Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, 19083 [2017-08343]

Download as PDF 19083 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 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. Dated: April 18, 2017. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2017–08232 Filed 4–24–17; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 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 1301.34(a), this is notice that on December 16, 2016, Janssen Ortho LLC, State Road 933 DM 0.1 Mamey Ward, Gurabo, Puerto Rico 00778 applied to be registered as an importer of tapentadol (9780), a basic class of controlled substance listed in schedule II. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol for distribution to its customers. [Docket No. DEA–392] Dated: April 18, 2017. Louis J. Milione, Assistant Administrator. Importer of Controlled Substances Application: Janssen Ortho LLC [FR Doc. 2017–08345 Filed 4–24–17; 8:45 am] ACTION: Registered bulk manufacturers of the affected basic class, 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 May 25, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 25, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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/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 DATES: asabaliauskas on DSK3SPTVN1PROD with NOTICES BILLING CODE 4410–09–P Notice of application. VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals 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 1301.33(a) on or before June 26, 2017. 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. DATES: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 In accordance with 21 CFR 1301.33(a), this is notice that on June 1, 2016, Cedarburg Pharmaceuticals Inc., A Division of Albany Molecular Research Inc. (AMRI), 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled Substance Marihuana ................... Tetrahydrocannabinols Lisdexamfetamine ...... 4-Anilino-N-phenethyl4-piperidine (ANPP). Remifentanil ................ Fentanyl ...................... Drug Code Schedule 7360 7370 1205 8333 I I II II 9739 9801 II II The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug codes 7360 marihuana, the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinols 7370. No other activity for this drug code is authorized for this registration. Dated: April 18, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017–08343 Filed 4–24–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Cambridge Isotope Laboratories 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 May 25, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 25, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement DATES: E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Page 19083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08343]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cedarburg 
Pharmaceuticals

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 June 26, 2017.

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 June 
1, 2016, Cedarburg Pharmaceuticals Inc., A Division of Albany Molecular 
Research Inc. (AMRI), 870 Badger Circle, Grafton, Wisconsin 53024 
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
Lisdexamfetamine......................      1205  II
4-Anilino-N-phenethyl-4-piperidine          8333  II
 (ANPP).
Remifentanil..........................      9739  II
Fentanyl..............................      9801  II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers. In reference to 
drug codes 7360 marihuana, the company plans to bulk manufacture 
cannabidiol as a synthetic intermediate. This controlled substance will 
be further synthesized to bulk manufacture a synthetic 
tetrahydrocannabinols 7370. No other activity for this drug code is 
authorized for this registration.

    Dated: April 18, 2017.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2017-08343 Filed 4-24-17; 8:45 am]
 BILLING CODE 4410-09-P