Importer of Controlled Substances Application: Sharp Clinical Services, LLC, 10730-10731 [2025-03060]

Download as PDF 10730 Federal Register / Vol. 90, No. 37 / Wednesday, February 26, 2025 / Notices INTERNATIONAL TRADE COMMISSION [Investigation No. 337–TA–1440] Certain Motorized Self-Balancing Vehicles; Notice of Institution of Investigation U.S. International Trade Commission. ACTION: Notice. AGENCY: Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on January 3, 2025, under section 337 of the Tariff Act of 1930, as amended, on behalf of Razor USA LLC of Cerritos, California and Shane Chen of Camas, Washington. An amended complaint was filed on January 21, 2025. The complaint, as amended, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain motorized self-balancing vehicles by reason of the infringement of certain claims of U.S. Patent No. RE46,964 (‘‘the ’964 patent’’), U.S. Patent No. RE49,608 (‘‘the ’608 patent’’), and U.S. Patent No. D739,906 (‘‘the ’906 patent’’). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders. ADDRESSES: The complaint, except for any confidential information contained therein, may be viewed on the Commission’s electronic docket (EDIS) at https://edis.usitc.gov. For help accessing EDIS, please email EDIS3Help@usitc.gov. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission’s TDD terminal on (202) 205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205– 2000. General information concerning the Commission may also be obtained by accessing its internet server at https://www.usitc.gov. FOR FURTHER INFORMATION CONTACT: Susan Orndoff, Office of Docket Services, U.S. International Trade Commission, telephone (202) 205–1802. SUPPLEMENTARY INFORMATION: Authority: The authority for institution of this investigation is khammond on DSK9W7S144PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:26 Feb 25, 2025 Jkt 265001 contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10 (2024). Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on February 20, 2025, Ordered that— (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 10–17 of the ’964 patent; claims 10–13 of the ’608 patent and claim 1 of the ’906 patent, and whether an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337; (2) Pursuant to section 210.10(b)(1) of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is ‘‘motorized twowheeled self-balancing vehicles without handlebars’’; (3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served: (a) The complainants are: Razor USA LLC, 12723 166th St., Cerritos, California 90703 Shane Chen, 1821 NW 8th Ave., Camas, Washington 98607 (b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: Golabs Inc. d/b/a Gotrax, 2201 Luna Road, Carrollton, Texas 75006 Dongguan Saibotan Nengyuan Keji Co., Ltd., d/b/a ‘‘Gyroor US’’, No. 1 Feida Rd. Building A, 2F, Zhangyang District, Zhangmatou Town, Guangdong, China 523637 Gyroor Technology (CHINA) Co., Ltd., d/b/a Gyroor, No. 1800112, Dafu Industrial Area, Guanlan Town, Longhua District, Shenzhen City, Guangdong, China 51800 Shenzhen Chitado Technology Co., Ltd., d/b/a Gyroor, Floor 901, 902, 11, 12, 13, Building 13, No., 6, Xincheng Avenue, Guangpei Community, Guanlan Town, Longhua District, Shenzhen City, Guangdong, China 51800 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 Unicorn Network, LLC. d/b/a Sisigad, c/o A Registered Agent, Inc., 8 The Green, Ste. A, Dover, Delaware 19901 (4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. The Office of Unfair Import Investigations will not participate as a party in this investigation. Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainants of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown. Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent. By order of the Commission. Issued: February 20, 2025. Lisa Barton, Secretary to the Commission. [FR Doc. 2025–03080 Filed 2–25–25; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1502] Importer of Controlled Substances Application: Sharp Clinical Services, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: E:\FR\FM\26FEN1.SGM 26FEN1 10731 Federal Register / Vol. 90, No. 37 / Wednesday, February 26, 2025 / Notices Sharp Clinical Services, 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 28, 2025. Such persons may also file a written request for a hearing on the application on or before March 28, 2025. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, SUMMARY: 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. In accordance with 21 CFR 1301.34(a), this is notice that on January 7, 2025, Sharp Clinical Services, LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020– 8024, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... 3,4-Methylenedioxymethamphetamine ............................................................................................................................ 5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. Psilocybin ......................................................................................................................................................................... The company plans to import the listed controlled substances for distribution and clinical trials. 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2025–03060 Filed 2–25–25; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1503] Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC Drug Enforcement Administration, Justice. khammond on DSK9W7S144PROD with NOTICES AGENCY: ACTION: Notice of application. Catalent Pharma Solutions, 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 28, 2025. Such persons may also file a written request for a hearing on the application on or before March 28, 2025. 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 SUMMARY: In accordance with 21 CFR 1301.34(a), this is notice that on November 19, 2024, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114–1123, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Ibogaine ........................................................................................................................................................................... VerDate Sep<11>2014 18:26 Feb 25, 2025 Jkt 265001 research, and analytical activities. No other activity for this drug code is authorized for this registration. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 I I I I 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. Controlled substance The company plans to import the listed controlled substance as finished dosage unit products for clinical trials, 2010 7405 7431 7437 Schedule 7260 Schedule I Approval of permit applications will occur only when the registrant’s business activity is consistent with what E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 90, Number 37 (Wednesday, February 26, 2025)]
[Notices]
[Pages 10730-10731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-03060]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1502]


Importer of Controlled Substances Application: Sharp Clinical 
Services, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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[[Page 10731]]

SUMMARY: Sharp Clinical Services, 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 28, 2025. Such persons may also file a written request for a 
hearing on the application on or before March 28, 2025.

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 January 7, 2025, Sharp Clinical Services, LLC, 2400 
Baglyos Circle, Bethlehem, Pennsylvania 18020-8024, 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
3,4-Methylenedioxymethamphetamine..            7405  I
5-Methoxy-N-N-dimethyltryptamine...            7431  I
Psilocybin.........................            7437  I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
distribution and clinical trials. 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.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2025-03060 Filed 2-25-25; 8:45 am]
BILLING CODE P
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