Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturers of Marihuana: Spocannabis LLC, 5985-5986 [2020-01966]

Download as PDF 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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 II II II II II II II II II II II 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 E:\FR\FM\03FEN1.SGM 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]


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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