Importer of Controlled Substances Application: Akorn, Inc., 54327 [2015-22625]
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54327
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
21 CFR 1301.43 on or before October 9,
2015.
Written comments should be
sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152. Comments
and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
ADDRESS:
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 July 22,
2015, Chattem Chemicals, Inc., 3801 St.
Elmo Avenue, Chattanooga, Tennessee
37409 applied to be registered as an
importer of the following basic classes
of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Lhorne on DSK5TPTVN1PROD with NOTICES
Methamphetamine (1105) ............
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Tapentadol (9780) ........................
II
II
II
II
II
II
The company plans to import the
listed controlled substances to bulk
manufacture other controlled substances
for distribution to its customers. The
company plans to import an
intermediate form of tapentadol (9780),
to bulk manufacturer tapentadol (9780)
for distribution to its customers. The
company plans to import Phenylacetone
(8501) in bulk for the manufacture of a
controlled substance.
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
Dated: September 1, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Dated: September 1, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–22624 Filed 9–8–15; 8:45 am]
[FR Doc. 2015–22625 Filed 9–8–15; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Akorn, Inc.
Manufacturer of Controlled
Substances Registration: PCASNanosyn, LLC
ACTION:
Notice of application.
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
October 9, 2015. Such persons may also
file a written request for a hearing on
the application pursuant to 21 CFR
1301.43 on or before October 9, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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 May 14,
2015, Akorn, Inc., 1222 W. Grand
Avenue, Decatur, Illinois 62522 applied
to be registered as an importer of
remifentanil (9739), a basic class of
controlled substance listed in schedule
II.
The company plans to import
remifentanil in dosage form for
distribution.
DATES:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Notice of registration.
PCAS-Nanosyn, LLC applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants PCASNanosyn, LLC registration as a
manufacturer of those controlled
substances.
SUMMARY:
SUPPLEMENTARY INFORMATION:
By notice dated May 15, 2015, and
published in the Federal Register on
May 21, 2015, 80 FR 29336, PCASNanosyn, LLC, 3331–B Industrial Drive,
Santa Rosa, California 95403 applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. No comments or objections
were submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of PCAS-Nanosyn, LLC
to manufacture the basic classes of
controlled substances is consistent with
the public interest and with United
States obligations under international
treaties, conventions, or protocols in
effect on May 1, 1971. The DEA
investigated the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances:
Controlled substance
Oxycodone (9143) ........................
Oripavine (9330) ...........................
Oxymorphone (9652) ...................
Fentanyl (9801) ............................
Schedule
II
II
II
II
The company is a contract
manufacturer. At the request of the
company’s customers, it manufacturers
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Page 54327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22625]
-----------------------------------------------------------------------
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 with 21 CFR
1301.34(a) on or before October 9, 2015. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before October 9, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 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 May
14, 2015, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522
applied to be registered as an importer of remifentanil (9739), a basic
class of controlled substance listed in schedule II.
The company plans to import remifentanil in dosage form for
distribution.
Dated: September 1, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-22625 Filed 9-8-15; 8:45 am]
BILLING CODE 4410-09-P
