Importer of Controlled Substances Application: Catalent Greenville, Inc., 37276 [2023-12128]
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37276
Federal Register / Vol. 88, No. 109 / Wednesday, June 7, 2023 / Notices
upon the Commission’s procedures with
respect to filings.
In accordance with §§ 201.16(c) and
207.3 of the rules, each document filed
by a party to the review must be served
on all other parties to the review (as
identified by either the public or BPI
service list), and a certificate of service
must be timely filed. The Secretary will
not accept a document for filing without
a certificate of service.
Determination.—The Commission has
determined this review is
extraordinarily complicated and
therefore has determined to exercise its
authority to extend the review period by
up to 90 days pursuant to 19 U.S.C.
1675(c)(5)(B).
Authority: This review is being
conducted under authority of title VII of
the Tariff Act of 1930; this notice is
published pursuant to § 207.62 of the
Commission’s rules.
By order of the Commission.
Issued: June 2, 2023.
Lisa Barton,
Secretary to the Commission.
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1215]
Bulk Manufacturer of Controlled
Substances Application: AMPAC Fine
Chemicals, LLC
lotter on DSK11XQN23PROD with NOTICES1
Jkt 259001
Schedule
9634
1724
9210
9220
9333
9739
9780
I
II
II
II
II
II
II
The company plans to bulk
manufacture the listed controlled
substances for distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
BILLING CODE P
AMPAC Fine Chemicals, 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 August 7, 2023. Such
persons may also file a written request
for a hearing on the application on or
before August 7, 2023.
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
17:01 Jun 06, 2023
Drug
code
[FR Doc. 2023–12137 Filed 6–6–23; 8:45 am]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VerDate Sep<11>2014
Controlled substance
Norlevorphanol ................
Methylphenidate ..............
Levomethorphan ..............
Levorphanol .....................
Thebaine ..........................
Remifentanil .....................
Tapentadol ......................
[FR Doc. 2023–12168 Filed 6–6–23; 8:45 am]
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on April 13, 2023, AMPAC
Fine Chemicals, LLC, Highway 50 &
Hazel Avenue, Rancho Cordova,
California 95670, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
hearing on the application on or before
July 7, 2023.
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 April 21, 2023, Catalent
Greenville, Inc., 1240 Sugg Parkway,
Greenville, North Carolina 27834–9006,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
DEPARTMENT OF JUSTICE
Controlled substance
Drug
code
Schedule
[Docket No. DEA–1211]
Lysergic Acid Diethylamide
7315
I
Importer of Controlled Substances
Application: Catalent Greenville, Inc.
The company plans to import the
listed controlled substance for the
development of bulk dosage
formulations for research and clinical
studies. No other activities for this drug
code 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.
Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Catalent Greenville, 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
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before July 7, 2023. Such persons
may also file a written request for a
SUMMARY:
PO 00000
Frm 00078
Fmt 4703
Sfmt 9990
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–12128 Filed 6–6–23; 8:45 am]
BILLING CODE P
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 88, Number 109 (Wednesday, June 7, 2023)]
[Notices]
[Page 37276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12128]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1211]
Importer of Controlled Substances Application: Catalent
Greenville, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Catalent Greenville, 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 applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
July 7, 2023. Such persons may also file a written request for a
hearing on the application on or before July 7, 2023.
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 April 21, 2023, Catalent Greenville, Inc., 1240 Sugg
Parkway, Greenville, North Carolina 27834-9006, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Lysergic Acid Diethylamide.............. 7315 I
------------------------------------------------------------------------
The company plans to import the listed controlled substance for the
development of bulk dosage formulations for research and clinical
studies. No other activities for this drug code 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-12128 Filed 6-6-23; 8:45 am]
BILLING CODE P
