Importer of Controlled Substances Application: Catalent CTS, LLC, 71927 [2024-19776]
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71927
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / 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.
In
accordance with 21 CFR 1301.33(a), this
SUPPLEMENTARY INFORMATION:
is notice that on July 16, 2024, 256 West
Cummings Park, Woburn,
Massachusetts 01801, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
Drug code
Fentanyl .........................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances for research and
development purposes only. No other
activity for this drug code is authorized
for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19756 Filed 9–3–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1414]
Importer of Controlled Substances
Application: Catalent CTS, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Catalent CTS, LLC has
applied to be registered as an importer
of basic class(es) of controlled
SUMMARY:
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 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before October 4, 2024.
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
In
accordance with 21 CFR 1301.34(a), this
is notice that on June 27, 2024, 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):
Drug code
ddrumheller on DSK120RN23PROD with NOTICES1
approved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19776 Filed 9–3–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1408]
Bulk Manufacturer of Controlled
Substances Application: Benuvia
Operations, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
21:26 Sep 03, 2024
Jkt 262001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
II
SUPPLEMENTARY INFORMATION:
Gamma Hydroxybutyric Acid .....................................................................................................................................
Marihuana Extract .....................................................................................................................................................
Marihuana .................................................................................................................................................................
Tetrahydrocannabinols ..............................................................................................................................................
VerDate Sep<11>2014
9801
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.
Controlled substance
The company plans to import the
listed controlled substances as dosage
unit products for clinical trials and
distribution. In reference to drug codes
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-
Schedule
ACTION:
2010
7350
7360
7370
Schedule
I
I
I
I
Notice of application.
Benuvia Operations, LLC 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 November 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
SUMMARY:
The Drug Enforcement
Administration requires that all
ADDRESSES:
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Page 71927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19776]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1414]
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 4, 2024. Such persons may also file a written request for a
hearing on the application on or before October 4, 2024.
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 June 27, 2024, 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 trials and distribution. In reference
to drug codes 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.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19776 Filed 9-3-24; 8:45 am]
BILLING CODE P
