82 FR 60041 - Michel P. Toret, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 241 (December 18, 2017)

Page Range		60041-60044
FR Document		2017-27186
Federal Register, Volume 82 Issue 241 (Monday, December 18, 2017)
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60041-60044]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27186]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Michel P. Toret, M.D.; Decision and Order

    On July 13, 2017, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Michel P. Toret, M.D. 
(hereinafter, Applicant) of Jeannette, Pennsylvania. GX 5. The Show 
Cause Order proposed the denial of Applicant's application for a DEA 
Certificate of Registration on the ground that Applicant's 
``registration is inconsistent with the public interest.'' GX 5, at 1 
(citing 21 U.S.C. 823(f)).
    As to the Agency's jurisdiction, the Show Cause Order alleged that, 
on February 14, 2017, Applicant applied for DEA Certificate of 
Registration. GX 5, at 2. See also GX 4 (DEA Form 224 submitted by 
Applicant).
    As the substantive grounds for the proceeding, the Show Cause Order 
alleged that Applicant was registered with the DEA as a practitioner in 
schedules II through V pursuant to Certificate of Registration No. 
AT9432460, and that Applicant surrendered that registration for cause 
on November 29, 2016. GX 5, at 1. The Show Cause Order further alleged 
that Applicant ``continued to issue prescriptions for controlled 
substances'' after he surrendered that DEA registration. GX 5, at 2. 
According to the Show Cause Order, ``DEA's investigation of . . . 
[Applicant's] medical practice reveals that . . . [Applicant] issued 
approximately 17 prescriptions for controlled substances after November 
29, 2016 in violation of Federal law.'' Id. (citing 21 U.S.C. 841(a) 
and 843(a)(2)).
    The Show Cause Order further alleged that Applicant materially 
falsified his application for a Certificate of Registration. GX 5, at 
2. Specifically, the Show Cause Order alleged that Applicant's material 
falsification was his having ``answered `no' when asked, `[h]as the 
applicant ever surrendered (for cause) or had a federal controlled 
substance(s) registration revoked, suspended, restricted, or denied, or 
is any such answer pending.' '' GX 5, at 2. According to the Show Cause 
Order, ``this answer represents a material falsification on an 
application for a DEA Registration and, as such, is sufficient for 
denial of the pending application.'' GX 5, at 2 (citing 21 U.S.C. 
843(a)(4) and 824(a)(1)).
    The Show Cause Order notified Applicant of his right to request a 
hearing on the allegations or to submit a written statement while 
waiving his right to a hearing, the procedures for electing each 
option, and the consequences for failing to elect either option. GX 5, 
at 2 (citing 21 CFR 1301.43). The Show Cause Order also notified 
Applicant of the opportunity to submit a corrective action plan. GX 5, 
at 3 (citing 21 U.S.C. 824(c)(2)(C)).

Adequacy of Service

    By Declaration dated August 23, 2017, a Diversion Investigator 
(hereinafter, DI), who described herself as the lead DI assigned to the 
regulatory matter involving Applicant, stated that, on July 21, 2017, 
she ``personally served Registrant with a copy of the Order to Show 
Cause why Registrant's application for a new DEA COR should not be 
denied.'' GX 6, at 2 (hereinafter, DI Declaration). Based on the 
Government's sworn statement, I find that the Government's service of 
the Show Cause Order on Applicant was legally sufficient.
    In its Request for Final Agency Action dated August 25, 2017, the 
Government represented that ``more than thirty days have passed since 
the Order to Show Cause was served on . . . [Applicant] and no request 
for hearing or other correspondence has been received by DEA.'' Request 
for Final Agency Action (hereinafter, RFAA), at 1. The Government 
requested that Applicant's application for a DEA Certificate of 
Registration be denied based on Applicant's ``issuing prescriptions 
without a DEA COR and then committing a material falsification on his 
subsequent application for a new DEA COR.'' RFAA, at 5.
    Based on the Government's sworn statement and written 
representations, and based on my review of the record, I find that more 
than 30 days have now passed since the date on which Applicant was 
served with the Show Cause Order. Further, based on the Government's 
written representations, I find that neither Applicant, nor anyone 
purporting to represent him, has requested a hearing, submitted a 
written statement while waiving Applicant's right to a hearing, or 
submitted a corrective action plan. Accordingly, I find that Applicant 
has waived his right to a hearing and his right to submit a written 
statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 
824(c)(2)(C). I, therefore, issue this Decision and Order based on the 
record submitted by the Government. 21 CFR 1301.43(e).

Findings of Fact

Jurisdictional Facts

    On or about February 13, 2017, Applicant submitted an application 
for a DEA registration under the Controlled Substances Act. GX 4. On 
that application, Applicant certified to the truth and correctness of 
the information he furnished on the application, including that he 
never ``surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied.'' Id. at 1. 
Based on the evidence in the record, I find that this certification was 
false.

[[Page 60042]]

Applicant's Voluntary Surrender of His Registration

    Applicant, a medical doctor, previously held DEA Certificate of 
Registration AT9432460, pursuant to which he was authorized to dispense 
controlled substances in schedules II-V, at the address of Colony 
Building, 8962 Hill Drive, North Huntingdon, PA 15642. GX 1. On 
November 29, 2016, Applicant signed a ``Voluntary Surrender of 
Controlled Substances Privileges,'' Form DEA-104 (hereinafter, 
Voluntary Surrender Form). GX 2. According to the Voluntary Surrender 
Form he signed, Applicant ``freely and under no duress, implied or 
express, execute[d] . . . [the] document and . . . [chose] to take the 
actions . . . [i]n view of . . . [his] alleged failure to comply with 
the Federal requirements pertaining to controlled substances, and as an 
indication of . . . [his] good faith in desiring to remedy any 
incorrect or unlawful practices.'' Id. Applicant's signed Voluntary 
Surrender Form stated that Applicant voluntarily surrendered his DEA 
registration certificate, unused order forms, and all controlled 
substances. Id. It also stated that, ``I understand that, beginning on 
the date that I sign below, I am not authorized to order, manufacture, 
distribute, possess, dispense, administer, prescribe, or engage in any 
other controlled substance activities whatsoever.'' Id.
    The only evidence the Government submitted with its RFAA concerning 
Applicant's voluntary surrender of his registration was the Voluntary 
Surrender Form. In other words, the Government did not submit any 
evidence concerning the events leading up to Applicant's voluntary 
surrender of his registration, the facts constituting Applicant's 
``alleged failure to comply with the Federal requirements pertaining to 
controlled substances,'' the specific Federal requirements that 
Applicant was alleged to have violated, or the resolution, if any, of 
the allegations against Applicant referenced in the Voluntary Surrender 
Form.

Applicant's Issuance of Controlled Substance Prescriptions After He 
Voluntarily Surrendered His Registration

    According to the Government, after Applicant voluntarily 
surrendered his DEA registration, Applicant issued 17 prescriptions for 
controlled substances. GX 5, at 2; GX 3. See also GX 6, at 2 (DI 
Declaration). According to the DI Declaration, GX 3 consisted of copies 
of the prescriptions Applicant issued after November 29, 2016. GX 6, at 
2.
    I reviewed each page of GX 3. Based on my review of GX 3, 15 of the 
pages reflect prescriptions clearly written after November 29, 2016, 
the date Applicant voluntarily surrendered his DEA registration. GX 3, 
at 1-8, 10-12, 14-17. Of those 15, 14 clearly concerned at least one 
controlled substance. Id. at 1-3, 5-8, 10-12, 14-17. Based on my review 
of GX 3, the prescriptions Applicant issued after November 29, 2016 
included Suboxone and Subutex, controlled substances in schedule III; 
Ambien, Tramadol, Lunesta, and Xanax, controlled substances in schedule 
IV; and Lyrica, a controlled substance in schedule V. Id. at 1, 5, 7-8; 
id. at 2, 3, 6, 10, 11, 14-17; and id. at 12, respectively.
    Thirteen of the pages in GX 3 were written on Applicant's 
prescription pad and included the number of the registration that 
Applicant voluntarily surrendered on November 29, 2016. GX 3, at 1, 3-
11, 13, 14, 17. Two of the pages in GX 3 were written on Applicant's 
prescription pad but did not show a DEA registration number on the line 
after ``DEA #.'' GX 3, at 2, 12. See 21 CFR 1306.05(a) (``All 
prescriptions for controlled substances shall be dated as of, and 
signed on, the day when issued and shall bear the . . . registration 
number of the practitioner.''). Two of the pages in GX 3 consisted of 
``365 Hospice LLC'' ``Medication Profile'' for patient PS and 
indicated, in their top right corner, that Applicant issued two ``new'' 
schedule IV prescriptions for patient PS on December 2nd and 19th, 
2016. GX 3, at 15-16.
    Based on my review of the Government's evidence, I find that 
Applicant issued at least 14 controlled substance prescriptions after 
he voluntarily surrendered his registration on November 29, 2016.

Discussion

    Pursuant to section 303(f) of the Controlled Substances Act, 
hereinafter CSA, ``[t]he 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.'' 21 U.S.C. 823(f). Section 303(f) 
further 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.'' 
Id. In making the public interest determination, the CSA requires 
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) 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 15,227, 15,230 (2003). 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.'' Id. Moreover, while I am required to 
consider each of the factors, I ``need not make explicit findings as to 
each one,'' and I ``can `give each factor the weight . . . [I] 
determine[ ] is appropriate.' '' MacKay v. Drug Enforcement Admin., 664 
F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. Drug Enforcement 
Admin., 567 F.3d 215, 222 (6th Cir. 2009) quoting Hoxie v. Drug 
Enforcement Admin., 419 F.3d 477, 482 (6th Cir. 2005)). In other words, 
the public interest determination ``is not a contest in which score is 
kept; the Agency is not required to mechanically count up the factors 
and determine how many favor the Government and how many favor the 
registrant. Rather, it is an inquiry which focuses on protecting the 
public interest; what matters is the seriousness of the registrant's 
misconduct.'' Jayam Krishna-Iyer, 74 FR 459, 462 (2009).
    Pursuant to section 304(a)(1), the Attorney General is also 
authorized to suspend or revoke a registration ``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). It 
is well established that the various grounds for revocation or 
suspension of an existing registration that Congress enumerated in this 
section are also properly considered in deciding whether to grant or 
deny an application under section 303. See Richard J. Settles, D.O., 81 
FR 64,940, 64,945 (2016); Arthur H. Bell, D.O., 80 FR 50,035, 50,037 
(2015); The Lawsons, Inc., 72 FR 74,334, 74,338 (2007); Samuel S. 
Jackson, D.D.S., 72 FR 23,848, 23,852 (2007); Alan R. Schankman, M.D., 
63 FR 45,260, 45,260 (1998); Kuen H. Chen, M.D., 58 FR 65,401, 65,402 
(1993). Thus, the allegation that Applicant materially

[[Page 60043]]

falsified his application is properly considered in this proceeding. 
Richard J. Settles, supra, 81 FR at 64,945; Arthur H. Bell, supra, 80 
FR at 50,037; Samuel S. Jackson, supra, 72 FR at 23,852. Moreover, just 
as materially falsifying an application provides a basis for revoking 
an existing registration without proof of any other misconduct, see 21 
U.S.C. 824(a)(1), it also provides an independent and adequate ground 
for denying an application. Richard J. Settles, supra, 81 FR at 64,945; 
Arthur H. Bell, supra, 80 FR at 50,037; The Lawsons, Inc., supra, 72 FR 
at 74,338; Bobby Watts, M.D., 58 FR 46,995, 46,995 (1993); Shannon L. 
Gallentine, D.P.M., 76 FR 45,864, 45,865 (2011).
    The Government has the burden of proving that the requirements for 
a registration are not satisfied. 21 CFR 1301.44(d).
    Having considered all of the public interest factors, as well as 
the separate allegation that Applicant materially falsified his 
application for a DEA registration, I conclude that the Government has 
established that the granting of Applicant's application would not be 
in the public interest because Applicant issued controlled substance 
prescriptions after he voluntarily surrendered his DEA registration. 
Accordingly, even though the Government did not submit sufficient 
evidence to prove that Applicant's false application was ``materially 
false,'' I will order that Applicant's application be denied.

Acts Inconsistent With the Public Interest Factors

    In its Show Cause Order, the Government alleged that Applicant's 
registration would be inconsistent with the public interest as that 
term is defined in 21 U.S.C. 823(f). As to this allegation, I reviewed 
the evidence the Government submitted and determined that Applicant 
issued at least 14 controlled substance prescriptions after he 
voluntarily surrendered his registration on November 29, 2016. This 
evidence is properly considered in the public interest determination. 
21 U.S.C. 823(f)(2) and (4).

Factors Two and Four--The Registrant's Experience in Dispensing 
Controlled Substances and Compliance With Applicable Laws Related to 
Controlled Substances

The Dispensing Allegations
    With limited exceptions not applicable here, ``[e]very person who 
dispenses . . . any controlled substance . . . shall obtain from the 
Attorney General a registration.'' 21 U.S.C. 822(a)(2). See also 21 
U.S.C. 822(b) (authorizing registered persons to prescribe a controlled 
substance). Further, according to the CSA, it is unlawful for any 
person knowingly or intentionally to dispense a controlled substance 
except as authorized by the CSA. 21 U.S.C. 841(a)(1). See also 21 
U.S.C. 843(a)(2); 21 CFR 1306.03(a)(2).
    Factor Two is Applicant's experience in dispensing controlled 
substances. According to my review of the Government's evidence, 
Applicant issued at least 14 controlled substance prescriptions after 
he voluntarily surrendered his registration on November 29, 2016. 
Applicant's issuance of these controlled substance prescriptions after 
he voluntarily surrendered his registration was contrary to legal 
requirements.
    Factor Four is Applicant's compliance with applicable State, 
Federal, or local laws relating to controlled substances. The 
Government's evidence showed that Applicant issued at least 14 
controlled substance prescriptions when Applicant was not registered 
with the Agency and, thus, in violation of Federal law relating to 
controlled substances. 21 U.S.C. 841(a)(1); 21 U.S.C. 822(a)(2).
    I therefore find that the evidence with respect to Factors Two and 
Four supports the conclusion that issuing a registration to Applicant 
``would be inconsistent with the public interest.'' 21 U.S.C. 823(f).
The Material Falsification Allegation
    When Applicant submitted his application for a registration on or 
about February 13, 2017, he answered ``no'' to whether he had ``ever 
surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied.'' GX 4, at 1. As 
found above, this certification was false. The Government alleged that 
this false certification was ``materially false,'' but the Government 
did not provide sufficient evidence for a finding of material 
falsification.
    The Supreme Court has held that the ``most common formulation'' of 
the concept of materiality is that ``a concealment or misrepresentation 
is material if it `has a natural tendency to influence, or was capable 
of influencing, the decision of' the decisionmaking body to which it 
was addressed.'' Kungys v. United States, 485 U.S. 759, 770 (1988) 
(quoting Weinstock v. United States, 231 F.2d 699, 701 (DC Cir. 1956) 
(other citation omitted)). The Court explicitly addressed what has 
``never been the test of materiality[,] that the misrepresentation or 
concealment would more likely than not have produced an erroneous 
decision, or even that it would more likely than not have triggered an 
investigation.'' Kungys, supra, 485 U.S. at 771. Instead, the Court 
articulated the specific test as ``whether the misrepresentation or 
concealment was predictably capable of affecting, i.e., had a natural 
tendency to affect, the official decision.'' Id.
    The Government's only evidence concerning the material 
falsification allegation was the Voluntary Surrender Form Applicant 
executed on November 29, 2016. On that Form, Applicant checked the box 
indicating that he ``freely and under no duress, implied or express, 
execute[d] . . . [the] document and . . . [chose] to take the actions . 
. . [i]n view of . . . [his] alleged failure to comply with the Federal 
requirements pertaining to controlled substances, and as an indication 
of . . . [his] good faith in desiring to remedy any incorrect or 
unlawful practices.'' GX 2.
    This evidence, alone, is an insufficient basis for a finding of 
``material falsification.'' The Voluntary Surrender Form indicated 
nothing about Applicant's failure to comply with any requirement 
concerning controlled substances. The Government did not submit any 
evidence explaining why Government investigators had sought the 
surrender of Applicant's registration. Applicant's admitting to an 
``alleged failure'' to ``comply with Federal requirements pertaining to 
controlled substances'' indicated nothing about the nature of his 
``alleged failure,'' let alone how that ``alleged failure'' was 
relevant to any of the public interest factors or to any other ground 
which would support the denial of his application. Thus, Applicant's 
admission, standing alone, is insufficient for a determination that a 
``misrepresentation or concealment was predictably capable of 
affecting, i.e., had a natural tendency to affect, the official 
decision.'' Kungys, supra, 485 U.S. at 771.
    Accordingly, I find that the Government did not meet its burden of 
showing that Applicant's false certification constituted a ``material 
falsification.''

Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 
823(f), as well as 28 CFR 0.100(b), I order that Applicant's 
application for DEA Certificate of Registration be denied. This order 
is effective January 17, 2018.


[[Page 60044]]


    Dated: December 1, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-27186 Filed 12-15-17; 8:45 am]
 BILLING CODE 4410-09-P
Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60041

statement of the reasons why the inconsistent with the public interest.’’ Registrant with a copy of the Order to
Commission should grant such GX 5, at 1 (citing 21 U.S.C. 823(f)). Show Cause why Registrant’s
treatment. See 19 CFR 201.6. Documents As to the Agency’s jurisdiction, the application for a new DEA COR should
for which confidential treatment by the Show Cause Order alleged that, on not be denied.’’ GX 6, at 2 (hereinafter,
Commission is properly sought will be February 14, 2017, Applicant applied DI Declaration). Based on the
treated accordingly. All information, for DEA Certificate of Registration. GX Government’s sworn statement, I find
including confidential business 5, at 2. See also GX 4 (DEA Form 224 that the Government’s service of the
information and documents for which submitted by Applicant). Show Cause Order on Applicant was
confidential treatment is properly As the substantive grounds for the
legally sufficient.
sought, submitted to the Commission for proceeding, the Show Cause Order
purposes of this Investigation may be alleged that Applicant was registered In its Request for Final Agency Action
disclosed to and used: (i) By the with the DEA as a practitioner in dated August 25, 2017, the Government
Commission, its employees and Offices, schedules II through V pursuant to represented that ‘‘more than thirty days
and contract personnel (a) for Certificate of Registration No. have passed since the Order to Show
developing or maintaining the records AT9432460, and that Applicant Cause was served on . . . [Applicant]
of this or a related proceeding, or (b) in surrendered that registration for cause and no request for hearing or other
internal investigations, audits, reviews, on November 29, 2016. GX 5, at 1. The correspondence has been received by
and evaluations relating to the Show Cause Order further alleged that DEA.’’ Request for Final Agency Action
programs, personnel, and operations of Applicant ‘‘continued to issue (hereinafter, RFAA), at 1. The
the Commission including under 5 prescriptions for controlled substances’’ Government requested that Applicant’s
U.S.C. Appendix 3; or (ii) by U.S. after he surrendered that DEA application for a DEA Certificate of
government employees and contract registration. GX 5, at 2. According to the Registration be denied based on
personnel,1 solely for cybersecurity Show Cause Order, ‘‘DEA’s
Applicant’s ‘‘issuing prescriptions
purposes. All nonconfidential written investigation of . . . [Applicant’s]
without a DEA COR and then
submissions will be available for public medical practice reveals that . . .
[Applicant] issued approximately 17 committing a material falsification on
inspection at the Office of the Secretary his subsequent application for a new
and on EDIS. prescriptions for controlled substances
after November 29, 2016 in violation of DEA COR.’’ RFAA, at 5.
The Commission has also determined
to extend the target date for completion Federal law.’’ Id. (citing 21 U.S.C. 841(a) Based on the Government’s sworn
of the above-captioned investigation to and 843(a)(2)). statement and written representations,
The Show Cause Order further alleged and based on my review of the record,
February 20, 2018.
that Applicant materially falsified his I find that more than 30 days have now
The authority for the Commission’s
application for a Certificate of passed since the date on which
determination is contained in section
Registration. GX 5, at 2. Specifically, the Applicant was served with the Show
337 of the Tariff Act of 1930, as
Show Cause Order alleged that Cause Order. Further, based on the
amended (19 U.S.C. 1337), and in part
Applicant’s material falsification was Government’s written representations, I
210 of the Commission’s Rules of
his having ‘‘answered ‘no’ when asked, find that neither Applicant, nor anyone
Practice and Procedure (19 CFR part
‘[h]as the applicant ever surrendered
210). purporting to represent him, has
(for cause) or had a federal controlled
By order of the Commission. requested a hearing, submitted a written
substance(s) registration revoked,
Issued: December 12, 2017. suspended, restricted, or denied, or is statement while waiving Applicant’s
Lisa R. Barton, any such answer pending.’ ’’ GX 5, at 2. right to a hearing, or submitted a
According to the Show Cause Order, corrective action plan. Accordingly, I
Secretary to the Commission.
‘‘this answer represents a material find that Applicant has waived his right
[FR Doc. 2017–27168 Filed 12–15–17; 8:45 am]
falsification on an application for a DEA to a hearing and his right to submit a
BILLING CODE 7020–02–P
Registration and, as such, is sufficient written statement and corrective action
for denial of the pending application.’’ plan. 21 CFR 1301.43(d) and 21 U.S.C.
GX 5, at 2 (citing 21 U.S.C. 843(a)(4) and 824(c)(2)(C). I, therefore, issue this
DEPARTMENT OF JUSTICE 824(a)(1)). Decision and Order based on the record
The Show Cause Order notified submitted by the Government. 21 CFR
Drug Enforcement Administration
Applicant of his right to request a 1301.43(e).
Michel P. Toret, M.D.; Decision and hearing on the allegations or to submit
a written statement while waiving his Findings of Fact
Order
right to a hearing, the procedures for Jurisdictional Facts
On July 13, 2017, the Acting Assistant electing each option, and the
Administrator, Diversion Control consequences for failing to elect either On or about February 13, 2017,
Division, Drug Enforcement option. GX 5, at 2 (citing 21 CFR Applicant submitted an application for
Administration (hereinafter, DEA or 1301.43). The Show Cause Order also a DEA registration under the Controlled
Government), issued an Order to Show notified Applicant of the opportunity to Substances Act. GX 4. On that
Cause to Michel P. Toret, M.D. submit a corrective action plan. GX 5, at application, Applicant certified to the
(hereinafter, Applicant) of Jeannette, 3 (citing 21 U.S.C. 824(c)(2)(C)). truth and correctness of the information
Pennsylvania. GX 5. The Show Cause he furnished on the application,
daltland on DSKBBV9HB2PROD with NOTICES

Order proposed the denial of Adequacy of Service
including that he never ‘‘surrendered
Applicant’s application for a DEA By Declaration dated August 23, 2017, (for cause) or had a federal controlled
Certificate of Registration on the ground a Diversion Investigator (hereinafter,
substance registration revoked,
that Applicant’s ‘‘registration is DI), who described herself as the lead DI
suspended, restricted or denied.’’ Id. at
assigned to the regulatory matter
1 All contract personnel will sign appropriate involving Applicant, stated that, on July 1. Based on the evidence in the record,
nondisclosure agreements. 21, 2017, she ‘‘personally served I find that this certification was false.

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falsified his application is properly 822(a)(2). See also 21 U.S.C. 822(b) produced an erroneous decision, or
considered in this proceeding. Richard (authorizing registered persons to even that it would more likely than not
J. Settles, supra, 81 FR at 64,945; Arthur prescribe a controlled substance). have triggered an investigation.’’
H. Bell, supra, 80 FR at 50,037; Samuel Further, according to the CSA, it is Kungys, supra, 485 U.S. at 771. Instead,
S. Jackson, supra, 72 FR at 23,852. unlawful for any person knowingly or the Court articulated the specific test as
Moreover, just as materially falsifying intentionally to dispense a controlled ‘‘whether the misrepresentation or
an application provides a basis for substance except as authorized by the concealment was predictably capable of
revoking an existing registration without CSA. 21 U.S.C. 841(a)(1). See also 21 affecting, i.e., had a natural tendency to
proof of any other misconduct, see 21 U.S.C. 843(a)(2); 21 CFR 1306.03(a)(2). affect, the official decision.’’ Id.
U.S.C. 824(a)(1), it also provides an Factor Two is Applicant’s experience
independent and adequate ground for in dispensing controlled substances. The Government’s only evidence
denying an application. Richard J. According to my review of the concerning the material falsification
Settles, supra, 81 FR at 64,945; Arthur Government’s evidence, Applicant allegation was the Voluntary Surrender
H. Bell, supra, 80 FR at 50,037; The issued at least 14 controlled substance Form Applicant executed on November
Lawsons, Inc., supra, 72 FR at 74,338; prescriptions after he voluntarily 29, 2016. On that Form, Applicant
Bobby Watts, M.D., 58 FR 46,995, 46,995 surrendered his registration on checked the box indicating that he
(1993); Shannon L. Gallentine, D.P.M., November 29, 2016. Applicant’s ‘‘freely and under no duress, implied or
76 FR 45,864, 45,865 (2011). issuance of these controlled substance express, execute[d] . . . [the] document
The Government has the burden of prescriptions after he voluntarily and . . . [chose] to take the actions . . .
proving that the requirements for a surrendered his registration was [i]n view of . . . [his] alleged failure to
registration are not satisfied. 21 CFR contrary to legal requirements. comply with the Federal requirements
1301.44(d). Factor Four is Applicant’s compliance pertaining to controlled substances, and
Having considered all of the public with applicable State, Federal, or local
as an indication of . . . [his] good faith
interest factors, as well as the separate laws relating to controlled substances.
in desiring to remedy any incorrect or
allegation that Applicant materially The Government’s evidence showed
that Applicant issued at least 14 unlawful practices.’’ GX 2.
falsified his application for a DEA
registration, I conclude that the controlled substance prescriptions when This evidence, alone, is an
Government has established that the Applicant was not registered with the insufficient basis for a finding of
granting of Applicant’s application Agency and, thus, in violation of ‘‘material falsification.’’ The Voluntary
would not be in the public interest Federal law relating to controlled Surrender Form indicated nothing about
because Applicant issued controlled substances. 21 U.S.C. 841(a)(1); 21 Applicant’s failure to comply with any
substance prescriptions after he U.S.C. 822(a)(2). requirement concerning controlled
I therefore find that the evidence with substances. The Government did not
voluntarily surrendered his DEA
respect to Factors Two and Four submit any evidence explaining why
registration. Accordingly, even though
supports the conclusion that issuing a Government investigators had sought
the Government did not submit
registration to Applicant ‘‘would be the surrender of Applicant’s
sufficient evidence to prove that
inconsistent with the public interest.’’ registration. Applicant’s admitting to an
Applicant’s false application was
21 U.S.C. 823(f).
‘‘materially false,’’ I will order that ‘‘alleged failure’’ to ‘‘comply with
Applicant’s application be denied. The Material Falsification Allegation Federal requirements pertaining to
Acts Inconsistent With the Public When Applicant submitted his controlled substances’’ indicated
Interest Factors application for a registration on or about nothing about the nature of his ‘‘alleged
February 13, 2017, he answered ‘‘no’’ to failure,’’ let alone how that ‘‘alleged
In its Show Cause Order, the failure’’ was relevant to any of the
whether he had ‘‘ever surrendered (for
Government alleged that Applicant’s public interest factors or to any other
cause) or had a federal controlled
registration would be inconsistent with ground which would support the denial
substance registration revoked,
the public interest as that term is
suspended, restricted or denied.’’ GX 4, of his application. Thus, Applicant’s
defined in 21 U.S.C. 823(f). As to this
at 1. As found above, this certification admission, standing alone, is
allegation, I reviewed the evidence the
was false. The Government alleged that insufficient for a determination that a
Government submitted and determined
this false certification was ‘‘materially ‘‘misrepresentation or concealment was
that Applicant issued at least 14
false,’’ but the Government did not predictably capable of affecting, i.e., had
controlled substance prescriptions after
provide sufficient evidence for a finding a natural tendency to affect, the official
he voluntarily surrendered his
of material falsification. decision.’’ Kungys, supra, 485 U.S. at
registration on November 29, 2016. This The Supreme Court has held that the
evidence is properly considered in the 771.
‘‘most common formulation’’ of the
public interest determination. 21 U.S.C. concept of materiality is that ‘‘a Accordingly, I find that the
823(f)(2) and (4). concealment or misrepresentation is Government did not meet its burden of
Factors Two and Four—The Registrant’s material if it ‘has a natural tendency to showing that Applicant’s false
Experience in Dispensing Controlled influence, or was capable of influencing, certification constituted a ‘‘material
Substances and Compliance With the decision of’ the decisionmaking falsification.’’
Applicable Laws Related to Controlled body to which it was addressed.’’ Order
Substances Kungys v. United States, 485 U.S. 759,
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770 (1988) (quoting Weinstock v. United Pursuant to the authority vested in me
The Dispensing Allegations States, 231 F.2d 699, 701 (DC Cir. 1956) by 21 U.S.C. 824(a) and 823(f), as well
With limited exceptions not (other citation omitted)). The Court as 28 CFR 0.100(b), I order that
applicable here, ‘‘[e]very person who explicitly addressed what has ‘‘never Applicant’s application for DEA
dispenses . . . any controlled substance been the test of materiality[,] that the Certificate of Registration be denied.
. . . shall obtain from the Attorney misrepresentation or concealment This order is effective January 17, 2018.
General a registration.’’ 21 U.S.C. would more likely than not have

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60044 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices

Dated: December 1, 2017. —Enhance the quality, utility, and DEPARTMENT OF LABOR
Robert W. Patterson, clarity of the information to be
Acting Administrator. collected; and Office of the Secretary
[FR Doc. 2017–27186 Filed 12–15–17; 8:45 am] —Minimize the burden of the collection Postponement of Meeting of the Labor
BILLING CODE 4410–09–P of information on those who are to Advisory Committee for Trade
respond, including through the use of Negotiation and Trade Policy
appropriate automated, electronic,
DEPARTMENT OF JUSTICE mechanical, or other technological AGENCY: Bureau of International Labor
collection techniques or other forms Affairs, U.S. Department of Labor and
[OMB Number 1110–NEW] Office of the United States Trade
of information technology, e.g.,
Agency Information Collection permitting electronic submission of Representative, Labor Advisory
Activities; Proposed eCollection, Committee for Trade Negotiations and
responses.
eComments Requested; Crime Data Trade Policy.
Explorer Feedback Survey Overview of This Information ACTION: Notice of postponement of
Collection meeting.
AGENCY: Federal Bureau of
Investigation, Department of Justice. (1) Type of Information Collection: SUMMARY: Notice is hereby given that a
ACTION: 30-Day notice. New collection. meeting of the Labor Advisory
(2) The Title of the Form/Collection: Committee for Trade Negotiation and
SUMMARY: Department of Justice (DOJ), Crime Data Explorer Feedback Survey. Trade Policy has been postponed until
Federal Bureau of Investigation, further notice. This meeting, which was
Criminal Justice Information Services (3) The agency form number, if any, closed to the public, was scheduled for
Division will be submitting the and the applicable component of the December 15, 2017, from 2 p.m. to 4
following information collection request Department sponsoring the collection: p.m., at the U.S. Department of Labor,
to the Office of Management and Budget No form number. The applicable Secretary’s Conference Room, 200
(OMB) for review and approval in component within the Department of Constitution Ave. NW, Washington, DC.
accordance with the Paperwork Justice is the Criminal Justice DATES: The meeting scheduled for
Reduction Act of 1995. Information Services Division, in the December 15, 2017, is cancelled.
DATES: Comments are encouraged and Federal Bureau of Investigation. FOR FURTHER INFORMATION CONTACT:
will be accepted for an additional 30 (4) Affected public who will be asked Anne M. Zollner, Chief, Trade Policy
day until January 17, 2018. or required to respond, as well as a brief and Negotiations Division; Phone: (202)
FOR FURTHER INFORMATION CONTACT: abstract: Primary: Law enforcement, 693–4890.
Written comments and/or suggestions academia and the general public. SUPPLEMENTARY INFORMATION: The
regarding the items contained in this Abstract: This survey is needed to original Federal Register notice
notice, especially the estimated public collect feedback on the functionality of announcing this meeting was published
burden and associated response time, the CDE in order to make improvements on November 17, 2017, at 82 FR 25011.
should be directed to Mrs. Amy Blasher, to the application. Signed at Washington, DC, the 13th day of
Unit Chief, Federal Bureau of (5) An estimate of the total number of December 2017.
Investigation, CJIS Division, Module E– respondents and the amount of time Martha E. Newton,
3, 1000 Custer Hollow Road, Clarksburg, Deputy Undersecretary, Bureau of
estimated for an average respondent to
West Virginia 26306; facsimile (304) International Labor Affairs.
respond: UCR Crime Data Explorer
625–3566. Written comments and/or [FR Doc. 2017–27182 Filed 12–13–17; 4:15 pm]
suggestions can also be sent to the Burden Estimation: It is estimated the
Office of Management and Budget, CDE will generate 200 feedback BILLING CODE 4510–28–P

Office of Information and Regulatory responses per year with an estimated
Affairs, Attention Department of Justice response time of 2 minutes per
response. DEPARTMENT OF LABOR
Desk Officer, Washington, DC 20503 or
sent to OIRA_submissions@ (6) An estimate of the total public Mine Safety and Health Administration
omb.eop.gov. burden (in hours) associated with the
collection: There are approximately 7 Petitions for Modification of
SUPPLEMENTARY INFORMATION: Written
hours, annual burden, associated with Application of Existing Mandatory
comments and suggestions from the
this information collection. Safety Standards
public and affected agencies concerning
the proposed collection of information If additional information is required AGENCY: Mine Safety and Health
are encouraged. Your comments should contact: Melody Braswell, Department Administration, Labor.
address one or more of the following Clearance Officer, United States ACTION: Notice.
four points: Department of Justice, Justice
—Evaluate whether the proposed Management Division, Policy and SUMMARY: This notice is a summary of
collection of information is necessary Planning Staff, Two Constitution petitions for modification submitted to
for the proper performance of the Square, 145 N Street NE, Suite 3E.405B, the Mine Safety and Health
functions of the agency, including Washington, DC 20530. Administration (MSHA) by the parties
daltland on DSKBBV9HB2PROD with NOTICES

whether the information will have listed below.
Dated: December 13, 2017.
practical utility; DATES: All comments on the petitions
—Evaluate the accuracy of the agency’s Melody Braswell, must be received by MSHA’s Office of
estimate of the burden of the Department Clearance Officer, PRA, U.S. Standards, Regulations, and Variances
proposed collection of information, Department of Justice. on or before January 17, 2018.
including the validity of the [FR Doc. 2017–27183 Filed 12–15–17; 8:45 am] ADDRESSES: You may submit your
methodology and assumptions used; BILLING CODE 4410–02–P comments, identified by ‘‘docket

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Document Created: 2017-12-15 23:54:57
Document Modified: 2017-12-15 23:54:57
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		82 FR 60041
82 FR 60041 - Michel P. Toret, M.D.; Decision and Order

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 82, Issue 241 (December 18, 2017)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
