[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Notices]
[Page 58392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20595]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-714]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: Bright Green Corporation

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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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 class(es) of controlled 
substances listed in schedule I. DEA intends to evaluate this and other 
pending applications according to proposed regulations that, if 
finalized, would govern the program of growing marihuana for scientific 
and medical research under DEA registration. Refer to Supplemental 
Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before November 17, 
2020. Such persons may also file a written request for a hearing on the 
application on or before November 17, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

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 class(es), 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 the 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 
manufacturer of marihuana, the application will be evaluated under the 
criteria of 21 U.S.C. 823(a). DEA proposes to conduct this evaluation 
in the manner described in the rule proposed at 85 FR 16292, published 
on March 23, 2020, if finalized.
    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on July 27, 2020, Bright Green Corporation, 1033 George Hanosh 
Boulevard, Grants, New Mexico 87020, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled substances:

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             Controlled  substance               Drug code     Schedule
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Marihuana Extract.............................         7350            I
Marihuana.....................................         7360            I
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    The applicant notice above applied to become registered with DEA to 
grow marihuana as a bulk manufacturer subsequent to a 2020 DEA notice 
of proposed rulemaking that provided information on how DEA intends to 
expand the number of registrations and described the way it would 
oversee those additional growers. If finalized, the proposed rule would 
govern persons seeking to become registered with DEA to grow marihuana 
as a bulk manufacturer, consistent with applicable law. The notice of 
proposed rulemaking is available at 85 FR 16292.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of the Food Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-20595 Filed 9-17-20; 8:45 am]
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