Importer of Controlled Substances Application: Fresenius Kabi USA, LLC, 54601-54602 [2016-19434]

Download as PDF Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices 54601 SUPPLEMENTARY INFORMATION: Oxford, MD 21654 DEPARTMENT OF JUSTICE Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission’s Rules of Practice and Procedure, 19 CFR 210.10 (2016). Dorado Soapstone LLC 940 S. Jason St., Unit 9 Denver, CO 80223 Drug Enforcement Administration Having considered the complaint, the U.S. International Trade Commission, on August 10, 2016, 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 quartz slabs and portions thereof (II) by reason of infringement of the claim of the ’666 patent; the claim of the ’670 patent; the claim of the ’298 patent; the claim of the ’161 patent; and the claim of the ’058 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337; (2) 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 complainant is: Cambria Company LLC 805 Enterprise Drive East Suite H Belle Plaine, MN 56011 (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: Stylen Quaza LLC DBA Vicostone USA 11620 Goodnight Lane, Suite 100 Dallas, TX 75229 Vicostone Joint Stock Company Hoalac Hi-tech Park Thachthat, Hanoi Vietnam Building Plastics Inc. 3263 Sharpe Avenue Memphis, TN 38111 Fasa Industrial Corporation, Ltd. 10th Floor, Building T6, Wisdom New Town No. 2 Jihua Road, Chancheng District, Foshan, Guangdong Province 528000 China Foshan FASA Building Material Co., Ltd. 10th Floor, Building T6, Wisdom New Town No. 2 Jihua Road, Chancheng District, Foshan, Guangdong Province 528000 China Solidtops LLC 27964 Oxford Road asabaliauskas on DSK3SPTVN1PROD with NOTICES SCOPE OF INVESTIGATION: VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 [Docket No. DEA–392] Importer of Controlled Substances Application: Fresenius Kabi USA, LLC Pental Granite and Marble Inc. 713 South Fidalgo Street Seattle, WA 98108 ACTION: (c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and (5) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge. The Chief Administrative Law Judge is authorized to consolidate Inv. No. 337–TA–996 and this investigation if he deems it appropriate. 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), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission 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: August 11, 2016. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2016–19498 Filed 8–15–16; 8:45 am] BILLING CODE 7020–02–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Notice of application. Registered bulk manufacturers of the affected basic class, and applicants therefor, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on June 13, 2016, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance for product SUMMARY: E:\FR\FM\16AUN1.SGM 16AUN1 54602 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices In accordance with 21 CFR 1301.34(a), this is notice that on June 29, 2016, ALMAC Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of the following basic classes of controlled substances: development and preparation of stability batches. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19434 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: ALMAC Clinical Services Incorp (ACSI) ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. asabaliauskas on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 Schedule Oxycodone (9143) ................ Hydromorphone (9150) ........ Morphine (9300) ................... Tapentadol (9780) ................ Fentanyl (9801) .................... II II II II II The company plans to import the listed controlled substances in dosage form for clinical trial only. 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 FDA approved or non-approved finished dosage forms for commercial sale. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19439 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Cody Laboratories, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on May 18, 2016, Cody Laboratories, Inc., 601 Yellowstone Avenue, Barry Baldwin, Controlled Substances Manager, Cody, Wyoming 82414–9321 applied to be registered as an importer of the following basic classes of controlled substances: Schedule Phenylacetone (8501) .......... Poppy Straw Concentrate (9670) ................................ Tapentadol (9780) ................ II II II The company plans to import narcotic raw materials to manufacture bulk controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacture tapentadol for distribution to its customers. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19435 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Actavis Laboratories FL., Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the DATES: E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54601-54602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19434]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Fresenius Kabi 
USA, LLC

ACTION: Notice of application.

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SUMMARY: Registered bulk manufacturers of the affected basic class, and 
applicants therefor, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.34(a) on or before September 15, 2016. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 15, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on June 
13, 2016, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New 
York 14072 applied to be registered as an importer of remifentanil 
(9739), a basic class of controlled substance listed in schedule II.
    The company plans to import the listed controlled substance for 
product

[[Page 54602]]

development and preparation of stability batches.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-19434 Filed 8-15-16; 8:45 am]
 BILLING CODE 4410-09-P