Importer of Controlled Substances Application: Catalent Greenville, Inc., 37276 [2023-12128]

Download as PDF 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.

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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
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