Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Maridose, LLC, 30983 [2021-12213]
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30983
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
import of the Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–12212 Filed 6–9–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–845]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Maridose,
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
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 its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
SUMMARY:
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 August 9, 2021.
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–845 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
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DATES:
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17:15 Jun 09, 2021
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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). In addition
to seeking to produce marihuana
extract, this applicant is separately
seeking to cultivate marihuana. See
Notice of Application, Bulk
Manufacturers of Marihuana, 84 FR
44920, 44922 (Aug. 27, 2019). DEA thus
will conduct this evaluation in the
manner described in the rule published
at 85 FR 82333 on December 18, 2020,
and reflected in DEA regulations at 21
CFR part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on May 6, 2021, Maridose, LLC., 74
Orion Street, Brunswick, Maine 04011,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Drug
code
Controlled substance
I
Marihuana Extract ........
7350
Schedule
II
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–12213 Filed 6–9–21; 8:45 am]
ACTION:
Notice of application.
National Center for Natural
Products Research has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to SUPPLEMENTARY INFORMATION
listed below for further drug
information.
SUMMARY:
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 July 12, 2021. Such persons
may also file a written request for a
hearing on the application on or before
July 12, 2021.
DATES:
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 request 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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on April 14, 2021,
National Center for Natural Products
Research, 806 Hathorn Road, 135 Coy
Waller Lab, University, Mississippi
38677–1848, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Marihuana Extract ..........
Marihuana .......................
Tetrahydrocannabinols ...
Drug
code
Schedule
7350
7360
7370
I
I
I
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–843]
Importer of Controlled Substances
Application: National Center for
Natural Products Research
Drug Enforcement
Administration, Justice.
AGENCY:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
The company plans to acquire new
genetic materials with improved
Cannabinoids for research and
manufacturing purposes. No other
activity for these drug codes is
authorized for this registration.
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 FDA-approved or non-
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12213]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-845]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Maridose, LLC
AGENCY: Drug Enforcement Administration, Justice.
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 class(es) of controlled
substances listed in schedule I. DEA intends to evaluate this and other
pending applications according to its regulations governing 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 August 9, 2021.
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-845 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). In addition to seeking to produce
marihuana extract, this applicant is separately seeking to cultivate
marihuana. See Notice of Application, Bulk Manufacturers of Marihuana,
84 FR 44920, 44922 (Aug. 27, 2019). DEA thus will conduct this
evaluation in the manner described in the rule published at 85 FR 82333
on December 18, 2020, and reflected in DEA regulations at 21 CFR part
1318.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on May 6, 2021, Maridose, LLC., 74 Orion Street, Brunswick, Maine
04011, applied to be registered as a bulk manufacturer of the following
basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana Extract...................... 7350 I
------------------------------------------------------------------------
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-12213 Filed 6-9-21; 8:45 am]
BILLING CODE 4410-09-P
