Importer of Controlled Substances Application: Hospira, 1208 [2016-212]
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Federal Register / Vol. 81, No. 6 / Monday, January 11, 2016 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Hospira
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
with 21 CFR 1301.34(a) on or before
February 10, 2016. Such persons may
also file a written request for a hearing
on the application pursuant to 21 CFR
1301.43 on or before February 10, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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
DATES:
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 October
1, 2015, Hospira, 1776 North Centennial
Drive, McPherson, Kansas 67460–1247
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 for use in dosage form
manufacturing. Placement of this drug
code onto the company’s registration
does not translate into automatic
approval of subsequent permit
applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: January 4, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–212 Filed 1–8–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Alltech
Associates, Inc.
ACTION:
Alltech Associates, Inc.
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Alltech Associates, Inc.
registration as a manufacturer of those
controlled substances.
SUMMARY:
By notice
dated August 10, 2015, and published in
the Federal Register on August 18,
2015, 80 FR 50041, Alltech Associates,
Inc., 2051 Waukegan Road, Deerfield,
Illinois 60015 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 Alltech Associates,
Inc. 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 following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Notice of registration.
mstockstill on DSK4VPTVN1PROD with NOTICES
Controlled substance
Schedule
Methcathinone (1237) ..................................................................................................................................................................................
N-Ethylamphetamine (1475) ........................................................................................................................................................................
N,N-Dimethylamphetamine (1480) ..............................................................................................................................................................
4-Methylaminorex (cis isomer) (1590) .........................................................................................................................................................
Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................
Alpha-ethyltryptamine (7249) ......................................................................................................................................................................
Lysergic acid diethylamide (7315) ...............................................................................................................................................................
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) (7348) ...............................................................................................................
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
Mescaline (7381) .........................................................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (7391) ..............................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (7392) ..........................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (7395) ..............................................................................................................................................
2,5-Dimethoxyamphetamine (7396) ............................................................................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (7399) ................................................................................................................................................
3,4-Methylenedioxyamphetamine (7400) ....................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine (7402) ..................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (7404) ........................................................................................................................................
3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................
4-Methoxyamphetamine (7411) ...................................................................................................................................................................
5-Methoxy-N–N-dimethyltryptamine (7431) .................................................................................................................................................
Alpha-methyltryptamine (7432) ...................................................................................................................................................................
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]]>Agencies
[Federal Register Volume 81, Number 6 (Monday, January 11, 2016)]
[Notices]
[Page 1208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-212]
[[Page 1208]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Hospira
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 February 10, 2016. Such persons may also file a
written request for a hearing on the application pursuant to 21 CFR
1301.43 on or before February 10, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
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
October 1, 2015, Hospira, 1776 North Centennial Drive, McPherson,
Kansas 67460-1247 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 for use in dosage form
manufacturing. Placement of this drug code onto the company's
registration does not translate into automatic approval of subsequent
permit applications to import controlled substances. Approval of permit
applications will occur only when the registrant's business activity is
consistent with what is authorized under to 21 U.S.C. 952(a)(2).
Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.
Dated: January 4, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-212 Filed 1-8-16; 8:45 am]
BILLING CODE 4410-09-P
