80 FR 8901 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 33 (February 19, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 33 (February 19, 2015)
| Page Range | 8901-8901 | |
| FR Document | 2015-03492 |
[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)] [Notices] [Page 8901] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8901
The Department of Justice will accept manufacturers, distributors, dispensers, DEPARTMENT OF JUSTICE
written comments relating to this importers, and exporters of controlled
proposed Consent Decree for thirty (30) substances (other than final orders in Drug Enforcement Administration
days from the date of publication of this connection with suspension, denial, or
Notice. Please address comments to revocation of registration) has been [Docket No. DEA–392]
Friedrich A. P. Siekert, AUSA, United redelegated to the Deputy Assistant
States Attorney’s Office, United States Administrator of the DEA Office of Bulk Manufacturer of Controlled
Courthouse, 300 South Fourth Street, Diversion Control (‘‘Deputy Assistant Substances Application: Navinta LLC
Suite 600, Minneapolis, MN 55415 and Administrator’’) pursuant to section 7 of
refer to United States v. Mlaskoch, et al., ACTION: Notice of application.
28 CFR part 0, appendix to subpart R.
USAO File No. 2009V00565, DJ# 90–5–
1–1–18624. In accordance with 21 CFR DATES: Registered bulk manufacturers of
The proposed Consent Decree may be 1301.33(a), this is notice that on the affected basic classes, and
examined at the Clerk’s Office, United September 3, 2014, Johnson Matthey, applicants therefore, may file written
States District Court for the District of Inc., Custom Pharmaceuticals comments on or objections to the
Minnesota, United States Courthouse, Department, 2003 Nolte Drive, West issuance of the proposed registration in
300 South Fourth Street, Suite 202, Deptford, New Jersey 08066–1742, accordance with 21 CFR 1301.33(a) on
Minneapolis, MN 55415. In addition, applied to be registered as a bulk or before April 20, 2015.
the proposed Consent Decree may be manufacturer of the following basic ADDRESSES: Written comments should
examined electronically at http:// classes of controlled substances: be sent to: Drug Enforcement
www.justice.gov/enrd/Consent_ Administration, Attention: DEA Federal
Decrees.html. Controlled substance Schedule Register Representative/ODW, 8701
Cherie L. Rogers, Morrissette Drive, Springfield, Virginia
Gamma Hydroxybutyric Acid I 22152. Request for hearings should be
Assistant Section Chief, Environmental (2010).
Defense Section, Environment and Natural sent to: Drug Enforcement
Marihuana (7360) ......................... I
Resources Division. Administration, Attention: Hearing
Tetrahydrocannabinols (7370) ..... I
[FR Doc. 2015–03409 Filed 2–18–15; 8:45 am] Dihydromorphine (9145) ............... I
Clerk/LJ, 8701 Morrissette Drive,
BILLING CODE 4410–15–P Difenoxin (9168) ........................... I
Springfield, Virginia 22152.
Propiram (9649) ........................... I SUPPLEMENTARY INFORMATION: The
Amphetamine (1100) .................... II Attorney General has delegated his
DEPARTMENT OF JUSTICE Methamphetamine (1105) ............ II authority under the Controlled
Lisdexamfetamine (1205) ............. II Substances Act to the Administrator of
Drug Enforcement Administration Methylphenidate (1724) ................ II the Drug Enforcement Administration
[Docket No. DEA–392] Nabilone (7379) ............................ II (DEA), 28 CFR 0.100(b). Authority to
Cocaine (9041) ............................. II exercise all necessary functions with
Bulk Manufacturer of Controlled Codeine (9050) ............................. II respect to the promulgation and
Substances Application: Johnson Dihydrocodeine (9120) ................. II implementation of 21 CFR part 1301,
Matthey, Inc. Oxycodone (9143) ........................ II incident to the registration of
Hydromorphone (9150) ................ II manufacturers, distributors, dispensers,
ACTION: Notice of application. Diphenoxylate (9170) ................... II importers, and exporters of controlled
Ecgonine (9180) ........................... II substances (other than final orders in
DATES: Registered bulk manufacturers of Hydrocodone (9193) ..................... II connection with suspension, denial, or
the affected basic classes, and Meperidine (9230) ........................ II revocation of registration) has been
applicants therefore, may file written Methadone (9250) ........................ II redelegated to the Deputy Assistant
comments on or objections to the Methadone intermediate (9254) ... II Administrator of the DEA Office of
issuance of the proposed registration in Morphine (9300) ........................... II Diversion Control (‘‘Deputy Assistant
accordance with 21 CFR 1301.33(a) on Thebaine (9333) ........................... II Administrator’’) pursuant to section 7 of
or before April 20, 2015. Oxymorphone (9652) ................... II 28 CFR part 0, appendix to subpart R.
ADDRESSES: Written comments should Noroxymorphone (9668) .............. II In accordance with 21 CFR
be sent to: Drug Enforcement Alfentanil (9737) ........................... II
1301.33(a), this is notice that on
Administration, Attention: DEA Federal Remifentanil (9739) ...................... II
September 5, 2014, Navinta LLC, 1499
Register Representative/ODW, 8701 Sufentanil (9740) .......................... II
Lower Ferry Road, Ewing, New Jersey
Morrissette Drive, Springfield, Virginia Tapentadol (9780) ........................ II
08618–1414, applied to be registered as
22152. Request for hearings should be Fentanyl (9801) ............................ II
a bulk manufacturer of the following
sent to: Drug Enforcement
basic classes of controlled substances:
Administration, Attention: Hearing The company plans to manufacture
Clerk/LJ, 8701 Morrissette Drive, the listed controlled substances in bulk Controlled substance Schedule
Springfield, Virginia 22152. for sale to its customers.
SUPPLEMENTARY INFORMATION: The Pentobarbital (2270) ..................... II
Attorney General has delegated his Dated: February 11, 2015. Remifentanil (9739) ...................... II
emcdonald on DSK67QTVN1PROD with NOTICES
authority under the Controlled Joseph T. Rannazzisi,
Substances Act to the Administrator of Deputy Assistant Administrator. The company plans to initially to
the Drug Enforcement Administration [FR Doc. 2015–03492 Filed 2–18–15; 8:45 am] manufacture API quantities of the listed
(DEA), 28 CFR 0.100(b). Authority to BILLING CODE 4410–09–P
controlled substances for validation
exercise all necessary functions with purposes and FDA approval, then to
respect to the promulgation and produce commercial size batches for
implementation of 21 CFR part 1301, distribution to dosage form
incident to the registration of manufacturers upon FDA approval.
VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1](https://thefederalregister.org/doc/80_FR_8934/page/1.svg)
Document Created: 2018-02-16 11:12:34
Document Modified: 2018-02-16 11:12:34
| 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 April 20, 2015. | |
| FR Citation | 80 FR 8901 |
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