Bulk Manufacturer of Controlled Substances Application: Noramco Inc., 5984-5985 [2020-01959]
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5984
Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
and his registration is currently ‘‘in a
renewal pending status.’’ Id.
lotter on DSKBCFDHB2PROD with NOTICES
Registrant’s Exclusion
The evidence in the record
demonstrates that, on September 25,
2018, Judgment was entered against
Registrant in E.D. La. ‘‘based on
[Registrant’s] conviction on one count of
‘Conspiracy to Commit Health Care
Fraud,’ in violation of 18 U.S.C. 1349,
one count of ‘Conspiracy to Pay and
Receive Illegal Health Care Kickbacks,’
in violation of 18 U.S.C. 371, fifteen
counts of ‘Health Care Fraud,’ in
violation of 18 U.S.C. 1347 and 2, and
one count of ‘Obstruction of a Federal
Audit,’ in violation of 18 U.S.C. 1516
and 2.’’ RFAA EX 3 (Judgment in a
Criminal Case at 1, United States v.
Barnes, No. 2:15–cr–61–SM–JCW (E.D.
La. September 28, 2018).
By letter dated March 29, 2019, HHS
OIG notified Registrant of his exclusion
from Medicare, Medicaid, and all
federal health care programs under 42
U.S.C. 1320a–7(a) for a minimum period
of twenty-five years based on
Registrant’s felony convictions in E.D.
La. RFAA, EX 4 (hereinafter, Exclusion
Letter), at 1. The Exclusion Letter stated
that the period of exclusion was greater
than the minimum of five years, because
the acts resulting in conviction ‘‘caused
a financial loss to a government agency
or program or to one or more entities of
$50,000 or more,’’ and specifically, the
court ordered Registrant ‘‘to pay
approximately $10,850,200 in
restitution.’’ Id. at 2. Further, the HHS
OIG reasoned that ‘‘the acts were
committed over a period of one year or
more,’’ and specifically, that ‘‘the acts
occurred from November 2008 to about
May 2014.’’ Id. Finally, the HHS OIG
considered whether the Registrant was
incarcerated and found that the ‘‘court
sentenced [Registrant] to 60 months of
incarceration.’’ Id. Per the Exclusion
Letter, the exclusion became effective
twenty days from the date of the letter,
or April 18, 2019. Id. at 1. The
Exclusion Letter notified Registrant of
his appeal rights. Id. at 2–4.
Accordingly, I find that the HHS OIG
excluded Registrant from Medicare,
Medicaid, and all federal health care
programs under 42 U.S.C. 1320a–7(a) for
twenty-five years, effective April 18,
2019, based on Registrant’s convictions
in the E.D. La.
Discussion
Under Section 824(a) of the
Controlled Substances Act (hereinafter,
CSA), a registration may be suspended
or revoked upon a finding of one or
more of five grounds. Each subsection of
Section 824(a) provides an independent
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16:47 Jan 31, 2020
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ground to impose a sanction on a
registrant. Arnold E. Feldman, M.D., 82
FR 39614, 39617 (2017); see also Gilbert
L. Franklin, D.D.S., 57 FR 3441 (1992)
(‘‘[M]andatory exclusion from
participation in the Medicare program
constitutes an independent ground for
revocation pursuant to 21 U.S.C. [§ ]
824(a)(5).’’). The ground in 21 U.S.C.
824(a)(5) requires that the registrant
‘‘has been excluded (or directed to be
excluded) from participation in a
program pursuant to section 1320a–7(a)
of Title 42.’’ 42 U.S.C. 1320a–7(a)
provides a list of four predicate offenses
for which exclusion from Medicare,
Medicaid, and other federal health care
programs is mandatory and sets out
mandatory timeframes for such
exclusion. Id.
When a registrant facing a sanction
under 21 U.S.C. 824(a)(5) offers no
mitigating evidence for the
Administrator to consider, ‘‘it is
reasonable that the Administrator might
revoke or suspend.’’ Jeffrey Stein, M.D.,
84 FR 46968, 46971 (2019); see, e.g.,
Narciso A. Reyes, M.D., 83 FR 61678,
61681 (2018); Richard Hauser, M.D., 83
FR 26308, 26310 (2018). Further,
‘‘[t]here does not need to be a nexus to
controlled substances to make a
connection between the activity that
caused the mandatory exclusion and the
potential for abuse of a DEA
registration.’’ Jeffrey Stein, M.D., 84 FR
at 46972; Narciso Reyes, M.D., 83 FR at
61681; KKK Pharmacy, 64 FR 49507,
49510 (1999) (collecting cases); Melvin
N. Seglin, M.D., 63 Red. Reg. 70431,
70433 (1998); Stanley Dubin, D.D.S., 61
FR 60727, 60728 (1996).
Here, there is no dispute in the record
that Registrant is mandatorily excluded
pursuant to Section 1320a–7(a) of Title
42 and, therefore, that a ground for the
revocation or suspension of Registrant’s
registration exists. 21 U.S.C. 824(a)(5).
Indeed, Registrant was convicted of
multiple counts involving fraud,
kickbacks, and obstruction of a federal
audit. The HHS OIG estimated that
Registrant’s criminality spanned six
years and resulted in a financial loss of
approximately $10,850,200. RFAA, EX
4, at 2.
Where, as here, the Government has
met its prima facie burden of showing
that a ground for revocation exists, the
burden shifts to the Registrant to show
why he can be entrusted with a
registration. See Jeffrey Stein, M.D., 84
FR at 46972. Registrant, as already
discussed, failed to respond in any way
to the OSC. See RFAA, at 6. Therefore,
among other things, Registrant has not
accepted responsibility for his
criminality, shown any remorse for it, or
provided any assurance that he would
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Sfmt 4703
not repeat it. See Jeffrey Stein, M.D., 84
FR at 46972–74. Such silence weighs
against the Registrant’s continued
registration. Zvi H. Perper, M.D., 77 FR
64131, 64142 (2012) (citing Medicine
Shoppe-Jonesborough, 73 FR 264, 387
(2008); Samuel S. Jackson, 72 FR 23848,
23853 (2007)); see also Jones Total
Health Care Pharmacy, LLC v. Drug
Enf’t Admin., 881 F.3d 823, 831 (11th
Cir. 2018) (‘‘ ‘An agency rationally may
conclude that past performance is the
best predictor of future performance.’ ’’
(quoting Alra Laboratories, Inc. v. Drug
Enf’t Admin., 54 F.3d 450, 452 (7th Cir.
1995))).
Based on the record before me, I
conclude that Registrant’s founded
criminality involving dishonesty and
obstruction, resulting in his exclusion
from Medicare, Medicaid, and all
federal health care programs, makes him
ineligible for a DEA registration at this
time. Accordingly, I shall order the
sanctions the Government requested, as
contained in the Order below.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. BB1040269 issued to
Shelton W. Barnes, M.D. Further, I
hereby deny any pending application of
Shelton W. Barnes, M.D., to renew or
modify this registration, as well as any
pending application of Shelton W.
Barnes, M.D., for registration in
Louisiana. This Order is effective March
4, 2020.
Dated: January 3, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020–01967 Filed 1–31–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–576]
Bulk Manufacturer of Controlled
Substances Application: Noramco Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 3, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
DATES:
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5985
Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on July 17, 2019, Noramco
Inc., 1550 Olympic Drive, Athens,
SUPPLEMENTARY INFORMATION:
Georgia 30601 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
Drug code
Cathinone .................................................................................................................................................................
Gamma Hydroxybutyric Acid ...................................................................................................................................
Marihuana Extract ....................................................................................................................................................
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
Codeine-N-oxide ......................................................................................................................................................
Dihydromorphine ......................................................................................................................................................
Hydromorphinol ........................................................................................................................................................
Morphine-N-oxide ....................................................................................................................................................
Normorphine ............................................................................................................................................................
Amphetamine ...........................................................................................................................................................
Lisdexamfetamine ....................................................................................................................................................
Methylphenidate .......................................................................................................................................................
Nabilone ...................................................................................................................................................................
Codeine ....................................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Oxycodone ...............................................................................................................................................................
Hydromorphone .......................................................................................................................................................
Hydrocodone ............................................................................................................................................................
Levorphanol .............................................................................................................................................................
Morphine ..................................................................................................................................................................
Oripavine ..................................................................................................................................................................
Thebaine ..................................................................................................................................................................
Oxymorphone ..........................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Alfentanil ..................................................................................................................................................................
Sufentanil .................................................................................................................................................................
Carfentanil ................................................................................................................................................................
Tapentadol ...............................................................................................................................................................
Fentanyl ...................................................................................................................................................................
The company plans to manufacture
bulk active pharmaceutical ingredients
(APIs) and reference standards for
distribution to their customers.
In reference to drug codes 7350
(marihuana extract), 7360 (marihuana),
and 7370 (tetrahydrocannabinols), the
company plans to bulk manufacture
these drugs as synthetics. No other
activities for these drugs are authorized
for this registration.
Dated: January 24, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–01959 Filed 1–31–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
lotter on DSKBCFDHB2PROD with NOTICES
[Docket No. DEA–567]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturers of Marihuana:
Spocannabis LLC
ACTION:
Notice of application.
The Drug Enforcement
Administration (DEA) is providing
SUMMARY:
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16:47 Jan 31, 2020
Jkt 250001
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic classes of
controlled substances listed in schedule
I. Prior to making decisions on this and
other pending applications, DEA
intends to promulgate regulations that
govern the program of growing
marihuana for scientific and medical
research under DEA registration.
DATES: Registered bulk manufacturers of
the affected basic classes, and
applicants therefor, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 3, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW 8701
Morrissette Drive, Springfield, Virginia
22152. To ensure proper handling of
comments, please reference ‘‘Docket No.
DEA–567’’ in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
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1235
2010
7350
7360
7370
9053
9145
9301
9307
9313
1100
1205
1724
7379
9050
9120
9143
9150
9193
9220
9300
9330
9333
9652
9668
9737
9740
9743
9780
9801
Schedule
I
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
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II
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II
II
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
classes, and applicants therefor, may file
written comments on or objections of
the requested registration, as provided
in this notice. This notice does not
constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA registered
researchers. If its application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a Bulk
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]]>Agencies
[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5984-5985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01959]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-576]
Bulk Manufacturer of Controlled Substances Application: Noramco
Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before April 3, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701
[[Page 5985]]
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on July 17, 2019, Noramco Inc., 1550 Olympic Drive,
Athens, Georgia 30601 applied to be registered as a bulk manufacturer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone............................... 1235 I
Gamma Hydroxybutyric Acid............... 2010 I
Marihuana Extract....................... 7350 I
Marihuana............................... 7360 I
Tetrahydrocannabinols................... 7370 I
Codeine-N-oxide......................... 9053 I
Dihydromorphine......................... 9145 I
Hydromorphinol.......................... 9301 I
Morphine-N-oxide........................ 9307 I
Normorphine............................. 9313 I
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
Nabilone................................ 7379 II
Codeine................................. 9050 II
Dihydrocodeine.......................... 9120 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Levorphanol............................. 9220 II
Morphine................................ 9300 II
Oripavine............................... 9330 II
Thebaine................................ 9333 II
Oxymorphone............................. 9652 II
Noroxymorphone.......................... 9668 II
Alfentanil.............................. 9737 II
Sufentanil.............................. 9740 II
Carfentanil............................. 9743 II
Tapentadol.............................. 9780 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to manufacture bulk active pharmaceutical
ingredients (APIs) and reference standards for distribution to their
customers.
In reference to drug codes 7350 (marihuana extract), 7360
(marihuana), and 7370 (tetrahydrocannabinols), the company plans to
bulk manufacture these drugs as synthetics. No other activities for
these drugs are authorized for this registration.
Dated: January 24, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-01959 Filed 1-31-20; 8:45 am]
BILLING CODE 4410-09-P
