81 FR 15567 - Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

Page Range		15567-15567
FR Document		2016-06537

Federal Register, Volume 81 Issue 56 (Wednesday, March 23, 2016)

[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15567]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06537]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Siegfried 
USA, LLC

ACTION: Notice of application.

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DATES: 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 May 23, 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 
November 12, 2015, Siegfried USA, LLC, 33 Industrial Park Road, 
Pennsville, New Jersey 08070 applied to be registered as a bulk 
manufacturer the following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Dihydromorphine (9145).....................  I
Hydromorphinol (9301)......................  I
Methylphenidate (1724).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Dextropropoxyphene, bulk (non-dosage forms)  II
 (9273).
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Thebaine (9333)............................  II
Opium tincture (9630)......................  II
Oxymorphone (9652).........................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution to its customers.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06537 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P

Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices 15567

Enforcement Administration, Attn: DATES: Registered bulk manufacturers of Dated: March 14, 2016.
Hearing Clerk/LJ, 8701 Morrissette the affected basic classes, and Louis J. Milione,
Drive, Springfield, Virginia 22152; and applicants therefore, may file written Deputy Assistant Administrator.
(2) Drug Enforcement Administration, comments on or objections to the [FR Doc. 2016–06537 Filed 3–22–16; 8:45 am]
Attn: DEA Federal Register issuance of the proposed registration in BILLING CODE 4410–09–P
Representative/ODW, 8701 Morrissette accordance with 21 CFR 1301.33(a) on
Drive, Springfield, Virginia 22152. or before May 23, 2016.
Comments and requests for hearing on DEPARTMENT OF JUSTICE
ADDRESSES: Written comments should
applications to import narcotic raw
be sent to: Drug Enforcement
material are not appropriate. 72 FR 3417 Drug Enforcement Administration
Administration, Attention: DEA Federal
(January 25, 2007).
Register Representative/ODW, 8701 [Docket No. DEA–392]
SUPPLEMENTARY INFORMATION: The Morrissette Drive, Springfield, Virginia
Attorney General has delegated her 22152. Manufacturer of Controlled
authority under the Controlled Substances Registration: Halo
Substances Act to the Administrator of SUPPLEMENTARY INFORMATION: The Pharmaceutical, Inc.
the Drug Enforcement Administration Attorney General has delegated her
(DEA), 28 CFR 0.100(b). Authority to authority under the Controlled ACTION: Notice of registration.
exercise all necessary functions with Substances Act to the Administrator of
SUMMARY: Halo Pharmaceutical, Inc.
respect to the promulgation and the Drug Enforcement Administration
applied to be registered as a
implementation of 21 CFR part 1301, (DEA), 28 CFR 0.100(b). Authority to
manufacturer of certain basic classes of
incident to the registration of exercise all necessary functions with
controlled substances. The Drug
manufacturers, distributors, dispensers, respect to the promulgation and
Enforcement Administration (DEA)
importers, and exporters of controlled implementation of 21 CFR part 1301,
grants Halo Pharmaceutical, Inc.
substances (other than final orders in incident to the registration of
registration as a manufacturer of those
connection with suspension, denial, or manufacturers, distributors, dispensers,
controlled substances.
revocation of registration) has been importers, and exporters of controlled
redelegated to the Deputy Assistant substances (other than final orders in SUPPLEMENTARY INFORMATION: By notice
Administrator of the DEA Office of connection with suspension, denial, or dated October 13, 2015, and published
Diversion Control (‘‘Deputy Assistant revocation of registration) has been in the Federal Register on October 21,
Administrator’’) pursuant to section 7 of redelegated to the Deputy Assistant 2015, 80 FR 63838, Halo
28 CFR part 0, appendix to subpart R. Administrator of the DEA Office of Pharmaceutical, Inc., 30 North Jefferson
In accordance with 21 CFR Diversion Control (‘‘Deputy Assistant Road, Whippany, New Jersey 07981
1301.34(a), this is notice that on Administrator’’) pursuant to section 7 of applied to be registered as a
December 22, 2015, Mallinckrodt LLC, 28 CFR part 0, appendix to subpart R. manufacturer of certain basic classes of
3600 North Second Street, Saint Louis, controlled substances. No comments or
In accordance with 21 CFR objections were submitted for this
Missouri 63147 applied to be registered 1301.33(a), this is notice that on
as an importer of the following basic notice.
November 12, 2015, Siegfried USA, The DEA has considered the factors in
classes of controlled substances: LLC, 33 Industrial Park Road, 21 U.S.C. 823(a) and determined that
Pennsville, New Jersey 08070 applied to the registration of Halo Pharmaceutical,
Controlled substance Schedule be registered as a bulk manufacturer the Inc. to manufacture the basic classes of
Phenylacetone (8501) .................. II following basic classes of controlled controlled substances is consistent with
Coca Leaves (9040) ..................... II substances: the public interest and with United
Opium, raw (9600) ....................... II States obligations under international
Poppy Straw Concentrate (9670) II Controlled substance Schedule
treaties, conventions, or protocols in
Gamma Hydroxybutyric Acid I effect on May 1, 1971. The DEA
The company plans to import the investigated the company’s maintenance
(2010).
listed controlled substances to bulk of effective controls against diversion by
Dihydromorphine (9145) ............... I
manufacture into Active Pharmaceutical Hydromorphinol (9301) ................. I inspecting and testing the company’s
Ingredients for distribution to its Methylphenidate (1724) ................ II physical security systems, verifying the
customers. Amobarbital (2125) ....................... II company’s compliance with state and
Dated: March 14, 2016. Pentobarbital (2270) ..................... II local laws, and reviewing the company’s
Secobarbital (2315) ...................... II
Louis J. Milione,
Codeine (9050) ............................. II
background and history.
Deputy Assistant Administrator. Oxycodone (9143) ........................ II Therefore, pursuant to 21 U.S.C.
[FR Doc. 2016–06543 Filed 3–22–16; 8:45 am] Hydromorphone (9150) ................ II 823(a), and in accordance with 21 CFR
BILLING CODE 4410–09–P Hydrocodone (9193) ..................... II 1301.33, the above-named company is
Methadone (9250) ........................ II granted registration as a bulk
Methadone intermediate (9254) ... II manufacturer of the following basic
DEPARTMENT OF JUSTICE Dextropropoxyphene, bulk (non- II classes of controlled substances:
dosage forms) (9273).
Drug Enforcement Administration Morphine (9300) ........................... II Controlled substance Schedule
jstallworth on DSK7TPTVN1PROD with NOTICES

Oripavine (9330) ........................... II
[Docket No. DEA–392] Thebaine (9333) ........................... II Dihydromorphine (9145) ............... I
Opium tincture (9630) .................. II Hydromorphone (9150) ................ II
Bulk Manufacturer of Controlled Oxymorphone (9652) ................... II
Substances Application: Siegfried The company plans to manufacture
USA, LLC The company plans to manufacture Hydromorphone HCl for sale to other
the listed controlled substances in bulk manufacturers and to manufacture other
ACTION: Notice of application.
for distribution to its customers. controlled substances for distribution to

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Document Created: 2016-03-23 00:03:27
Document Modified: 2016-03-23 00:03:27

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 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 May 23, 2016.
FR Citation		81 FR 15567

81 FR 15567 - Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration