[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21268-21269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07999]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-616]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Denco, LLC
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 June 15, 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-616 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
[[Page 21269]]
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 March 2, 2020, Denco, LLC, 5155 East 46th Avenue, Denver, Colorado
80216, 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............................. 7360 I
Tetrahydrocannabinols................. 7370 I
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The applicant's notice 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. In order to complete the
evaluation and registration process for applicants to grow marihuana,
DEA has proposed regulations that, if finalized, would supersede the
2016 policy statement and govern persons seeking to become registered
with DEA to grow marihuana as a bulk manufacturer, consistent with
applicable law. The proposed regulations are available at 85 FR 16292.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-07999 Filed 4-15-20; 8:45 am]
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