Milad I. Shaker, M.D.; Decision and Order, 10335-10337 [2021-03358]
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
destabilization, channel widening,
arroyo mouth management, construction
of inset floodplains, construction of
wetland depressions, and use of
supplemental water for on-site
irrigation.
Based on a review of the facts and
analyses contained in the Amended
Draft EA, the USIBWC has selected five
projects as the Preferred Alternatives:
Alternative D—Broad Canyon Arroyo,
Alternative F—Las Cruces Effluent,
Alternative G—Mesilla Valley Bosque
State Park (MVBSP), Alternative H—
Downstream of Courchesne Bridge, and
Alternative J—Trujillo Arroyo.
Alternatives Las Cruces Effluent and
Downstream of Courchesne Bridge
would require engineering designs prior
to construction, while Alternatives
Broad Canyon Arroyo and Trujillo
Restoration Site, which are smaller and
less complicated projects, could be
constructed from conceptual designs.
Downstream of Courchesne Bridge
would be implemented as part of
compensatory mitigation for future
levee improvement projects. All
alternatives would require appropriate
permits from the United States Army
Corps of Engineers for dredge and fill of
Waters of the United States, per the
Clean Water Act Sections 404 and 401.
Potential impacts on natural, cultural,
and other resources were evaluated in
the Draft EA. The USIBWC has prepared
a FONSI for the Preferred Alternatives,
based on a review of the facts and
analyses contained in the amended
Draft EA.
Availability: The electronic version of
the amended Draft EA is available at the
USIBWC web page: https://
www.ibwc.gov/EMD/EIS_EA_Public_
Comment.html.
Dated: February 10, 2021.
Jennifer Pen˜a,
Chief Legal Counsel, International Boundary
and Water Commission, United States
Section.
[FR Doc. 2021–03303 Filed 2–18–21; 8:45 am]
BILLING CODE 7010–01–P
INTERNATIONAL TRADE
COMMISSION
tkelley on DSKBCP9HB2PROD with NOTICES
[Investigation No. 337–TA–1217]
Enforcement Proceeding; Certain
Blowers and Components Thereof;
Notice of Institution of Formal
Enforcement Proceeding
U.S. International Trade
Commission.
ACTION: Notice.
AGENCY:
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21:07 Feb 18, 2021
Jkt 253001
Notice is hereby given that
the U.S. International Trade
Commission has instituted a formal
enforcement proceeding relating to the
Consent Order issued on November 12,
2020, in the above-referenced
investigation.
FOR FURTHER INFORMATION CONTACT:
Cathy Chen, Office of the General
Counsel, U.S. International Trade
Commission, 500 E Street SW,
Washington, DC 20436, telephone 202–
205–2392. Copies of non-confidential
documents filed in connection with this
investigation may be viewed on the
Commission’s electronic docket (EDIS)
at https://edis.usitc.gov. For help
accessing EDIS, please email
EDIS3Help@usitc.gov. General
information concerning the Commission
may also be obtained by accessing its
internet server at https://www.usitc.gov.
Hearing-impaired persons are advised
that information on this matter can be
obtained by contacting the
Commission’s TDD terminal on (202)
205–1810.
SUPPLEMENTARY INFORMATION: The
Commission instituted the original
investigation on September 8, 2020,
based on a complaint filed by Regal
Beloit America, Inc (‘‘Regal’’) of Beloit,
Wisconsin. 85 FR 55491–92 (Sep. 8,
2020). The complaint alleged violations
of section 337 of the Tariff Act of 1930,
as amended, 19 U.S.C. 1337, in the
importation into the United States, the
sale for importation, or the sale within
the United States after importation of
certain blowers and components thereof
by reason of infringement of one or
more of claims 1, 2, 7–10, and 15 of U.S.
Patent No. 8,079,834 (‘‘the ’834 patent’’).
Id. at 55492. The Commission’s notice
of investigation named as respondents
East West Manufacturing, LLC of
Atlanta, Georgia, and East West
Industries of Binh Duong, Vietnam
(collectively, ‘‘Respondents’’). Id. at
55492. The Office of Unfair Import
Investigations (‘‘OUII’’) did not
participate as a party in the original
investigation. Id.
On October 14, 2020, Respondents
filed a motion to terminate the
investigation with respect to themselves
based upon a consent order stipulation.
The motion included a consent order
stipulation and a proposed consent
order.
On October 22, 2020, the presiding
administrative law judge (‘‘ALJ’’) issued
an initial determination (‘‘ID’’) granting
the motion and terminating the
investigation with respect to
Respondents based on the entry of a
consent order. Order No. 6 at 3 (Oct. 22,
2020). Thereafter, the Commission
SUMMARY:
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10335
determined not to review the ID and
issued a Consent Order. 85 FR 73511
(Nov. 18, 2020). Respondents were
therefore terminated from the original
investigation and the investigation was
terminated in its entirety. Id.
On January 15, 2021, Regal filed a
complaint requesting that the
Commission institute a formal
enforcement proceeding under
Commission Rule 210.75 to investigate
the alleged violation of the Consent
Order by Respondents.
Having examined the enforcement
complaint and the supporting
documents, the Commission has
determined to institute a formal
enforcement proceeding, pursuant to 19
CFR 210.75(a), to determine whether a
violation of the Consent Order, issued
on November 12, 2020, in the original
investigation has occurred and to
determine what, if any, enforcement
measures are appropriate. The named
respondents are East West
Manufacturing, LLC of Atlanta, Georgia,
and East West Industries of Binh Duong,
Vietnam. OUII is also named as a party.
The Commission vote for this
determination took place on February
16, 2021.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended, 19 U.S.C. 1337, and in Part
210 of the Commission’s Rules of
Practice and Procedure, 19 CFR part
p10.
By order of the Commission.
Issued: February 16, 2021.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2021–03409 Filed 2–18–21; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Milad I. Shaker, M.D.; Decision and
Order
On October 5, 2020, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter,
Government), signed an Order to Show
Cause (hereinafter, OSC) addressed to
Milad I. Shaker, M.D. (hereinafter,
Registrant). OSC, at 1. The OSC
proposed the revocation of Registrant’s
Certificate of Registration No.
FS1471818. Id. It alleged that Registrant
is without ‘‘authority to handle
controlled substances in the State of
Pennsylvania, the state in which
[Registrant is] registered with DEA.’’
OSC, at 2 (citing 21 U.S.C. 824(a)(3)).
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I. Background
The OSC alleged that the
Pennsylvania State Board of Medicine
(hereinafter, Board) issued a Preliminary
Order October 29, 2019. Id. This
Preliminary Order, according to the
OSC, indefinitely suspended
Registrant’s Pennsylvania Medical
Physician and Surgeon license
following the Board’s ‘‘finding of
[Registrant’s] noncompliance with
conditions of probation approved by the
Board on December 18, 2018.’’ Id.
The OSC notified Registrant of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 2 (citing 21
CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
a corrective action plan. OSC, at 3
(citing 21 U.S.C. 824(c)(2)(C)).
tkelley on DSKBCP9HB2PROD with NOTICES
a. Adequacy of Service
According to the declaration of a DEA
Diversion Investigator (hereinafter, DI),
DEA made arrangements for service of
the OSC on Registrant, while he was
incarcerated at the United States
Penitentiary (USP)—Hazelton
correctional facility in Bruceton, West
Virginia. Request for Final Agency
Action (hereinafter, RFAA) Exhibit
(hereinafter, RFAAX) 10 (Declaration of
DI), at 1–3. To accomplish service, DEA
established a point of contact with
Special Investigative Services at USP—
Hazelton, and made arrangements to
serve the OSC on Registrant by hand
delivery. Id. at 3; RFAAX 5 (emails to
and from Special Investigative Services,
dated October 20–21, 2020). According
to the emails, the OSC was served on
Registrant on October 21, 2020. RFAAX
5, at 1; RFAAX 10, at 3.
In its RFAA, the Government
represents that ‘‘more than 30-days have
passed since Registrant received the
[OSC]’’ and that ‘‘Registrant has not
submitted to DEA a request for hearing.’’
RFAA, at 2; see also RFAAX 6 (email,
dated December 17, 2020, confirming no
correspondence from Registrant). The
Government also represents that DEA
has not received ‘‘any other written
correspondence, telephonic
communication, or any other
communication from Registrant, or any
representative on his behalf in response
to the [OSC].’’ RFAA, at 4. I find that
more than thirty days have now passed
since the Government accomplished
service of the OSC. Accordingly, I find
that Registrant has waived the right to
a hearing and the right to submit a
written statement and corrective action
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plan. 21 CFR 1301.43(d) and 21 U.S.C.
824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record
submitted by the Government, which
constitutes the entire record before me.
21 CFR 1301.46.
II. Findings of Fact
a. Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
FS1471818 at the registered address of
308 Bessemer Road, Suite 100, Mount
Pleasant, Pennsylvania 15666. RFAA, at
2; RFAAX 1 (Controlled Substance
Registration Certificate); RFAAX 2
(Certification of Registration History).
Pursuant to this registration, Registrant
is authorized to dispense controlled
substances in schedules II through V as
a practitioner. Id. Registrant’s
registration expires on February 28,
2021, and is ‘‘in an active pending
status.’’ RFAAX 2, at 1.
b. The Status of Registrant’s State
License
On October 2, 2018, Registrant was
indicted by a grand jury for fifty-four
felony charges, which appear to be
related to Registrant’s practice of
medicine (hereinafter, Indictment).1
RFAAX 3 (Board’s Preliminary Order
with Exhibits), at 37–47. As a result of
the Indictment, the Board petitioned for
immediate temporary suspension of
Registrant’s license, alleging that
Registrant was ‘‘guilty of unprofessional
conduct by failing to conform to the
quality standard of the profession,’’ and
an Order of Temporary Suspension was
issued on October 9, 2018. Id. at 15; see
also RFAAX 3, at 12. On December 13,
2018, Registrant and the Board entered
into a Consent Agreement and Order
(hereinafter, Consent Agreement). Id. at
11–36.
Pursuant to the Consent Agreement,
the Board indefinitely suspended
Registrant’s state license, but
immediately stayed the suspension ‘‘in
favor of a period of indefinite
probation.’’ Id. at 16–17 (emphasis
omitted). The Board required that
Registrant satisfy a number of
conditions during his indefinite
probation.2 Id. at 17–26. On October 29,
1 The felony charges included allegations that
Registrant ‘‘issued prescriptions for controlled
substances to [two patients] in return for sexual
favors;’’ issued thirty-six Schedule II controlled
substance prescriptions ‘‘outside of the usual course
of professional practice and not for a legitimate
medical purpose;’’ issued 16 Schedule IV controlled
substances ‘‘outside of the usual course of
professional practice and not for a legitimate
medical purpose;’’ and engaged in two ‘‘[f]elony
counts of Health Care Fraud.’’ RFAAX 3, at 13–14.
2 One of the conditions required that Registrant
‘‘contract for the services of a Board Approved
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2019, the Board made a probable cause
determination that Registrant violated
the terms of the Consent Agreement and
issued a Preliminary Order. Id. at 2. The
Preliminary Order stated ‘‘the stay of the
suspension of [Registrant’s] license is
now VACATED, the period of probation
is now TERMINATED, and [Registrant’s]
license to practice as a physician and
surgeon, license number MD437512,
along with any other licenses . . . are
now actively indefinitely
SUSPENDED.’’ Id. (emphasis in
original). Registrant was ordered to
‘‘immediately cease practicing the
profession.’’ Id. The Preliminary Order’s
indefinite suspension of Registrant’s
state medical license served as the basis
for the OSC’s allegation that Registrant
lacked state authority to handle
controlled substances. RFAAX 10, at 2;
OSC, at 1.
On April 30, 2020, the Board issued
a Notice and Order of Automatic
Suspension, which automatically
suspended Registrant’s license to
practice medicine and surgery based on
Registrant’s ‘‘conviction in Federal court
for unlawful distribution of a Schedule
II controlled substance’’ (hereinafter,
second suspension). RFAAX 8 (Final
Order dated December 1, 2020 3), at 5.
The second suspension was affirmed by
the Board in a Final Order dated
December 1, 2020. The Final Order was
retroactive to July 28, 2020, and
suspended Registrant’s license to
practice medicine and surgery for at
least 10 years.4 Id. at 1, 18. Similar to the
Preliminary Order, the Final Order
provided that Registrant ‘‘shall
immediately CEASE the practice of
Practice Monitor,’’ ‘‘allow the Practice Monitor
access to all aspects of his practice,’’ and allow the
Practice Monitor a minimum of ‘‘[m]onthly inperson overview[s] . . . to determine that the
monitor’s directions are being implemented.’’
RFAAX 3 22–23. On September 3, 2019,
Registrant’s practice monitor notified Registrant and
the Board that they were ‘‘ceasing all services . . .
effective immediately’’ based on Registrant’s failure
to allow two of the required monthly visits and his
failure to respond to communications. Id. at 50–51.
On October 29, 2019, a Petition for Appropriate
Relief was filed with the Board seeking suspension
of Registrant’s license because ‘‘[Registrant’s] failure
to fully cooperate and successfully comply with the
monitoring terms and conditions of the probation
[was] a violation of [the Consent Agreement].’’ Id.
at 9.
3 DEA obtained a copy of the Board’s Final Order
after the OSC was issued to Registrant. RFAAX 10,
at 3. The Final Order is not material as the record
is clear that Registrant’s license had been
suspended since the Preliminary Order issued on
October 29, 2019.
4 The suspension of the license was retroactive to
May 20, 2020. It appears that as of May 20, 2020,
there were two concurrent suspension applied to
Registrant’s license. The number of suspensions is
not material as the record is clear that Registrant’s
license had been suspended since October 29, 2019.
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
medicine and surgery.’’ Id. at 18
(emphasis in original).
According to DI, on December 17,
2019, DI queried the Pennsylvania
Department of State licensing
verification website at https://
www.pals.pa.gov/#/page/searchresult
and determined that Registrant’s
medical physician license was still
suspended at that time and that
Registrant was without authorization to
handle controlled substances or practice
medicine in Pennsylvania. RFAAX 10,
at 3. According to Pennsylvania’s online
records, of which I take official notice,
Registrant’s license is still revoked.5
Pennsylvania Licensing System
Verification, https://www.pals.pa.gov/#/
page/search (last visited date of
signature of this Order).
Accordingly, I find that Registrant
currently is neither licensed to engage
in the practice of medicine nor
registered to dispense controlled
substances in Pennsylvania, the state in
which Registrant is registered with the
DEA.
tkelley on DSKBCP9HB2PROD with NOTICES
III. 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 also 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.,
5 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,
Registrant may dispute my finding by filing a
properly supported motion for reconsideration of
finding of fact within fifteen 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
Registrant files a motion, the Government shall
have fifteen calendar days to file a response. Any
such motion and response shall be filed and served
by email to the other party and to Office of the
Administrator, Drug Enforcement Administration at
dea.addo.attorneys@dea.usdoj.gov.
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21:07 Feb 18, 2021
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James L. Hooper, M.D., 76 FR 71,371
(2011), pet. for rev. denied, 481 F. App’x
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.,
James L. Hooper, 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); Frederick Marsh Blanton, 43 FR
at 27,617.
Under the Pennsylvania Controlled
Substance, Drug, Device and Cosmetic
Act, ‘‘no controlled substance in
Schedule II shall be dispensed without
an electronic prescription of a
practitioner.’’ 35 PA. Stat. and Const.
Stat. Ann. § 780–111(a) (West October
24, 2019). Further, ‘‘no controlled
substance in Schedule III, IV or V shall
be dispensed without an electronic
prescription of a practitioner.’’ Id. at
§ 780–111(b). The definition of
‘‘practitioner,’’ as used in the state Act,
includes a ‘‘physician . . . or other
person licensed, registered or otherwise
permitted to distribute, dispense,
conduct research with respect to or to
administer a controlled substance . . .
in the course of professional practice
. . . in the Commonwealth of
Pennsylvania.’’ Id. at 780–102(b).
Here, the undisputed evidence in the
record is that Registrant currently lacks
authority to practice medicine in
Pennsylvania. As already discussed, a
physician must be a licensed
practitioner to dispense a controlled
substance in Pennsylvania. Thus,
because Registrant lacks a license to
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Sfmt 4703
10337
practice medicine in Pennsylvania and,
therefore, is not authorized to handle
controlled substances in Pennsylvania,
Registrant is not eligible to maintain a
DEA registration. Accordingly, I will
order that Registrant’s DEA registration
be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. FS1471818 issued to
Milad I. Shaker, M.D. Further, pursuant
to 28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 823(f), I
hereby deny any pending application of
Milad I. Shaker, M.D. to renew or
modify this registration or for any other
registration in Pennsylvania. This Order
is effective March 22, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–03358 Filed 2–18–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 17–33]
Michael W. Carlton, M.D.; Decision and
Order
On April 18, 2017, a former Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Michael W.
Carlton, M.D. (hereinafter, Respondent).
Administrative Law Judge Exhibit
(hereinafter, ALJX) 1 (Order to Show
Cause), at 1. The OSC proposed the
revocation of Respondent’s Certificate of
Registration No. BC3579969 pursuant to
21 U.S.C. 824(a)(4) ‘‘because [his]
continued registration is inconsistent
with the public interest . . . .’’ Id.
(citing 21 U.S.C. 823(f)).
I. Procedural History
The OSC alleged that ‘‘between May
8, 2015 and November 21, 2015, on
approximately forty-two (42) occasions,
[Respondent] unlawfully prescribed
controlled substances to thirty-one (31)
patients by issuing prescriptions for
other than a legitimate medical purpose
and outside the usual course of
professional practice.’’ OSC, at 1–2. The
OSC alleged violations of 21 U.S.C.
841(a), 21 CFR 1306.04(a), and Ariz.
Rev. Stat. Ann. § 32–1401(27). Id. at 2.
The OSC stated that ‘‘a medical expert
has concluded that [Respondent’s]
issuance of the [forty-two] prescriptions
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Agencies
[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10335-10337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03358]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Milad I. Shaker, M.D.; Decision and Order
On October 5, 2020, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, Government),
signed an Order to Show Cause (hereinafter, OSC) addressed to Milad I.
Shaker, M.D. (hereinafter, Registrant). OSC, at 1. The OSC proposed the
revocation of Registrant's Certificate of Registration No. FS1471818.
Id. It alleged that Registrant is without ``authority to handle
controlled substances in the State of Pennsylvania, the state in which
[Registrant is] registered with DEA.'' OSC, at 2 (citing 21 U.S.C.
824(a)(3)).
[[Page 10336]]
I. Background
The OSC alleged that the Pennsylvania State Board of Medicine
(hereinafter, Board) issued a Preliminary Order October 29, 2019. Id.
This Preliminary Order, according to the OSC, indefinitely suspended
Registrant's Pennsylvania Medical Physician and Surgeon license
following the Board's ``finding of [Registrant's] noncompliance with
conditions of probation approved by the Board on December 18, 2018.''
Id.
The OSC notified Registrant of the right to request a hearing on
the allegations or to submit a written statement, while waiving the
right to a hearing, the procedures for electing each option, and the
consequences for failing to elect either option. Id. at 2 (citing 21
CFR 1301.43). The OSC also notified Registrant of the opportunity to
submit a corrective action plan. OSC, at 3 (citing 21 U.S.C.
824(c)(2)(C)).
a. Adequacy of Service
According to the declaration of a DEA Diversion Investigator
(hereinafter, DI), DEA made arrangements for service of the OSC on
Registrant, while he was incarcerated at the United States Penitentiary
(USP)--Hazelton correctional facility in Bruceton, West Virginia.
Request for Final Agency Action (hereinafter, RFAA) Exhibit
(hereinafter, RFAAX) 10 (Declaration of DI), at 1-3. To accomplish
service, DEA established a point of contact with Special Investigative
Services at USP--Hazelton, and made arrangements to serve the OSC on
Registrant by hand delivery. Id. at 3; RFAAX 5 (emails to and from
Special Investigative Services, dated October 20-21, 2020). According
to the emails, the OSC was served on Registrant on October 21, 2020.
RFAAX 5, at 1; RFAAX 10, at 3.
In its RFAA, the Government represents that ``more than 30-days
have passed since Registrant received the [OSC]'' and that ``Registrant
has not submitted to DEA a request for hearing.'' RFAA, at 2; see also
RFAAX 6 (email, dated December 17, 2020, confirming no correspondence
from Registrant). The Government also represents that DEA has not
received ``any other written correspondence, telephonic communication,
or any other communication from Registrant, or any representative on
his behalf in response to the [OSC].'' RFAA, at 4. I find that more
than thirty days have now passed since the Government accomplished
service of the OSC. Accordingly, I find that Registrant has waived the
right to a hearing and the right to submit a written statement and
corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C).
I, therefore, issue this Decision and Order based on the record
submitted by the Government, which constitutes the entire record before
me. 21 CFR 1301.46.
II. Findings of Fact
a. Registrant's DEA Registration
Registrant is the holder of DEA Certificate of Registration No.
FS1471818 at the registered address of 308 Bessemer Road, Suite 100,
Mount Pleasant, Pennsylvania 15666. RFAA, at 2; RFAAX 1 (Controlled
Substance Registration Certificate); RFAAX 2 (Certification of
Registration History). Pursuant to this registration, Registrant is
authorized to dispense controlled substances in schedules II through V
as a practitioner. Id. Registrant's registration expires on February
28, 2021, and is ``in an active pending status.'' RFAAX 2, at 1.
b. The Status of Registrant's State License
On October 2, 2018, Registrant was indicted by a grand jury for
fifty-four felony charges, which appear to be related to Registrant's
practice of medicine (hereinafter, Indictment).\1\ RFAAX 3 (Board's
Preliminary Order with Exhibits), at 37-47. As a result of the
Indictment, the Board petitioned for immediate temporary suspension of
Registrant's license, alleging that Registrant was ``guilty of
unprofessional conduct by failing to conform to the quality standard of
the profession,'' and an Order of Temporary Suspension was issued on
October 9, 2018. Id. at 15; see also RFAAX 3, at 12. On December 13,
2018, Registrant and the Board entered into a Consent Agreement and
Order (hereinafter, Consent Agreement). Id. at 11-36.
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\1\ The felony charges included allegations that Registrant
``issued prescriptions for controlled substances to [two patients]
in return for sexual favors;'' issued thirty-six Schedule II
controlled substance prescriptions ``outside of the usual course of
professional practice and not for a legitimate medical purpose;''
issued 16 Schedule IV controlled substances ``outside of the usual
course of professional practice and not for a legitimate medical
purpose;'' and engaged in two ``[f]elony counts of Health Care
Fraud.'' RFAAX 3, at 13-14.
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Pursuant to the Consent Agreement, the Board indefinitely suspended
Registrant's state license, but immediately stayed the suspension ``in
favor of a period of indefinite probation.'' Id. at 16-17 (emphasis
omitted). The Board required that Registrant satisfy a number of
conditions during his indefinite probation.\2\ Id. at 17-26. On October
29, 2019, the Board made a probable cause determination that Registrant
violated the terms of the Consent Agreement and issued a Preliminary
Order. Id. at 2. The Preliminary Order stated ``the stay of the
suspension of [Registrant's] license is now VACATED, the period of
probation is now TERMINATED, and [Registrant's] license to practice as
a physician and surgeon, license number MD437512, along with any other
licenses . . . are now actively indefinitely SUSPENDED.'' Id. (emphasis
in original). Registrant was ordered to ``immediately cease practicing
the profession.'' Id. The Preliminary Order's indefinite suspension of
Registrant's state medical license served as the basis for the OSC's
allegation that Registrant lacked state authority to handle controlled
substances. RFAAX 10, at 2; OSC, at 1.
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\2\ One of the conditions required that Registrant ``contract
for the services of a Board Approved Practice Monitor,'' ``allow the
Practice Monitor access to all aspects of his practice,'' and allow
the Practice Monitor a minimum of ``[m]onthly in-person overview[s]
. . . to determine that the monitor's directions are being
implemented.'' RFAAX 3 22-23. On September 3, 2019, Registrant's
practice monitor notified Registrant and the Board that they were
``ceasing all services . . . effective immediately'' based on
Registrant's failure to allow two of the required monthly visits and
his failure to respond to communications. Id. at 50-51. On October
29, 2019, a Petition for Appropriate Relief was filed with the Board
seeking suspension of Registrant's license because ``[Registrant's]
failure to fully cooperate and successfully comply with the
monitoring terms and conditions of the probation [was] a violation
of [the Consent Agreement].'' Id. at 9.
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On April 30, 2020, the Board issued a Notice and Order of Automatic
Suspension, which automatically suspended Registrant's license to
practice medicine and surgery based on Registrant's ``conviction in
Federal court for unlawful distribution of a Schedule II controlled
substance'' (hereinafter, second suspension). RFAAX 8 (Final Order
dated December 1, 2020 \3\), at 5. The second suspension was affirmed
by the Board in a Final Order dated December 1, 2020. The Final Order
was retroactive to July 28, 2020, and suspended Registrant's license to
practice medicine and surgery for at least 10 years.\4\ Id. at 1, 18.
Similar to the Preliminary Order, the Final Order provided that
Registrant ``shall immediately CEASE the practice of
[[Page 10337]]
medicine and surgery.'' Id. at 18 (emphasis in original).
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\3\ DEA obtained a copy of the Board's Final Order after the OSC
was issued to Registrant. RFAAX 10, at 3. The Final Order is not
material as the record is clear that Registrant's license had been
suspended since the Preliminary Order issued on October 29, 2019.
\4\ The suspension of the license was retroactive to May 20,
2020. It appears that as of May 20, 2020, there were two concurrent
suspension applied to Registrant's license. The number of
suspensions is not material as the record is clear that Registrant's
license had been suspended since October 29, 2019.
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According to DI, on December 17, 2019, DI queried the Pennsylvania
Department of State licensing verification website at https://www.pals.pa.gov/#/page/searchresult and determined that Registrant's
medical physician license was still suspended at that time and that
Registrant was without authorization to handle controlled substances or
practice medicine in Pennsylvania. RFAAX 10, at 3. According to
Pennsylvania's online records, of which I take official notice,
Registrant's license is still revoked.\5\ Pennsylvania Licensing System
Verification, https://www.pals.pa.gov/#/page/search (last visited date
of signature of this Order).
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\5\ 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, Registrant may dispute my finding by filing
a properly supported motion for reconsideration of finding of fact
within fifteen 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 Registrant
files a motion, the Government shall have fifteen calendar days to
file a response. Any such motion and response shall be filed and
served by email to the other party and to Office of the
Administrator, Drug Enforcement Administration at
[email protected].
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Accordingly, I find that Registrant currently is neither licensed
to engage in the practice of medicine nor registered to dispense
controlled substances in Pennsylvania, the state in which Registrant is
registered with the DEA.
III. 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 also 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 F. App'x 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., James L. Hooper, 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); Frederick Marsh Blanton, 43
FR at 27,617.
Under the Pennsylvania Controlled Substance, Drug, Device and
Cosmetic Act, ``no controlled substance in Schedule II shall be
dispensed without an electronic prescription of a practitioner.'' 35
PA. Stat. and Const. Stat. Ann. Sec. 780-111(a) (West October 24,
2019). Further, ``no controlled substance in Schedule III, IV or V
shall be dispensed without an electronic prescription of a
practitioner.'' Id. at Sec. 780-111(b). The definition of
``practitioner,'' as used in the state Act, includes a ``physician . .
. or other person licensed, registered or otherwise permitted to
distribute, dispense, conduct research with respect to or to administer
a controlled substance . . . in the course of professional practice . .
. in the Commonwealth of Pennsylvania.'' Id. at 780-102(b).
Here, the undisputed evidence in the record is that Registrant
currently lacks authority to practice medicine in Pennsylvania. As
already discussed, a physician must be a licensed practitioner to
dispense a controlled substance in Pennsylvania. Thus, because
Registrant lacks a license to practice medicine in Pennsylvania and,
therefore, is not authorized to handle controlled substances in
Pennsylvania, Registrant is not eligible to maintain a DEA
registration. Accordingly, I will order that Registrant's DEA
registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
FS1471818 issued to Milad I. Shaker, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny any pending application of Milad I. Shaker, M.D. to renew or
modify this registration or for any other registration in Pennsylvania.
This Order is effective March 22, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-03358 Filed 2-18-21; 8:45 am]
BILLING CODE 4410-09-P