Charles Szyman, D.O.; Decision and Order, 64937-64940 [2016-22677]
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Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices
(2) For the purpose of the
investigation so instituted, the following
are hereby named as parties upon which
this notice of investigation shall be
served:
(a) The complainants are:
Segway Inc., 14 Technology Drive,
Bedford, NH 03110
DEKA Products Limited Partnership,
340 Commercial Street, Suite 401,
Manchester, NH 03101
Ninebot (Tianjin) Technology Co., Ltd.,
Building 9, Jiasuqi, Tianrui Road,
Science and Technology Park Center,
Auto Industrial Park, Wuqing,
Tianjin, China
(b) The respondents are the following
entities alleged to be in violation of
section 337, and are the parties upon
which the complaint is to be served:
Powerboard LLC, 9363 E Bahia Drive,
Scottsdale, AZ 85260
Metem Teknoloji Sistemleri San,
¨
Necatibey Cad. No: 61, Karakoy,
Istanbul, Turkey
Changzhou Airwheel Technology Co.,
Ltd., Fl. 9 Zhongchuang Building, No.
396 Tongjiang Road, Xinbei District,
Changzhou, Jiangsu, China
Airwheel, Kabelweg 43 1014 BA,
Amsterdam, Netherlands
Nanjing Fastwheel Intelligent
Technology Co., Ltd., C2–1 Hongfeng
Science & Technology Park, Qixia
District, Nanjing, China
Shenzhen Chenduoxing Electronic,
Technology Ltd., China, a.k.a. C-Star,
4F, block C11, Fuyuan Industrial
Area, Jiuwei, Xixiang, Bao’an,
Shenzhen, China
Hangzhou Chic Intelligent Technology
Co., Ltd., 2/F, No. 2 Building,
Liangzhu University, Science and
Technology Park, No. 1 Jingyi Road,
Hangzhou, 311112, China
Hovershop, 330 East Orange Thorpe
Avenue, Suite K, Placentia, CA 92871
Shenzhen Jomo Technology Co., Ltd.,
a.k.a. Koowheel, Floor 4th and 7th,
Caiyue Building, Meilong Road,
Bao’an District, Shenzhen City,
518112, China
Guanghzou Kebye Electronic
Technology Co., Ltd., a.k.a. Gotway,
A2, 2nd Floor, Building 39,
Dayangtian Industry Park, Wanfeng,
No. 56, Fengtang Road, Bao’an
District, Shenzhen, China
Inventist, Inc., 4901 NW Camas
Meadows Drive, Camas, WA 98607
(c) The Office of Unfair Import
Investigations, U.S. International Trade
Commission, 500 E Street SW., Suite
401, Washington, DC 20436; and
(3) For the investigation so instituted,
the Honorable David P. Shaw is
designated as the presiding
Administrative Law Judge.
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The Commission has determined to
assign this investigation to Judge Shaw,
who is the presiding administrative law
judge in Certain Personal Transporters,
Components Thereof, and Packaging
and Manuals Therefor, Inv. No. 337–
TA–1007, and hereby directs Judge
Shaw to consolidate the two
proceedings in view of the overlapping
general exclusion orders requested in
the two investigations.
Responses to the complaint and the
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
days after the date of service by the
Commission of the complaint and the
notice of investigation. Extensions of
time for submitting responses to the
complaint and the notice of
investigation will not be granted unless
good cause therefor is shown.
Failure of a respondent to file a timely
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
administrative law judge and the
Commission, without further notice to
the respondent, to find the facts to be as
alleged in the complaint and this notice
and to enter an initial determination
and a final determination containing
such findings, and may result in the
issuance of an exclusion order or a cease
and desist order or both directed against
the respondent.
By order of the Commission.
Issued: September 15, 2016.
Lisa R. Barton,
Secretary to the Commission.
[FR Doc. 2016–22758 Filed 9–20–16; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Charles Szyman, D.O.; Decision and
Order
On February 10, 2016, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration (DEA), issued an Order
to Show Cause to Charles Szyman, D.O.
(hereinafter, Respondent), of
Manitowoc, Wisconsin. The Show
Cause Order proposed the revocation of
Respondent’s DEA Certificate of
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Registration AS3236406, pursuant to
which he is authorized to dispense
controlled substances in schedules II
through V as a practitioner, on the
ground that he does not have authority
to handle controlled substances in
Wisconsin, the State in which he is
registered with the Agency. Order to
Show Cause, at 1 (citing 21 U.S.C. 823(f)
and 824(a)(3)).
The Show Cause Order alleged that
Respondent is registered as a DATAwaived/100 practitioner pursuant to
Certificate of Registration No.
AS3236406, with authority to handle
controlled substances in schedules II
through V, at the registered address of
P.O. Box 1450, 3200 Western Avenue,
Manitowoc, Wisconsin. Id. The Order
also alleged that Respondent’s
registration does not expire until
February 28, 2017. Id.
The Show Cause Order then alleged
that State of Wisconsin Medical
Examining Board (hereinafter, Board)
issued an order suspending
Respondent’s authority to practice
medicine and surgery, effective October
21, 2015. Id. The Show Cause Order
thus asserted that ‘‘DEA must revoke
[Respondent’s registration] based upon
[his] lack of authority to handle
controlled substances in the State of
Wisconsin.’’ Id. (citing 21 U.S.C.
802(21), 823(f) and 824(a)(3)). The Show
Cause Order also notified 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 procedure for electing
either option, and the consequence of
failing to electing either option. Id. at 2
(citing 21 CFR 1301.43).
On March 7, 2016, Respondent,
through his counsel, requested a hearing
on the allegations of the Show Cause
Order. Resp.’s Hrng. Req., at 1. In his
hearing request, Respondent conceded
that his state license had been
summarily suspended, but argued that
21 U.S.C. 824(a)(3) does not require that
DEA revoke a registration if the
practitioner has had his state license
suspended. Id. at 2. He also requested a
stay of the proceeding until after the
resolution of the Board’s case. Id.
The matter was placed on the docket
of the Office of Administrative Law
Judges, and assigned to the Chief
Administrative Law Judge (hereinafter,
CALJ). Order Directing the Filing of
Government Evidence of Lack of State
Authority Allegation and Briefing
Schedule, at 1. The same day, the CALJ
issued an order directing the
Government to ‘‘provide its position
regarding the Respondent’s request for a
stay’’ and to file evidence to support its
allegation of Respondent’s lack of state
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authority. Id. at 1–2. He also ordered
Respondent to file a timely reply if the
Government filed a motion for summary
disposition. Id. at 2.
On March 18, 2016, the Government
filed it Motion for Summary
Disposition, which it supported by
attaching a copy of the Board’s October
21, 2015 Order of Summary Suspension.
Mot. for Summ. Disp., at Appendix B.
Therein, the Government argued that it
was undisputed that the Board
suspended Respondent’s state license
on October 21, 2015. Mot. for Summ.
Disp., at 2. The Government further
argued that because Respondent no
longer meets the statutory definition of
a practitioner and ‘‘the Agency has
consistently held that ‘the CSA requires
the revocation of a registration issued to
a practitioner . . . even where a state
board has suspended . . . a
practitioner’s authority with the
possibility that the authority may be
restored at some point in the future,’ ’’
it was entitled to summary disposition
and the recommendation that
Respondent’s registration be revoked.
Id. at 4 (citations omitted). The
Government also requested that the
CALJ deny Respondent’s stay request.
Id.
In his Reply, Respondent argued that
‘‘the plain language of section 824(a)(3)
provides that the loss of state authority
constitutes a discretionary, not
mandatory, basis for revocation.’’
Respondent Reply to Gov. Mot. for
Summ. Disp., at 1 (citing James Alvin
Chaney, 80 FR 57391 n.1 (2015)).1
Respondent’s Reply, at 1. However,
Respondent also acknowledged that the
CALJ’s recommended decision in
Chaney ‘‘deferred to Agency precedent’’
and recommended revocation, and thus
he would not ‘‘belabor his objection.’’
Id. Respondent argued, however, that
‘‘[a] stay . . . would afford [him] with
1 Respondent’s citation refers to Footnote 1 of the
Recommended Decision in Chaney and not to the
Agency’s Decision and Order. In the latter, the
Agency made clear that although the language of
section 824(a) authorizes either the suspension or
revocation of a registration upon the making of one
of the five findings enumerated therein, based on
the CSA’s definition of the term practitioner, see 21
U.S.C. 802(21), and the provision which sets forth
the criteria for evaluating an application for a
practitioner’s registration, see id. § 823(f), the
Agency has consistently interpreted the CSA as
mandating the revocation of a practitioner’s
registration where the practitioner’s state authority
has been suspended or revoked. 80 FR 57392 n.2.
This interpretation has been upheld by the federal
courts. As the Fourth Circuit has held, ‘‘[b]ecause
sections 823(f) and 802(21) make clear that a
practitioner’s registration is dependent upon the
practitioner having state authority to dispense
controlled substances, the [Administrator’s]
decision to construe section 824(a)(3) as mandating
revocation upon suspension of a state license is not
an unreasonable interpretation of the CSA.’’ Hooper
v. Holder, 481 Fed.Appx. 826, 828 (4th Cir. 2012).
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his due process right to be heard in a
meaningful manner in the State . . .
proceeding.’’ Id. (citing Dusenberry v.
United States, 543 U.S. 161 (2002);
Mathews v. Eldridge, 424 U.S. 319
(1976)).
On March 29, 2016, the CALJ granted
the Government’s Motion for Summary
Disposition, finding that Respondent
conceded in his Hearing Request that he
is currently without state authority to
handle controlled substances in
Wisconsin, and thus ‘‘no genuine
dispute exists over the fact that
[Respondent] lacks state authority to
handle controlled substances in
Wisconsin.’’ Recommended Rulings,
Findings of Fact, Conclusions of Law
and Decision of the Administrative Law
Judge, at 7. The CALJ also denied
Respondent’s request for a stay, noting
that ‘‘the Agency has previously stated
that a stay is ‘‘unlikely to ever be
justified due to ancillary proceedings’’
and ‘‘it is not DEA’s policy to stay
[administrative] proceedings . . . while
registrants litigate in other forums.’’ Id.
(citing Grider Drug #1 & Grider Drug #2,
77 FR 44070, 44104 n.97 (2012);
Newcare Home Health Services, 72 FR
42126 (2007)).
Neither party filed Exceptions to the
CALJ’s Recommended Decision.
Thereafter, the record was forward to
this office for Final Agency Action.
Having considered the entire record, I
will adopt the ALJ’s ruling that a stay of
the proceeding was not warranted, his
finding that ‘‘Respondent lacks state
authority to handle controlled
substances’’ and ‘‘is not entitled to
maintain his DEA registration,’’ and his
recommendation that I revoke
Respondent’s registration. I make the
following factual findings.
Findings
Respondent holds DEA Certificate of
Registration AS3236406. Pursuant to
this registration, Respondent is
authorized to dispense controlled
substances in schedules II through V, at
the registered location of P.O. Box 1450,
2300 Western Avenue, Manitowoc,
Wisconsin. Appendix A to Gov. Mot. for
Summ. Disp., at 1. Under this
registration, Respondent is also
authorized to treat up to 100 patients as
a DATA-waived physician. Id.
Respondent’s registration does not
expire until February 28, 2017. Id.
It is undisputed that the Wisconsin
Medical Board issued an Order
summarily suspending Respondent’s
state license to practice medicine
effective on October 21, 2015. See also
Appendix B to Gov. Mot. for Summ.
Disp., at 3. While according to
Respondent’s Hearing Request, a
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hearing to challenge the Board’s action
was set for May 18, 2016, Respondent’s
state license remains suspended as of
the date of this Decision and Order.2
Resp. Hrng. Req., at 2. See also https://
app.wi.gov/LicenseSearch/Individual
License/SearchResultsSummary (visited
Sept. 13, 2016).
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, ‘‘upon a finding that
the Registrant . . . has had his State
license . . . suspended [or] revoked
. . . by competent State authority and is
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ Moreover, DEA
has held repeatedly 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, 76 FR 71371 (2011),
pet. for rev. denied, 481 Fed. Appx. 826
(4th Cir. 2012).
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 physician
possess state authority in order to be
deemed a practitioner under the Act,
2 In its Order, the Board found that Respondent
‘‘prescribes unusually large amounts of controlled
substances, opioid pain medications in particular,
without adequate or any medical support’’ and
‘‘without adequate or any physical examinations or
medical testing,’’ that he ‘‘allowed patients to
request specific drugs and dosages,’’ and that he
‘‘knows or should know the prescriptions he writes
are being diverted, abused and are causing the
accidental and intentional deaths of patients and
others in the community where he practices.’’
Appendix B (Board Order), at 1–2. The Board
concluded that ‘‘there is probable cause to believe
that unprofessional conduct has occurred’’ and that
‘‘it is necessary to suspend the license and
registration of Respondent . . . immediately to
protect the public health, safety or welfare.’’ Id. at
2 (citing Wis. Admin. Code § Med. 10.02(2)(h) (Nov.
2002) and Wis. Admin. Code §§ Med. 10.03(2)(b)
and (c) (Oct. 2013)).
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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 medicine. See, e.
g., Calvin Ramsey, 76 FR 20034, 20036
(2011); Sheran Arden Yeates, M.D., 71
FR 39130, 39131 (2006); Dominick A.
Ricci, 58 FR 51104, 51105 (1993); Bobby
Watts, 53 FR 11919, 11920 (1988); see
also Hooper v. Holder, 481 Fed. Appx.
at 828.
In his Reply to the Government’s
Motion, Respondent argues that ‘‘the
plain language of section 824(a)(3)
provides that the loss of state authority
constitutes a discretionary, not
mandatory, basis for revocation.’’ Resp.
Reply, at 1. This Agency has explained,
however, that Section 824(a)’s grant of
authority to suspend or revoke a
registration applies across all categories
of registration, including manufacturers,
distributors, importers, exporters,
narcotic treatment programs, list I
distributors, and practitioners, and it
applies to five different grounds for
sanctioning a registrant. Hooper, 76 FR,
at 71372. The Agency has further
explained that ‘‘this general grant of
authority in imposing a sanction must
be reconciled with the CSA’s specific
provisions which mandate that a
practitioner hold authority under state
law in order to obtain and maintain a
DEA registration.’’ 3 Id. See also GozlonPeretz v. United States, 498 U.S. 395,
407 (1991) (‘‘A specific provision
controls over one of more general
application.’’); Bloate v. United States,
559 U.S. 196, 207 (2010) (‘‘language of
a statutory provision, although broad
enough to include it, will not be held to
apply to a matter specifically dealt with
in another part of the same
enactment.’ ’’).
3 By contrast, in Bio-Diagnostic International, 78
FR 39327 (2013), a case involving a list I chemical
distributor which did not possess state authority,
the Agency held that granting summary disposition
to the Government on this basis was improper
because neither the provision setting forth the
standards for the registration of list I distributors,
nor the definition of a distributor, requires that a
distributor possess state authority in order to be
registered. While Bio-Diagnostic involved an
application, in a footnote, the decision explained
that while ‘‘section 824(a)(3) authorizes revocation
where a registrant ‘has had [its] State license
suspended, revoked, or denied by competent state
authority and is no longer authorized by State law
to engage in the manufacturing [or] distribution of
. . . list I chemicals[,]’ [this] does not mean that
revocation is warranted in all instances.’’ Id. at
39330 n.6. Continuing, the decision explained that
‘‘[t]his provision grants the Agency discretionary
authority to impose an appropriate sanction; the
failure to consider factors such as the egregiousness
of the misconduct and mitigating factors in
imposing the sanction would render the sanction
arbitrary and capricious.’’ Id.
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Thus, in Hooper v. Holder, a
physician whose state authority was
suspended for a period of one year,
challenged the revocation of his
registration, arguing that the Agency
‘‘failed to recognize the discretion under
§ 824(a) to revoke or suspend a
registration and that it was
impermissible for the [Agency] to
conclude that the CSA requires
revocation of a practitioner’s DEA
registration when the practitioner’s
State license is suspended.’’ 481 Fed.
App’x, at 826. The Fourth Circuit
rejected the physician’s challenge,
explaining:
We find Hooper’s contention
unconvincing. Section 824(a) does state that
the [Agency] may ‘‘suspend or revoke’’ a
registration, but the statute provides for this
sanction in five different circumstances, only
one of which is loss of a State license.
Because § 823(f) and § 802(21) make clear
that a practitioner’s registration is dependent
upon the practitioner having state authority
to dispense controlled substances, the
[Agency’s] decision to construe § 824(a)(3) as
mandating revocation upon suspension of a
state license is not an unreasonable
interpretation of the CSA. The [Agency’s]
decision does not ‘‘read[] the suspension
option’’ out of the statute, because that
option may still be available for the other
circumstances enumerated in § 824(a).
Id. See also Maynard v. DEA, 117 Fed.
Appx. 941, 945 (5th Cir. 2004)
(upholding revocation of DEA
registration after Texas DPS summarily
suspended practitioner’s controlled
substance registration, noting that the
Agency ‘‘has construed the CSA to
require revocation when a registrant no
longer possesses valid state authority to
handle controlled substances’’; ‘‘We
agree with [the] argument that it may
have been arbitrary and capricious had
the DEA failed to revoke [the
physician’s] registration under the
circumstances.’’).
Indeed, DEA has interpreted the CSA
in this manner for nearly 40 years. See
Frederick Marsh Blanton, M.D., 43 FR
27616 (1978). In Blanton, a physician’s
state license was suspended for a period
of one year. Id. at 27616. The Agency
nonetheless revoked the physician’s
registration, explaining that ‘‘it is the
Administrator’s finding and conclusion
that there is a lawful or statutory basis
for the revocation of the Respondent’s
DEA registration. State authorization to
dispense or otherwise handle controlled
substances is a prerequisite to the
issuance and maintenance of a Federal
controlled substances registration. The
Respondent’s registration must,
therefore, be revoked.’’ Id. at 27617
(emphasis added). See also Alfred
Tennyson Smurthwaite, 43 FR at 11873
(same).
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Put another way, because a
practitioner’s registration is dependent
upon state authority to dispense
controlled substances, when that
practitioner’s state authority has been
revoked or suspended, the practitioner
no longer meets the statutory definition.
See 21 U.S.C. § 802(21). And because
the CSA makes clear 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 both obtaining and
maintaining a practitioner’s registration,
‘‘revocation is warranted even where a
practitioner’s state authority has been
summarily suspended and the State has
yet to provide the practitioner with a
hearing to challenge the State’s action at
which he may ultimately prevail.’’
Kamal Tiwari, 76 FR 71604, 71606
(2011); see also Bourne Pharmacy, Inc.,
72 FR 18273, 18274 (2007); Anne Lazar
Thorn, 62 FR 12847 (1997).
In his Reply to the Motion for
Summary Disposition, Respondent also
argues that a stay ‘‘would afford [him]
with his due process right to be heard
in a meaningful manner in the State
Medical Examining Board proceeding.’’
Reply, at 1. Respondent, however, offers
no explanation as to how my
adjudication of this matter impacts, in
any manner, his right to be heard in the
State proceeding. Indeed, in
circumstances similar to those of
Respondent, this Agency ‘‘has
repeatedly denied requests to stay the
issuance of a final order of revocation
. . . [because] under the Controlled
Substances Act, ‘a practitioner must be
currently authorized to handle
controlled substances . . . to maintain
[his] DEA registration.’ ’’ Gregory F.
Saric, M.D., 76 FR 16821 (2011) (quoting
21 U.S.C. § 802(21)); see also Irwin
August, 81 FR 3158 (2016). As the
Agency has explained, because
‘‘whether Respondent’s state license
will be re-instated is entirely
speculative, id., ‘[i]t is not DEA’s policy
to stay proceedings . . . while
registrants litigate in other forums.’ ’’
August, 81 FR at 3159 (quoting Newcare
Home Health Servs., 72 FR 42126,
42127 n.2 (2007) (citing Bourne
Pharmacy, 72 FR 18273 (2007))). I
therefore affirm the ALJ’s ruling denying
Respondent’s stay request.
In conclusion, because Respondent is
not currently authorized to dispense
controlled substances in Wisconsin, the
State in which he is registered with the
Agency, he is not entitled to maintain
his registration. Accordingly, I will
adopt the ALJ’s recommendation that I
revoke Respondent’s registration.
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Order
Pursuant to the authority vested in me
by 21 U.S.C. § 824(a), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration AS3236406, issued to
Charles Szyman, D.O., be, and it hereby
is, revoked. This Order is effective
immediately.4
Dated: September 13, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016–22677 Filed 9–20–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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Richard J. Settles, D.O.; Decision and
Order
On September 9, 2015, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Richard J. Settles, D.O.
(hereinafter, Respondent), of Grand
Junction, Colorado. The Show Cause
Order proposed the revocation of
Respondent’s DEA Certificate of
Registration FS3717975, pursuant to
which he is authorized to dispense
controlled substances in schedules II
through V, as a practitioner, at the
registered address of 715 Horizon Drive,
Suite 200, Grand Junction, Colorado. GX
2, at 1 (citing 21 U.S.C. 824(a)(1) and
(4)). The Show Cause Order also
proposed the denial of any pending
application to renew or modify
Respondent’s registration, on the ground
that his ‘‘continued registration is
inconsistent with the public interest.’’
Id.
As grounds for the proposed actions,
the Government alleged that
Respondent had materially falsified his
March 4, 2013 application for
registration. Id. at 2 (21 U.S.C.
824(a)(1)). The Order also alleged that
he had issued prescriptions for
controlled substances without authority
to do so under both Arizona and Federal
law. Id. at 3 (citing 21 U.S.C. 824(a)(4)).
With respect to the material
falsification allegation, the Government
alleged that on March 4, 2013,
Respondent applied for a DEA
registration at a location in Chattanooga,
Tennessee. Id. at 1. The Government
alleged that Respondent provided a
‘‘yes’’ answer to the application
4 For the same reasons which led the Wisconsin
Board to summarily suspend Respondent’s
osteopathic license, see supra note 2, I find that the
public interest necessitates that this Order be
effective immediately. 21 CFR 1316.67.
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question: ‘‘Has the applicant ever
surrendered (for cause) or had a state
professional license or controlled
substances registration revoked,
suspended, restricted, or placed on
probation, or is any such action
pending?’’ and that ‘‘[i]n furtherance of
[his] answer,’’ Respondent explained
that on July 17, 2012, ‘‘the Arizona
Board of Osteopathic Examiners placed
my license on a 5 year probation,’’ and
that as a result, ‘‘I voluntarily
surrendered my Arizona license and
DEA registration as I knew I was moving
to Tennessee in the next few months.’’
Id. at 1–2.
The Government then alleged that
Respondent’s answer was materially
false because he was ‘‘aware of at least
two . . . other state professional license
actions’’ when he submitted the
application and failed to disclose them.
Id. at 2. The Government alleged that
these actions included a November 17,
2012 Interim Consent Order issued by
the Arizona Board, which restricted
Respondent’s license to practice
osteopathic medicine pending the
Board’s investigation into whether he
violated its July 17, 2012 Order by
prescribing controlled substances as his
authority to do so had been restricted by
that Order. Id. As for the second Board
action, the Government alleged that on
February 6, 2013, Respondent entered
into a Stipulation and Order with the
Utah Division of Occupational and
Professional Licensing, in which he
admitted that he had falsified a May 4,
2012 application for licensure in that
State, because he failed to disclose that
he was then under investigation by the
Arizona Board, and that he had
surrendered his Utah license to practice
as an osteopath. Id. at 2–3 (citing 21
U.S.C. 824(a)(1), 823(f), 843(a)(4)(A)).
As for the prescribing allegations, the
Government alleged that pursuant to the
July 17, 2012 Arizona Board Order,
Respondent was restricted from
prescribing schedule I through IV
controlled substances. Id. at 3. The
Order alleged that the Board
subsequently found that after the
effective date of the Order, Respondent
became the medical director of a
hospice program and prescribed
controlled substances to 10 of the
program’s patients. Id. The Order then
alleged that ‘‘[p]rescribing controlled
substances without appropriate
authority is contrary to Federal law.’’ Id.
at 3 (citations omitted).
Next, the Order alleged that on May
7, 2014, one day before the Tennessee
State Board of Osteopathic Examination
issued a Consent Order which
indefinitely suspended his Tennessee
license, Respondent applied to modify
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
his registered address from Tennessee to
an address in Dolores, Colorado. Id. at
4. The Order alleged that Respondent
made several additional requests to
modify his registered address,
concluding with his February 18, 2015
request to change his address to a
location in Grand Junction, Colorado
and that the Agency approved this
request on March 17, 2015. Id.
The Order then alleged that prior to
the Agency’s approval of his
modification request, Respondent
issued controlled substance
prescriptions in Colorado, ‘‘in violation
of 21 U.S.C. 810(10),1 822(e), and
841(a)(1).’’ Id. at 4 (citing, inter alia, 21
CFR 1301.12(a), 1301.13(a)).
Specifically, the Order alleged that
‘‘from July 2014 through February 2015,
[Respondent] issued over 250
prescriptions when [he] lacked the
requisite federal authority to issue
prescriptions in Colorado.’’ Id. The
Order then set forth multiple instances
of such prescriptions. Id. at 5–6. The
Order further alleged that Respondent
‘‘issued multiple prescriptions to
patients within a thirty-day window,
amounting to prescriptions for large
dosages of highly abused controlled
substances’’ and set forth a dozen
patients to whom he issued the
prescriptions. Id. at 6–7.
On September 14, 2015, the Show
Cause Order, which also notified
Respondent of his right to request a
hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedure for electing either option,
and the consequence for failing to elect
either option, was served on
Respondent by certified mail, return
receipt requested. GX 4, at 1. Thereafter,
on October 14, 2015, Respondent,
through his attorney, filed a document
entitled ‘‘Waiver of Hearing, Statement
of Position on the Facts and Law’’
(hereinafter ‘‘Position Statement’’) with
the Office of Administrative Law Judges.
See 21 CFR 1301.43(c); GX 5. Therein,
Respondent acknowledged service of
the Order to Show Cause on September
14, 2015, see GX 5 at 5, and explained
he was waiving his right to a hearing
and filing his ‘‘Statement of Position on
the Facts and Law regarding the matters
alleged in the Order to Show Cause.’’
GX 5, at 2.
On February 29, 2016, the
Government forwarded its Request for
Final Agency action, the Investigative
Record, and Respondent’s Position
Statement. Subsequently, on March 21,
2016, the Government filed an
Addendum to its Request for Final
Agency Action (hereinafter, First
1 There
E:\FR\FM\21SEN1.SGM
is no such provision in the CSA.
21SEN1
Agencies
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64937-64940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22677]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Charles Szyman, D.O.; Decision and Order
On February 10, 2016, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Charles Szyman, D.O. (hereinafter, Respondent),
of Manitowoc, Wisconsin. The Show Cause Order proposed the revocation
of Respondent's DEA Certificate of Registration AS3236406, pursuant to
which he is authorized to dispense controlled substances in schedules
II through V as a practitioner, on the ground that he does not have
authority to handle controlled substances in Wisconsin, the State in
which he is registered with the Agency. Order to Show Cause, at 1
(citing 21 U.S.C. 823(f) and 824(a)(3)).
The Show Cause Order alleged that Respondent is registered as a
DATA-waived/100 practitioner pursuant to Certificate of Registration
No. AS3236406, with authority to handle controlled substances in
schedules II through V, at the registered address of P.O. Box 1450,
3200 Western Avenue, Manitowoc, Wisconsin. Id. The Order also alleged
that Respondent's registration does not expire until February 28, 2017.
Id.
The Show Cause Order then alleged that State of Wisconsin Medical
Examining Board (hereinafter, Board) issued an order suspending
Respondent's authority to practice medicine and surgery, effective
October 21, 2015. Id. The Show Cause Order thus asserted that ``DEA
must revoke [Respondent's registration] based upon [his] lack of
authority to handle controlled substances in the State of Wisconsin.''
Id. (citing 21 U.S.C. 802(21), 823(f) and 824(a)(3)). The Show Cause
Order also notified 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 procedure for electing either option, and the
consequence of failing to electing either option. Id. at 2 (citing 21
CFR 1301.43).
On March 7, 2016, Respondent, through his counsel, requested a
hearing on the allegations of the Show Cause Order. Resp.'s Hrng. Req.,
at 1. In his hearing request, Respondent conceded that his state
license had been summarily suspended, but argued that 21 U.S.C.
824(a)(3) does not require that DEA revoke a registration if the
practitioner has had his state license suspended. Id. at 2. He also
requested a stay of the proceeding until after the resolution of the
Board's case. Id.
The matter was placed on the docket of the Office of Administrative
Law Judges, and assigned to the Chief Administrative Law Judge
(hereinafter, CALJ). Order Directing the Filing of Government Evidence
of Lack of State Authority Allegation and Briefing Schedule, at 1. The
same day, the CALJ issued an order directing the Government to
``provide its position regarding the Respondent's request for a stay''
and to file evidence to support its allegation of Respondent's lack of
state
[[Page 64938]]
authority. Id. at 1-2. He also ordered Respondent to file a timely
reply if the Government filed a motion for summary disposition. Id. at
2.
On March 18, 2016, the Government filed it Motion for Summary
Disposition, which it supported by attaching a copy of the Board's
October 21, 2015 Order of Summary Suspension. Mot. for Summ. Disp., at
Appendix B. Therein, the Government argued that it was undisputed that
the Board suspended Respondent's state license on October 21, 2015.
Mot. for Summ. Disp., at 2. The Government further argued that because
Respondent no longer meets the statutory definition of a practitioner
and ``the Agency has consistently held that `the CSA requires the
revocation of a registration issued to a practitioner . . . even where
a state board has suspended . . . a practitioner's authority with the
possibility that the authority may be restored at some point in the
future,' '' it was entitled to summary disposition and the
recommendation that Respondent's registration be revoked. Id. at 4
(citations omitted). The Government also requested that the CALJ deny
Respondent's stay request. Id.
In his Reply, Respondent argued that ``the plain language of
section 824(a)(3) provides that the loss of state authority constitutes
a discretionary, not mandatory, basis for revocation.'' Respondent
Reply to Gov. Mot. for Summ. Disp., at 1 (citing James Alvin Chaney, 80
FR 57391 n.1 (2015)).\1\ Respondent's Reply, at 1. However, Respondent
also acknowledged that the CALJ's recommended decision in Chaney
``deferred to Agency precedent'' and recommended revocation, and thus
he would not ``belabor his objection.'' Id. Respondent argued, however,
that ``[a] stay . . . would afford [him] with his due process right to
be heard in a meaningful manner in the State . . . proceeding.'' Id.
(citing Dusenberry v. United States, 543 U.S. 161 (2002); Mathews v.
Eldridge, 424 U.S. 319 (1976)).
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\1\ Respondent's citation refers to Footnote 1 of the
Recommended Decision in Chaney and not to the Agency's Decision and
Order. In the latter, the Agency made clear that although the
language of section 824(a) authorizes either the suspension or
revocation of a registration upon the making of one of the five
findings enumerated therein, based on the CSA's definition of the
term practitioner, see 21 U.S.C. 802(21), and the provision which
sets forth the criteria for evaluating an application for a
practitioner's registration, see id. Sec. 823(f), the Agency has
consistently interpreted the CSA as mandating the revocation of a
practitioner's registration where the practitioner's state authority
has been suspended or revoked. 80 FR 57392 n.2. This interpretation
has been upheld by the federal courts. As the Fourth Circuit has
held, ``[b]ecause sections 823(f) and 802(21) make clear that a
practitioner's registration is dependent upon the practitioner
having state authority to dispense controlled substances, the
[Administrator's] decision to construe section 824(a)(3) as
mandating revocation upon suspension of a state license is not an
unreasonable interpretation of the CSA.'' Hooper v. Holder, 481
Fed.Appx. 826, 828 (4th Cir. 2012).
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On March 29, 2016, the CALJ granted the Government's Motion for
Summary Disposition, finding that Respondent conceded in his Hearing
Request that he is currently without state authority to handle
controlled substances in Wisconsin, and thus ``no genuine dispute
exists over the fact that [Respondent] lacks state authority to handle
controlled substances in Wisconsin.'' Recommended Rulings, Findings of
Fact, Conclusions of Law and Decision of the Administrative Law Judge,
at 7. The CALJ also denied Respondent's request for a stay, noting that
``the Agency has previously stated that a stay is ``unlikely to ever be
justified due to ancillary proceedings'' and ``it is not DEA's policy
to stay [administrative] proceedings . . . while registrants litigate
in other forums.'' Id. (citing Grider Drug #1 & Grider Drug #2, 77 FR
44070, 44104 n.97 (2012); Newcare Home Health Services, 72 FR 42126
(2007)).
Neither party filed Exceptions to the CALJ's Recommended Decision.
Thereafter, the record was forward to this office for Final Agency
Action. Having considered the entire record, I will adopt the ALJ's
ruling that a stay of the proceeding was not warranted, his finding
that ``Respondent lacks state authority to handle controlled
substances'' and ``is not entitled to maintain his DEA registration,''
and his recommendation that I revoke Respondent's registration. I make
the following factual findings.
Findings
Respondent holds DEA Certificate of Registration AS3236406.
Pursuant to this registration, Respondent is authorized to dispense
controlled substances in schedules II through V, at the registered
location of P.O. Box 1450, 2300 Western Avenue, Manitowoc, Wisconsin.
Appendix A to Gov. Mot. for Summ. Disp., at 1. Under this registration,
Respondent is also authorized to treat up to 100 patients as a DATA-
waived physician. Id. Respondent's registration does not expire until
February 28, 2017. Id.
It is undisputed that the Wisconsin Medical Board issued an Order
summarily suspending Respondent's state license to practice medicine
effective on October 21, 2015. See also Appendix B to Gov. Mot. for
Summ. Disp., at 3. While according to Respondent's Hearing Request, a
hearing to challenge the Board's action was set for May 18, 2016,
Respondent's state license remains suspended as of the date of this
Decision and Order.\2\ Resp. Hrng. Req., at 2. See also https://app.wi.gov/LicenseSearch/IndividualLicense/SearchResultsSummary
(visited Sept. 13, 2016).
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\2\ In its Order, the Board found that Respondent ``prescribes
unusually large amounts of controlled substances, opioid pain
medications in particular, without adequate or any medical support''
and ``without adequate or any physical examinations or medical
testing,'' that he ``allowed patients to request specific drugs and
dosages,'' and that he ``knows or should know the prescriptions he
writes are being diverted, abused and are causing the accidental and
intentional deaths of patients and others in the community where he
practices.'' Appendix B (Board Order), at 1-2. The Board concluded
that ``there is probable cause to believe that unprofessional
conduct has occurred'' and that ``it is necessary to suspend the
license and registration of Respondent . . . immediately to protect
the public health, safety or welfare.'' Id. at 2 (citing Wis. Admin.
Code Sec. Med. 10.02(2)(h) (Nov. 2002) and Wis. Admin. Code
Sec. Sec. Med. 10.03(2)(b) and (c) (Oct. 2013)).
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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, ``upon a
finding that the Registrant . . . has had his State license . . .
suspended [or] revoked . . . by competent State authority and is no
longer authorized by State law to engage in the . . . dispensing of
controlled substances.'' Moreover, DEA has held repeatedly 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, 76 FR 71371
(2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012).
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 physician possess state authority in order to be deemed a
practitioner under the Act,
[[Page 64939]]
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 medicine. See, e. g., Calvin Ramsey, 76 FR
20034, 20036 (2011); Sheran Arden Yeates, M.D., 71 FR 39130, 39131
(2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53
FR 11919, 11920 (1988); see also Hooper v. Holder, 481 Fed. Appx. at
828.
In his Reply to the Government's Motion, Respondent argues that
``the plain language of section 824(a)(3) provides that the loss of
state authority constitutes a discretionary, not mandatory, basis for
revocation.'' Resp. Reply, at 1. This Agency has explained, however,
that Section 824(a)'s grant of authority to suspend or revoke a
registration applies across all categories of registration, including
manufacturers, distributors, importers, exporters, narcotic treatment
programs, list I distributors, and practitioners, and it applies to
five different grounds for sanctioning a registrant. Hooper, 76 FR, at
71372. The Agency has further explained that ``this general grant of
authority in imposing a sanction must be reconciled with the CSA's
specific provisions which mandate that a practitioner hold authority
under state law in order to obtain and maintain a DEA registration.''
\3\ Id. See also Gozlon-Peretz v. United States, 498 U.S. 395, 407
(1991) (``A specific provision controls over one of more general
application.''); Bloate v. United States, 559 U.S. 196, 207 (2010)
(``language of a statutory provision, although broad enough to include
it, will not be held to apply to a matter specifically dealt with in
another part of the same enactment.' '').
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\3\ By contrast, in Bio-Diagnostic International, 78 FR 39327
(2013), a case involving a list I chemical distributor which did not
possess state authority, the Agency held that granting summary
disposition to the Government on this basis was improper because
neither the provision setting forth the standards for the
registration of list I distributors, nor the definition of a
distributor, requires that a distributor possess state authority in
order to be registered. While Bio-Diagnostic involved an
application, in a footnote, the decision explained that while
``section 824(a)(3) authorizes revocation where a registrant `has
had [its] State license suspended, revoked, or denied by competent
state authority and is no longer authorized by State law to engage
in the manufacturing [or] distribution of . . . list I chemicals[,]'
[this] does not mean that revocation is warranted in all
instances.'' Id. at 39330 n.6. Continuing, the decision explained
that ``[t]his provision grants the Agency discretionary authority to
impose an appropriate sanction; the failure to consider factors such
as the egregiousness of the misconduct and mitigating factors in
imposing the sanction would render the sanction arbitrary and
capricious.'' Id.
---------------------------------------------------------------------------
Thus, in Hooper v. Holder, a physician whose state authority was
suspended for a period of one year, challenged the revocation of his
registration, arguing that the Agency ``failed to recognize the
discretion under Sec. 824(a) to revoke or suspend a registration and
that it was impermissible for the [Agency] to conclude that the CSA
requires revocation of a practitioner's DEA registration when the
practitioner's State license is suspended.'' 481 Fed. App'x, at 826.
The Fourth Circuit rejected the physician's challenge, explaining:
We find Hooper's contention unconvincing. Section 824(a) does
state that the [Agency] may ``suspend or revoke'' a registration,
but the statute provides for this sanction in five different
circumstances, only one of which is loss of a State license. Because
Sec. 823(f) and Sec. 802(21) make clear that a practitioner's
registration is dependent upon the practitioner having state
authority to dispense controlled substances, the [Agency's] decision
to construe Sec. 824(a)(3) as mandating revocation upon suspension
of a state license is not an unreasonable interpretation of the CSA.
The [Agency's] decision does not ``read[] the suspension option''
out of the statute, because that option may still be available for
the other circumstances enumerated in Sec. 824(a).
Id. See also Maynard v. DEA, 117 Fed. Appx. 941, 945 (5th Cir. 2004)
(upholding revocation of DEA registration after Texas DPS summarily
suspended practitioner's controlled substance registration, noting that
the Agency ``has construed the CSA to require revocation when a
registrant no longer possesses valid state authority to handle
controlled substances''; ``We agree with [the] argument that it may
have been arbitrary and capricious had the DEA failed to revoke [the
physician's] registration under the circumstances.'').
Indeed, DEA has interpreted the CSA in this manner for nearly 40
years. See Frederick Marsh Blanton, M.D., 43 FR 27616 (1978). In
Blanton, a physician's state license was suspended for a period of one
year. Id. at 27616. The Agency nonetheless revoked the physician's
registration, explaining that ``it is the Administrator's finding and
conclusion that there is a lawful or statutory basis for the revocation
of the Respondent's DEA registration. State authorization to dispense
or otherwise handle controlled substances is a prerequisite to the
issuance and maintenance of a Federal controlled substances
registration. The Respondent's registration must, therefore, be
revoked.'' Id. at 27617 (emphasis added). See also Alfred Tennyson
Smurthwaite, 43 FR at 11873 (same).
Put another way, because a practitioner's registration is dependent
upon state authority to dispense controlled substances, when that
practitioner's state authority has been revoked or suspended, the
practitioner no longer meets the statutory definition. See 21 U.S.C.
Sec. 802(21). And because the CSA makes clear 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 both obtaining and maintaining a
practitioner's registration, ``revocation is warranted even where a
practitioner's state authority has been summarily suspended and the
State has yet to provide the practitioner with a hearing to challenge
the State's action at which he may ultimately prevail.'' Kamal Tiwari,
76 FR 71604, 71606 (2011); see also Bourne Pharmacy, Inc., 72 FR 18273,
18274 (2007); Anne Lazar Thorn, 62 FR 12847 (1997).
In his Reply to the Motion for Summary Disposition, Respondent also
argues that a stay ``would afford [him] with his due process right to
be heard in a meaningful manner in the State Medical Examining Board
proceeding.'' Reply, at 1. Respondent, however, offers no explanation
as to how my adjudication of this matter impacts, in any manner, his
right to be heard in the State proceeding. Indeed, in circumstances
similar to those of Respondent, this Agency ``has repeatedly denied
requests to stay the issuance of a final order of revocation . . .
[because] under the Controlled Substances Act, `a practitioner must be
currently authorized to handle controlled substances . . . to maintain
[his] DEA registration.' '' Gregory F. Saric, M.D., 76 FR 16821 (2011)
(quoting 21 U.S.C. Sec. 802(21)); see also Irwin August, 81 FR 3158
(2016). As the Agency has explained, because ``whether Respondent's
state license will be re-instated is entirely speculative, id., `[i]t
is not DEA's policy to stay proceedings . . . while registrants
litigate in other forums.' '' August, 81 FR at 3159 (quoting Newcare
Home Health Servs., 72 FR 42126, 42127 n.2 (2007) (citing Bourne
Pharmacy, 72 FR 18273 (2007))). I therefore affirm the ALJ's ruling
denying Respondent's stay request.
In conclusion, because Respondent is not currently authorized to
dispense controlled substances in Wisconsin, the State in which he is
registered with the Agency, he is not entitled to maintain his
registration. Accordingly, I will adopt the ALJ's recommendation that I
revoke Respondent's registration.
[[Page 64940]]
Order
Pursuant to the authority vested in me by 21 U.S.C. Sec. 824(a),
as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration AS3236406, issued to Charles Szyman, D.O., be, and it
hereby is, revoked. This Order is effective immediately.\4\
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\4\ For the same reasons which led the Wisconsin Board to
summarily suspend Respondent's osteopathic license, see supra note
2, I find that the public interest necessitates that this Order be
effective immediately. 21 CFR 1316.67.
Dated: September 13, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-22677 Filed 9-20-16; 8:45 am]
BILLING CODE 4410-09-P