Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc., 5808 [2018-02644]

Download as PDF 5808 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: February 6, 2018. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2018–02616 Filed 2–8–18; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Noramco, 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 on or before April 10, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 July 6, 2017, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: sradovich on DSK3GMQ082PROD with NOTICES DATES: 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. VerDate Sep<11>2014 16:57 Feb 08, 2018 Jkt 244001 Controlled substance Cathinone ..................... Gamma Hydroxybutyric Acid. Marihuana Extract ........ Marihuana ..................... Tetrahydrocannabinols Codeine-N-oxide ........... Dihydromorphine .......... Hydromorphinol ............ Morphine-N-oxide ......... Amphetamine ............... Lisdexamfetamine ........ Methylphenidate ........... Nabilone ....................... Codeine ........................ Dihydrocodeine ............. Oxycodone ................... Hydromorphone ............ Hydrocodone ................ Morphine ....................... Oripavine ...................... Thebaine ....................... Opium tincture .............. Oxymorphone ............... Noroxymorphone .......... Alfentanil ....................... Sufentanil ...................... Carfentanil .................... Tapentadol .................... Fentanyl ........................ Drug code Schedule 1235 2010 I I 7350 7360 7370 9053 9145 9301 9307 1100 1205 1724 7379 9050 9120 9143 9150 9193 9300 9330 9333 9630 9652 9668 9737 9740 9743 9780 9801 I I I I I I I II II II II II II II II II II II II II II II II II II II II The company plans to manufacture bulk active pharmaceutical ingredients (APIs) and reference standards for distribution to their 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. Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–02645 Filed 2–8–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, 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 on or before April 10, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement DATES: PO 00000 Frm 00055 Fmt 4703 Sfmt 9990 Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 December 6, 2017, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Marihuana ..................... Tetrahydrocannabinols Amphetamine ............... Lisdexamfetamine ........ Pentobarbital ................ 4-Anilino-N-phenethyl-4piperidine (ANPP). Codeine ........................ Oxycodone ................... Hydromorphone ............ Hydrocodone ................ Meperidine .................... Morphine ....................... Drug code Schedule 7360 7370 1100 1205 2270 8333 I I II II II II 9050 9143 9150 9193 9230 9300 II II II II II II The company plans to manufacture bulk controlled substances for use in product development and for distribution to its customers. 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: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–02644 Filed 2–8–18; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\09FEN1.SGM 09FEN1

Agencies

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Page 5808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02644]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: AMRI 
Rensselaer, 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 on or before April 10, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 
December 6, 2017, AMRI Rensselaer, Inc., 33 Riverside Avenue, 
Rensselaer, New York 12144 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Amphetamine............................     1100  II
Lisdexamfetamine.......................     1205  II
Pentobarbital..........................     2270  II
4-Anilino-N-phenethyl-4-piperidine          8333  II
 (ANPP).
Codeine................................     9050  II
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Hydrocodone............................     9193  II
Meperidine.............................     9230  II
Morphine...............................     9300  II
------------------------------------------------------------------------

    The company plans to manufacture bulk controlled substances for use 
in product development and for distribution to its customers.
    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: January 31, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-02644 Filed 2-8-18; 8:45 am]
 BILLING CODE 4410-09-P
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