Bulk Manufacturer of Controlled Substances Application: PCI Synthesis, 9539-9540 [2021-02973]
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
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 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 January 13, 2021, JW Colorado, LLC,
3601 Freedom Road, Trinidad, Colorado
81082, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Controlled substance
Marihuana Extract ........
Marihuana .....................
Drug
code
Schedule
7350
7360
I
I
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–02972 Filed 2–12–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
khammond on DSKJM1Z7X2PROD with NOTICES
Drug Enforcement Administration
[Docket No. DEA–779]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Titan
Health LLC
Drug Enforcement
Administration, Justice.
AGENCY:
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Jkt 253001
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 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 April 19, 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–779 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
SUMMARY:
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Sfmt 4703
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). 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 January 18, 2021, Titan Health LLC,
5959 East 39th Avenue, Suite 102,
Denver, Colorado 80207 applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
Controlled substance
Marihuana Extract ........
Marihuana .....................
Drug
code
7350
7360
Schedule
I
I
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–02968 Filed 2–12–21; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–776]
Bulk Manufacturer of Controlled
Substances Application: PCI Synthesis
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PCI Synthesis, 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 April 19, 2021. Such persons
may also file a written request for a
hearing on the application on or before
April 19, 2021.
ADDRESS: Written comments should be
sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 24, 2020, PCI
Synthesis, 9 Opportunity Way,
Newburyport, Massachusetts 01950–
0195, applied to be registered as a bulk
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Amphetamine ...............
Methamphetamine ........
Drug
code
Schedule
1100
1105
II
II
The company plans to use the listed
controlled substances to develop
manufacturing processes, and conduct
analytical and stability testing. The
company has demonstrated and
received patent numbers U.S. 9,278,904
and U.S. 9,321,794 from the U.S. Patent
Office for the synthesis process for
amphetamines.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–02973 Filed 2–12–21; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–783]
Importer of Controlled Substances
Application: Siegfried USA, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Siegfried USA, LLC 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.
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 March 18, 2021. Such persons
may also file a written request for a
hearing on the application on or before
March 18, 2021.
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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17:04 Feb 12, 2021
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In
accordance with 21 CFR 1301.34(a), this
is notice that on January 6, 2021,
Siegfried USA, LLC, 33 Industrial Park
Road, Pennsville, New Jersey 08070,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Phenylacetone ..............
Opium, Raw ..................
Poppy Straw Concentrate.
8501
9600
9670
Schedule
II
II
II
The company plans to import the
listed controlled substances to
manufacture bulk active pharmaceutical
ingredients (API) for distribution to its
customers. Phenylacetone will be used
to manufacture Amphetamine. No other
activity for this drug code 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–02974 Filed 2–12–21; 8:45 am]
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DEPARTMENT OF JUSTICE
National Institute of Corrections
Advisory Board; Notice of Meeting
This notice announces a forthcoming
meeting of the National Institute of
Corrections (NIC) Advisory Board. At
least one portion of the meeting will be
closed to the public.
Name of the Committee: NIC
Advisory Board.
General Function of the Committee:
To aid the National Institute of
Corrections in developing long-range
plans, advise on program development,
and recommend guidance to assist NIC’s
efforts in the areas of training, technical
assistance, information services, and
policy/program development assistance
to Federal, state, and local corrections
agencies.
Date and Time: 1:00–4:00 p.m. EDT
on Wednesday, March 10, 2021
(approximate time).
Location: Virtual Platform.
Contact Person: Leslie LeMaster,
Executive Assistant, National Institute
of Corrections, 320 First Street NW,
PO 00000
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Room 901–3, Washington, DC 20534. To
contact Ms. LeMaster, please call (303)
338–6620.
Agenda: On March 10, 2021, the
Advisory Board will: (1) Receive a brief
Agency Report from the NIC Acting
Director, (2) provide input and counsel
into an agency decision regarding access
to online training courses hosted by
NIC, and (3) receive a Subcommittee
Report related to the identification of
potential NIC Director candidates. Time
for questions and counsel is built in to
the agenda.
Procedure: On March 10, 2021, from
1:00 p.m. until 3:00 p.m., the meeting is
open to the public. Interested persons
may request to attend virtually, present
data, information, or views, orally or in
writing, on issues pending before the
committee. Such requests must be made
to the contact person on or before
February 26, 2021. Oral presentations
from the public will be scheduled
between approximately 2:45 p.m. to
3:00 p.m. on March 10, 2021. Time
allotted for each presentation may be
limited. Those who wish to make formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 26, 2021.
Closed Committee Deliberations: On
March 10, 2021, between 3:00 p.m. and
4:00 p.m., the meeting will be closed to
permit discussion of information that (1)
relates solely to the internal personnel
rules and practices of an agency (5
U.S.C. 552b(c)(2)), and (2) is of a
personal nature where disclosure would
constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The Advisory Board will
discuss the outcomes of the
subcommittee’s review of potential
candidates for the position of Director of
the National Institute of Corrections and
make determinations as to the Advisory
Board’s recommendations to the U.S.
Attorney General.
General Information: NIC welcomes
the attendance of the public at its
advisory committee meetings and will
make every effort to accommodate
persons with physical disabilities or
special needs. If you require special
accommodations due to a disability,
please contact Leslie LeMaster at least 7
days in advance of the meeting. Notice
of this meeting is given under the
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]]>Agencies
[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9539-9540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02973]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-776]
Bulk Manufacturer of Controlled Substances Application: PCI
Synthesis
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: PCI Synthesis, 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 April 19, 2021.
Such persons may also file a written request for a hearing on the
application on or before April 19, 2021.
ADDRESS: 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 March 24, 2020, PCI Synthesis, 9 Opportunity Way,
Newburyport, Massachusetts 01950-0195, applied to be registered as a
bulk
[[Page 9540]]
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
Methamphetamine........................ 1105 II
------------------------------------------------------------------------
The company plans to use the listed controlled substances to
develop manufacturing processes, and conduct analytical and stability
testing. The company has demonstrated and received patent numbers U.S.
9,278,904 and U.S. 9,321,794 from the U.S. Patent Office for the
synthesis process for amphetamines.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-02973 Filed 2-12-21; 8:45 am]
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