Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City, 48692-48693 [2022-17175]
Download as PDF
<![CDATA[
48692
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
written submissions will be available for
public inspection at the Office of the
Secretary and on EDIS.
The Commission voted to approve
this determination on August 4, 2022.
The authority for the Commission’s
determinations is contained in Section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in part
210 of the Commission’s Rules of
Practice and Procedure (19 CFR part
210).
By order of the Commission.
Issued: August 4, 2022.
Katherine Hiner,
Acting Secretary to the Commission.
[FR Doc. 2022–17111 Filed 8–9–22; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1041]
Importer of Controlled Substances
Application: Lipomed
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Lipomed 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 September 9, 2022. Such
persons may also file a written request
for a hearing on the application on or
before September 9, 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
SUMMARY:
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 June 13, 2022,
Lipomed, 150 Cambridgepark Drive,
Suite 705, Cambridge, Massachusetts
02140, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine) .......................................................................
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. 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. 2022–17174 Filed 8–9–22; 8:45 am]
BILLING CODE P
khammond on DSKJM1Z7X2PROD with NOTICES
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1048]
Bulk Manufacturer of Controlled
Substances Application: Cambrex
Charles City
Drug Enforcement
Administration, Justice.
AGENCY:
VerDate Sep<11>2014
17:26 Aug 09, 2022
Jkt 256001
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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before October 11, 2022. Such
persons may also file a written request
for a hearing on the application on or
before October 11, 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
SUMMARY:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
7286
Schedule
I
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 May 9, 2022, 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):
Controlled substance
Gamma Hydroxybutyric
Acid.
Tetrahydrocannabinols
Amphetamine ...............
Lisdexamfetamine ........
Methylphenidate ...........
ANPP (4-Anilino-Nphenethyl-4-piperidine).
Phenylacetone ..............
Codeine ........................
Oxycodone ...................
Hydromorphone ............
Hydrocodone ................
Methadone ....................
Morphine .......................
Oripavine ......................
E:\FR\FM\10AUN1.SGM
10AUN1
Drug
code
Schedule
2010
I
7370
1100
1205
1724
8333
I
II
II
II
II
8501
9050
9143
9150
9193
9250
9300
9330
II
II
II
II
II
II
II
II
48693
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
Controlled substance
Thebaine .......................
Opium extracts .............
Opium fluid extract .......
Opium tincture ..............
Opium, powdered .........
Oxymorphone ...............
Noroxymorphone ..........
Fentanyl ........................
Drug
code
Schedule
9333
9610
9620
9630
9639
9652
9668
9801
II
II
II
II
II
II
II
II
The company plans to manufacture
the 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 codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–17175 Filed 8–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[Docket No. DEA–1057]
Tetrahydrocannabinols
Importer of Controlled Substances
Application: VA Cooperative Studies
Program
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VA Cooperative Studies
Program 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 September 9, 2022. Such
persons may also file a written request
for a hearing on the application on or
before September 9, 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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
17:26 Aug 09, 2022
Jkt 256001
Drug
code
Controlled substance
Drug Enforcement Administration
VerDate Sep<11>2014
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 June 9, 2022, VA
Cooperative Studies Program, 2401
Centre Avenue SE, Albuquerque, New
Mexico 87106, applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
I
7370
Schedule
II
The company plans to import finished
dosage unit products containing
Tetrahydrocannabinols drug code (7370)
for research and clinical trial studies.
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. 2022–17177 Filed 8–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
ACTION:
Notice of application.
Epic 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 September 9, 2022. Such
persons may also file a written request
for a hearing on the application on or
before September 9, 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 July 19, 2022, Epic
Pharma, LLC, 22715 North Conduit
Avenue, Laurelton, New York 11413–
3134, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUMMARY:
Controlled substance
Drug
code
Schedule
Drug Enforcement Administration
Methadone ....................
[Docket No. DEA–1066]
Importer of Controlled Substances
Application: Epic Pharma, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
9250
II
The company plans to import the
listed controlled substance for research
and development purposes. No other
activity for this drug code is authorized
for this registration.
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48692-48693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17175]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1048]
Bulk Manufacturer of Controlled Substances Application: Cambrex
Charles City
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
October 11, 2022. Such persons may also file a written request for a
hearing on the application on or before October 11, 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on May 9, 2022, 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):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............. 2010 I
Tetrahydrocannabinols.................. 7370 I
Amphetamine............................ 1100 II
Lisdexamfetamine....................... 1205 II
Methylphenidate........................ 1724 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
Phenylacetone.......................... 8501 II
Codeine................................ 9050 II
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Methadone.............................. 9250 II
Morphine............................... 9300 II
Oripavine.............................. 9330 II
[[Page 48693]]
Thebaine............................... 9333 II
Opium extracts......................... 9610 II
Opium fluid extract.................... 9620 II
Opium tincture......................... 9630 II
Opium, powdered........................ 9639 II
Oxymorphone............................ 9652 II
Noroxymorphone......................... 9668 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture the 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 codes 7360 (Marihuana), and 7370
(Tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetic. No other activities for these drug codes are
authorized for this registration.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-17175 Filed 8-9-22; 8:45 am]
BILLING CODE P
