Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Spocannabis LLC, 5985-5986 [2020-01966]
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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:
VerDate Sep<11>2014
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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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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03FEN1
5986
Federal Register / Vol. 85, No. 22 / Monday, February 3, 2020 / Notices
Manufacturer of Marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a) as described
in 84 FR 44920, published on August
27, 2019.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on October 25, 2019, Spocannabis LLC,
1321 North Stanley Road, Suite B,
Spokane Valley, Washington 99212
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled
substance
Marihuana ...............
Tetrahydrocannabinols.
Drug code
Schedule
7360
7370
I
I
I
I
The applicant noticed above applied
to become registered with DEA to grow
marihuana as a bulk manufacturer
subsequent to a 2016 DEA policy
statement that provided information on
how it intended to expand the number
of registrations, and described in general
terms the way it would oversee those
additional growers. Before DEA
completes the evaluation and
registration process for applicants to
grow marihuana, DEA intends to
propose regulations in the near future
that would supersede the 2016 policy
statement and govern persons seeking to
become registered with DEA to grow
marihuana as bulk manufacturers,
consistent with applicable law, as
described in 84 FR 44920.
Dated: January 7, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–01966 Filed 1–31–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
lotter on DSKBCFDHB2PROD with NOTICES
Theresa L. Wendt, N.P.; Decision and
Order
On January 24, 2019, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter,
Government), issued an Order to Show
Cause to Theresa L. Wendt, N.P.,
(hereinafter, Registrant), of Milwaukee,
Wisconsin. Order to Show Cause
(hereinafter, OSC), at 1. The OSC
proposed the revocation of Registrant’s
Certificate of Registration No.
MW2120006. It alleged that Registrant is
‘‘without authority to handle controlled
substances in the State of Wisconsin,
the state in which . . . [she is]
VerDate Sep<11>2014
17:33 Jan 31, 2020
Jkt 250001
registered with the DEA.’’ Id. at 2 (citing
21 U.S.C. 824(a)(3)).
Specifically, the OSC alleged that the
Wisconsin Board of Nursing
(hereinafter, BON) issued an Order on
January 19, 2018, suspending
Registrant’s professional nursing
(hereinafter, RN) license and her
advanced practice nurse prescriber
(hereinafter, APNP) certificate. OSC, at
1. The OSC further alleged that
Registrant’s RN license expired on
February 28, 2018, and her APNP
certificate expired on September 30,
2018. Id. at 1–2.
The Show Cause Order notified
Registrant of the right to request a
hearing on its allegations or to submit a
written statement, while waiving the
right to a hearing, the procedures for
electing each option, and the
consequences for failing to elect either
option. Id. at 2 (citing 21 CFR 1301.43).
The OSC also notified Registrant of the
opportunity to submit a corrective
action plan. OSC, at 1, 2–3 (citing 21
U.S.C. 824(c)(2)(C)).
Adequacy of Service
In a Declaration dated April 2, 2019,
a Diversion Investigator (hereinafter, DI)
assigned to the Milwaukee District
Office, Chicago Field Division, stated
that she and a Special Agent
(hereinafter, SA) travelled to
Registrant’s home address on February
6, 2019, to personally serve Registrant
with the OSC. RFAA, Exhibit (EX) 4 (DI
Declaration), at 1. The DI stated she
‘‘knew this was Registrant’s home
address because it was the address
listed on her Wisconsin d[r]iver’s
license’’ and, upon arriving at the
residence, the DI ‘‘recognized Registrant
because [she] had previously met with
her.’’ Id. The DI further stated that she
‘‘personally served the [OSC] on
Registrant by handing it to her’’ and
‘‘Registrant signed a DEA–12, Receipt
for Cash or Other Items, acknowledging
her receipt’’ of the OSC. Id., see also
RFAA, EX 4B (executed DEA–12).
The Government forwarded its RFAA,
along with the evidentiary record, for
adjudication on April 3, 2019. The
Government represents that ‘‘at least
thirty days have passed since the time
the [OSC] was served on Registrant’’ and
she ‘‘has not requested a hearing and
has not otherwise corresponded or
communicated with DEA.’’ RFAA, at 2.
The Government requests that
‘‘Registrant’s DEA registration be
revoked based on 21 U.S.C. 824(a)(3)
because Registrant has no valid nursing
license in Wisconsin.’’ Id. at 3.
Based on the DI’s Declaration, the
Government’s written representations,
and my review of the record, I find that
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
the Government accomplished service
of the OSC on Registrant on February 6,
2019. I also find that more than thirty
days have now passed since the
Government accomplished service of
the OSC. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent Registrant,
requested a hearing, submitted a written
statement while waiving Registrant’s
right to a hearing, or submitted a
corrective action plan. Accordingly, I
find that Registrant has waived the right
to a hearing and the right to submit a
written statement and corrective action
plan. 21 CFR 1301.43(d) and 21 U.S.C.
824(c)(2)(C). I, therefore, issue this
Decision and Order based on the record
submitted by the Government, which
constitutes the entire record before me.
21 CFR 1301.43(e).
Findings of Fact
Registrant’s DEA Registration
On February 17, 2010, DEA Certificate
of Registration No. MW2120006 was
assigned to Registrant at the registered
address of 6001 W North Ave.,
Milwaukee, Wisconsin. RFAA, EX 5
(Certification of Registration History), at
1. This registration authorized
Registrant to dispense controlled
substances in schedules II through V as
a practitioner. Id. Registrant’s
registration expired on May 31, 2019. Id.
According to Agency records, Registrant
did not submit a renewal application
and her registration was retired on July
1, 2019.1
The Status of Registrant’s State
Licensure
On May 11, 2017, the Wisconsin BON
issued a Final Decision and Order
(hereinafter, collectively, Final
Decision) restricting Registrant’s RN
license and APNP certificate.2 RFAA,
EX 3, at 3–5. On January 19, 2018, the
BON determined that Registrant failed
to comply with the Final Decision’s
restrictions and issued an Order,
effective immediately, suspending both
Registrant’s RN license and her APNP
certificate. RFAA, EX 3, at 9 (Order
Suspending License).
1 The fact that a Registrant allows her registration
to expire during the pendency of an OSC does not
impact my jurisdiction or prerogative under the
Controlled Substances Act (hereinafter, CSA) to
adjudicate the OSC to finality. Jeffrey D. Olsen,
M.D., 84 FR 68474 (2019).
2 In its Final Decision, the BON found that
Registrant issued a controlled substance
prescription to an individual who was not a patient
at the pain clinic where Registrant was employed,
substituted her cell number for the clinic’s phone
number, and did not maintain a treatment record
at the clinic for that individual.
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 85, Number 22 (Monday, February 3, 2020)]
[Notices]
[Pages 5985-5986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01966]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-567]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturers of Marihuana: Spocannabis LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is providing 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 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
[[Page 5986]]
Manufacturer of Marihuana, the application will be evaluated under the
criteria of 21 U.S.C. 823(a) as described in 84 FR 44920, published on
August 27, 2019.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on October 25, 2019, Spocannabis LLC, 1321 North Stanley Road, Suite B,
Spokane Valley, Washington 99212 applied to be registered as a bulk
manufacturer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana............................ 7360 I
Tetrahydrocannabinols................ 7370 I
------------------------------------------------------------------------
The applicant noticed above applied to become registered with DEA
to grow marihuana as a bulk manufacturer subsequent to a 2016 DEA
policy statement that provided information on how it intended to expand
the number of registrations, and described in general terms the way it
would oversee those additional growers. Before DEA completes the
evaluation and registration process for applicants to grow marihuana,
DEA intends to propose regulations in the near future that would
supersede the 2016 policy statement and govern persons seeking to
become registered with DEA to grow marihuana as bulk manufacturers,
consistent with applicable law, as described in 84 FR 44920.
Dated: January 7, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-01966 Filed 1-31-20; 8:45 am]
BILLING CODE 4410-09-P
