Importer of Controlled Substances Application: Akorn, Inc., 57935-57936 [2016-20236]

Download as PDF 57935 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices Controlled substance Schedule mstockstill on DSK3G9T082PROD with NOTICES Allylprodine (9602) ....................................................................................................................................................................................... Alphacetylmethadol except levo-alphacetylmethadol (9603) ...................................................................................................................... Alphameprodine (9604) ............................................................................................................................................................................... Alphamethadol (9605) ................................................................................................................................................................................. Betacetylmethadol (9607) ............................................................................................................................................................................ Betameprodine (9608) ................................................................................................................................................................................. Betamethadol (9609) ................................................................................................................................................................................... Betaprodine (9611) ...................................................................................................................................................................................... Dextromoramide (9613) ............................................................................................................................................................................... Dipipanone (9622) ....................................................................................................................................................................................... Hydroxypethidine (9627) ............................................................................................................................................................................. Noracymethadol (9633) ............................................................................................................................................................................... Norlevorphanol (9634) ................................................................................................................................................................................. Normethadone (9635) ................................................................................................................................................................................. Racemoramide (9645) ................................................................................................................................................................................. Trimeperidine (9646) ................................................................................................................................................................................... 1-Methyl-4-phenyl-4-propionoxypiperidine (9661) ....................................................................................................................................... Tilidine (9750) .............................................................................................................................................................................................. Para-Fluorofentanyl (9812) .......................................................................................................................................................................... 3-Methylfentanyl (9813) ............................................................................................................................................................................... Alpha-methylfentanyl (9814) ........................................................................................................................................................................ Acetyl-alpha-methylfentanyl (9815) ............................................................................................................................................................. Beta-hydroxyfentanyl (9830) ....................................................................................................................................................................... Beta-hydroxy-3-methylfentanyl (9831) ........................................................................................................................................................ Alpha-methylthiofentanyl (9832) .................................................................................................................................................................. 3-Methylthiofentanyl (9833) ......................................................................................................................................................................... Thiofentanyl (9835) ...................................................................................................................................................................................... Methamphetamine (1105) ........................................................................................................................................................................... Methylphenidate (1724) ............................................................................................................................................................................... Amobarbital (2125) ...................................................................................................................................................................................... Pentobarbital (2270) .................................................................................................................................................................................... Secobarbital (2315) ..................................................................................................................................................................................... Glutethimide (2550) ..................................................................................................................................................................................... Nabilone (7379) ........................................................................................................................................................................................... 1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. Phencyclidine (7471) ................................................................................................................................................................................... Phenylacetone (8501) ................................................................................................................................................................................. 1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................ Alphaprodine (9010) .................................................................................................................................................................................... Dihydrocodeine (9120) ................................................................................................................................................................................ Ecgonine (9180) .......................................................................................................................................................................................... Ethylmorphine (9190) .................................................................................................................................................................................. Levomethorphan (9210) .............................................................................................................................................................................. Levorphanol (9220) ..................................................................................................................................................................................... Meperidine (9230) ....................................................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. Levo-alphacetylmethadol (9648) ................................................................................................................................................................. Noroxymorphone (9668) .............................................................................................................................................................................. Racemethorphan (9732) .............................................................................................................................................................................. Alfentanil (9737) .......................................................................................................................................................................................... Remifentanil (9739) ..................................................................................................................................................................................... Sufentanil (9740) ......................................................................................................................................................................................... Carfentanil (9743) ........................................................................................................................................................................................ Tapentadol (9780) ....................................................................................................................................................................................... The company plans to import small quantities of the listed controlled substances for the manufacture of analytical reference standards and distribution to their research and forensic customers. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. In reference to drug code 7360 (Marihuana) the company plans to import a synthetic cannabidiol. No other VerDate Sep<11>2014 20:16 Aug 23, 2016 Jkt 238001 activity for this drug code is authorized for this registration. Louis J. Milione, Deputy Assistant Administrator. PO 00000 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] [FR Doc. 2016–20237 Filed 8–23–16; 8:45 am] BILLING CODE 4410–09–P I I I I I I I I I I I I I I I I I I I I 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 II II II II II II II Importer of Controlled Substances Application: Akorn, Inc. ACTION: Notice of application. 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 DATES: Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 57936 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices with 21 CFR 1301.34(a) on or before September 23, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 23, 2016. 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. ADDRESSES: SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with NOTICES 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 June 3, 2016, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substances listed in schedule II. The company plans to import remifentanil in dosage form for distribution. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–20236 Filed 8–23–16; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 20:16 Aug 23, 2016 Jkt 238001 drug codes are authorized for this registration. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. ACTION: Notice of application. Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Hydromorphinol (9301) ................. Nabilone (7379) ............................ Schedule I I I 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 manufacturer these drugs as synthetic. No other activities for these PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 [FR Doc. 2016–20235 Filed 8–23–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE 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 October 24, 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 July 20, 2016, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: DATES: Controlled substance Louis J. Milione, Deputy Assistant Administrator. Notice of Lodging of Proposed Consent Decree Under the Clean Air Act On August 18, 2016, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Columbia in the lawsuit entitled United States v. HarleyDavidson, Inc., et al., Civil Action No. 1:16–cv–01687. The United States’ Complaint alleges that Harley-Davidson, Inc. (and three related companies) manufactured and sold over 339,392 after-market devices (known as ‘‘Super Tuners’’ and used with Harley-Davidson motorcycles) in violation of the Clean Air Act prohibition on the manufacture or sale of devices that defeat the functioning of the motorcycle’s certified emissions control system. The Complaint also alleges, relatedly, that Defendants violated the provision of the Act that prohibits any person from removing or rendering inoperative a motor vehicle’s certified emissions control system and from causing such ‘‘tampering.’’ Finally, the Complaint alleges that Defendants manufactured and sold more than 12,000 motorcycles from model years 2006, 2007 and 2008 that were not certified by EPA as required by the Clean Air Act. The Consent Decree requires Defendants to stop selling the illegal tuners in the United States by August 23, 2016. Defendants will also offer to buy back all such tuners in stock at Harley-Davidson dealerships across the country and destroy them. The Decree requires Defendants to obtain an Executive order from the California Air Resources Board (CARB) for any tuners it sells in the United States in the future. These Executive orders (E.O.s) will demonstrate that the CARB-certified tuners do not cause Defendants’ motorcycles to exceed the EPA-certified emissions limits. Defendants must also conduct tests on motorcycles that have been tuned with the E.O.-certified tuners and provide the results to EPA to ensure that their motorcycles remain in compliance with EPA emissions requirements. In addition, for any uncertified Super Tuners that Defendants sell outside the United E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57935-57936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20236]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Akorn, Inc.

ACTION: Notice of application.

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DATES: 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

[[Page 57936]]

with 21 CFR 1301.34(a) on or before September 23, 2016. Such persons 
may also file a written request for a hearing on the application 
pursuant to 21 CFR 1301.43 on or before September 23, 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.

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 1301.34(a), this is notice that on June 
3, 2016, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 
applied to be registered as an importer of remifentanil (9739), a basic 
class of controlled substances listed in schedule II.
    The company plans to import remifentanil in dosage form for 
distribution.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-20236 Filed 8-23-16; 8:45 am]
BILLING CODE 4410-09-P