Bulk Manufacturer of Controlled Substances Application: Cambrex High Point, Inc., 61365-61366 [2022-21933]
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<![CDATA[
61365
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
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
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.
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 2, 2022,
Hybrid Pharma, 1015 West Newport
Center Drive, Suite 106A, Deerfield
Beach, Florida 33442–7707, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
khammond on DSKJM1Z7X2PROD with NOTICES
Dimethyltryptamine .......
Drug
code
7435
Schedule
I
The company plans to import the
listed controlled substance to
manufacture dosage forms to support
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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21946 Filed 10–7–22; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
DEPARTMENT OF JUSTICE
Drug
code
Controlled substance
Schedule
Drug Enforcement Administration
[Docket No. DEA–1084]
Importer of Controlled Substances
Application: Groff NA Hemplex LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Groff NA Hemplex 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 November 10, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 10, 2022.
ADDRESSES: The Drug Enforcement
Administration 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
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 August 18, 2022, Groff
NA Hemplex LLC, 100 Redco Avenue,
Suite A, Red Lion, Pennsylvania 17356–
1436, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUMMARY:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
Marihuana Extract ........
Marihuana .....................
Tetrahydrocannabinols
I
7350
7360
7370
I
I
I
I
The company plans to import the
above listed controlled substance(s) as
bulk to manufacture research grade
material for clinical trial studies.
Several types of Marihuana Extract
compounds are listed under drug code
7350. No other activity for these drug
codes are 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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21939 Filed 10–7–22; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1080]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
High Point, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Cambrex High Point, Inc 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before December 12, 2022. Such
persons may also file a written request
for a hearing on the application on or
before December 12, 2022.
ADDRESSES: The Drug Enforcement
Administration 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
SUMMARY:
E:\FR\FM\11OCN1.SGM
11OCN1
61366
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
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: In
accordance with 21 CFR 1301.33(a), this
is notice that on July 26, 2022, Cambrex
High Point, Inc, 4180 Mendenhall Oaks
Parkway, High Point, North Carolina
27265–8017, applied to be registered as
a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
Drug
code
Controlled substance
Oxymorphone ...............
Noroxymorphone ..........
I
9652
9668
Schedule
II
I II
The company plans to manufacture
the above listed controlled substances in
bulk for use as internal intermediates
and distribution to its customers. No
other activities for these drug codes are
authorized for this registration.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–21933 Filed 10–7–22; 8:45 am]
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: In
accordance with 21 CFR 1301.33(a), this
is notice that on August 11, 2022, Curia
Missouri, Inc., 2460 West Bennett
Street, Springfield, Missouri 65807–
1229, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Drug
code
Controlled substance
Gamma Hydroxybutyric
Acid.
Amphetamine ................
Lisdexamfetamine .........
Methylphenidate ............
Phenylacetone ...............
Tapentadol .....................
Schedule
2010
I
1100
1205
1724
8501
9780
II
II
II
II
II
BILLING CODE 4410–09–P
The company plans to bulk
manufacture the listed controlled
substances for internal use
intermediates or for sale to its
customers.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1079]
Kristi O’Malley,
Assistant Administrator.
Bulk Manufacturer of Controlled
Substances Application: Curia
Missouri, Inc.
[FR Doc. 2022–21931 Filed 10–7–22; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Curia Missouri, Inc., 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before December 12, 2022. Such
persons may also file a written request
for a hearing on the application on or
before December 12, 2022.
ADDRESSES: The Drug Enforcement
Administration requires that all
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF JUSTICE
VerDate Sep<11>2014
17:37 Oct 07, 2022
Jkt 259001
Drug Enforcement Administration
[Docket No. DEA–1078]
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 10, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 10, 2022.
The Drug Enforcement
Administration 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
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 25, 2022, Curia
Wisconsin, Inc., 870 Badger Circle,
Grafton, Wisconsin 53024–9436,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
AGENCY:
Gamma Hydroxybutyric
Acid.
Marihuana Extract ........
Marihuana .....................
Dimethyltryptamine .......
Curia Wisconsin, Inc. 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
The company plans to import
Dimethyltryptamine and a derivative of
Gamma Hydroxybutyric Acid to support
post procurement reprocessing. The
cannabidiol from Marihuana and
Marihuana Extract is intended for
analytical purposes with
Tetramethylpyrazine (TMP). No other
activities for these drug codes are
authorized for this registration.
Importer of Controlled Substances
Application: Curia Wisconsin, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
SUMMARY:
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
E:\FR\FM\11OCN1.SGM
11OCN1
2010
I
7350
7360
7435
I
I
I
]]>Agencies
[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61365-61366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21933]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1080]
Bulk Manufacturer of Controlled Substances Application: Cambrex
High Point, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Cambrex High Point, Inc 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
December 12, 2022. Such persons may also file a written request for a
hearing on the application on or before December 12, 2022.
ADDRESSES: The Drug Enforcement Administration 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
[[Page 61366]]
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: In accordance with 21 CFR 1301.33(a), this
is notice that on July 26, 2022, Cambrex High Point, Inc, 4180
Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017, applied
to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Oxymorphone............................ 9652 II
Noroxymorphone......................... 9668 II
------------------------------------------------------------------------
The company plans to manufacture the above listed controlled
substances in bulk for use as internal intermediates and distribution
to its customers. No other activities for these drug codes are
authorized for this registration.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-21933 Filed 10-7-22; 8:45 am]
BILLING CODE 4410-09-P
