81_FR_54759 81 FR 54601 - Importer of Controlled Substances Application: Fresenius Kabi USA, LLC

81 FR 54601 - Importer of Controlled Substances Application: Fresenius Kabi USA, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

Page Range54601-54602
FR Document2016-19434

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.

Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016) 
[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54601-54602]
From the Federal Register Online  [www.thefederalregister.org]
[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

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 Dorado Soapstone LLC this investigation is contained in section 337 Drug Enforcement Administration of the Tariff Act of 1930, as amended, and 940 S. Jason St., Unit 9 [Docket No. DEA–392] in section 210.10 of the Commission’s Rules Denver, CO 80223 of Practice and Procedure, 19 CFR 210.10 Importer of Controlled Substances (2016). Pental Granite and Marble Inc. Application: Fresenius Kabi USA, LLC SCOPE OF INVESTIGATION: Having 713 South Fidalgo Street considered the complaint, the U.S. ACTION: Notice of application. Seattle, WA 98108 International Trade Commission, on (c) The Office of Unfair Import SUMMARY: Registered bulk August 10, 2016, Ordered that— Investigations, U.S. International Trade manufacturers of the affected basic (1) Pursuant to subsection (b) of class, and applicants therefor, may file section 337 of the Tariff Act of 1930, as Commission, 500 E Street SW., Suite written comments on or objections to amended, an investigation be instituted 401, Washington, DC 20436; and the issuance of the proposed registration to determine whether there is a (5) For the investigation so instituted, in accordance with 21 CFR 1301.34(a) violation of subsection (a)(1)(B) of the Chief Administrative Law Judge, on or before September 15, 2016. Such section 337 in the importation into the U.S. International Trade Commission, persons may also file a written request United States, the sale for importation, shall designate the presiding for a hearing on the application or the sale within the United States after pursuant to 21 CFR 1301.43 on or before Administrative Law Judge. importation of certain quartz slabs and September 15, 2016. portions thereof (II) by reason of The Chief Administrative Law Judge is authorized to consolidate Inv. No. ADDRESSES: Written comments should infringement of the claim of the ’666 337–TA–996 and this investigation if he be sent to: Drug Enforcement patent; the claim of the ’670 patent; the deems it appropriate. Administration, Attention: DEA Federal claim of the ’298 patent; the claim of the Register Representative/ODW, 8701 ’161 patent; and the claim of the ’058 Responses to the complaint and the Morrissette Drive, Springfield, Virginia patent, and whether an industry in the notice of investigation must be 22152. All requests for hearing must be United States exists as required by submitted by the named respondents in sent to: Drug Enforcement subsection (a)(2) of section 337; accordance with section 210.13 of the Administration, Attn: Administrator, (2) For the purpose of the Commission’s Rules of Practice and 8701 Morrissette Drive, Springfield, investigation so instituted, the following Virginia 22152. All requests for hearing Procedure, 19 CFR 210.13. Pursuant to are hereby named as parties upon which should also be sent to: (1) Drug 19 CFR 201.16(e) and 210.13(a), such this notice of investigation shall be Enforcement Administration, Attn: responses will be considered by the served: Hearing Clerk/LJ, 8701 Morrissette (a) The complainant is: Commission if received not later than 20 days after the date of service by the Drive, Springfield, Virginia 22152; and Cambria Company LLC (2) Drug Enforcement Administration, Commission of the complaint and the 805 Enterprise Drive East Attn: DEA Federal Register Suite H notice of investigation. Extensions of time for submitting responses to the Representative/ODW, 8701 Morrissette Belle Plaine, MN 56011 Drive, Springfield, Virginia 22152. complaint and the notice of (b) The respondents are the following SUPPLEMENTARY INFORMATION: The investigation will not be granted unless entities alleged to be in violation of Attorney General has delegated her section 337, and are the parties upon good cause therefor is shown. authority under the Controlled which the complaint is to be served: Failure of a respondent to file a timely Substances Act to the Administrator of Stylen Quaza LLC DBA Vicostone USA response to each allegation in the the Drug Enforcement Administration 11620 Goodnight Lane, Suite 100 complaint and in this notice may be (DEA), 28 CFR 0.100(b). Authority to Dallas, TX 75229 deemed to constitute a waiver of the exercise all necessary functions with Vicostone Joint Stock Company right to appear and contest the respect to the promulgation and Hoalac Hi-tech Park allegations of the complaint and this implementation of 21 CFR part 1301, Thachthat, Hanoi notice, and to authorize the incident to the registration of Vietnam administrative law judge and the manufacturers, distributors, dispensers, Building Plastics Inc. Commission, without further notice to importers, and exporters of controlled 3263 Sharpe Avenue the respondent, to find the facts to be as substances (other than final orders in Memphis, TN 38111 alleged in the complaint and this notice connection with suspension, denial, or and to enter an initial determination revocation of registration) has been Fasa Industrial Corporation, Ltd. and a final determination containing redelegated to the Deputy Assistant 10th Floor, Building T6, Wisdom New such findings, and may result in the Administrator of the DEA Office of Town issuance of an exclusion order or a cease Diversion Control (‘‘Deputy Assistant No. 2 Jihua Road, Chancheng District, and desist order or both directed against Administrator’’) pursuant to section 7 of Foshan, Guangdong Province 528000 the respondent. 28 CFR part 0, appendix to subpart R. China In accordance with 21 CFR Foshan FASA Building Material Co., By order of the Commission. 1301.34(a), this is notice that on June asabaliauskas on DSK3SPTVN1PROD with NOTICES Ltd. Issued: August 11, 2016. 13, 2016, Fresenius Kabi USA, LLC, 10th Floor, Building T6, Wisdom New 3159 Staley Road, Grand Island, New Lisa R. Barton, Town York 14072 applied to be registered as No. 2 Jihua Road, Chancheng District, Secretary to the Commission. an importer of remifentanil (9739), a Foshan, Guangdong Province 528000 [FR Doc. 2016–19498 Filed 8–15–16; 8:45 am] basic class of controlled substance listed China BILLING CODE 7020–02–P in schedule II. Solidtops LLC The company plans to import the 27964 Oxford Road listed controlled substance for product VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\16AUN1.SGM 16AUN1

54602 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices development and preparation of In accordance with 21 CFR Attn: DEA Federal Register stability batches. 1301.34(a), this is notice that on June Representative/ODW, 8701 Morrissette 29, 2016, ALMAC Clinical Services Drive, Springfield, Virginia 22152. Louis J. Milione, Incorp (ACSI), 25 Fretz Road, SUPPLEMENTARY INFORMATION: The Deputy Assistant Administrator. Souderton, Pennsylvania 18964 applied Attorney General has delegated her [FR Doc. 2016–19434 Filed 8–15–16; 8:45 am] to be registered as an importer of the authority under the Controlled BILLING CODE 4410–09–P following basic classes of controlled Substances Act to the Administrator of substances: the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to DEPARTMENT OF JUSTICE Controlled substance Schedule exercise all necessary functions with Drug Enforcement Administration respect to the promulgation and Oxycodone (9143) ................ II implementation of 21 CFR part 1301, [Docket No. DEA–392] Hydromorphone (9150) ........ II Morphine (9300) ................... II incident to the registration of Tapentadol (9780) ................ II manufacturers, distributors, dispensers, Importer of Controlled Substances Fentanyl (9801) .................... II importers, and exporters of controlled Application: ALMAC Clinical Services substances (other than final orders in Incorp (ACSI) The company plans to import the connection with suspension, denial, or ACTION: Notice of application. listed controlled substances in dosage revocation of registration) has been form for clinical trial only. Approval of redelegated to the Deputy Assistant DATES: Registered bulk manufacturers of permit applications will occur only Administrator of the DEA Office of the affected basic classes, and when the registrant’s business activity is Diversion Control (‘‘Deputy Assistant applicants therefore, may file written consistent with what is authorized Administrator’’) pursuant to section 7 of comments on or objections to the under 21 U.S.C. 952(a)(2). Authorization 28 CFR part 0, appendix to subpart R. issuance of the proposed registration in will not extend to the import of FDA In accordance with 21 CFR accordance with 21 CFR 1301.34(a) on approved or non-approved finished 1301.34(a), this is notice that on May 18, or before September 15, 2016. Such dosage forms for commercial sale. 2016, Cody Laboratories, Inc., 601 persons may also file a written request Yellowstone Avenue, Barry Baldwin, Louis J. Milione, for a hearing on the application Controlled Substances Manager, Cody, pursuant to 21 CFR 1301.43 on or before Deputy Assistant Administrator. Wyoming 82414–9321 applied to be September 15, 2016. [FR Doc. 2016–19439 Filed 8–15–16; 8:45 am] registered as an importer of the ADDRESSES: Written comments should BILLING CODE 4410–09–P following basic classes of controlled be sent to: Drug Enforcement substances: Administration, Attention: DEA Federal Register Representative/ODW, 8701 DEPARTMENT OF JUSTICE Controlled substance Schedule Morrissette Drive, Springfield, Virginia Drug Enforcement Administration Phenylacetone (8501) .......... II 22152. All requests for hearing must be Poppy Straw Concentrate sent to: Drug Enforcement [Docket No. DEA–392] (9670) ................................ II Administration, Attn: Administrator, Tapentadol (9780) ................ II 8701 Morrissette Drive, Springfield, Importer of Controlled Substances Virginia 22152. All requests for hearing Application: Cody Laboratories, Inc. The company plans to import narcotic should also be sent to: (1) Drug ACTION: Notice of application. raw materials to manufacture bulk Enforcement Administration, Attn: controlled substances for distribution to Hearing Clerk/LJ, 8701 Morrissette SUMMARY: Registered bulk its customers. The company plans to Drive, Springfield, Virginia 22152; and manufacturers of the affected basic import an intermediate form of (2) Drug Enforcement Administration, classes, and applicants therefore, may tapentadol (9780), to bulk manufacture Attn: DEA Federal Register file written comments on or objections tapentadol for distribution to its Representative/ODW, 8701 Morrissette to the issuance of the proposed customers. Drive, Springfield, Virginia 22152. registration in accordance with 21 CFR Louis J. Milione, SUPPLEMENTARY INFORMATION: The 1301.34(a) on or before September 15, Deputy Assistant Administrator. Attorney General has delegated her 2016. Such persons may also file a written request for a hearing on the [FR Doc. 2016–19435 Filed 8–15–16; 8:45 am] authority under the Controlled Substances Act to the Administrator of application pursuant to 21 CFR 1301.43 BILLING CODE 4410–09–P the Drug Enforcement Administration on or before September 15, 2016. (DEA), 28 CFR 0.100(b). Authority to ADDRESSES: Written comments should DEPARTMENT OF JUSTICE exercise all necessary functions with be sent to: Drug Enforcement respect to the promulgation and Administration, Attention: DEA Federal Drug Enforcement Administration implementation of 21 CFR part 1301, Register Representative/ODW, 8701 incident to the registration of Morrissette Drive, Springfield, Virginia [Docket No. DEA–392] manufacturers, distributors, dispensers, 22152. All requests for hearing must be Importer of Controlled Substances importers, and exporters of controlled sent to: Drug Enforcement asabaliauskas on DSK3SPTVN1PROD with NOTICES Application: Actavis Laboratories FL., substances (other than final orders in Administration, Attn: Administrator, Inc. connection with suspension, denial, or 8701 Morrissette Drive, Springfield, revocation of registration) has been Virginia 22152. All requests for hearing ACTION: Notice of application. redelegated to the Deputy Assistant should also be sent to: (1) Drug Administrator of the DEA Office of Enforcement Administration, Attn: DATES: Registered bulk manufacturers of Diversion Control (‘‘Deputy Assistant Hearing Clerk/LJ, 8701 Morrissette the affected basic classes, and Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152; and applicants therefore, may file written 28 CFR part 0, appendix to subpart R. (2) Drug Enforcement Administration, comments on or objections to the VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\16AUN1.SGM 16AUN1


Document Created: 2016-08-16 03:20:23
Document Modified: 2016-08-16 03:20:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
FR Citation81 FR 54601 
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