[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Page 57388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24125]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: 
Mallinckrodt 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 November 23, 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 1301.33(a), this is notice that on July 
21, 2015, Mallinckrodt LLC, 3600 North Second Street, Saint. Louis, 
Missouri 63147 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
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Gamma Hydroxybutyric Acid (2010)...........  I
Tetrahydrocannabinols (7370)...............  I
Codeine-N-oxide (9053).....................  I
Dihydromorphine (9145).....................  I
Difenoxin (9168)...........................  I
Morphine-N-oxide (9307)....................  I
Normorphine (9313).........................  I
Norlevorphanol (9634)......................  I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-  I
 yl)-N-phenylacetamide) (9821).
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
4-Anilino-N-phenethyl-4-piperidine (8333)..  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Diphenoxylate (9170).......................  II
Ecgonine (9180)............................  II
Hydrocodone (9193).........................  II
Levorphanol (9220).........................  II
Meperidine (9230)..........................  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
Opium, powdered (9639).....................  II
Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
Alfentanil (9737)..........................  II
Remifentanil (9739)........................  II
Sufentanil (9740)..........................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to manufacturer bulk active pharmaceutical 
ingredients (API) for distribution its customers.

    Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24125 Filed 9-22-15; 8:45 am]
 BILLING CODE 4410-09-P