Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Absolute Standards, Inc., 21891 [2020-08332]
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21891
Federal Register / Vol. 85, No. 76 / Monday, April 20, 2020 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–627]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Absolute
Standards, Inc.
ACTION:
Notice of application.
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 19, 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–627 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 its application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:34 Apr 17, 2020
Jkt 250001
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 February 7, 2020, Absolute
Standards, Inc., 44 Rossotto Drive
Hamden, Connecticut 06514, applied to
be registered as a bulk manufacturer of
the following basic class(es) of
controlled substances:
Controlled substance
Marihuana .......................
Marihuana Extract ..........
Tetrahydrocannabinols ...
Drug
code
Schedule
7360
7350
7370
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. 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.
Registered bulk manufacturer 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 May 20, 2020. Such persons
may also file a written request for a
hearing on the application on or before
May 20, 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: In
accordance with 21 CFR 1301.34(a), this
is notice that on March 9, 2020, AMRI
Rensselaer, Inc., 33 Riverside Avenue,
Rensselaer, New York 12144, applied to
be registered as an importer of the
following basic class(es) of a controlled
substance:
DATES:
Controlled substance
Poppy Straw Concentrate
BILLING CODE 4410–09–P
Drug Enforcement Administration
The company plans to import the
listed controlled substance to
manufacture a bulk controlled substance
for distribution to its customers.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–08271 Filed 4–17–20; 8:45 am]
BILLING CODE 4410–09–P
[Docket No. DEA–615]
ACTION:
Notice of application.
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 May 20, 2020. Such persons
may also file a written request for a
DATES:
[Docket No. DEA–625]
Importer of Controlled Substances
Application: AMRI Rensselaer, Inc.
Frm 00070
Fmt 4703
Sfmt 4703
II
Importer of Controlled Substances
Application: Lipomed
DEPARTMENT OF JUSTICE
PO 00000
9670
Drug Enforcement Administration
[FR Doc. 2020–08332 Filed 4–17–20; 8:45 am]
Notice of application.
Schedule
DEPARTMENT OF JUSTICE
William T. McDermott,
Assistant Administrator.
ACTION:
Drug
code
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Notices]
[Page 21891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08332]
[[Page 21891]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-627]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Absolute Standards, Inc.
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 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 19, 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-627 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 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
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 February 7, 2020, Absolute Standards, Inc., 44 Rossotto Drive
Hamden, Connecticut 06514, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Marihuana Extract...................... 7350 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. 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. 2020-08332 Filed 4-17-20; 8:45 am]
BILLING CODE 4410-09-P
