Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Annac Medical Center LC, 33359 [2021-13249]
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33359
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices
ACTION:
Notice of application.
Cambrex Charles City has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY 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 August 23, 2021. Such persons
may also file a written request for a
hearing on the application on or before
August 23, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on May 6, 2021, Cambrex
Charles City, 1205 11th Street, Charles
City, Iowa 50616–3466, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUMMARY:
Controlled substance
khammond on DSKJM1Z7X2PROD with NOTICES
Gamma Hydroxybutyric
Acid .............................
Tetrahydrocannabinols ...
Amphetamine ..................
Lisdexamfetamine ...........
Methylphenidate .............
ANPP (4-Anilino-Nphenethyl-4-piperidine)
Phenylacetone ................
Codeine ..........................
Oxycodone ......................
Hydromorphone ..............
Hydrocodone ..................
Methadone ......................
Morphine .........................
Oripavine ........................
Thebaine .........................
Opium extracts ...............
Opium fluid extract .........
Opium tincture ................
Opium, powdered ...........
Oxymorphone .................
Noroxymorphone ............
Fentanyl ..........................
Drug
code
Schedule
2010
7370
1100
1205
1724
I
I
II
II
II
8333
8501
9050
9143
9150
9193
9250
9300
9330
9333
9610
9620
9630
9639
9652
9668
9801
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
19:19 Jun 23, 2021
Jkt 253001
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–13252 Filed 6–23–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–858]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Annac
Medical Center LC
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 23, 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–858 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
DATES:
The company plans to manufacture
the above-listed controlled substances
in bulk for conversion to other
controlled substances and sales to its
customers for dosage form development,
clinical trials and use in stability
qualification studies. In reference to
drug code 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture this drug as
synthetic. No other activities for these
VerDate Sep<11>2014
drug codes are authorized for this
registration.
PO 00000
Frm 00154
Fmt 4703
Sfmt 4703
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 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 April 14, 2021, Annac Medical
Center, LC, 5172 West Patrick Lane,
Suite 100, Las Vegas, Nevada 89117–
8911, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled substance
Tetrahydrocannabinols ...
Drug
code
Schedule
I 7370 II
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–13249 Filed 6–23–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Oil
Pollution Act
On June 17, 2021, the Department of
Justice lodged a proposed Consent
Decree with the United States District
Court for the Western District of
Louisiana in the lawsuit entitled United
States of America and Louisiana v.
CITGO Petroleum Corp., Civil Action
No. 2:21–cv–1705. The United States is
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Page 33359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13249]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-858]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Annac Medical Center LC
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 23, 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-858 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 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 April 14, 2021, Annac Medical Center, LC, 5172 West Patrick Lane,
Suite 100, Las Vegas, Nevada 89117-8911, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols............................... 7370 I
------------------------------------------------------------------------
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-13249 Filed 6-23-21; 8:45 am]
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