Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC, 75689 [2015-30556]

Download as PDF 75689 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before January 4, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before January 4, 2016. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/OD/D, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 October 29, 2015, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Lhorne on DSK5TPTVN1PROD with NOTICES Methylphenidate (1724) ................ Fentanyl (9801) ............................ II II The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domesticallymanufactured FDF to foreign markets. Dated: November 27, 2015. Louis J. Milione, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC ACTION: Fresenius Kabi USA, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Fresenius Kabi USA, LLC registration as an importer of this controlled substance. SUMMARY: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57389 Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Fresenius Kabi USA, LLC to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration 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 development and preparation of stability batches. SUPPLEMENTARY INFORMATION: Dated: November 27, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015–30556 Filed 12–2–15; 8:45 am] [FR Doc. 2015–30555 Filed 12–2–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 15:11 Dec 02, 2015 ACTION: Notice of registration. BILLING CODE 4410–09–P Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Importer of Controlled Substances Registration: United States Pharmacopeial Convention Notice of registration. United States Pharmacopeial Convention applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants United States Pharmacopeial Convention registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated June 25, 2015, and published in the Federal Register on July 6, 2015, 80 FR 38466, United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of United States Pharmacopeial Convention to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the basic classes of controlled substances: SUMMARY: Controlled substance Cathinone (1235) .......................... Methaqualone (2565) ................... Lysergic acid diethylamide (7315) Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... 4-Methyl-2,5dimethoxyamphetamine (7395). 3,4-Methylenedioxyamphetamine (7400). Codeine-N-oxide (9053) ............... Difenoxin (9168) ........................... Heroin (9200) ............................... Morphine-N-oxide (9307) ............. Norlevorphanol (9634) .................. Amphetamine (1100) .................... E:\FR\FM\03DEN1.SGM 03DEN1 Schedule I I I I I I I I I I I I II

Agencies

[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Page 75689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30556]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Fresenius Kabi 
USA, LLC

ACTION: Notice of registration.

-----------------------------------------------------------------------

SUMMARY: Fresenius Kabi USA, LLC applied to be registered as an 
importer of a certain basic class of controlled substance. The Drug 
Enforcement Administration (DEA) grants Fresenius Kabi USA, LLC 
registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and 
published in the Federal Register on September 23, 2015, 80 FR 57389 
Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072 
applied to be registered as an importer of a certain basic class of 
controlled substance. No comments or objections were submitted for this 
notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Fresenius Kabi USA, LLC 
to import the basic class of controlled substance is consistent with 
the public interest and with United States obligations under 
international treaties, conventions, or protocols in effect on May 1, 
1971. The DEA investigated the company's maintenance of effective 
controls against diversion by inspecting and testing the company's 
physical security systems, verifying the company's compliance with 
state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration 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 development and preparation of stability batches.

    Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30556 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.