Importer of Controlled Substances Application: Catalent CTS, LLC, 55040-55041 [2022-19394]
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55040
Federal Register / Vol. 87, No. 173 / Thursday, September 8, 2022 / Notices
Controlled substance
Drug code
ortho-Fluoroacryl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)acrylamide) ...............................................
ortho-Fluoroisobutyryl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) ..................................
Para-Fluoro furanyl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide) ...........................
2′-Fluoro ortho-fluorofentanyl (N-(1-(2-fluorophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamide; also known as
2′-fluoro 2-fluorofentanyl).
beta-Methyl fentanyl (N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)propionamide; also known as b-methyl fentanyl)
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Lisdexamfetamine ............................................................................................................................................................
Phenmetrazine .................................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Amobarbital ......................................................................................................................................................................
Pentobarbital ....................................................................................................................................................................
Secobarbital .....................................................................................................................................................................
Glutethimide .....................................................................................................................................................................
1-Phenylcyclohexylamine ................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
ANPP (4-Anilino-N-phenethyl-4-piperidine) .....................................................................................................................
Norfentanyl (N-phenyl-N-(piperidin-4-yl) propionamide) .................................................................................................
Phenylacetone .................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Etorphine HCl ..................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Ethylmorphine ..................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levomethorphan ..............................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Isomethadone ..................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Meperidine intermediate-B ..............................................................................................................................................
Oliceridine (N-[(3-methoxythiophen-2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-oxaspiro[4.5] decan-9-yl] ethyl
{time})amine fumarate).
Methadone .......................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Thiafentanil ......................................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
The company plans to bulk
manufacture the listed controlled
substances for internal use or for sale to
its customers. 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. 2022–19391 Filed 9–7–22; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014
18:19 Sep 07, 2022
Jkt 256001
Drug Enforcement Administration
[Docket No. DEA–1077]
Importer of Controlled Substances
Application: Catalent CTS, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Frm 00087
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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.
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
ADDRESSES:
Catalent CTS, 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.
PO 00000
9852
9853
9854
9855
DATES:
DEPARTMENT OF JUSTICE
SUMMARY:
Schedule
E:\FR\FM\08SEN1.SGM
08SEN1
55041
Federal Register / Vol. 87, No. 173 / Thursday, September 8, 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. 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 26, 2022, Catalent
CTS, LLC, 10245 Hickman Mills Drive,
Kansas City, Missouri 64137–1418,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Controlled
substance
Drug code
The company plans to import the
listed controlled substances as dosage
unit products for clinical trial studies.
In reference to drug code 7370
(Tetrahydrocannabinols), the company
plans to import a synthetic
tetrahydrocannabinol. No other
activities 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. 2022–19394 Filed 9–7–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1076]
Bulk Manufacturer of Controlled
Substances Application: Curia
Wisconsin, Inc.
Schedule
2010
I
7350
I
7360
7370
I
I
ACTION:
Notice of application.
Curia Wisconsin, Inc., has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUMMARY:
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 7, 2022. Such
persons may also file a written request
for a hearing on the application on or
before November 7, 2022.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on July 25, 2022, Curia
Wisconsin, Inc., 870 Badger Circle,
Grafton, Wisconsin 53024–0000,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement
Administration, Justice.
AGENCY:
Gamma Hydroxybutyric Acid.
Marihuana Extract.
Marihuana .........
Tetrahydrocannabinols.
Supplementary Information listed below
for further drug information.
Controlled substance
Drug code
khammond on DSKJM1Z7X2PROD with NOTICES
Lysergic acid diethylamide ..............................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine ..........................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Nabilone ...........................................................................................................................................................................
ANPP (4-Anilino-N-phenethyl-4-piperidine) .....................................................................................................................
Fentanyl ...........................................................................................................................................................................
VerDate Sep<11>2014
18:19 Sep 07, 2022
Jkt 256001
PO 00000
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Fmt 4703
Sfmt 4703
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08SEN1
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Schedule
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]]>Agencies
[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Pages 55040-55041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19394]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1077]
Importer of Controlled Substances Application: Catalent CTS, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Catalent CTS, 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
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
[[Page 55041]]
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 26, 2022, Catalent CTS, LLC, 10245 Hickman Mills
Drive, Kansas City, Missouri 64137-1418, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.......... 2010 I
Marihuana Extract.................. 7350 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
------------------------------------------------------------------------
The company plans to import the listed controlled substances as
dosage unit products for clinical trial studies. In reference to drug
code 7370 (Tetrahydrocannabinols), the company plans to import a
synthetic tetrahydrocannabinol. No other activities 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 non-approved finished
dosage forms for commercial sale.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-19394 Filed 9-7-22; 8:45 am]
BILLING CODE P
