Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc., 8901 [2015-03492]

Download as PDF 8901 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices The Department of Justice will accept written comments relating to this proposed Consent Decree for thirty (30) days from the date of publication of this Notice. Please address comments to Friedrich A. P. Siekert, AUSA, United States Attorney’s Office, United States Courthouse, 300 South Fourth Street, Suite 600, Minneapolis, MN 55415 and refer to United States v. Mlaskoch, et al., USAO File No. 2009V00565, DJ# 90–5– 1–1–18624. The proposed Consent Decree may be examined at the Clerk’s Office, United States District Court for the District of Minnesota, United States Courthouse, 300 South Fourth Street, Suite 202, Minneapolis, MN 55415. In addition, the proposed Consent Decree may be examined electronically at https:// www.justice.gov/enrd/Consent_ Decrees.html. 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 September 3, 2014, Johnson Matthey, Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Cherie L. Rogers, Assistant Section Chief, Environmental Defense Section, Environment and Natural Resources Division. Gamma Hydroxybutyric Acid (2010). Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Dihydromorphine (9145) ............... Difenoxin (9168) ........................... Propiram (9649) ........................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Diphenoxylate (9170) ................... Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Tapentadol (9780) ........................ Fentanyl (9801) ............................ [FR Doc. 2015–03409 Filed 2–18–15; 8:45 am] BILLING CODE 4410–15–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc. ACTION: Notice of application. 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 April 20, 2015. 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 his 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 emcdonald on DSK67QTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 Controlled substance Schedule I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. Dated: February 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–03492 Filed 2–18–15; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Navinta LLC ACTION: Notice of application. 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 April 20, 2015. 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 his 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 September 5, 2014, Navinta LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618–1414, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: DATES: Controlled substance Pentobarbital (2270) ..................... Remifentanil (9739) ...................... Schedule II II The company plans to initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then to produce commercial size batches for distribution to dosage form manufacturers upon FDA approval. E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Page 8901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03492]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Johnson 
Matthey, Inc.

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 April 20, 2015.

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 his 
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 
September 3, 2014, Johnson Matthey, Inc., Custom Pharmaceuticals 
Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742, 
applied to be registered as a bulk manufacturer of the following basic 
classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
Dihydromorphine (9145).....................  I
Difenoxin (9168)...........................  I
Propiram (9649)............................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Diphenoxylate (9170).......................  II
Ecgonine (9180)............................  II
Hydrocodone (9193).........................  II
Meperidine (9230)..........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Thebaine (9333)............................  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 manufacture the listed controlled substances 
in bulk for sale to its customers.

    Dated: February 11, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-03492 Filed 2-18-15; 8:45 am]
BILLING CODE 4410-09-P
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