Importer of Controlled Substances Application: Akorn, Inc., 57935-57936 [2016-20236]
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Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices
Controlled substance
Schedule
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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]
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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:
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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
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
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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
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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
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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
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]]>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]
-----------------------------------------------------------------------
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
