Decision and Order: Zelideh I. Cordova-Velazco, M.D., 62902-62907 [2018-26485]
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83 FR 48868 ....................................................
[FR Doc. 2018–26509 Filed 12–4–18; 8:45 am]
BILLING CODE 4410–09–P
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Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
The registrant listed below
has applied for and been granted a
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of a schedule I controlled
substance.
SUMMARY:
The
company listed below applied to be
registered as a bulk manufacturer of a
controlled substance. Information on the
previously published notice is listed in
the table below. No comments or
objections were submitted for this
notice.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–11–P
FR Docket
Dated: November 30, 2018.
John J. Martin,
Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2018–26398 Filed 12–4–18; 8:45 am]
Company
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this registrant to
manufacture the applicable basic classes
of controlled substances is consistent
with the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed company.
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Networking & Imaging Systems, LLC,
Dallas, TX; LeoLabs, Inc., Menlo Park,
CA; Microwave Photonics Systems, Inc.,
West Chester, PA; Astrapi Corporation,
Dallas, TX; and SA Photonics, Los
Gatos, CA, have been added as parties
to this venture.
Also, Blacknight Cybersecurity
International, Inc., Redmond, VA; CMA
Technologies, Orlando, FL; and ATS–
MER, LLC, Tuscon, AZ have withdrawn
as parties to this venture.
No other changes have been made in
either the membership or planned
activity of the group research project.
Membership in this group research
project remains open, and SpEC intends
to file additional written notifications
disclosing all changes in membership.
On August 23, 2018, SpEC filed its
original notification pursuant to Section
6(a) of the Act. The Department of
Justice published a notice in the Federal
Register pursuant to Section 6(b) of the
Act on October 2, 2018 (83 FR 49576).
Published
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 18–21]
Decision and Order: Zelideh I.
Cordova-Velazco, M.D.
On February 27, 2018, the Acting
Assistant Administrator, Diversion
Control Division, issued an Order to
Show Cause to Zelideh I. CordovaVelazco, M.D. (Respondent), of Puerto
Rico. The Show Cause Order proposed
the denial of the Respondent’s
application for a DEA Certificate of
Registration in Puerto Rico as a
practitioner, Control No. W16052461C,
on the grounds that Respondent
materially falsified that application.
Order to Show Cause, at 1 (citing 21
U.S.C. 824(a)(1)).
With respect to the Agency’s
jurisdiction, the Show Cause Order
alleged that on June 16, 2016,
Respondent applied for a DEA
Registration as a practitioner in
schedules II through V at the proposed
business address of Hacienda Del
Dorado, K1 Calle Delonix, Toa Alta,
Puerto Rico. Id. The Order also alleged
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September 27, 2018.
that DEA assigned Control No.
W16052461C to the application. Id.
As to the substantive grounds for the
proceeding, the Show Cause Order
alleged that Respondent previously held
DEA Certificate of Registration No.
BC4141139 in Michigan. Id. at 2. In
addition, the Order alleged that
Respondent ‘‘voluntarily surrendered
for cause’’ that Registration ‘‘on or about
January 17, 2014.’’ Id. The Order further
alleged that Respondent materially
falsified her application for a new DEA
Registration in Puerto Rico on June 16,
2016 with respect to two liability
questions on the application. Id. The
Order alleged that the first material
falsification was that the Respondent
answered ‘‘N’’ when asked: ‘‘Has the
applicant ever surrendered (for cause) or
had a federal controlled substance
registration, revoked, suspended,
restricted or denied, or is any such
action pending?’’ Id. The Order alleged
that the second material falsification
was that Respondent answered ‘‘N’’
when asked: ‘‘Has the applicant ever
surrendered (for cause) or had a state
professional license or controlled
substance registration revoked,
suspended, denied, restricted, or placed
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on probation, or is any such action
pending?’’ Id. The Order asserted that
these alleged material falsifications
‘‘warrant the denial of your application
for registration.’’ Id. (citing 21 U.S.C
§ 824(a)(1)).
The Show Cause Order notified
Respondent of her right to request a
hearing on the allegations or to submit
a written statement while waiving her
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 Order also notified
Respondent of the opportunity to
submit a corrective action plan. Id. at 3
(citing 21 U.S.C. § 824(c)(2)(C)).
After being served with the Order,
Respondent filed a timely ‘‘Request for
Hearing’’ on March 26, 2018 requesting
a hearing on the allegations. Request for
Hearing (dated March 22, 2018)
(hereinafter Hearing Request). In her
Hearing Request, Respondent states that
she ‘‘d[id] not recall that I indicate [sic]
‘no’ to the questions’’ in the application
and that she ‘‘was helped by a friend in
filling out the application and probably
by mistake and/or ignorance in
understanding the questions I answered
‘no.’’’ Id. at 2. Respondent also states
that she surrendered her Michigan
medical license and ‘‘accept[ed] a six
months and one day suspension, for
being negligent, in not securing my
prescription pad’’ and then ‘‘voluntarily
surrender[ed her] DEA license to
prescribe[] control[led] substance[s].’’
Id. She also asserts that ‘‘[i]f I would
have known the consequences of
accepting the suspension, I would have
litigated the case in Michigan, because
I did nothing wrong. There is no
practical reason not to inform the
suspension of Michigan. The
suspension appears online in the
medical board data bank.’’ Id. She also
‘‘request[ed] discovery in the present
matter, including [a] copy of the record
and/or file with DEA.’’ Id.
The matter was placed on the docket
of the Office of Administrative Law
Judges and assigned to Administrative
Law Judge Charles Wm. Dorman (ALJ).
Thereafter, on March 26, 2018, the ALJ
entered an Order for Prehearing
Statements, directing the Government to
file its Prehearing Statement on April
10, 2018, and the Respondent to file
hers on April 24, 2018. Order for
Prehearing Statements, at 1. The Order
also directed the parties to participate in
a telephonic prehearing conference on
April 25, 2018. Id. at 2. The Government
filed its Prehearing Statement on April
10, 2018, and Respondent filed, through
counsel, her Prehearing Statement on
April 20, 2018.
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In Respondent’s Prehearing
Statement, Respondent stipulated that
she voluntarily surrendered her
Michigan medical license after being
informed of an investigation for
improperly prescribing medication.
Respondent’s Prehearing Statement, at
2. In addition, Respondent stipulated
that she was previously registered with
DEA pursuant to DEA Certificate of
Registration No. BC4141139, and that
she voluntarily surrendered for cause
that registration. Id. at 3.
On April 20, 2018, the Government
filed a Motion for Summary Disposition
based upon the Respondent’s material
falsification of her application for a DEA
Registration in Puerto Rico on June 16,
2016. Specifically, the Government
alleged that there was no dispute of
material fact that Respondent materially
falsified her application for a DEA
Registration when she answered ‘‘N’’ to
the following liability questions on the
application: (1) ‘‘Has the applicant ever
surrendered (for cause) or had a federal
controlled substance registration,
revoked, suspended, restricted or
denied, or is any such action pending?’’;
and (2) ‘‘Has the applicant ever
surrendered (for cause) or had a state
professional license or controlled
substance registration revoked,
suspended, denied, restricted, or placed
on probation, or is any such action
pending?’’ Government’s Motion for
Summary Disposition (hereinafter
‘‘Government’s Motion’’ or ‘‘Govt.
Mot.’’), at 2.
On April 25, 2018, the ALJ held a
telephonic prehearing conference
pursuant to 21 CFR 1316.55. The ALJ
entered a Prehearing Ruling (PHR) on
April 26, 2018, reflecting that the parties
had agreed to a series of factual
stipulations, including the fact that (1)
on April 19, 2013, the Michigan Board
of Medicine suspended Respondent’s
Michigan medical license for a
minimum period of six months and one
day; (2) in January 2014, Respondent
‘‘voluntarily surrendered for cause’’ a
DEA Registration that Respondent had
previously held in Michigan; (3)
Respondent answered ‘‘N’’ when asked:
‘‘Has the applicant ever surrendered (for
cause) or had a federal controlled
substance registration revoked,
suspended, restricted or denied, or is
any such action pending?’’ and (4)
Respondent answered ‘‘N’’ when asked:
‘‘Has the applicant ever surrendered (for
cause) or had a state professional license
or controlled substance registration
revoked, suspended, denied, restricted,
or placed on probation, or is any such
action pending?’’ PHR, at 1–2.
In his Prehearing Ruling, the ALJ also
ordered Respondent to file a response to
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the Government’s Motion by May 4,
2018, and directed the parties to attempt
to draft additional ‘‘mutually agreeable
joint stipulations’’ by May 30, 2018. Id.
at 2. On May 3, 2018, Respondent filed
her response to the Government’s
Motion and asserted that the
Government had failed to ‘‘establish bad
faith, negligence or intentionally trying
to mislead,’’ and failed to prove that she
‘‘is unfit to practice medicine, and
therefore, unfit to prescribe
medication.’’ ‘‘Respondent’s Response
to Government’s Motion for Summary
Disposition and Respondant’s [sic]
‘Motion for Summary Disposition’’’
(Resp. Reply), at 4. In addition,
Respondent attached a certificate of
good standing for her Puerto Rico
medical license and a copy of her
license. Id., Attachment (Att.) 1–2.
Additionally, she attached her own
sworn statement, in which she asserts
that she ‘‘misunderstood the questions.’’
Id., Att. 3, at 2. She also argued that
approving her application was
warranted because she holds an active
medical license in good standing and
has never been sued for malpractice. Id.
at 3–4.
On May 8, 2018, after considering
these pleadings, the ALJ entered an
Order recommending that I find that
Respondent had failed to raise a triable
issue of material fact as to whether she
had materially falsified her application.
Order Granting Government’s Motion
for Summary Disposition and
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
(Recommended Decision or R.D.), at 8–
9. As a result, the ALJ granted the
Government’s Motion and
recommended that I deny Respondent’s
DEA application Control No.
W1602461C. Id. at 12.
On May 17, 2018, Respondent filed
her ‘‘Request for Reconsideration’’ of the
ALJ’s Recommended Decision,1 and on
the same day the ALJ entered an Order
Directing Government to Respond to
Respondent’s Request for
Reconsideration. In that Order, the ALJ
noted that there is no provision in
DEA’s regulations for either party to
request reconsideration of an ALJ’s
recommended decision, and thus the
ALJ would treat the request as
Exceptions to the Recommended
Decision. Order Directing Government
1 On May 11, 2018, Respondent also filed a
‘‘Supplemental Motion Submitting Document’’
enclosing ‘‘a certified translation of Resolution
Num. 2017–118, issued by the Health Department
Board of Licensing and Medical Discipline of
Puerto Rico, in the case of In Re: Sr. Zelideh
Cordova Velazco (Lic. #4865), Case No. Q–JDLM–
2013–41.’’ Supplemental Motion Submitting
Document, at 1.
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to Respond to Respondent’s Request for
Reconsideration, at 1. The Order
directed the Government to file any
response to Respondent’s Exceptions by
May 22, 2018. According to the record,
the Government filed no Exceptions of
its own nor any response to
Respondent’s Exceptions. On June 4,
2018, the record was forwarded to my
Office for Final Agency Action.2
2 Respondent submitted two post-certification
filings. On June 12, 2018, Respondent filed her
Request to Grant Motion for Reconsideration As
Unopposed, and on August 17, 2018, Respondent
filed her Second Request to Grant Motion for
Reconsideration As Unopposed. On June 12, 2018
and on August 20, 2018, respectively, the ALJ
issued Orders forwarding Respondent’s postcertification filings to my Office and noted that his
‘‘jurisdiction over the case terminated upon
transmittal of the record to the Acting
Administrator.’’ Order Forwarding Respondent’s
Motion to Acting Administrator, at 1; Second Order
Forwarding Respondent’s Motion to Acting
Administrator, at 1. I find that the ALJ properly
forwarded Respondent’s post-certification filings for
my consideration because, as the ALJ correctly
notes, his jurisdiction over this matter terminated
when he certified and transmitted the record to my
Office.
Regarding the timing of Respondent’s filings,
neither the Controlled Substances Act nor DEA’s
implementing regulations provide for a
supplemental filing by a party after the ALJ has
certified the record. However, the Agency has, on
occasion, exercised its discretion to consider such
filings (however styled) after the ALJ has certified
and transmitted the administrative record to my
Office. E.g., Joe W. Morgan, D.O., 78 FR 61961,
61961 (2013) (allowing Respondent’s postcertification filing and ‘‘treat[ing it] as a motion for
reconsideration’’); Wesley G. Harline, M.D., 64 FR
72678, 72684–85 (1999) (allowing Respondent’s
post-certification filing and treating it as a motion
to reopen the record); Robert M. Golden, M.D., 61
FR 24808, 24808 (1996) (same). Indeed, the Agency
has even exercised its discretion to consider
motions for reconsideration after the Agency has
issued its final decision and order. E.g., Lyle E.
Craker, Ph.D., 76 FR 51403, 51405 (2011).
To justify consideration of her filings at this stage
of the case, Respondent must show that there has
been an intervening change of controlling law, the
availability of new evidence, or the need to correct
a clear error or prevent manifest injustice. E.g.,
Foster v. Sedgwick Claims Mgmt. Services, 842 F.3d
721, 735 (D.C. Cir. 2016) (‘‘A motion for
reconsideration is discretionary and need not be
granted unless the district court finds that there is
an intervening change of controlling law, the
availability of new evidence, or the need to correct
a clear error or prevent manifest injustice.’’)
(citations and internal quotation marks omitted);
Virgin Atl. Airways v. Nat’l Mediation Bd., 956 F.2d
1245, 1255 (2d Cir.) (same), cert. denied, 506 U.S.
820 (1992).
Here, Respondent claims in both filings that her
Exceptions should be deemed ‘‘unopposed’’
because the Government chose not to respond to
her Exceptions. Respondent failed to offer any other
basis in fact that her Exceptions were ‘‘unopposed’’
by the Government. I am aware of no DEA
regulation or Agency precedent compelling a
finding that a party who does not respond to an
opposing party’s Exceptions to an ALJ’s
Recommended Decision is deemed to have taken a
position of ‘‘unopposed’’ to the opposing party’s
Exceptions. Moreover, Respondent’s claim is not
the type of intervening change in controlling law,
newly available evidence, or clear error that would
justify consideration of her post-certification filings
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Having considered the entire record,
including the ALJ’s Recommended
Decision, I find that Respondent
materially falsified her application for
DEA registration with respect to
Liability Questions 2 and 3 on her 2016
application. I therefore adopt the ALJ’s
recommendation that I deny
Respondent’s DEA Registration
application. I make the following factual
findings.
Findings of Fact
Respondent is a physician who
previously held an active medical
license, No. 43–01063034, in the State
of Michigan. Ex. 4 to Govt. Mot. On
April 19, 2013, Respondent entered into
a Consent Order with the Michigan
Board of Medicine in which she agreed
to the suspension of her medical license
for a minimum period of six months and
one day based on her improper
prescribing of controlled substances to
home health patients. See id.; see also
R.D., at 10. Specifically, the Michigan
administrative complaint against
Respondent alleged, among other things,
that she prescribed controlled
substances, primarily oxycodone,
Xanax, and Phenergan with codeine, to
26 patients despite: ‘‘failing to
document medical indication or
necessity for these controlled
substances’’; failing to document ‘‘any
physical examination or clinical
findings to justify the combination of’’
controlled drugs prescribed; failing to
document an appropriate medical
history; failing to make ‘‘any findings
pertaining to pain assessment, level of
dysfunction from pain, treatment plan
or diagnostic testing’’; failing to obtain
‘‘a report from the Michigan Automated
Prescription System’’; failing to conduct
a toxicology screen; failing to monitor
the ‘‘patients’ use of the controlled
substances for drug dependency or
diversion’’; failing to counsel the
patients regarding the risks associated
with controlled substances; and
consistently prescribing the maximum
dose of Xanax ‘‘without documenting
prior medication use or use of Xanax.’’
Ex. 4 to Govt. Mot., at 9–11.3
Respondent also previously held DEA
Certificate of Registration No.
BC4141139. Ex. 3 to Govt. Mot. In
January 2014, Respondent voluntarily
surrendered this registration for cause.
Exs. 3, 5 to Govt. Mot.
under Agency precedent at this stage of the case.
For all these reasons, I do not consider
Respondent’s post-certification filings.
3 The Consent Order recited that Respondent
‘‘does not contest the allegations of fact and law’’
in the state administrative complaint against her. Id.
at 3.
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On June 15, 2016, Respondent applied
for a practitioner’s registration seeking
authority to dispense controlled
substances in schedules II through V
with a proposed business address of
Hacienda Del Dorado, K1 Calle Delonix,
Toa Alta, Puerto Rico. Exhibits (Exs.) 1,
2 to Govt. Mot. DEA assigned
Respondent’s DEA registration
application Control No. W16052461C.4
DEA’s Application for Registration
includes liability questions which an
applicant must answer either
affirmatively (‘‘Y’’) or negatively (‘‘N’’).
Exs. 1–3 to Govt. Mot. Liability
Question 2 on the DEA Application for
Registration filed by Respondent asks:
‘‘Has the applicant ever surrendered (for
cause) or had a federal controlled
substance registration revoked,
suspended, restricted or denied, or is
any such action pending?’’ Exs. 1–2 to
Govt. Mot. Respondent answered this
question: ‘‘N’’ for no. Id. I find that this
answer was false.
Liability Question 3 on the DEA
Application for Registration filed by
Respondent asks: ‘‘Has the applicant
ever surrendered (for cause) or had a
state professional license or controlled
substance registration revoked,
suspended, denied, restricted, or placed
on probation, or is any such action
pending?’’ Id. Respondent answered this
question: ‘‘N’’ for no. I find that this
answer was also false.
Discussion
A. Standard for Denial of an
Application for Registration
Section 303(f) of the Controlled
Substances Act provides that an
application for a practitioner’s
registration may be denied upon a
determination ‘‘that the issuance of such
registration would be inconsistent with
the public interest.’’ 21 U.S.C. 823(f). In
making the public interest
determination, the CSA requires the
consideration of the following factors:
(1) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(2) The applicant’s experience in
dispensing . . . controlled substances.
(3) The applicant’s conviction record
under Federal or State laws relating to
the manufacture, distribution, or
dispensing of controlled substances.
4 The ALJ recommended that I make this fact
finding based on the parties’ stipulation that DEA
assigned Control No. W16052461C to Respondent’s
DEA application. R.D., at 3 (citing PHR, 1–2). In
addition, the record includes a notarized sworn
statement by Respondent that DEA assigned Control
No. W16052461C to her. Att. 3 to Resp. Reply, at
1.
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(4) Compliance with applicable State,
Federal, or local laws relating to
controlled substances.
(5) Such other conduct which may
threaten the public health and safety.
Id. ‘‘These factors are . . . considered in
the disjunctive.’’ Robert A. Leslie, M.D.,
68 FR 15227, 15230 (2003). DEA
precedent provides that I ‘‘may rely on
any one or a combination of factors, and
may give each factor the weight I deem
appropriate in determining whether
. . . an application for registration
should be denied.’’ Richard D. Vitalis,
79 FR 68701, 68708 (2014) (citing
Robert A. Leslie, M.D., supra). Moreover,
it is well established that I am ‘‘not
required to make findings as to all of the
factors.’’ Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); see also Kevin
Dennis, M.D., 78 FR 52787, 52974
(2013); MacKay v. DEA, 664 F.3d 808,
816 (10th Cir. 2011).
‘‘The provision of truthful
information on applications is
absolutely essential’’ to a determination
of whether granting an application is in
the public interest. Peter H. Ahles, M.D.,
71 FR 50097, 50098 (2006). ‘‘Since DEA
must rely on the truthfulness of
information supplied by applicants in
registering them to handle controlled
substances, falsification cannot be
tolerated.’’ Bobby Watts, M.D., 58 FR
46995, 46995 (1993). Accordingly,
‘‘materially falsifying an application
. . . provides an independent and
adequate ground for denying an
application.’’ The Lawsons, Inc., 72 FR
74334, 74338 (2007); see also Richard A.
Herbert, M.D., 76 FR 53942, 53945
(2011) (‘‘Under the CSA, material
falsification provides a separate and
independent ground for denying an
application.’’).5 One materially false
statement is enough to justify revocation
or denial. Harold Edward Smith, M.D.,
76 FR 53961, 53964 (2011). The
Government bears the burden of proof
in showing that the issuance of a
registration is inconsistent with the
public interest. 21 CFR 1301.44(d).
5 Under Section 304(a)(1) of the Controlled
Substances Act (CSA), a registration may be
revoked or suspended ‘‘upon a finding that the
registrant * * * has materially falsified any
application filed pursuant to or required by this
subchapter.’’ 21 U.S.C. 824(a)(1). ‘‘DEA has long
held that the various grounds for revocation or
suspension of an existing registration that Congress
enumerated in section 304(a), 21 U.S.C. 824(a), are
also properly considered in deciding whether to
grant or deny an application under section 303.’’
Richard D. Vitalis, D.O., 79 FR 68701, 68708 (2014)
(citing Anthony D. Funches, 64 FR 14267, 14268
(1999); Alan R. Schankman, 63 FR 45260 (1998);
Kuen H. Chen, 58 FR 65401, 65402 (1993)). Thus,
the allegation that Respondent materially falsified
his application is properly considered in this
proceeding. Vitalis, 79 FR at 68708 (citing Samuel
S. Jackson, 72 FR 23848, 23852 (2007)).
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Having considered the record, including
the ALJ’s Recommended Decision and
Respondent’s Exceptions, I conclude
that the Government was entitled to
summary disposition on the grounds
that Respondent materially falsified her
application for a DEA Certificate of
Registration.
B. Material Falsification
Here, as I have already noted,
Respondent made two false statements
when she submitted her DEA
Application for Registration in 2016 in
Puerto Rico. First, Respondent falsely
stated in her response to Liability
Question 2 on her DEA Application for
Registration that she had never
surrendered a DEA registration for cause
when, in fact, she had surrendered DEA
Certificate of Registration No.
BC4141139 in Michigan for cause in
January 2014. Second, Respondent
falsely stated in her response to Liability
Question 3 on her DEA Application that
she has not had her state professional
license revoked, even though in 2013
she had entered into a Consent Order
with the Michigan Board of Medicine
agreeing to the suspension of her
Michigan medical license.
Turning to whether these false
statements were material, Agency
precedent establishes that ‘‘[a] false
statement is material if it ‘has a natural
tendency to influence, or was capable of
influencing the decision of the
decision[-]making body to which it was
addressed.’ ’’ Gilbert Eugene Johnson,
M.D., 75 FR 65663, 65665 (2010)
(quoting Kungys v. United States, 485
U.S. 759, 770 (1998)). The false
statement need only have the capacity
to influence the decision-making body;
it does not need to have exerted any
actual influence. Alvin Darby, M.D., 75
FR 26993, 26998 (2010) (citing United
States v. Alemany Rivera, 781 F.2d 229,
234 (1st Cir. 1985)). The Government
must prove that the false information is
material by ‘‘clear, unequivocal, and
convincing’’ evidence. Hoi Y. Kam,
M.D., 78 FR 62694, 62696 (2013)
(quoting Kungys, 485 U.S. at 772).
Whether a falsification is material is a
question of law. Harold Edward Smith,
M.D., 76 FR 53961, 53964 (2011) (citing
Kungys, 485 U.S. at 772).
As stated below, I find that the
Respondent’s answers to both Liability
Question 2 and Liability Question 3
were material. As far as Liability
Question 3 is concerned, DEA precedent
holds that the failure to disclose a prior
suspension relating to the prescribing of
controlled substances is material, even
where the suspension was no longer
effective at the time of the application:
‘‘[E]ven where an applicant currently
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
62905
holds unrestricted state authority to
dispense controlled substances, the
failure to disclose state action against
his medical license may be material if
the action was based on conduct (or on
the status arising from such conduct,
i.e., a conviction for a controlled
substance offense or mandatory
exclusion from federal health care
programs) which is actionable under
either the public interest factors or the
grounds for denial, suspension, and
revocation set forth in section 824.’’
Richard D. Vitalis, 79 FR at 681708
(2014).
Here, the Government has provided
evidence demonstrating that the
underlying state investigation which
prompted the suspension of
Respondent’s Michigan medical license
and the surrender of her DEA
registration concerned unlawful
prescribing of controlled substances.
See Ex. 4 to Govt. Mot. Given that the
allegations concern the unlawful
prescribing of controlled substances, I
find that they are material because they
are ‘‘capable of influencing’’ the DEA’s
decision.6 Kungys, 485 U.S. at 770; Jose
G. Zavaleta, M.D., 78 FR 27431, 27435
(2013); Smith, 76 FR at 53964. Likewise,
Respondent’s failure to disclose her
surrender for cause of her prior DEA
registration in Michigan in response to
Liability Question 2 was also material
according to DEA precedent. Zavaleta,
78 FR at 27435 (failure to disclose
voluntary surrender of DEA registration
following an investigation into unlawful
prescribing was ‘‘clearly capable of
influencing’’ the DEA’s decision and
was thus material); Smith, 76 FR at
53964 (failure to disclose fact that the
applicant had ‘‘been accused of writing
unlawful prescriptions . . . [was]
material to the [DEA’s] investigation and
assessment of [the applicant’s]
experience in dispensing controlled
substances and his compliance with
applicable laws related to’’ controlled
substances).
In addition, the Government must
show that Respondent ‘‘knew or should
have known that [her] response[s] given
to the liability question[s] [were] false.’’
Samuel S. Jackson, D.D.S., 72 FR 23848,
23852 (2007) (quoting Samuel Arnold,
D.D.S., 63 FR 8687, 8688 (1998)); Merlin
E. Shuck, D.V.M., 69 FR 22566, 22568
(2004). ‘‘Under DEA precedent, the
Government is not required to show that
the falsification was intentional but only
that the applicant ‘knew or should have
known that the response given to the
6 The Consent Order recited that Respondent
‘‘does not contest the allegations of fact and law’’
in the state administrative complaint against her. Id.
at 3.
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liability question was false.’’’ Alvin
Darby, M.D., 75 FR 26993, 26999 (2010)
(quoting The Lawsons, Inc., 72 FR
74334, 74339 (2007)).
In Richard Jay Blackburn, D.O., the
Acting Administrator determined that a
copy of the state administrative
complaint, the respondent’s letter to the
state board ‘‘surrendering his state
license,’’ the state board’s acceptance of
the surrender, and a printout displaying
the status of respondent’s state license
were sufficient to demonstrate that
respondent ‘‘knowingly falsified his
application.’’ 82 FR 18669, 18673
(2017). The DEA has found that material
falsifications are committed knowingly
even where, as here, a respondent
claims that he or she misunderstood the
questions. Darby, 75 FR at 26999.
Here, the Government attached a copy
of the Respondent’s 2016 application, a
copy of the administrative complaint
and Consent Order issued by the
Michigan Department of Licensing and
Regulatory Affairs against Respondent,
and a copy of the form which
Respondent signed surrendering her
Michigan DEA registration. See Exs. 1,
4–5 to Govt. Mot. Additionally, the
Government attached two notarized
documents signed by the Chief of DEA’s
Registration and Program Support
Section verifying the Respondent’s DEA
registration history and her responses
on her 2016 application. Exs. 2–3 to
Govt. Mot. The Government’s evidence
is the same type of evidence as that
submitted in Blackburn and therefore is
sufficient to show that Respondent
either knew or should have known that
her application was materially false. 82
FR at 18673. As a result, even if
Respondent’s statements that she
misunderstood the questions were true,
I find that she should have known
under the facts in this case that her
responses to the liability questions in
this case were false. See Darby, 75 FR
at 26999.
Thus, I find that the Government has
offered sufficient evidence to show that
the Respondent materially falsified her
2016 application for a DEA registration
in Puerto Rico.
C. Sanction
Once the Government makes a prima
facie case for material falsification, the
next question ‘‘becomes whether
revocation [or denial] is the appropriate
sanction in light of the facts.’’ Arnold,
63 FR at 8688. Although the Respondent
acknowledges that the answers she
provided in response to Liability
Questions 2 and 3 on her 2016
application were false, she explains that
she did not intend to provide false
statements, but instead misunderstood
VerDate Sep<11>2014
20:35 Dec 04, 2018
Jkt 247001
the questions. Resp. Reply, at 4–5; App.
3, at 2, para. 7.
Respondent’s insistence that her
undisputed false statements should be
excused because she ‘‘misunderstood’’
the liability questions is misplaced. In
her Request for Hearing, the Respondent
merely stated the following concerning
her alleged misunderstanding of the
questions: ‘‘I was helped by a friend in
filling out the application and probably
by mistake and/or ignorance in
understanding the questions I answered
‘no.’’ Resp. Request for Hearing, at 2.
Later, in her Response to Government’s
Motion for Summary Disposition, she
further specified that she
‘‘misunderstood’’ Liability Questions 2
and 3, but her purported explanation
disregards the actual wording of the
questions. Att. 3 to Resp. Reply, at 2.
For example, as to Liability Question 2,
Respondent claims she misunderstood
that question because her registration
was surrendered voluntarily, and was
not revoked, suspended or denied. Id.
However, Liability Question 2 not only
asked whether the applicant ever had a
registration ‘‘revoked, suspended,
restricted or denied,’’ but also expressly
asked whether any registration had ever
been surrendered for cause. Ex. 1 to
Govt. Mot. Moreover, Respondent
stipulated that her prior registration was
surrendered for cause, so her negative
answer was clearly false, and her
claimed ‘‘misunderstanding’’ of
Liability Question 2 rings hollow. See
Shannon L. Gallentine, D.P.M., 76 FR
45864, 45866 (2011).
Similarly, Respondent’s claim that
she misunderstood Liability Question 3
also ignores the question itself.
Respondent explained her
‘‘misunderstanding’’ as to Liability
Question 3 as follows: ‘‘As to question
#3, again Ms. Cordova[’s] Registration
was not revoked, suspended, denied,
restricted, or placed on probation, nor is
[sic] any such action was pending when
she voluntarily surrender [sic] her
Registration.’’ Att. 3 to Resp. Reply, at
2. However, Liability Question 3
actually inquires: ‘‘Has the applicant
ever surrendered (for cause) or had a
state professional license or controlled
substance registration revoked,
suspended, denied, restricted, or placed
on probation, or is any such action
pending?’’ Ex. 1 to Govt. Mot. (emphasis
added). It is undisputed that
Respondent’s state professional license
for Michigan was suspended, and she
clearly knew it was suspended, because
she is the one who agreed to that
suspension in writing when she entered
into a Consent Order with the State of
Michigan Board of Medicine. Thus,
Respondent’s claimed
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
misunderstanding of Liability Question
3 is untenable on its face.
Moreover, applicants for DEA
registrations bear ‘‘‘the responsibility to
carefully read the question and to
honestly answer all parts of the
question.’’’ Arnold, 63 FR at 8688
(quoting Martha Hernandez, M.D., 62
FR 61145, 61147 (1997)). Allegedly
misunderstanding or misinterpreting
liability questions does not relieve the
applicant of this responsibility.
Hernandez, 62 FR at 61147–48
(concluding applicant committed
material falsification despite
misinterpreting one question); see also
Gallentine, 76 FR at 45866.
Additionally, inadvertence is legally
irrelevant in resolving a material
falsification case because the
Government only needs to prove that
Respondent ‘‘‘knew or should have
known’’’ that the answers were false.
Richard A. Herbert, M.D., 76 FR 53942,
53956 (2011) (quoting The Lawsons,
Inc., 72 FR 74334, 74338 (2007))
(emphasis added). See, e.g., Zavaleta, 78
FR at 27436, 27438–39 (ruling
respondent materially falsified his
application even where respondent
testified that he made mistakes in filling
out the application and ‘‘should have
give[n] [his applications] more careful
review’’). Thus, Respondent’s defense of
inadvertence, even if it were true, is
legally inconsequential in deciding
whether she materially falsified her
2016 application.
Furthermore, the evidence that
Respondent now holds a valid medical
license in good standing in Puerto Rico
is simply not relevant in terms of
resolving the allegation that she
materially falsified her application.
Resp. Reply, at 3; Att. 1–2 to Resp.
Reply; Hernandez, 62 FR at 61147. The
same holds true of the evidence that
Respondent has never been sued for
malpractice or been the subject of a
professional complaint, except for the
Michigan action, in her 19–20 year
career. Resp. Reply at Att. 3, para. 8, 10.
With respect to Liability Questions 2
and 3 of Respondent’s DEA Application,
a material false statement is a material
false statement regardless of her
professional credentials.
Although lack of intent to deceive and
history of licensure are relevant in
assessing the appropriate sanction, what
is most dispositive is the fact that
Respondent has not accepted
responsibility for her materially false
statements. See Lon F. Alexander, M.D.,
82 FR 49704, 49728 (2017); Arthur H.
Bell, 80 FR 50035, 50041 (2015) (finding
that applicant’s failure to accept
responsibility for materially falsifying
application was ‘‘reason alone to
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06DEN1
Federal Register / Vol. 83, No. 234 / Thursday, December 6, 2018 / Notices
conclude that he cannot be entrusted
with a new registration’’). I have
considered the fact that Respondent
currently holds a medical license in
good standing in Puerto Rico, and her
sworn statement that she has never been
sued for malpractice and received only
one professional complaint in her 19–20
year career. Att. 1–2 to Resp. Reply; Att.
3 to Resp. Reply, at 2–4. None of these
facts outweighs Respondent’s materially
false application, especially given her
failure to disclose extensive and serious
allegations against her involving the
unlawful prescribing of controlled
substances. See William M. Knarr, D.O.,
51 FR 2772, 2773 (1986). Thus, I find
that this mitigating evidence fails to
diminish the gravity of her failure to
reveal the alleged misconduct in her
state of prior registration.
Accordingly, based upon the
foregoing, I conclude that the
Government was entitled to summary
disposition on the allegation that
Respondent materially falsified her
application for a new DEA registration.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
I order that the application of Zelidah H.
Cordova-Velazco, M.D., for a DEA
Certificate of Registration as a
practitioner, be, and it hereby is, denied.
This Order is effective immediately.
Dated: November 20, 2018.
Uttam Dhillon,
Acting Administrator.
DEPARTMENT OF JUSTICE
Foreign Claims Settlement
Commission
[F.C.S.C. Meeting and Hearing Notice No.
11–18]
Sunshine Act Meeting
The Foreign Claims Settlement
Commission, pursuant to its regulations
(45 CFR part 503.25) and the
Government in the Sunshine Act (5
U.S.C. 552b), hereby gives notice in
regard to the scheduling of open
meetings as follows:
Thursday, December 13, 2018: 11:00
a.m.—Issuance of Proposed Decisions in
claims against Iraq.
11:30 a.m.—Issuance of Proposed
Decisions under the Guam World War II
Loyalty Recognition Act, Title XVII,
Public Law 114–328.
Status: Open.
All meetings are held at the Foreign
Claims Settlement Commission, 601 D
Street NW, Suite 10300, Washington,
DC. Requests for information, or
advance notices of intention to observe
an open meeting, may be directed to:
Patricia M. Hall, Foreign Claims
Settlement Commission, 601 D Street
NW, Suite 10300, Washington, DC
20579. Telephone: (202) 616–6975.
Brian Simkin,
Chief Counsel.
[FR Doc. 2018–26576 Filed 12–3–18; 4:15 pm]
BILLING CODE 4410–BA–P
DEPARTMENT OF JUSTICE
Notice of Filing of Proposed
Settlement Agreement Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
[FR Doc. 2018–26485 Filed 12–4–18; 8:45 am]
BILLING CODE 4410–09–P
On November 21, 2018, a Notice of
Settlement Agreement was filed in the
Superior Court for the State of New
Amount
Site
$16,000,000 ........................
Sharon Steel Corporation (Farrell Works Disposal
Area) Superfund Site.
Lower Duwamish Waterway Superfund Site ................
Lower Duwamish Waterway Superfund Site ................
San Gabriel Valley Area 2 Site .....................................
U.S. Oil Recovery Site ..................................................
Lee’s Lane Landfill Superfund Site ...............................
Petroleum Products Superfund Site ..............................
khammond on DSK30JT082PROD with NOTICES
6,298,630 ............................
2,200,000 ............................
2,224,999 ............................
300,000 ...............................
19,609 .................................
908 ......................................
For each Class II priority distribution
that Home makes, Home shall use the
above amounts to determine the
appropriate distribution for each of the
six Superfund Sites. In consideration of
payments made on the allowed Class II
VerDate Sep<11>2014
20:35 Dec 04, 2018
Jkt 247001
Frm 00075
Hampshire, Merrimack County in the
proceeding entitled In the Matter of the
Liquidation of The Home Insurance
Company, Docket No. 217–2003–EQ–
00106. The Notice informs the Court
that at the conclusion of a public
comment period, John R. Elias,
Insurance Commissioner of the State of
New Hampshire, in his capacity as
Liquidator (the ‘‘Liquidator’’) of the
Home Insurance Company (‘‘Home’’)
may seek court approval of a Settlement
Agreement between the Liquidator, and
the United States of America on behalf
of the U.S. Environmental Protection
Agency (‘‘EPA’’), the U.S. Department of
the Navy, U.S. Department of the
Interior (‘‘DOI’’), and the National
Oceanic and Atmospheric
Administration of the U.S. Department
of Commerce (‘‘NOAA’’) (collectively
referred to as ‘‘the Federal Claimants’’),
acting by and through the United States
Department of Justice (‘‘DOJ’’).
The Settlement Agreement would
resolve seven proofs of claim the
Federal Claimants’ have filed. The seven
proofs of claim assert claims under
Section 107 of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(‘‘CERCLA’’), 42 U.S.C. 9607, against
insured parties in connection with six
Superfund Sites: The Sharon Steel
Corporation (Farrell Works Disposal
Area) Superfund Site in Hermitage, PA;
the Lower Duwamish Waterway
Superfund Site in Seattle, WA; the San
Gabriel Valley Area 2 Site in Los
Angeles, CA; the U.S. Oil Recovery Site
in Pasadena, TX; the Lee’s Lane Landfill
Superfund Site in Louisville, KY; and
the Petroleum Products Superfund Site
in Pembroke Park, FL.
Under the Settlement Agreement, the
United States will have an allowed
Class II priority claim in the amount of
$27,044,146 allocated to the six
Superfund Sites as follows:
Home insured
Sharon Steel Corporation.
Manson Construction and Engineering Company.
Duwamish Shipyard, Inc.
Azusa Pipe & Tube Bending, Corp.
Explorer Pipeline Company.
Louisville Varnish Company, Inc.
Shaw Trucking.
Priority Claim, upon approval of the
Settlement Agreement the Federal
Claimants provide a covenant not to sue
to Home and the Liquidator as described
in the Agreement under CERCLA under
the policies that are identified in the
PO 00000
62907
Fmt 4703
Sfmt 4703
Settlement Agreement and in the proofs
of claim.
The publication of this notice opens
a period for public comment on the
Settlement Agreement. Comments
should be addressed to the Assistant
E:\FR\FM\06DEN1.SGM
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Agencies
[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62902-62907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26485]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 18-21]
Decision and Order: Zelideh I. Cordova-Velazco, M.D.
On February 27, 2018, the Acting Assistant Administrator, Diversion
Control Division, issued an Order to Show Cause to Zelideh I. Cordova-
Velazco, M.D. (Respondent), of Puerto Rico. The Show Cause Order
proposed the denial of the Respondent's application for a DEA
Certificate of Registration in Puerto Rico as a practitioner, Control
No. W16052461C, on the grounds that Respondent materially falsified
that application. Order to Show Cause, at 1 (citing 21 U.S.C.
824(a)(1)).
With respect to the Agency's jurisdiction, the Show Cause Order
alleged that on June 16, 2016, Respondent applied for a DEA
Registration as a practitioner in schedules II through V at the
proposed business address of Hacienda Del Dorado, K1 Calle Delonix, Toa
Alta, Puerto Rico. Id. The Order also alleged that DEA assigned Control
No. W16052461C to the application. Id.
As to the substantive grounds for the proceeding, the Show Cause
Order alleged that Respondent previously held DEA Certificate of
Registration No. BC4141139 in Michigan. Id. at 2. In addition, the
Order alleged that Respondent ``voluntarily surrendered for cause''
that Registration ``on or about January 17, 2014.'' Id. The Order
further alleged that Respondent materially falsified her application
for a new DEA Registration in Puerto Rico on June 16, 2016 with respect
to two liability questions on the application. Id. The Order alleged
that the first material falsification was that the Respondent answered
``N'' when asked: ``Has the applicant ever surrendered (for cause) or
had a federal controlled substance registration, revoked, suspended,
restricted or denied, or is any such action pending?'' Id. The Order
alleged that the second material falsification was that Respondent
answered ``N'' when asked: ``Has the applicant ever surrendered (for
cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed
[[Page 62903]]
on probation, or is any such action pending?'' Id. The Order asserted
that these alleged material falsifications ``warrant the denial of your
application for registration.'' Id. (citing 21 U.S.C Sec. 824(a)(1)).
The Show Cause Order notified Respondent of her right to request a
hearing on the allegations or to submit a written statement while
waiving her 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 Order also notified Respondent of the
opportunity to submit a corrective action plan. Id. at 3 (citing 21
U.S.C. Sec. 824(c)(2)(C)).
After being served with the Order, Respondent filed a timely
``Request for Hearing'' on March 26, 2018 requesting a hearing on the
allegations. Request for Hearing (dated March 22, 2018) (hereinafter
Hearing Request). In her Hearing Request, Respondent states that she
``d[id] not recall that I indicate [sic] `no' to the questions'' in the
application and that she ``was helped by a friend in filling out the
application and probably by mistake and/or ignorance in understanding
the questions I answered `no.''' Id. at 2. Respondent also states that
she surrendered her Michigan medical license and ``accept[ed] a six
months and one day suspension, for being negligent, in not securing my
prescription pad'' and then ``voluntarily surrender[ed her] DEA license
to prescribe[] control[led] substance[s].'' Id. She also asserts that
``[i]f I would have known the consequences of accepting the suspension,
I would have litigated the case in Michigan, because I did nothing
wrong. There is no practical reason not to inform the suspension of
Michigan. The suspension appears online in the medical board data
bank.'' Id. She also ``request[ed] discovery in the present matter,
including [a] copy of the record and/or file with DEA.'' Id.
The matter was placed on the docket of the Office of Administrative
Law Judges and assigned to Administrative Law Judge Charles Wm. Dorman
(ALJ). Thereafter, on March 26, 2018, the ALJ entered an Order for
Prehearing Statements, directing the Government to file its Prehearing
Statement on April 10, 2018, and the Respondent to file hers on April
24, 2018. Order for Prehearing Statements, at 1. The Order also
directed the parties to participate in a telephonic prehearing
conference on April 25, 2018. Id. at 2. The Government filed its
Prehearing Statement on April 10, 2018, and Respondent filed, through
counsel, her Prehearing Statement on April 20, 2018.
In Respondent's Prehearing Statement, Respondent stipulated that
she voluntarily surrendered her Michigan medical license after being
informed of an investigation for improperly prescribing medication.
Respondent's Prehearing Statement, at 2. In addition, Respondent
stipulated that she was previously registered with DEA pursuant to DEA
Certificate of Registration No. BC4141139, and that she voluntarily
surrendered for cause that registration. Id. at 3.
On April 20, 2018, the Government filed a Motion for Summary
Disposition based upon the Respondent's material falsification of her
application for a DEA Registration in Puerto Rico on June 16, 2016.
Specifically, the Government alleged that there was no dispute of
material fact that Respondent materially falsified her application for
a DEA Registration when she answered ``N'' to the following liability
questions on the application: (1) ``Has the applicant ever surrendered
(for cause) or had a federal controlled substance registration,
revoked, suspended, restricted or denied, or is any such action
pending?''; and (2) ``Has the applicant ever surrendered (for cause) or
had a state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation, or is
any such action pending?'' Government's Motion for Summary Disposition
(hereinafter ``Government's Motion'' or ``Govt. Mot.''), at 2.
On April 25, 2018, the ALJ held a telephonic prehearing conference
pursuant to 21 CFR 1316.55. The ALJ entered a Prehearing Ruling (PHR)
on April 26, 2018, reflecting that the parties had agreed to a series
of factual stipulations, including the fact that (1) on April 19, 2013,
the Michigan Board of Medicine suspended Respondent's Michigan medical
license for a minimum period of six months and one day; (2) in January
2014, Respondent ``voluntarily surrendered for cause'' a DEA
Registration that Respondent had previously held in Michigan; (3)
Respondent answered ``N'' when asked: ``Has the applicant ever
surrendered (for cause) or had a federal controlled substance
registration revoked, suspended, restricted or denied, or is any such
action pending?'' and (4) Respondent answered ``N'' when asked: ``Has
the applicant ever surrendered (for cause) or had a state professional
license or controlled substance registration revoked, suspended,
denied, restricted, or placed on probation, or is any such action
pending?'' PHR, at 1-2.
In his Prehearing Ruling, the ALJ also ordered Respondent to file a
response to the Government's Motion by May 4, 2018, and directed the
parties to attempt to draft additional ``mutually agreeable joint
stipulations'' by May 30, 2018. Id. at 2. On May 3, 2018, Respondent
filed her response to the Government's Motion and asserted that the
Government had failed to ``establish bad faith, negligence or
intentionally trying to mislead,'' and failed to prove that she ``is
unfit to practice medicine, and therefore, unfit to prescribe
medication.'' ``Respondent's Response to Government's Motion for
Summary Disposition and Respondant's [sic] `Motion for Summary
Disposition''' (Resp. Reply), at 4. In addition, Respondent attached a
certificate of good standing for her Puerto Rico medical license and a
copy of her license. Id., Attachment (Att.) 1-2. Additionally, she
attached her own sworn statement, in which she asserts that she
``misunderstood the questions.'' Id., Att. 3, at 2. She also argued
that approving her application was warranted because she holds an
active medical license in good standing and has never been sued for
malpractice. Id. at 3-4.
On May 8, 2018, after considering these pleadings, the ALJ entered
an Order recommending that I find that Respondent had failed to raise a
triable issue of material fact as to whether she had materially
falsified her application. Order Granting Government's Motion for
Summary Disposition and Recommended Rulings, Findings of Fact,
Conclusions of Law, and Decision (Recommended Decision or R.D.), at 8-
9. As a result, the ALJ granted the Government's Motion and recommended
that I deny Respondent's DEA application Control No. W1602461C. Id. at
12.
On May 17, 2018, Respondent filed her ``Request for
Reconsideration'' of the ALJ's Recommended Decision,\1\ and on the same
day the ALJ entered an Order Directing Government to Respond to
Respondent's Request for Reconsideration. In that Order, the ALJ noted
that there is no provision in DEA's regulations for either party to
request reconsideration of an ALJ's recommended decision, and thus the
ALJ would treat the request as Exceptions to the Recommended Decision.
Order Directing Government
[[Page 62904]]
to Respond to Respondent's Request for Reconsideration, at 1. The Order
directed the Government to file any response to Respondent's Exceptions
by May 22, 2018. According to the record, the Government filed no
Exceptions of its own nor any response to Respondent's Exceptions. On
June 4, 2018, the record was forwarded to my Office for Final Agency
Action.\2\
---------------------------------------------------------------------------
\1\ On May 11, 2018, Respondent also filed a ``Supplemental
Motion Submitting Document'' enclosing ``a certified translation of
Resolution Num. 2017-118, issued by the Health Department Board of
Licensing and Medical Discipline of Puerto Rico, in the case of In
Re: Sr. Zelideh Cordova Velazco (Lic. #4865), Case No. Q-JDLM-2013-
41.'' Supplemental Motion Submitting Document, at 1.
\2\ Respondent submitted two post-certification filings. On June
12, 2018, Respondent filed her Request to Grant Motion for
Reconsideration As Unopposed, and on August 17, 2018, Respondent
filed her Second Request to Grant Motion for Reconsideration As
Unopposed. On June 12, 2018 and on August 20, 2018, respectively,
the ALJ issued Orders forwarding Respondent's post-certification
filings to my Office and noted that his ``jurisdiction over the case
terminated upon transmittal of the record to the Acting
Administrator.'' Order Forwarding Respondent's Motion to Acting
Administrator, at 1; Second Order Forwarding Respondent's Motion to
Acting Administrator, at 1. I find that the ALJ properly forwarded
Respondent's post-certification filings for my consideration
because, as the ALJ correctly notes, his jurisdiction over this
matter terminated when he certified and transmitted the record to my
Office.
Regarding the timing of Respondent's filings, neither the
Controlled Substances Act nor DEA's implementing regulations provide
for a supplemental filing by a party after the ALJ has certified the
record. However, the Agency has, on occasion, exercised its
discretion to consider such filings (however styled) after the ALJ
has certified and transmitted the administrative record to my
Office. E.g., Joe W. Morgan, D.O., 78 FR 61961, 61961 (2013)
(allowing Respondent's post-certification filing and ``treat[ing it]
as a motion for reconsideration''); Wesley G. Harline, M.D., 64 FR
72678, 72684-85 (1999) (allowing Respondent's post-certification
filing and treating it as a motion to reopen the record); Robert M.
Golden, M.D., 61 FR 24808, 24808 (1996) (same). Indeed, the Agency
has even exercised its discretion to consider motions for
reconsideration after the Agency has issued its final decision and
order. E.g., Lyle E. Craker, Ph.D., 76 FR 51403, 51405 (2011).
To justify consideration of her filings at this stage of the
case, Respondent must show that there has been an intervening change
of controlling law, the availability of new evidence, or the need to
correct a clear error or prevent manifest injustice. E.g., Foster v.
Sedgwick Claims Mgmt. Services, 842 F.3d 721, 735 (D.C. Cir. 2016)
(``A motion for reconsideration is discretionary and need not be
granted unless the district court finds that there is an intervening
change of controlling law, the availability of new evidence, or the
need to correct a clear error or prevent manifest injustice.'')
(citations and internal quotation marks omitted); Virgin Atl.
Airways v. Nat'l Mediation Bd., 956 F.2d 1245, 1255 (2d Cir.)
(same), cert. denied, 506 U.S. 820 (1992).
Here, Respondent claims in both filings that her Exceptions
should be deemed ``unopposed'' because the Government chose not to
respond to her Exceptions. Respondent failed to offer any other
basis in fact that her Exceptions were ``unopposed'' by the
Government. I am aware of no DEA regulation or Agency precedent
compelling a finding that a party who does not respond to an
opposing party's Exceptions to an ALJ's Recommended Decision is
deemed to have taken a position of ``unopposed'' to the opposing
party's Exceptions. Moreover, Respondent's claim is not the type of
intervening change in controlling law, newly available evidence, or
clear error that would justify consideration of her post-
certification filings under Agency precedent at this stage of the
case. For all these reasons, I do not consider Respondent's post-
certification filings.
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Having considered the entire record, including the ALJ's
Recommended Decision, I find that Respondent materially falsified her
application for DEA registration with respect to Liability Questions 2
and 3 on her 2016 application. I therefore adopt the ALJ's
recommendation that I deny Respondent's DEA Registration application. I
make the following factual findings.
Findings of Fact
Respondent is a physician who previously held an active medical
license, No. 43-01063034, in the State of Michigan. Ex. 4 to Govt. Mot.
On April 19, 2013, Respondent entered into a Consent Order with the
Michigan Board of Medicine in which she agreed to the suspension of her
medical license for a minimum period of six months and one day based on
her improper prescribing of controlled substances to home health
patients. See id.; see also R.D., at 10. Specifically, the Michigan
administrative complaint against Respondent alleged, among other
things, that she prescribed controlled substances, primarily oxycodone,
Xanax, and Phenergan with codeine, to 26 patients despite: ``failing to
document medical indication or necessity for these controlled
substances''; failing to document ``any physical examination or
clinical findings to justify the combination of'' controlled drugs
prescribed; failing to document an appropriate medical history; failing
to make ``any findings pertaining to pain assessment, level of
dysfunction from pain, treatment plan or diagnostic testing''; failing
to obtain ``a report from the Michigan Automated Prescription System'';
failing to conduct a toxicology screen; failing to monitor the
``patients' use of the controlled substances for drug dependency or
diversion''; failing to counsel the patients regarding the risks
associated with controlled substances; and consistently prescribing the
maximum dose of Xanax ``without documenting prior medication use or use
of Xanax.'' Ex. 4 to Govt. Mot., at 9-11.\3\
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\3\ The Consent Order recited that Respondent ``does not contest
the allegations of fact and law'' in the state administrative
complaint against her. Id. at 3.
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Respondent also previously held DEA Certificate of Registration No.
BC4141139. Ex. 3 to Govt. Mot. In January 2014, Respondent voluntarily
surrendered this registration for cause. Exs. 3, 5 to Govt. Mot.
On June 15, 2016, Respondent applied for a practitioner's
registration seeking authority to dispense controlled substances in
schedules II through V with a proposed business address of Hacienda Del
Dorado, K1 Calle Delonix, Toa Alta, Puerto Rico. Exhibits (Exs.) 1, 2
to Govt. Mot. DEA assigned Respondent's DEA registration application
Control No. W16052461C.\4\ DEA's Application for Registration includes
liability questions which an applicant must answer either affirmatively
(``Y'') or negatively (``N''). Exs. 1-3 to Govt. Mot. Liability
Question 2 on the DEA Application for Registration filed by Respondent
asks: ``Has the applicant ever surrendered (for cause) or had a federal
controlled substance registration revoked, suspended, restricted or
denied, or is any such action pending?'' Exs. 1-2 to Govt. Mot.
Respondent answered this question: ``N'' for no. Id. I find that this
answer was false.
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\4\ The ALJ recommended that I make this fact finding based on
the parties' stipulation that DEA assigned Control No. W16052461C to
Respondent's DEA application. R.D., at 3 (citing PHR, 1-2). In
addition, the record includes a notarized sworn statement by
Respondent that DEA assigned Control No. W16052461C to her. Att. 3
to Resp. Reply, at 1.
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Liability Question 3 on the DEA Application for Registration filed
by Respondent asks: ``Has the applicant ever surrendered (for cause) or
had a state professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation, or is
any such action pending?'' Id. Respondent answered this question: ``N''
for no. I find that this answer was also false.
Discussion
A. Standard for Denial of an Application for Registration
Section 303(f) of the Controlled Substances Act provides that an
application for a practitioner's registration may be denied upon a
determination ``that the issuance of such registration would be
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making
the public interest determination, the CSA requires the consideration
of the following factors:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing . . . controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
[[Page 62905]]
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id. ``These factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). DEA precedent provides that
I ``may rely on any one or a combination of factors, and may give each
factor the weight I deem appropriate in determining whether . . . an
application for registration should be denied.'' Richard D. Vitalis, 79
FR 68701, 68708 (2014) (citing Robert A. Leslie, M.D., supra).
Moreover, it is well established that I am ``not required to make
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482
(6th Cir. 2005); see also Kevin Dennis, M.D., 78 FR 52787, 52974
(2013); MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011).
``The provision of truthful information on applications is
absolutely essential'' to a determination of whether granting an
application is in the public interest. Peter H. Ahles, M.D., 71 FR
50097, 50098 (2006). ``Since DEA must rely on the truthfulness of
information supplied by applicants in registering them to handle
controlled substances, falsification cannot be tolerated.'' Bobby
Watts, M.D., 58 FR 46995, 46995 (1993). Accordingly, ``materially
falsifying an application . . . provides an independent and adequate
ground for denying an application.'' The Lawsons, Inc., 72 FR 74334,
74338 (2007); see also Richard A. Herbert, M.D., 76 FR 53942, 53945
(2011) (``Under the CSA, material falsification provides a separate and
independent ground for denying an application.'').\5\ One materially
false statement is enough to justify revocation or denial. Harold
Edward Smith, M.D., 76 FR 53961, 53964 (2011). The Government bears the
burden of proof in showing that the issuance of a registration is
inconsistent with the public interest. 21 CFR 1301.44(d). Having
considered the record, including the ALJ's Recommended Decision and
Respondent's Exceptions, I conclude that the Government was entitled to
summary disposition on the grounds that Respondent materially falsified
her application for a DEA Certificate of Registration.
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\5\ Under Section 304(a)(1) of the Controlled Substances Act
(CSA), a registration may be revoked or suspended ``upon a finding
that the registrant * * * has materially falsified any application
filed pursuant to or required by this subchapter.'' 21 U.S.C.
824(a)(1). ``DEA has long held that the various grounds for
revocation or suspension of an existing registration that Congress
enumerated in section 304(a), 21 U.S.C. 824(a), are also properly
considered in deciding whether to grant or deny an application under
section 303.'' Richard D. Vitalis, D.O., 79 FR 68701, 68708 (2014)
(citing Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R.
Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402
(1993)). Thus, the allegation that Respondent materially falsified
his application is properly considered in this proceeding. Vitalis,
79 FR at 68708 (citing Samuel S. Jackson, 72 FR 23848, 23852
(2007)).
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B. Material Falsification
Here, as I have already noted, Respondent made two false statements
when she submitted her DEA Application for Registration in 2016 in
Puerto Rico. First, Respondent falsely stated in her response to
Liability Question 2 on her DEA Application for Registration that she
had never surrendered a DEA registration for cause when, in fact, she
had surrendered DEA Certificate of Registration No. BC4141139 in
Michigan for cause in January 2014. Second, Respondent falsely stated
in her response to Liability Question 3 on her DEA Application that she
has not had her state professional license revoked, even though in 2013
she had entered into a Consent Order with the Michigan Board of
Medicine agreeing to the suspension of her Michigan medical license.
Turning to whether these false statements were material, Agency
precedent establishes that ``[a] false statement is material if it `has
a natural tendency to influence, or was capable of influencing the
decision of the decision[-]making body to which it was addressed.' ''
Gilbert Eugene Johnson, M.D., 75 FR 65663, 65665 (2010) (quoting Kungys
v. United States, 485 U.S. 759, 770 (1998)). The false statement need
only have the capacity to influence the decision-making body; it does
not need to have exerted any actual influence. Alvin Darby, M.D., 75 FR
26993, 26998 (2010) (citing United States v. Alemany Rivera, 781 F.2d
229, 234 (1st Cir. 1985)). The Government must prove that the false
information is material by ``clear, unequivocal, and convincing''
evidence. Hoi Y. Kam, M.D., 78 FR 62694, 62696 (2013) (quoting Kungys,
485 U.S. at 772). Whether a falsification is material is a question of
law. Harold Edward Smith, M.D., 76 FR 53961, 53964 (2011) (citing
Kungys, 485 U.S. at 772).
As stated below, I find that the Respondent's answers to both
Liability Question 2 and Liability Question 3 were material. As far as
Liability Question 3 is concerned, DEA precedent holds that the failure
to disclose a prior suspension relating to the prescribing of
controlled substances is material, even where the suspension was no
longer effective at the time of the application: ``[E]ven where an
applicant currently holds unrestricted state authority to dispense
controlled substances, the failure to disclose state action against his
medical license may be material if the action was based on conduct (or
on the status arising from such conduct, i.e., a conviction for a
controlled substance offense or mandatory exclusion from federal health
care programs) which is actionable under either the public interest
factors or the grounds for denial, suspension, and revocation set forth
in section 824.'' Richard D. Vitalis, 79 FR at 681708 (2014).
Here, the Government has provided evidence demonstrating that the
underlying state investigation which prompted the suspension of
Respondent's Michigan medical license and the surrender of her DEA
registration concerned unlawful prescribing of controlled substances.
See Ex. 4 to Govt. Mot. Given that the allegations concern the unlawful
prescribing of controlled substances, I find that they are material
because they are ``capable of influencing'' the DEA's decision.\6\
Kungys, 485 U.S. at 770; Jose G. Zavaleta, M.D., 78 FR 27431, 27435
(2013); Smith, 76 FR at 53964. Likewise, Respondent's failure to
disclose her surrender for cause of her prior DEA registration in
Michigan in response to Liability Question 2 was also material
according to DEA precedent. Zavaleta, 78 FR at 27435 (failure to
disclose voluntary surrender of DEA registration following an
investigation into unlawful prescribing was ``clearly capable of
influencing'' the DEA's decision and was thus material); Smith, 76 FR
at 53964 (failure to disclose fact that the applicant had ``been
accused of writing unlawful prescriptions . . . [was] material to the
[DEA's] investigation and assessment of [the applicant's] experience in
dispensing controlled substances and his compliance with applicable
laws related to'' controlled substances).
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\6\ The Consent Order recited that Respondent ``does not contest
the allegations of fact and law'' in the state administrative
complaint against her. Id. at 3.
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In addition, the Government must show that Respondent ``knew or
should have known that [her] response[s] given to the liability
question[s] [were] false.'' Samuel S. Jackson, D.D.S., 72 FR 23848,
23852 (2007) (quoting Samuel Arnold, D.D.S., 63 FR 8687, 8688 (1998));
Merlin E. Shuck, D.V.M., 69 FR 22566, 22568 (2004). ``Under DEA
precedent, the Government is not required to show that the
falsification was intentional but only that the applicant `knew or
should have known that the response given to the
[[Page 62906]]
liability question was false.''' Alvin Darby, M.D., 75 FR 26993, 26999
(2010) (quoting The Lawsons, Inc., 72 FR 74334, 74339 (2007)).
In Richard Jay Blackburn, D.O., the Acting Administrator determined
that a copy of the state administrative complaint, the respondent's
letter to the state board ``surrendering his state license,'' the state
board's acceptance of the surrender, and a printout displaying the
status of respondent's state license were sufficient to demonstrate
that respondent ``knowingly falsified his application.'' 82 FR 18669,
18673 (2017). The DEA has found that material falsifications are
committed knowingly even where, as here, a respondent claims that he or
she misunderstood the questions. Darby, 75 FR at 26999.
Here, the Government attached a copy of the Respondent's 2016
application, a copy of the administrative complaint and Consent Order
issued by the Michigan Department of Licensing and Regulatory Affairs
against Respondent, and a copy of the form which Respondent signed
surrendering her Michigan DEA registration. See Exs. 1, 4-5 to Govt.
Mot. Additionally, the Government attached two notarized documents
signed by the Chief of DEA's Registration and Program Support Section
verifying the Respondent's DEA registration history and her responses
on her 2016 application. Exs. 2-3 to Govt. Mot. The Government's
evidence is the same type of evidence as that submitted in Blackburn
and therefore is sufficient to show that Respondent either knew or
should have known that her application was materially false. 82 FR at
18673. As a result, even if Respondent's statements that she
misunderstood the questions were true, I find that she should have
known under the facts in this case that her responses to the liability
questions in this case were false. See Darby, 75 FR at 26999.
Thus, I find that the Government has offered sufficient evidence to
show that the Respondent materially falsified her 2016 application for
a DEA registration in Puerto Rico.
C. Sanction
Once the Government makes a prima facie case for material
falsification, the next question ``becomes whether revocation [or
denial] is the appropriate sanction in light of the facts.'' Arnold, 63
FR at 8688. Although the Respondent acknowledges that the answers she
provided in response to Liability Questions 2 and 3 on her 2016
application were false, she explains that she did not intend to provide
false statements, but instead misunderstood the questions. Resp. Reply,
at 4-5; App. 3, at 2, para. 7.
Respondent's insistence that her undisputed false statements should
be excused because she ``misunderstood'' the liability questions is
misplaced. In her Request for Hearing, the Respondent merely stated the
following concerning her alleged misunderstanding of the questions: ``I
was helped by a friend in filling out the application and probably by
mistake and/or ignorance in understanding the questions I answered
`no.'' Resp. Request for Hearing, at 2. Later, in her Response to
Government's Motion for Summary Disposition, she further specified that
she ``misunderstood'' Liability Questions 2 and 3, but her purported
explanation disregards the actual wording of the questions. Att. 3 to
Resp. Reply, at 2. For example, as to Liability Question 2, Respondent
claims she misunderstood that question because her registration was
surrendered voluntarily, and was not revoked, suspended or denied. Id.
However, Liability Question 2 not only asked whether the applicant ever
had a registration ``revoked, suspended, restricted or denied,'' but
also expressly asked whether any registration had ever been surrendered
for cause. Ex. 1 to Govt. Mot. Moreover, Respondent stipulated that her
prior registration was surrendered for cause, so her negative answer
was clearly false, and her claimed ``misunderstanding'' of Liability
Question 2 rings hollow. See Shannon L. Gallentine, D.P.M., 76 FR
45864, 45866 (2011).
Similarly, Respondent's claim that she misunderstood Liability
Question 3 also ignores the question itself. Respondent explained her
``misunderstanding'' as to Liability Question 3 as follows: ``As to
question #3, again Ms. Cordova['s] Registration was not revoked,
suspended, denied, restricted, or placed on probation, nor is [sic] any
such action was pending when she voluntarily surrender [sic] her
Registration.'' Att. 3 to Resp. Reply, at 2. However, Liability
Question 3 actually inquires: ``Has the applicant ever surrendered (for
cause) or had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed on
probation, or is any such action pending?'' Ex. 1 to Govt. Mot.
(emphasis added). It is undisputed that Respondent's state professional
license for Michigan was suspended, and she clearly knew it was
suspended, because she is the one who agreed to that suspension in
writing when she entered into a Consent Order with the State of
Michigan Board of Medicine. Thus, Respondent's claimed misunderstanding
of Liability Question 3 is untenable on its face.
Moreover, applicants for DEA registrations bear ```the
responsibility to carefully read the question and to honestly answer
all parts of the question.''' Arnold, 63 FR at 8688 (quoting Martha
Hernandez, M.D., 62 FR 61145, 61147 (1997)). Allegedly misunderstanding
or misinterpreting liability questions does not relieve the applicant
of this responsibility. Hernandez, 62 FR at 61147-48 (concluding
applicant committed material falsification despite misinterpreting one
question); see also Gallentine, 76 FR at 45866. Additionally,
inadvertence is legally irrelevant in resolving a material
falsification case because the Government only needs to prove that
Respondent ```knew or should have known''' that the answers were false.
Richard A. Herbert, M.D., 76 FR 53942, 53956 (2011) (quoting The
Lawsons, Inc., 72 FR 74334, 74338 (2007)) (emphasis added). See, e.g.,
Zavaleta, 78 FR at 27436, 27438-39 (ruling respondent materially
falsified his application even where respondent testified that he made
mistakes in filling out the application and ``should have give[n] [his
applications] more careful review''). Thus, Respondent's defense of
inadvertence, even if it were true, is legally inconsequential in
deciding whether she materially falsified her 2016 application.
Furthermore, the evidence that Respondent now holds a valid medical
license in good standing in Puerto Rico is simply not relevant in terms
of resolving the allegation that she materially falsified her
application. Resp. Reply, at 3; Att. 1-2 to Resp. Reply; Hernandez, 62
FR at 61147. The same holds true of the evidence that Respondent has
never been sued for malpractice or been the subject of a professional
complaint, except for the Michigan action, in her 19-20 year career.
Resp. Reply at Att. 3, para. 8, 10. With respect to Liability Questions
2 and 3 of Respondent's DEA Application, a material false statement is
a material false statement regardless of her professional credentials.
Although lack of intent to deceive and history of licensure are
relevant in assessing the appropriate sanction, what is most
dispositive is the fact that Respondent has not accepted responsibility
for her materially false statements. See Lon F. Alexander, M.D., 82 FR
49704, 49728 (2017); Arthur H. Bell, 80 FR 50035, 50041 (2015) (finding
that applicant's failure to accept responsibility for materially
falsifying application was ``reason alone to
[[Page 62907]]
conclude that he cannot be entrusted with a new registration''). I have
considered the fact that Respondent currently holds a medical license
in good standing in Puerto Rico, and her sworn statement that she has
never been sued for malpractice and received only one professional
complaint in her 19-20 year career. Att. 1-2 to Resp. Reply; Att. 3 to
Resp. Reply, at 2-4. None of these facts outweighs Respondent's
materially false application, especially given her failure to disclose
extensive and serious allegations against her involving the unlawful
prescribing of controlled substances. See William M. Knarr, D.O., 51 FR
2772, 2773 (1986). Thus, I find that this mitigating evidence fails to
diminish the gravity of her failure to reveal the alleged misconduct in
her state of prior registration.
Accordingly, based upon the foregoing, I conclude that the
Government was entitled to summary disposition on the allegation that
Respondent materially falsified her application for a new DEA
registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of Zelidah H. Cordova-
Velazco, M.D., for a DEA Certificate of Registration as a practitioner,
be, and it hereby is, denied. This Order is effective immediately.
Dated: November 20, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-26485 Filed 12-4-18; 8:45 am]
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