Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc., 9219 [2016-03852]

Download as PDF 9219 Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices Controlled substance Schedule mstockstill on DSK4VPTVN1PROD with NOTICES 2-(4-chloro-2,5-dimethoxyphenyl)N-(2-methoxybenzyl)ethanamine (25C– NBOMe) (7537). 2-(4-iodo-2,5-dimethoxyphenyl)-N(2-methoxybenzyl)ethanamine (25I–NBOMe) (7538). Methylone (3,4-Methylenedioxy-Nmethylcathinone) (7540). Butylone (7541) ............................ Pentylone (7542) .......................... alpha-pyrrolidinopentiophenone (a-PVP) (7545). alpha-pyrrolidinobutiophenone (aPBP) (7546). AM–694 (1-(5-Fluoropentyl)-3-(2iodobenzoyl)indole) (7694). Acetyldihydrocodeine (9051) ........ Benzylmorphine (9052) ................ Codeine-N-oxide (9053) ............... Desomorphine (9055) ................... Dihydromorphine (9145) ............... Heroin (9200) ............................... Morphine-N-oxide (9307) ............. Normorphine (9313) ..................... Tilidine (9750) ............................... Acetyl Fentanyl (N-(1phenethylpiperidin-4-yl)-Nphenylacetamide) (9821). Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Phencyclidine (7471) .................... Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Meperidine (9230) ........................ Meperidine intermediate-B (9233) Methadone (9250) ........................ Dextropropoxyphene, bulk. (non-dosage forms) (9273) .......... Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ I 17:59 Feb 23, 2016 Controlled substance [FR Doc. 2016–03854 Filed 2–23–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE I Drug Enforcement Administration I I I [Docket No. DEA–392] I Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc. I ACTION: I I I I I I I I I I DATES: II II II II II II II II II II II II II II II II II II II II II II II II II II II II II Jkt 238001 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 1301.33(a) on or before April 25, 2016 ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: 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 1301.33(a), this is notice that on November 12, 2015, Janssen Pharmaceutical, Inc., 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 II II Dated: February 16, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–03852 Filed 2–23–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Notice of application. Controlled substance Tapentadol (9780) ........................ Fentanyl (9801) ............................ Schedule The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. I The company plans to manufacture reference standards for distribution to their research and forensics customers. In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. VerDate Sep<11>2014 Dated: February 16, 2016. Louis J. Milione, Deputy Assistant Administrator. Schedule II II II II II II II Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Cedarburg Pharmaceuticals, Inc. ACTION: Notice of registration. Cedarburg Pharmaceuticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cedarburg Pharmaceuticals, Inc. registration as a manufacturer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57390, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a manufacturer 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(a) and determined that the registration of Cedarburg Pharmaceuticals, Inc. to manufacture 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. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances: SUMMARY: E:\FR\FM\24FEN1.SGM 24FEN1

Agencies

[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Page 9219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03852]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Janssen 
Pharmaceutical, Inc.

ACTION: Notice of application.

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DATES: 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 
1301.33(a) on or before April 25, 2016

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: 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 1301.33(a), this is notice that on 
November 12, 2015, Janssen Pharmaceutical, Inc., 1440 Olympic Drive, 
Athens, Georgia 30601 applied to be registered as a bulk manufacturer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Oxymorphone (9652).........................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................   II
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    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers.

    Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03852 Filed 2-23-16; 8:45 am]
 BILLING CODE 4410-09-P