Emmanuel A. Ayodele, M.D.; Decision and Order, 24020-24022 [2021-09461]
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Federal Register / Vol. 86, No. 85 / Wednesday, May 5, 2021 / Notices
Respondent had accepted responsibility.
RX 9.*E
Although correcting improper
behavior and practices is very important
to establish acceptance of responsibility,
conceding wrongdoing is critical to
reestablishing trust with the Agency.
Holiday CVS, L.L.C., 77 FR 62316,
62346 (2012); Daniel A. Glick, D.D.S., 80
FR at 74801. Based upon the evidence
presented, I find that the Respondent
has demonstrated the full measure of
acceptance of responsibility, and has
fully demonstrated that she is
remorseful of her actions and has taken
considerable rehabilitative steps to
ensure that this conduct will not be
repeated.
Loss of Trust
Where the Government has sustained
its burden and established that a
registrant has committed acts
inconsistent with the public interest,
that registrant must present sufficient
mitigating evidence to assure the Acting
Administrator that he can be entrusted
with the responsibility commensurate
with such a registration. Medicine
Shoppe, 73 FR at 387.
As demonstrated by the evidence
presented in this matter, it is clear to me
that the Respondent has unequivocally
accepted responsibility for her conduct.
She continues to not only improve
herself, but works to ensure that current
and future practitioners learn from her
past criminal conduct and will not make
the same choices. [I also find credible
Respondent’s statement that she would
‘‘never do anything to compromise [her]
license ever again.’’ Tr. 122.] Her
underlying criminal conduct did not
relate to her handling of controlled
substances and the Government has not
alleged any deficiencies by the
Respondent related to controlled
substances. The Government argues that
revocation in this matter is appropriate
for its deterrent effect. *[ ]*[Further,
although I am not bound by them in this
case, I agree with the statements of] U.S.
District Court Judge Chesler found that
‘‘in many ways your efforts may have as
much, if not more, impact than the
prosecutions per se because it sends out
a message and it sends out a message
from someone who has personally
impacted by having made the wrong
decision.’’ RX 9. It appears the
Respondent’s outreach to physicians,
*E Removed text. I agree with the Government that
the District Court’s findings on acceptance of
responsibility are not binding on this agency, see
Govt Posthearing Brief, at 9; however, I also agree
with the ALJ that these findings are relevant in that
they further support the ALJ’s finding of
Respondent’s credible acceptance of responsibility.
See Mohammed Asgar, MD., 83 FR at 29573 n.3.
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medical staff and to students has
provided and continues to provide
valuable deterrence to the medical
community. The Respondent’s efforts
have greatly satisfied the need for
deterrence. At sentencing, the AUSA
stated that the Respondent’s ‘‘efforts
have been substantial, including the
speaking engagements that she’s been
involved with. I can tell you, your
Honor, that I have heard unsolicited
from folks in the medical field about the
work that she has been doing and folks
who are involved in educating
physicians and supervising physicians
have reported to me that her efforts have
made an impact in educating the
community, which is meaningful thing
from the government’s perspective.’’ RX
9. *[In this case,] the Respondent has
clearly demonstrated that she can be
entrusted to properly maintain her COR.
Recommendation
Considering the entire record before
me, the conduct of the hearing, and
observation of the testimony of the
witnesses presented, I find that the
Government has met its burden of proof
and has established a prima facie case
for revocation. However, *[ ] the
evidence overwhelmingly suggests that
the Respondent has unequivocally
accepted responsibility, is remorseful
for her conduct, has worked to
rehabilitate herself, has taken
extraordinary steps to educate medical
personnel and students, and has
presented convincing evidence
demonstrating that the Agency can
entrust her to maintain her COR.
Therefore, I recommend the
Respondent’s DEA COR BM9434440
should Not be Revoked and any pending
applications for renewal or modification
of such registration, or for additional
DEA registrations, be Granted
December 4, 2019
Mark M. Dowd,
U.S. Administrative Law Judge.
[FR Doc. 2021–09464 Filed 5–4–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20–21]
Emmanuel A. Ayodele, M.D.; Decision
and Order
On April 29, 2020, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause (hereinafter, OSC) to Emmanuel
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Ayodele, M.D. (hereinafter, Applicant)
of Compton, California. OSC, at 1. The
OSC proposed the denial of Applicant’s
application for a DEA Certificate of
Registration. Id. It alleged that
Applicant is without ‘‘authority to
handle controlled substances in
California, the state in which
[Applicant] seek[s] registration with
DEA.’’ Id. (citing 21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that the
Medical Board of California (hereinafter,
MBC) issued an order on February 3,
2020, revoking Applicant’s California
Physician’s and Surgeon’s Certificate.
Id. at 2. The OSC further alleged that,
because the Board revoked Applicant’s
medical license, Applicant lacks the
authority to handle controlled
substances in the State of California. Id.
The OSC notified Applicant 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 2–3 (citing
21 CFR 1301.43). The OSC also notified
Applicant of the opportunity to submit
a corrective action plan. Id. at 3 (citing
21 U.S.C. 824(c)(2)(C)).
On June 24, 2020, Applicant, through
counsel, requested a hearing, stating
that Applicant ‘‘has filed a writ of
administrative mandate in the Superior
Court of California, San Francisco
Division . . . for judicial review of the
decision of the Medical Board of
California’’ and that ‘‘DEA should await
the final judgment.’’ Request for a
Hearing, at 1.
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,
Chief ALJ), who issued an Order
Directing the Filing of Government
Evidence Regarding its Lack of State
Authority Allegation and Briefing
Schedule on June 25, 2020, with which
the Government complied by filing a
Motion for Summary Disposition
(hereinafter, Govt Motion) on July 7,
2020.
In its Motion, the Government
submitted evidence that the MBC
‘‘found [Applicant] non-compliant with
the probationary terms of its June 2017
order, ultimately resulting in the
revocation of his California Physician’s
and Surgeon’s Certificate.’’ Govt Motion,
at 3–4. Further, the Government noted
that the MBC had denied Applicant’s
Petition for Review of his revocation on
April 14, 2020. Id. In light of these facts,
the Government argued that DEA must
deny Applicant’s application. Id. at 5.
On July 15, 2020, Applicant filed
‘‘Applicant’s Reply’’ (hereinafter, App
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Federal Register / Vol. 86, No. 85 / Wednesday, May 5, 2021 / Notices
Reply), in which he argued that there
are no proceedings to stay, because
Applicant is not requesting an action on
his application at this time; therefore, he
argued that the ‘‘sole issue presented is
whether the DEA should withhold
action on [Applicant’s] application—
which was submitted before his
[California] medical license was
revoked—until a final judgment is
entered on his state petition for judicial
review of the MBC’s decision.’’ App
Reply, at 1.
On July 21, 2020, the Chief ALJ issued
an Order Granting the Government’s
Motion for Summary Disposition, and
Recommended Rulings, Findings of
Fact, Conclusions of Law, and
Recommended Decision of the
Administrative Law Judge (hereinafter,
Summary Disposition or SD). The Chief
ALJ noted that, ‘‘[c]ontrary to the
[Applicant’s] assertions . . . the instant
proceedings are, in fact, proceedings.’’
SD, at 4 (citations omitted). Further, the
ALJ noted that it appeared that
Applicant was not contesting the
underlying facts surrounding the
grounds for the proceedings. Id. at 5.
Therefore, the Chief ALJ determined
that ‘‘in view of the Applicant’s current
lack of state authority, denial of the
Applicant’s application stands as the
only legally available resolution.’’ Id.
The Chief ALJ further concluded that
‘‘[s]ummary disposition is proper in an
administrative enforcement proceeding
where no genuine factual dispute
exists.’’ Id. at 6 (citing Veg-Mix, Inc. v.
U.S. Dept. of Agriculture, 832 F.3d 601,
607 (D.C. Cir. 1987) (comparing the
standard for summary disposition in an
administrative proceeding to summary
judgment in a civil proceeding); Citizens
for Allegan County, Inc. v. Federal
Power Commission, 414 F.2d 1125, 1128
(D.C. Cir. 1969) (affirming that ‘‘the right
of opportunity for hearing does not
require a procedure that will be empty
sound and show, signifying nothing’’)).
By letter dated August 18, 2020, the
ALJ certified and transmitted the record
to me for final Agency action. In that
letter, the ALJ advised that neither party
filed exceptions. I find that the time
period to file exceptions has expired.
See 21 CFR 1316.66.
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
Applicant’s DEA Registration
On or about June 6, 2018, Applicant
filed an application (Application
Control No. H18074119C) for a DEA
Certificate of Registration as a
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practitioner in schedules II–V, with the
proposed registered location of 1406 W
134th Street, Compton, California
90222. Govt Motion Exhibit (hereinafter,
GX) 2 (Certification of Registration
History), at 1.
The Status of Applicant’s California
License
On February 3, 2020, the MBC
revoked Applicant’s medical license.
GX 3 (MBC Order), at 19. According to
the Order, Applicant was suspended by
the MBC following Applicant’s October
10, 2013 felony conviction for health
care fraud. Id. On June 16, 2017, the
MBC adopted a Stipulated Settlement
and Disciplinary Order, which imposed
a period of probation, during which
Applicant would be required to
complete continuing medical education
coursework, perform community
service, obtain a psychological
evaluation at his own expense, pay all
probation costs, and complete a clinical
competence assessment program. Id. at
3. Applicant failed to meet the terms of
his probation and therefore, the MBC
revoked Applicant’s medical license.
GX 3, at 19. The Applicant petitioned
the MBC for reconsideration and his
petition was denied on April 14, 2020.
GX 4 (MBC Order Denying Petition for
Reconsideration).
According to the online records of the
California Department of Consumer
Affairs, of which I take official notice,
Applicant’s license remains
revoked.1 https://search.dca.ca.gov/
results (last visited date of signature of
this Order). California’s online records
show that Applicant’s medical license
remains revoked and that Applicant is
not authorized in California to practice
medicine. Id.
As the Chief ALJ noted, Applicant
does not appear to contest the status of
his medical license or his state
authorization to handle controlled
substances. See SD, at 5 (citing App
Reply, at 2). Based on the entire record
1 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,
Applicant may dispute my finding by filing a
properly supported motion for reconsideration
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 Applicant
files a motion, the Government shall have fifteen
calendar days to file a response. Any such motion
and response may be filed and served by email
(dea.addo.attorneys@dea.usdoj.gov).
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24021
before me, I find that Applicant
currently is not licensed to engage in the
practice of medicine in California.
Discussion
Applicant’s application requests
registration as a ‘‘practitioner’’ in
California. GX 1 (Applicant’s
Application). 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 71371
(2011), pet. for rev. denied, 481 F. App’x
826 (4th Cir. 2012); Frederick Marsh
Blanton, M.D., 43 FR 27616, 27617
(1978).
This rule derives from the text of two
provisions of the Controlled Substances
Act (hereinafter, CSA). Controlled
Substances Act (hereinafter, CSA).
Pursuant to section 303(f) of the CSA, a
prerequisite to registration as a
practitioner is authorization to dispense
controlled substances under the laws of
the state in which the Applicant seeks
to be registered.2 21 U.S.C. 823(f) (‘‘The
Attorney General shall register
practitioners . . . to dispense . . .
controlled substances . . . if the
Applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’).
Further, the CSA defines ‘‘practitioner’’
as ‘‘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).
The Agency has long interpreted these
statutory requirements strictly. The
‘‘controlling question’’ is ‘‘whether the
Applicant is currently authorized to
handle controlled substances in the
state.’’ Anne Lazar Thorn, M.D., 62 FR
12847, 12848 (1997); see also Frederick
Marsh Blanton, M.D., 43 FR 27616
(1978). Accordingly, the Agency has
rejected arguments that it should relax
these statutory requirements. For
example, the Agency rejected as ‘‘of no
consequence’’ the fact that the MBC
summarily suspended a doctor’s
California medical license. Robert T.
Perez, M.D., 84 FR 3247, 3248 (2019).
‘‘What is consequential,’’ the Agency
2 ‘‘[D]ispense[ ] means to deliver a controlled
substance to an ultimate user . . . by, or pursuant
to the lawful order of, a practitioner, including the
prescribing and administering of a controlled
substance. . . .’’ 21 CFR 802(10).
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Federal Register / Vol. 86, No. 85 / Wednesday, May 5, 2021 / Notices
determined, ‘‘is my finding that
Registrant is no longer currently
authorized to dispense controlled
substances in California, the State in
which he is registered.’’ Id. Similarly,
the Agency rejected as ‘‘of no
consequence’’ the argument that the
MBC had not yet afforded the doctor a
hearing to challenge the suspension of
his California medical license. Frank D.
Li, M.D., 82 FR 11238, 11240 (2017). See
also Miles J. Nelson, M.D., 84 FR 3248,
3250 (2019) (summary suspension of
state authority or state authority
pending a final decision on the merits
are of no consequence); Bourne
Pharmacy, Inc., 72 FR 18273, 18274
(2007) (‘‘Under the . . . [CSA], it is
irrelevant that Applicant’s state
registration is being held in escrow
pending state proceedings. Under the
. . . [CSA], a practitioner must be
currently authorized to handle
controlled substances in ‘the
jurisdiction in which [it] practices’ in
order to maintain its DEA
registration.’’).
According to California statute, ‘‘[n]o
person other than a physician . . . shall
write or issue a prescription.’’ Cal.
Health & Safety Code § 11150 (West
2021). Further, ‘‘physician,’’ as defined
by California statute, is a person who is
‘‘licensed to practice’’ in California. Id.
at § 11024.
Here, the undisputed evidence in the
record is that Applicant currently lacks
authority to practice medicine in
California. As already discussed, a
physician must be a licensed
practitioner to dispense a controlled
substance in California. Thus, because
Applicant lacks authority to practice
medicine in California and, therefore, is
not authorized to handle controlled
substances in California, Applicant is
not eligible to be granted a DEA
registration. Accordingly, I will order
that Applicant’s application for a DEA
registration be denied.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny the application
submitted by Emmanuel Ayodele, M.D
for a Certificate of Registration, Control
Number H18074119C, as well as any
other pending application of Emmanuel
Ayodele, M.D. for additional registration
in California. This Order is effective
June 4, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–09461 Filed 5–4–21; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF LABOR
Employment and Training
Administration
Notice of Determinations Regarding
Eligibility To Apply for Trade
Adjustment Assistance
In accordance with the Section 223
(19 U.S.C. 2273) of the Trade Act of
1974 (19 U.S.C. 2271, et seq.) (‘‘Act’’), as
amended, the Department of Labor
herein presents summaries of
determinations regarding eligibility to
apply for trade adjustment assistance
under Chapter 2 of the Act (‘‘TAA’’) for
workers by (TA–W) number issued
during the period of March 1, 2021
through March 31, 2021. (This Notice
primarily follows the language of the
Trade Act. In some places however,
changes such as the inclusion of
subheadings, a reorganization of
language, or ‘‘and,’’ ‘‘or,’’ or other words
are added for clarification.)
Section 222(a)—Workers of a Primary
Firm
In order for an affirmative
determination to be made for workers of
a primary firm and a certification issued
regarding eligibility to apply for TAA,
the group eligibility requirements under
Section 222(a) of the Act (19 U.S.C.
2272(a)) must be met, as follows:
(1) The first criterion (set forth in
Section 222(a)(1) of the Act, 19 U.S.C.
2272(a)(1)) is that a significant number
or proportion of the workers in such
workers’ firm (or ‘‘such firm’’) have
become totally or partially separated, or
are threatened to become totally or
partially separated;
AND (2(A) or 2(B) below)
(2) The second criterion (set forth in
Section 222(a)(2) of the Act, 19 U.S.C.
2272(a)(2)) may be satisfied by either (A)
the Increased Imports Path, or (B) the
Shift in Production or Services to a
Foreign Country Path/Acquisition of
Articles or Services from a Foreign
Country Path, as follows:
(A) Increased Imports Path
(i) The sales or production, or both, of
such firm, have decreased absolutely;
AND (ii and iii below)
(ii) (I) imports of articles or services
like or directly competitive with articles
produced or services supplied by such
firm have increased; OR
(II)(aa) imports of articles like or
directly competitive with articles into
which one or more component parts
produced by such firm are directly
incorporated, have increased; OR
(II)(bb) imports of articles like or
directly competitive with articles which
are produced directly using the services
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supplied by such firm, have increased;
OR
(III) imports of articles directly
incorporating one or more component
parts produced outside the United
States that are like or directly
competitive with imports of articles
incorporating one or more component
parts produced by such firm have
increased;
AND
(iii) the increase in imports described
in clause (ii) contributed importantly to
such workers’ separation or threat of
separation and to the decline in the
sales or production of such firm; OR
(B) Shift in Production or Services to a
Foreign Country Path OR Acquisition of
Articles or Services From a Foreign
Country Path
(i) (I) there has been a shift by such
workers’ firm to a foreign country in the
production of articles or the supply of
services like or directly competitive
with articles which are produced or
services which are supplied by such
firm; OR
(II) such workers’ firm has acquired
from a foreign country articles or
services that are like or directly
competitive with articles which are
produced or services which are
supplied by such firm;
AND
(ii) the shift described in clause (i)(I)
or the acquisition of articles or services
described in clause (i)(II) contributed
importantly to such workers’ separation
or threat of separation.
Section 222(b)—Adversely Affected
Secondary Workers
In order for an affirmative
determination to be made for adversely
affected secondary workers of a firm and
a certification issued regarding
eligibility to apply for TAA, the group
eligibility requirements of Section
222(b) of the Act (19 U.S.C. 2272(b))
must be met, as follows:
(1) A significant number or proportion
of the workers in the workers’ firm or
an appropriate subdivision of the firm
have become totally or partially
separated, or are threatened to become
totally or partially separated;
AND
(2) the workers’ firm is a supplier or
downstream producer to a firm that
employed a group of workers who
received a certification of eligibility
under Section 222(a) of the Act (19
U.S.C. 2272(a)), and such supply or
production is related to the article or
service that was the basis for such
certification (as defined in subsection
222(c)(3) and (4) of the Act (19 U.S.C.
2272(c)(3) and (4));
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Agencies
[Federal Register Volume 86, Number 85 (Wednesday, May 5, 2021)]
[Notices]
[Pages 24020-24022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09461]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20-21]
Emmanuel A. Ayodele, M.D.; Decision and Order
On April 29, 2020, the Assistant Administrator, Diversion Control
Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause (hereinafter, OSC) to
Emmanuel Ayodele, M.D. (hereinafter, Applicant) of Compton, California.
OSC, at 1. The OSC proposed the denial of Applicant's application for a
DEA Certificate of Registration. Id. It alleged that Applicant is
without ``authority to handle controlled substances in California, the
state in which [Applicant] seek[s] registration with DEA.'' Id. (citing
21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that the Medical Board of California
(hereinafter, MBC) issued an order on February 3, 2020, revoking
Applicant's California Physician's and Surgeon's Certificate. Id. at 2.
The OSC further alleged that, because the Board revoked Applicant's
medical license, Applicant lacks the authority to handle controlled
substances in the State of California. Id.
The OSC notified Applicant 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 2-3 (citing 21
CFR 1301.43). The OSC also notified Applicant of the opportunity to
submit a corrective action plan. Id. at 3 (citing 21 U.S.C.
824(c)(2)(C)).
On June 24, 2020, Applicant, through counsel, requested a hearing,
stating that Applicant ``has filed a writ of administrative mandate in
the Superior Court of California, San Francisco Division . . . for
judicial review of the decision of the Medical Board of California''
and that ``DEA should await the final judgment.'' Request for a
Hearing, at 1.
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, Chief ALJ), who issued an Order Directing
the Filing of Government Evidence Regarding its Lack of State Authority
Allegation and Briefing Schedule on June 25, 2020, with which the
Government complied by filing a Motion for Summary Disposition
(hereinafter, Govt Motion) on July 7, 2020.
In its Motion, the Government submitted evidence that the MBC
``found [Applicant] non-compliant with the probationary terms of its
June 2017 order, ultimately resulting in the revocation of his
California Physician's and Surgeon's Certificate.'' Govt Motion, at 3-
4. Further, the Government noted that the MBC had denied Applicant's
Petition for Review of his revocation on April 14, 2020. Id. In light
of these facts, the Government argued that DEA must deny Applicant's
application. Id. at 5.
On July 15, 2020, Applicant filed ``Applicant's Reply''
(hereinafter, App
[[Page 24021]]
Reply), in which he argued that there are no proceedings to stay,
because Applicant is not requesting an action on his application at
this time; therefore, he argued that the ``sole issue presented is
whether the DEA should withhold action on [Applicant's] application--
which was submitted before his [California] medical license was
revoked--until a final judgment is entered on his state petition for
judicial review of the MBC's decision.'' App Reply, at 1.
On July 21, 2020, the Chief ALJ issued an Order Granting the
Government's Motion for Summary Disposition, and Recommended Rulings,
Findings of Fact, Conclusions of Law, and Recommended Decision of the
Administrative Law Judge (hereinafter, Summary Disposition or SD). The
Chief ALJ noted that, ``[c]ontrary to the [Applicant's] assertions . .
. the instant proceedings are, in fact, proceedings.'' SD, at 4
(citations omitted). Further, the ALJ noted that it appeared that
Applicant was not contesting the underlying facts surrounding the
grounds for the proceedings. Id. at 5. Therefore, the Chief ALJ
determined that ``in view of the Applicant's current lack of state
authority, denial of the Applicant's application stands as the only
legally available resolution.'' Id. The Chief ALJ further concluded
that ``[s]ummary disposition is proper in an administrative enforcement
proceeding where no genuine factual dispute exists.'' Id. at 6 (citing
Veg-Mix, Inc. v. U.S. Dept. of Agriculture, 832 F.3d 601, 607 (D.C.
Cir. 1987) (comparing the standard for summary disposition in an
administrative proceeding to summary judgment in a civil proceeding);
Citizens for Allegan County, Inc. v. Federal Power Commission, 414 F.2d
1125, 1128 (D.C. Cir. 1969) (affirming that ``the right of opportunity
for hearing does not require a procedure that will be empty sound and
show, signifying nothing'')).
By letter dated August 18, 2020, the ALJ certified and transmitted
the record to me for final Agency action. In that letter, the ALJ
advised that neither party filed exceptions. I find that the time
period to file exceptions has expired. See 21 CFR 1316.66.
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
Applicant's DEA Registration
On or about June 6, 2018, Applicant filed an application
(Application Control No. H18074119C) for a DEA Certificate of
Registration as a practitioner in schedules II-V, with the proposed
registered location of 1406 W 134th Street, Compton, California 90222.
Govt Motion Exhibit (hereinafter, GX) 2 (Certification of Registration
History), at 1.
The Status of Applicant's California License
On February 3, 2020, the MBC revoked Applicant's medical license.
GX 3 (MBC Order), at 19. According to the Order, Applicant was
suspended by the MBC following Applicant's October 10, 2013 felony
conviction for health care fraud. Id. On June 16, 2017, the MBC adopted
a Stipulated Settlement and Disciplinary Order, which imposed a period
of probation, during which Applicant would be required to complete
continuing medical education coursework, perform community service,
obtain a psychological evaluation at his own expense, pay all probation
costs, and complete a clinical competence assessment program. Id. at 3.
Applicant failed to meet the terms of his probation and therefore, the
MBC revoked Applicant's medical license. GX 3, at 19. The Applicant
petitioned the MBC for reconsideration and his petition was denied on
April 14, 2020. GX 4 (MBC Order Denying Petition for Reconsideration).
According to the online records of the California Department of
Consumer Affairs, of which I take official notice, Applicant's license
remains revoked.\1\ https://search.dca.ca.gov/results (last visited
date of signature of this Order). California's online records show that
Applicant's medical license remains revoked and that Applicant is not
authorized in California to practice medicine. Id.
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\1\ 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, Applicant may dispute my finding by filing
a properly supported motion for reconsideration 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 Applicant files a motion, the
Government shall have fifteen calendar days to file a response. Any
such motion and response may be filed and served by email
([email protected]).
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As the Chief ALJ noted, Applicant does not appear to contest the
status of his medical license or his state authorization to handle
controlled substances. See SD, at 5 (citing App Reply, at 2). Based on
the entire record before me, I find that Applicant currently is not
licensed to engage in the practice of medicine in California.
Discussion
Applicant's application requests registration as a ``practitioner''
in California. GX 1 (Applicant's Application). 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 71371 (2011),
pet. for rev. denied, 481 F. App'x 826 (4th Cir. 2012); Frederick Marsh
Blanton, M.D., 43 FR 27616, 27617 (1978).
This rule derives from the text of two provisions of the Controlled
Substances Act (hereinafter, CSA). Controlled Substances Act
(hereinafter, CSA). Pursuant to section 303(f) of the CSA, a
prerequisite to registration as a practitioner is authorization to
dispense controlled substances under the laws of the state in which the
Applicant seeks to be registered.\2\ 21 U.S.C. 823(f) (``The Attorney
General shall register practitioners . . . to dispense . . . controlled
substances . . . if the Applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.''). Further, the CSA defines ``practitioner'' as ``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).
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\2\ ``[D]ispense[ ] means to deliver a controlled substance to
an ultimate user . . . by, or pursuant to the lawful order of, a
practitioner, including the prescribing and administering of a
controlled substance. . . .'' 21 CFR 802(10).
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The Agency has long interpreted these statutory requirements
strictly. The ``controlling question'' is ``whether the Applicant is
currently authorized to handle controlled substances in the state.''
Anne Lazar Thorn, M.D., 62 FR 12847, 12848 (1997); see also Frederick
Marsh Blanton, M.D., 43 FR 27616 (1978). Accordingly, the Agency has
rejected arguments that it should relax these statutory requirements.
For example, the Agency rejected as ``of no consequence'' the fact that
the MBC summarily suspended a doctor's California medical license.
Robert T. Perez, M.D., 84 FR 3247, 3248 (2019). ``What is
consequential,'' the Agency
[[Page 24022]]
determined, ``is my finding that Registrant is no longer currently
authorized to dispense controlled substances in California, the State
in which he is registered.'' Id. Similarly, the Agency rejected as ``of
no consequence'' the argument that the MBC had not yet afforded the
doctor a hearing to challenge the suspension of his California medical
license. Frank D. Li, M.D., 82 FR 11238, 11240 (2017). See also Miles
J. Nelson, M.D., 84 FR 3248, 3250 (2019) (summary suspension of state
authority or state authority pending a final decision on the merits are
of no consequence); Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007)
(``Under the . . . [CSA], it is irrelevant that Applicant's state
registration is being held in escrow pending state proceedings. Under
the . . . [CSA], a practitioner must be currently authorized to handle
controlled substances in `the jurisdiction in which [it] practices' in
order to maintain its DEA registration.'').
According to California statute, ``[n]o person other than a
physician . . . shall write or issue a prescription.'' Cal. Health &
Safety Code Sec. 11150 (West 2021). Further, ``physician,'' as defined
by California statute, is a person who is ``licensed to practice'' in
California. Id. at Sec. 11024.
Here, the undisputed evidence in the record is that Applicant
currently lacks authority to practice medicine in California. As
already discussed, a physician must be a licensed practitioner to
dispense a controlled substance in California. Thus, because Applicant
lacks authority to practice medicine in California and, therefore, is
not authorized to handle controlled substances in California, Applicant
is not eligible to be granted a DEA registration. Accordingly, I will
order that Applicant's application for a DEA registration be denied.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(f), I hereby deny the application submitted by Emmanuel
Ayodele, M.D for a Certificate of Registration, Control Number
H18074119C, as well as any other pending application of Emmanuel
Ayodele, M.D. for additional registration in California. This Order is
effective June 4, 2021.
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-09461 Filed 5-4-21; 8:45 am]
BILLING CODE 4410-09-P