Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Tikun Olam Adelanto LLC, 12980-12981 [2022-04804]
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12980
Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices
inspection at the Office of the Secretary
and on EDIS.3
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of §§ 201.10 and 210.8(c) of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Issued: March 2, 2022.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2022–04835 Filed 3–7–22; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Morrissette Drive, Springfield, Virginia
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on December 24, 2021,
S&B Pharma LLC, 405 South Motor
Avenue, Azusa, California 91702,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Drug Enforcement Administration
4-Anilino-N-Phenethyl4-Piperdine (ANPP).
Tapentadol ....................
Importer of Controlled Substances
Application: S&B Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
S&B Pharma 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 7, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 2022.
ADDRESSES: The DEA requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
VerDate Sep<11>2014
17:25 Mar 07, 2022
Drug
code
Controlled substance
[Docket No. DEA–969]
Jkt 256001
I
Schedule
8333
II
9780
I II
The company plans to import
intermediate forms of Tapentadol (9780)
for further manufacturing prior to
distribution to its customers. The
company plans to import ANPP (8333)
to bulk manufacture other controlled
substances for distribution to its
customers. 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04805 Filed 3–7–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–973]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Tikun
Olam Adelanto 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
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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 May 9, 2022.
ADDRESSES: DEA requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.’’
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
E:\FR\FM\08MRN1.SGM
08MRN1
12981
Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Notices
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 September 30, 2021, Tikun Olam
Adelanto LLC, 16605 Koala Road,
Adelanto, California 92301–3925,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substances:
Drug
code
Controlled substance
Marihuana Extract ........
Marihuana .....................
I
Schedule
7350
7360
I
I
I
In
accordance with 21 CFR 1301.34(a), this
is notice that on December 21, 2021,
Caligor Coghlan Pharma Services, 1500
Business Park Drive, Unit B, Bastrop,
Texas 78602, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04804 Filed 3–7–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances
Application: Caligor Coghlan Pharma
Services
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Caligor Coghlan Pharma
Services 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before April 7, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 2022.
ADDRESSES: The DEA requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
lotter on DSK11XQN23PROD with NOTICES1
VerDate Sep<11>2014
17:25 Mar 07, 2022
Jkt 256001
Drug
code
Controlled substance
[Docket No. DEA–971]
SUMMARY:
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
Lysergic acid
diethylamide.
Schedule
7315
I
I
I
The company plans to import drug
Lysergic acid diethylamide (7315) in
finished dosage forms for pediatric
clinical trials. 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.
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–04807 Filed 3–7–22; 8:45 am]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–970]
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 April 7, 2022. Such persons
may also file a written request for a
hearing on the application on or before
April 7, 2022.
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 December 8, 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):
SUMMARY:
Controlled substance
Phenylacetone ..............
Opium, raw ...................
Poppy Straw Concentrate.
Drug
code
8501
9600
9670
Schedule
II
II
II
BILLING CODE P
PO 00000
The company plans to import the
listed controlled substances to
manufacture bulk active
pharmaceuticals ingredients (API) for
distribution to its customers.
Phenylacetone will be used to
manufacture Amphetamine. No other
Frm 00058
Fmt 4703
Sfmt 4703
E:\FR\FM\08MRN1.SGM
08MRN1
]]>Agencies
[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Pages 12980-12981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04804]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-973]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Tikun Olam Adelanto 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 May 9, 2022.
ADDRESSES: DEA requires that all comments be submitted electronically
through the Federal eRulemaking Portal, which provides the ability to
type short comments directly into the comment field on the web page or
attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for
submitting comments. Upon submission of your comment, you will receive
a Comment Tracking Number. Please be aware that submitted comments are
not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number,
your comment has been successfully submitted and there is no need to
resubmit the same comment.''
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
[[Page 12981]]
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 September 30, 2021, Tikun Olam Adelanto LLC, 16605 Koala Road,
Adelanto, California 92301-3925, 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
Marihuana.............................. 7360 I
------------------------------------------------------------------------
Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-04804 Filed 3-7-22; 8:45 am]
BILLING CODE P
