[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Notices]
[Pages 68090-68091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23767]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-738]


Bulk Manufacturer of Controlled Substances Application: Bulk 
Manufacturer of Marihuana: API GLOBAL LLC

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.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefor, may file written comments on or objections to 
the issuance of the proposed registration on or before December 28, 
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-738 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 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.

[[Page 68091]]

    In accordance with 21 CFR 1301.33(a), DEA is providing notice that 
on September 15, 2020, API Global LLC, 30 Hillview Road, Lincoln Park, 
New Jersey 07035, applied to be registered as a bulk manufacturer of 
the following basic class(es) of controlled substances:

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                                           Drug
          Controlled substance             code          Schedule
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Tetrahydrocannabinols...................   7370  I
Marihuana Extract.......................   7350  I
Marihuana...............................   7360  I
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    The applicant noticed 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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-23767 Filed 10-26-20; 8:45 am]
BILLING CODE 4410-09-P