Importer of Controlled Substances Application: Globyz Pharma, LLC, 5920 [2023-01816]

Download as PDF 5920 Federal Register / Vol. 88, No. 19 / Monday, January 30, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 (March 19, 2020). Submissions should refer to the investigation number (‘‘Inv. No. 337–TA–1291’’) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, https:// www.usitc.gov/secretary/fed_reg_ notices/rules/handbook_on_electronic_ filing.pdf). Persons with questions regarding filing should contact the Secretary (202–205–2000). Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. A redacted nonconfidential version of the document must also be filed simultaneously with any confidential filing. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS. This action is taken under the authority of 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: January 25, 2023. Katherine Hiner, Acting Secretary to the Commission. [FR Doc. 2023–01823 Filed 1–27–23; 8:45 am] BILLING CODE 7020–02–P VerDate Sep<11>2014 17:30 Jan 27, 2023 Jkt 259001 DEPARTMENT OF JUSTICE Controlled substance Drug code Schedule 1205 II Drug Enforcement Administration Lisdexamfetamine .......... [Docket No. DEA–1139] Importer of Controlled Substances Application: Globyz Pharma, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Globyz 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 March 1, 2023. Such persons may also file a written request for a hearing on the application on or before March 1, 2023. SUMMARY: 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 December 30, 2022, Globyz Pharma LLC, 7 Chelsea Parkway, Suite 707, Boothwyn, Pennsylvania 19061–1300, applied to be registered as an importer of the following basic class(es) of controlled substance(s): ADDRESSES: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 The company plans to import the listed controlled substance in dosage form for use in a clinical trial. No other activities 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–01816 Filed 1–27–23; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Clean Water Act (CWA), and the Oil Pollution Act (OPA) On January 24, 2023, the Department of Justice lodged a proposed consent decree with the United States District Court for the Western District of Washington in the lawsuit entitled United States of America, State of Washington, Suquamish Tribe, and Muckleshoot Indian Tribe v. Lynden, Inc., et al., Civil Action No. 2:23–cv– 00101. The proposed consent decree resolves claims brought by the United States on behalf of the National Oceanic and Atmospheric Administration and the Department of the Interior, the State of Washington, the Suquamish Tribe, and the Muckleshoot Indian Tribe (collectively, the Natural Resource Trustees) against Lynden, Inc., Knik Construction Co., Inc., Douglas Management Company, Alaska Marine Lines, Inc., Swan Bay Holdings, Inc., Bering Marine Corp., 7100 First Avenue S Seattle, LLC, 5615 West Marginal Way SW Seattle, LLC, 5600 West Marginal Way SW Seattle, LLC, LTI, Inc., Lynden Transport, Inc. (f/k/a Lynden Transfer, Inc.), and Alagnak Holdings, LLC (Defendants) for natural resource damages caused by releases of hazardous substances and discharges of oil from facilities owned and/or operated at various times by the Defendants, located along and near the Lower Duwamish River, pursuant to E:\FR\FM\30JAN1.SGM 30JAN1

Agencies

[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Page 5920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01816]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1139]


Importer of Controlled Substances Application: Globyz Pharma, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Globyz 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 
March 1, 2023. Such persons may also file a written request for a 
hearing on the application on or before March 1, 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 December 30, 2022, Globyz Pharma LLC, 7 Chelsea 
Parkway, Suite 707, Boothwyn, Pennsylvania 19061-1300, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Lisdexamfetamine.......................    1205  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substance in 
dosage form for use in a clinical trial. No other activities 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 non-approved finished 
dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-01816 Filed 1-27-23; 8:45 am]
BILLING CODE 4410-09-P
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