81 FR 57935 - Importer of Controlled Substances Application: Akorn, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 164 (August 24, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 164 (August 24, 2016)
| Page Range | 57935-57936 | |
| FR Document | 2016-20236 |
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)] [Notices] [Pages 57935-57936] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20236] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Akorn, Inc. ACTION: Notice of application. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices 57935
Controlled substance Schedule
Allylprodine (9602) ....................................................................................................................................................................................... I
Alphacetylmethadol except levo-alphacetylmethadol (9603) ...................................................................................................................... I
Alphameprodine (9604) ............................................................................................................................................................................... I
Alphamethadol (9605) ................................................................................................................................................................................. I
Betacetylmethadol (9607) ............................................................................................................................................................................ I
Betameprodine (9608) ................................................................................................................................................................................. I
Betamethadol (9609) ................................................................................................................................................................................... I
Betaprodine (9611) ...................................................................................................................................................................................... I
Dextromoramide (9613) ............................................................................................................................................................................... I
Dipipanone (9622) ....................................................................................................................................................................................... I
Hydroxypethidine (9627) ............................................................................................................................................................................. I
Noracymethadol (9633) ............................................................................................................................................................................... I
Norlevorphanol (9634) ................................................................................................................................................................................. I
Normethadone (9635) ................................................................................................................................................................................. I
Racemoramide (9645) ................................................................................................................................................................................. I
Trimeperidine (9646) ................................................................................................................................................................................... I
1-Methyl-4-phenyl-4-propionoxypiperidine (9661) ....................................................................................................................................... I
Tilidine (9750) .............................................................................................................................................................................................. I
Para-Fluorofentanyl (9812) .......................................................................................................................................................................... I
3-Methylfentanyl (9813) ............................................................................................................................................................................... I
Alpha-methylfentanyl (9814) ........................................................................................................................................................................ I
Acetyl-alpha-methylfentanyl (9815) ............................................................................................................................................................. I
Beta-hydroxyfentanyl (9830) ....................................................................................................................................................................... I
Beta-hydroxy-3-methylfentanyl (9831) ........................................................................................................................................................ I
Alpha-methylthiofentanyl (9832) .................................................................................................................................................................. I
3-Methylthiofentanyl (9833) ......................................................................................................................................................................... I
Thiofentanyl (9835) ...................................................................................................................................................................................... I
Methamphetamine (1105) ........................................................................................................................................................................... II
Methylphenidate (1724) ............................................................................................................................................................................... II
Amobarbital (2125) ...................................................................................................................................................................................... II
Pentobarbital (2270) .................................................................................................................................................................................... II
Secobarbital (2315) ..................................................................................................................................................................................... II
Glutethimide (2550) ..................................................................................................................................................................................... II
Nabilone (7379) ........................................................................................................................................................................................... II
1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. II
Phencyclidine (7471) ................................................................................................................................................................................... II
Phenylacetone (8501) ................................................................................................................................................................................. II
1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................ II
Alphaprodine (9010) .................................................................................................................................................................................... II
Dihydrocodeine (9120) ................................................................................................................................................................................ II
Ecgonine (9180) .......................................................................................................................................................................................... II
Ethylmorphine (9190) .................................................................................................................................................................................. II
Levomethorphan (9210) .............................................................................................................................................................................. II
Levorphanol (9220) ..................................................................................................................................................................................... II
Meperidine (9230) ....................................................................................................................................................................................... II
Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. II
Levo-alphacetylmethadol (9648) ................................................................................................................................................................. II
Noroxymorphone (9668) .............................................................................................................................................................................. II
Racemethorphan (9732) .............................................................................................................................................................................. II
Alfentanil (9737) .......................................................................................................................................................................................... II
Remifentanil (9739) ..................................................................................................................................................................................... II
Sufentanil (9740) ......................................................................................................................................................................................... II
Carfentanil (9743) ........................................................................................................................................................................................ II
Tapentadol (9780) ....................................................................................................................................................................................... II
The company plans to import small activity for this drug code is authorized DEPARTMENT OF JUSTICE
quantities of the listed controlled for this registration.
substances for the manufacture of Drug Enforcement Administration
Louis J. Milione,
analytical reference standards and
Deputy Assistant Administrator. [Docket No. DEA–392]
distribution to their research and
forensic customers. Placement of these [FR Doc. 2016–20237 Filed 8–23–16; 8:45 am]
Importer of Controlled Substances
drug codes onto the company’s BILLING CODE 4410–09–P
Application: Akorn, Inc.
registration does not translate into
mstockstill on DSK3G9T082PROD with NOTICES
automatic approval of subsequent ACTION: Notice of application.
permit applications to import controlled
substances. DATES: Registered bulk manufacturers of
In reference to drug code 7360 the affected basic class, and applicants
therefore, may file written comments on
(Marihuana) the company plans to
or objections to the issuance of the
import a synthetic cannabidiol. No other
proposed registration in accordance
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![57936 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
with 21 CFR 1301.34(a) on or before DEPARTMENT OF JUSTICE drug codes are authorized for this
September 23, 2016. Such persons may registration.
also file a written request for a hearing Drug Enforcement Administration
Louis J. Milione,
on the application pursuant to 21 CFR [Docket No. DEA–392] Deputy Assistant Administrator.
1301.43 on or before September 23,
[FR Doc. 2016–20235 Filed 8–23–16; 8:45 am]
2016. Bulk Manufacturer of Controlled
Substances Application: Noramco, Inc. BILLING CODE 4410–09–P
ADDRESSES: Written comments should
be sent to: Drug Enforcement ACTION: Notice of application.
Administration, Attention: DEA Federal DEPARTMENT OF JUSTICE
Register Representative/ODW, 8701 DATES: Registered bulk manufacturers of
the affected basic classes, and Notice of Lodging of Proposed
Morrissette Drive, Springfield, Virginia Consent Decree Under the Clean Air
applicants therefore, may file written
22152. All requests for hearing must be Act
comments on or objections to the
sent to: Drug Enforcement
issuance of the proposed registration in On August 18, 2016, the Department
Administration, Attn: Administrator, accordance with 21 CFR 1301.33(a) on
8701 Morrissette Drive, Springfield, of Justice lodged a proposed Consent
or before October 24, 2016. Decree with the United States District
Virginia 22152. All requests for hearing
ADDRESSES: Written comments should Court for the District of Columbia in the
should also be sent to: (1) Drug be sent to: Drug Enforcement
Enforcement Administration, Attn: lawsuit entitled United States v. Harley-
Administration, Attention: DEA Federal Davidson, Inc., et al., Civil Action No.
Hearing Clerk/LJ, 8701 Morrissette Register Representative/ODW, 8701
Drive, Springfield, Virginia 22152; and 1:16–cv–01687.
Morrissette Drive, Springfield, Virginia The United States’ Complaint alleges
(2) Drug Enforcement Administration, 22152.
Attn: DEA Federal Register that Harley-Davidson, Inc. (and three
SUPPLEMENTARY INFORMATION: The related companies) manufactured and
Representative/ODW, 8701 Morrissette
Attorney General has delegated her sold over 339,392 after-market devices
Drive, Springfield, Virginia 22152.
authority under the Controlled (known as ‘‘Super Tuners’’ and used
SUPPLEMENTARY INFORMATION: Substances Act to the Administrator of with Harley-Davidson motorcycles) in
The Attorney General has delegated the Drug Enforcement Administration violation of the Clean Air Act
her authority under the Controlled (DEA), 28 CFR 0.100(b). Authority to prohibition on the manufacture or sale
Substances Act to the Administrator of exercise all necessary functions with of devices that defeat the functioning of
respect to the promulgation and the motorcycle’s certified emissions
the Drug Enforcement Administration
implementation of 21 CFR part 1301, control system. The Complaint also
(DEA), 28 CFR 0.100(b). Authority to
incident to the registration of alleges, relatedly, that Defendants
exercise all necessary functions with manufacturers, distributors, dispensers, violated the provision of the Act that
respect to the promulgation and importers, and exporters of controlled prohibits any person from removing or
implementation of 21 CFR part 1301, substances (other than final orders in rendering inoperative a motor vehicle’s
incident to the registration of connection with suspension, denial, or certified emissions control system and
manufacturers, distributors, dispensers, revocation of registration) has been from causing such ‘‘tampering.’’ Finally,
importers, and exporters of controlled redelegated to the Deputy Assistant the Complaint alleges that Defendants
substances (other than final orders in Administrator of the DEA Office of manufactured and sold more than
connection with suspension, denial, or Diversion Control (‘‘Deputy Assistant 12,000 motorcycles from model years
revocation of registration) has been Administrator’’) pursuant to section 7 of 2006, 2007 and 2008 that were not
redelegated to the Deputy Assistant 28 CFR part 0, appendix to subpart R. certified by EPA as required by the
Administrator of the DEA Office of In accordance with 21 CFR Clean Air Act.
Diversion Control (‘‘Deputy Assistant 1301.33(a), this is notice that on July 20, The Consent Decree requires
Administrator’’) pursuant to section 7 of 2016, Noramco, Inc., 1440 Olympic Defendants to stop selling the illegal
28 CFR part 0, appendix to subpart R. Drive, Athens, Georgia 30601 applied to tuners in the United States by August
be registered as a bulk manufacturer the 23, 2016. Defendants will also offer to
In accordance with 21 CFR
following basic classes of controlled buy back all such tuners in stock at
1301.34(a), this is notice that on June 3,
substances: Harley-Davidson dealerships across the
2016, Akorn, Inc., 1222 W. Grand
Avenue, Decatur, Illinois 62522 applied country and destroy them. The Decree
requires Defendants to obtain an
to be registered as an importer of Controlled substance Schedule Executive order from the California Air
remifentanil (9739), a basic class of
Resources Board (CARB) for any tuners
controlled substances listed in schedule Marihuana (7360) ......................... I
it sells in the United States in the future.
II. Tetrahydrocannabinols (7370) ..... I
Hydromorphinol (9301) ................. I These Executive orders (E.O.s) will
The company plans to import Nabilone (7379) ............................ II demonstrate that the CARB-certified
remifentanil in dosage form for tuners do not cause Defendants’
distribution. motorcycles to exceed the EPA-certified
The company plans to manufacture emissions limits. Defendants must also
Louis J. Milione,
bulk active pharmaceutical ingredients conduct tests on motorcycles that have
mstockstill on DSK3G9T082PROD with NOTICES
Deputy Assistant Administrator. (APIs) and reference standards for been tuned with the E.O.-certified
[FR Doc. 2016–20236 Filed 8–23–16; 8:45 am] distribution to their customers. tuners and provide the results to EPA to
BILLING CODE 4410–09–P In reference to drug codes 7360 ensure that their motorcycles remain in
(marihuana) and 7370 compliance with EPA emissions
(tetrahydrocannabinols), the company requirements. In addition, for any
plans to bulk manufacturer these drugs uncertified Super Tuners that
as synthetic. No other activities for these Defendants sell outside the United
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Document Created: 2016-08-24 03:02:25
Document Modified: 2016-08-24 03:02:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of application. | |
| 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 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. | |
| FR Citation | 81 FR 57935 |
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