any such motion shall be filed with
the Office of the Administrator and a copy shall be served on the
Government; in the event Respondent files a motion, the Government
shall have 15 calendar days to file a response.
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Accordingly, I find that Respondent currently is without authority
to dispense controlled substances in Oklahoma, the State in which he is
registered.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (hereinafter, CSA), ``upon a finding that the
registrant . . . has had his State license or registration suspended .
. . [or] revoked . . . by competent State authority and is no longer
authorized by State law to engage in the . . . dispensing of controlled
substances.'' With respect to a practitioner, the DEA has long held
that the possession of authority to dispense controlled substances
under the laws of the State in which a practitioner engages in
professional practice is a fundamental condition for obtaining and
maintaining a practitioner's registration. See, e.g., James L. Hooper,
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826
(4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617
(1978).
This rule derives from the text of two provisions of the CSA.
First, Congress defined the term ``practitioner'' to mean ``a physician
. . . 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). Second, in
setting the requirements for obtaining a practitioner's registration,
Congress directed that ``[t]he Attorney General shall register
practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated
that a practitioner possess State authority in order to be deemed a
practitioner under the CSA, the DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction whenever
he is no longer authorized to dispense controlled substances under the
laws of the State in which he practices. See, e.g., Hooper, supra, 76
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11,919, 11,920 (1988), Blanton, supra, 43 FR at
27,617.
Under longstanding Agency precedent, DEA revokes the registration
of a practitioner who lacks State authority to handle controlled
substances even when the practitioner's State authority was suspended
summarily or pending a final decision on the merits. See, e.g., Bourne
Pharmacy, Inc., 72 FR 18,273, 18,274 (2007). Similarly, as the CALJ
made clear, the facts that a State immediately suspended a respondent's
registration and that the respondent may, some day, regain his State
registration to dispense controlled substances do not change the
salient fact--the respondent is not currently authorized to handle
controlled substances in the State in which he is registered.\3\ Mehdi
Nikparvarfard, M.D., 83 FR 14,503, 14,504 (2018).
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\3\ The CALJ's denial of Respondent's request for an enlargement
of time is the correct result. Also, as already discussed,
Oklahoma's online records still indicate that Respondent's Oklahoma
controlled substances registrations are inactive or inactivated.
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Here, Respondent admits that the OBNDDC suspended his Oklahoma
controlled substances registration. Further, there is no evidence in
the record that Respondent holds any active Oklahoma registration to
handle controlled substances. As such, according to Oklahoma law,
Respondent currently does not have authority to handle controlled
substances in Oklahoma. Okla. Stat. tit. 63, Sec. 2-302 (Westlaw,
current with legislation of the Second Regular Session of the 56th
Legislature (2018)) (Every person who dispenses any controlled
dangerous substance within Oklahoma shall obtain a registration issued
by OBNDDC.). Respondent, therefore, is not eligible for a DEA
registration. Accordingly, I will order that Respondent's DEA
registrations be revoked and that any pending application for the
renewal or modification of those registrations be denied. 21 U.S.C.
824(a)(3).
Order
Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by
21 U.S.C. 824(a), I order that DEA Certificate of Registration Nos.
BK9173840 and BK7370492 issued to Stephen R. Kovacs, D.O., be, and they
hereby are, revoked. I further order that any pending application of
Stephen R. Kovacs, D.O., to renew or modify these registration, as well
as any other pending application by him for registration in the State
of Oklahoma, be, and it hereby is, denied. This Order is effective
immediately.\4\
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\4\ For the same reasons the OBNDDC found by clear and
convincing evidence that Respondent's continuing status as an
Oklahoma Bureau of Narcotics registrant represents an imminent
danger to the public health, safety and welfare of the citizens of
Oklahoma, I find that the public interest necessitates that this
Order be effective immediately. 21 CFR 1316.67.
[[Page 66750]]
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Dated: December 11, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-28072 Filed 12-26-18; 8:45 am]
BILLING CODE 4410-09-P
