Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 64509 [2016-22526]

Download as PDF 64509 Federal Register / Vol. 81, No. 182 / Tuesday, September 20, 2016 / Notices Register pursuant to Section 6(b) of the Act on May 18, 2016 (81 FR 31259). Controlled substance Noroxymorphone (9668) .............. Patricia A. Brink, Director of Civil Enforcement, Antitrust Division. Schedule II [Docket No. DEA–392] The company plans to manufacture the above-listed controlled substances as Active Pharmaceutical Ingredient (API) for clinical trials. In reference to drug codes 7360 (marihuana), and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration. Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc. Dated: September 12, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–22590 Filed 9–19–16; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [FR Doc. 2016–22526 Filed 9–19–16; 8:45 am] ACTION: Notice of application. BILLING CODE 4410–09–P 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 November 21, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: 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 January 13, 2016, Patheon API Manufacturing, Inc., 309 Delaware Street, Building 1106, Greenville, South Carolina 29605 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: sradovich on DSK3GMQ082PROD with NOTICES SUPPLEMENTARY INFORMATION: Controlled substance Schedule Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... VerDate Sep<11>2014 17:13 Sep 19, 2016 I I Jkt 238001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] 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 April 4, 2015, R & D Systems, Inc., 614 McKinley Place NE., Minneapolis, Minnesota 55413 applied to be registered as an importer of the following basic classes of controlled substances: Importer of Controlled Substances Application: R & D Systems, 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 October 20, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 20, 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. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). SUPPLEMENTARY INFORMATION: The Attorney General has delegated her DATES: PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 Controlled substance Mephedrone (4-Methyl-Nmethylcathinone) (1248). JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl) indole) (7118). CP–47,497 (5-(1,1Dimethylheptyl)-2-[(1R,3S)-3hydroxycyclohexyl-phenol) (7297). Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... 4-Bromo-2,5dimethoxyamphetamine (7391). 3,4Methylenedioxymethamphetamine (7405). Dimethyltryptamine (7435) ........... Psilocyn (7438) ............................. Pentobarbital (2270) ..................... Phencyclidine (7471) .................... Cocaine (9041) ............................. Schedule I I I I I I I I I II II II The company plans to manufacture bulk active pharmaceutical controlled substances for distribution to its customers for analytical purposes. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. Dated: September 12, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–22525 Filed 9–19–16; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Page 64509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22526]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Patheon 
API Manufacturing, 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 November 21, 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 
January 13, 2016, Patheon API Manufacturing, Inc., 309 Delaware Street, 
Building 1106, Greenville, South Carolina 29605 applied to be 
registered as a bulk manufacturer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Noroxymorphone (9668)......................  II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances as Active Pharmaceutical Ingredient (API) for clinical 
trials.
    In reference to drug codes 7360 (marihuana), and 7370 (THC), the 
company plans to bulk manufacture these drugs as synthetics. No other 
activities for these drug codes are authorized for this registration.

    Dated: September 12, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22526 Filed 9-19-16; 8:45 am]
 BILLING CODE 4410-09-P
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