80 FR 22554 - Importer of Controlled Substances Application: Actavis Laboratories FL, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 77 (April 22, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 77 (April 22, 2015)
| Page Range | 22554-22555 | |
| FR Document | 2015-09339 |
[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)] [Notices] [Pages 22554-22555] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09339] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Actavis Laboratories FL, 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 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 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 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 1301.34(a), this is notice that on November 19, 2014, Actavis Laboratories FL, Inc., 4955 Orange Drive, Davie, Florida 33314 applied to be registered as an importer of the following basic classes of controlled substances: [[Page 22555]] ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Amphetamine (1100)......................... II Methylphenidate (1724)..................... II Oxycodone (9143)........................... II Hydromorphone (9150)....................... II Hydrocodone (9193)......................... II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to import the listed controlled substances for clinical trials, research and analytical purposes. Dated: April 14, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-09339 Filed 4-21-15; 8:45 am] BILLING CODE 4410-09-P
![22554 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
the application pursuant to 21 CFR DEPARTMENT OF JUSTICE Dated: April 14, 2015.
1301.43 on or before May 22, 2015. Joseph T. Rannazzisi,
Drug Enforcement Administration Deputy Assistant Administrator.
ADDRESSES: Written comments should
[FR Doc. 2015–09334 Filed 4–21–15; 8:45 am]
be sent to: Drug Enforcement
[Docket No. DEA–392] BILLING CODE P
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701 Bulk Manufacturer of Controlled
Morrissette Drive, Springfield, Virginia Substances Application: Pharmacore, DEPARTMENT OF JUSTICE
22152. Request for hearings should be Inc.
sent to: Drug Enforcement Drug Enforcement Administration
Administration, Attention: Hearing ACTION: Notice of application.
Clerk/LJ, 8701 Morrissette Drive, [Docket No. DEA–392]
Springfield, Virginia 22152. DATES: Registered bulk manufacturers of
the affected basic classes, and Importer of Controlled Substances
SUPPLEMENTARY INFORMATION: The Application: Actavis Laboratories FL,
Attorney General has delegated his applicants therefore, may file written
comments on or objections to the Inc.
authority under the Controlled
Substances Act to the Administrator of issuance of the proposed registration in
ACTION: Notice of application.
the Drug Enforcement Administration accordance with 21 CFR 1301.33(a) on
(DEA), 28 CFR 0.100(b). Authority to or before June 22, 2015. DATES: Registered bulk manufacturers of
exercise all necessary functions with ADDRESSES: Written comments should the affected basic classes, and
respect to the promulgation and be sent to: Drug Enforcement applicants therefore, may file written
implementation of 21 CFR part 1301, Administration, Attention: DEA Federal comments on or objections to the
incident to the registration of Register Representative/ODXL, 8701 issuance of the proposed registration in
manufacturers, distributors, dispensers, Morrissette Drive, Springfield, Virginia accordance with 21 CFR 1301.34(a) on
importers, and exporters of controlled 22152. Request for hearings should be or before May 22, 2015. Such persons
substances (other than final orders in sent to: Drug Enforcement may also file a written request for a
connection with suspension, denial, or Administration, Attention: Hearing hearing on the application pursuant to
revocation of registration) has been Clerk/LJ, 8701 Morrissette Drive, 21 CFR 1301.43 on or before May 22,
redelegated to the Deputy Assistant Springfield, Virginia 22152. 2015.
Administrator of the DEA Office of SUPPLEMENTARY INFORMATION: The ADDRESSES: Written comments should
Diversion Control (‘‘Deputy Assistant Attorney General has delegated his be sent to: Drug Enforcement
Administrator’’) pursuant to section 7 of authority under the Controlled Administration, Attention: DEA Federal
28 CFR part 0, appendix to subpart R. Substances Act to the Administrator of Register Representative/ODXL, 8701
the Drug Enforcement Administration Morrissette Drive, Springfield, Virginia
In accordance with 21 CFR
(DEA), 28 CFR 0.100(b). Authority to 22152. Request for hearings should be
1301.34(a), this is notice that on January sent to: Drug Enforcement
exercise all necessary functions with
8, 2015, Meridian Medical Administration, Attention: Hearing
respect to the promulgation and
Technologies, 2555 Hermelin Drive, St. Clerk/LJ, 8701 Morrissette Drive,
implementation of 21 CFR part 1301,
Louis, Missouri 63144 applied to be Springfield, Virginia 22152.
incident to the registration of
registered as an importer of morphine manufacturers, distributors, dispensers, SUPPLEMENTARY INFORMATION: The
(9300), a basic class of controlled importers, and exporters of controlled Attorney General has delegated his
substance listed in schedule II. substances (other than final orders in authority under the Controlled
The company manufactures a product connection with suspension, denial, or Substances Act to the Administrator of
containing morphine in the United revocation of registration) has been the Drug Enforcement Administration
States. The company exports this redelegated to the Deputy Assistant (DEA), 28 CFR 0.100(b). Authority to
product to customers around the world. Administrator of the DEA Office of exercise all necessary functions with
The company has been asked to ensure Diversion Control (‘‘Deputy Assistant respect to the promulgation and
that its product, which is sold to Administrator’’) pursuant to section 7 of implementation of 21 CFR part 1301,
European customers, meets the 28 CFR part 0, appendix to subpart R. incident to the registration of
standards established by the European In accordance with 21 CFR manufacturers, distributors, dispensers,
Pharmacopeia, administered by the 1301.33(a), this is notice that on importers, and exporters of controlled
Directorate for the Quality of Medicines February 4, 2015, Pharmacore, Inc., substances (other than final orders in
(EDQM). In order to ensure that its 4180 Mendenhall Oaks Parkway, High connection with suspension, denial, or
product will meet European Point, North Carolina 27265, applied to revocation of registration) has been
specifications, the company seeks to be registered as a bulk manufacturer of redelegated to the Deputy Assistant
the following basic classes of controlled Administrator of the DEA Office of
import morphine supplied by EDQM for
substances: Diversion Control (‘‘Deputy Assistant
use as reference standards.
Administrator’’) pursuant to section 7 of
This is the sole purpose for which the 28 CFR part 0, appendix to subpart R.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Controlled substance Schedule
company will be authorized by the DEA In accordance with 21 CFR
to import morphine. Oxymorphine (9652) ..................... II 1301.34(a), this is notice that on
Noroxymorphone (9668) .............. II November 19, 2014, Actavis
Dated: April 14, 2015.
Joseph T. Rannazzisi,
Laboratories FL, Inc., 4955 Orange
The company plans to manufacture Drive, Davie, Florida 33314 applied to
Deputy Assistant Administrator. the listed controlled substance as an be registered as an importer of the
[FR Doc. 2015–09343 Filed 4–21–15; 8:45 am] active pharmaceutical ingredient (API) following basic classes of controlled
BILLING CODE 4410–09–P for clinical trials. substances:
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![Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22555
Controlled substance Schedule February 10, 2015, Stepan Company, In accordance with 21 CFR
Natural Products Department, 100 W. 1301.33(a), this is notice that on January
Amphetamine (1100) .................... II Hunter Avenue, Maywood, New Jersey 29, 2015, Noramco, Inc., 500 Swedes
Methylphenidate (1724) ................ II 07607 applied to be registered as a bulk Landing Road, Wilmington, Delaware
Oxycodone (9143) ........................ II manufacturer of the following basic 19801–4417 applied to be registered as
Hydromorphone (9150) ................ II
classes of controlled substances: a bulk manufacturer of the following
Hydrocodone (9193) ..................... II
Fentanyl (9801) ............................ II basic classes of controlled substances:
Controlled substance Schedule
The company plans to import the Controlled substance Schedule
Cocaine (9041) ............................. II
listed controlled substances for clinical Ecgonine (9180) ........................... II Codeine-N-oxide (9053) ............... I
trials, research and analytical purposes. Dihydromorphine (9145) ............... I
Dated: April 14, 2015. The company plans to manufacture Morphine-N-oxide (9307) ............. I
Joseph T. Rannazzisi, the listed controlled substances in bulk Amphetamine (1100) .................... II
for distribution to its customer. Methylphenidate (1724) ................ II
Deputy Assistant Administrator. Phenylacetone (8501) .................. II
[FR Doc. 2015–09339 Filed 4–21–15; 8:45 am] Dated: April 14, 2015. Codeine (9050) ............................. II
BILLING CODE 4410–09–P Joseph T. Rannazzisi, Dihydrocodeine (9120) ................. II
Deputy Assistant Administrator. Oxycodone (9143) ........................ II
[FR Doc. 2015–09327 Filed 4–21–15; 8:45 am] Hydromorphone (9150) ................ II
DEPARTMENT OF JUSTICE Hydrocodone (9193) ..................... II
BILLING CODE 4410–09–P
Morphine (9300) ........................... II
Drug Enforcement Administration Oripavine (9330) ........................... II
Thebaine (9333) ........................... II
[Docket No. DEA–392] DEPARTMENT OF JUSTICE Opium extracts (9610) .................. II
Opium fluid extract (9620) ............ II
Bulk Manufacturer of Controlled Drug Enforcement Administration Opium tincture (9630) .................. II
Substances Application: Stepan [Docket No. DEA–392] Opium, powdered (9639) ............. II
Company Opium, granulated (9640) ............ II
Bulk Manufacturer of Controlled Oxymorphone (9652) ................... II
ACTION: Notice of application. Substances Application: Noramco, Inc.
Noroxymorphone (9668) .............. II
Tapentadol (9780) ........................ II
DATES: Registered bulk manufacturers of ACTION: Notice of application.
the affected basic classes, and The company plans to manufacture
applicants therefore, may file written DATES: Registered bulk manufacturers of the above-listed controlled substances
comments on or objections to the the affected basic classes, and in bulk for distribution to its customers.
issuance of the proposed registration in applicants therefore, may file written Dated: April 14, 2015.
accordance with 21 CFR 1301.33(a) on comments on or objections to the Joseph T. Rannazzisi,
or before June 22, 2015. issuance of the proposed registration in Deputy Assistant Administrator.
ADDRESSES: Written comments should accordance with 21 CFR 1301.33(a) on [FR Doc. 2015–09331 Filed 4–21–15; 8:45 am]
be sent to: Drug Enforcement or before June 22, 2015.
BILLING CODE 4410–09–P
Administration, Attention: DEA Federal ADDRESSES: Written comments should
Register Representative/ODXL, 8701 be sent to: Drug Enforcement
Morrissette Drive, Springfield, Virginia Administration, Attention: DEA Federal DEPARTMENT OF JUSTICE
22152. Request for hearings should be Register Representative/ODW, 8701
sent to: Drug Enforcement Morrissette Drive, Springfield, Virginia Drug Enforcement Administration
Administration, Attention: Hearing 22152. Request for hearings should be [Docket No. DEA–392]
Clerk/LJ, 8701 Morrissette Drive, sent to: Drug Enforcement
Springfield, Virginia 22152. Administration, Attention: Hearing Bulk Manufacturer of Controlled
SUPPLEMENTARY INFORMATION: The Clerk/LJ, 8701 Morrissette Drive, Substances Application: Cambrex
Attorney General has delegated his Springfield, Virginia 22152. Charles City
authority under the Controlled SUPPLEMENTARY INFORMATION: The
Substances Act to the Administrator of Attorney General has delegated his ACTION: Notice of application.
the Drug Enforcement Administration authority under the Controlled
(DEA), 28 CFR 0.100(b). Authority to Substances Act to the Administrator of DATES: Registered bulk manufacturers of
exercise all necessary functions with the Drug Enforcement Administration the affected basic classes, and
respect to the promulgation and (DEA), 28 CFR 0.100(b). Authority to applicants therefore, may file written
implementation of 21 CFR part 1301, exercise all necessary functions with comments on or objections to the
incident to the registration of respect to the promulgation and issuance of the proposed registration in
manufacturers, distributors, dispensers, implementation of 21 CFR part 1301, accordance with 21 CFR 1301.33(a) on
importers, and exporters of controlled incident to the registration of or before June 22, 2015.
substances (other than final orders in manufacturers, distributors, dispensers, ADDRESSES: Written comments should
connection with suspension, denial, or importers, and exporters of controlled be sent to: Drug Enforcement
asabaliauskas on DSK5VPTVN1PROD with NOTICES
revocation of registration) has been substances (other than final orders in Administration, Attention: DEA Federal
redelegated to the Deputy Assistant connection with suspension, denial, or Register Representative/ODXL, 8701
Administrator of the DEA Office of revocation of registration) has been Morrissette Drive, Springfield, Virginia
Diversion Control (‘‘Deputy Assistant redelegated to the Deputy Assistant 22152. Request for hearings should be
Administrator’’) pursuant to section 7 of Administrator of the DEA Office of sent to: Drug Enforcement
28 CFR part 0, appendix to subpart R. Diversion Control (‘‘Deputy Assistant Administration, Attention: Hearing
In accordance with 21 CFR Administrator’’) pursuant to section 7 of Clerk/LJ, 8701 Morrissette Drive,
1301.33(a), this is notice that on 28 CFR part 0, appendix to subpart R. Springfield, Virginia 22152.
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Document Created: 2015-12-16 08:27:58
Document Modified: 2015-12-16 08:27:58
| 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 1301.34(a) on or before May 22, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before May 22, 2015. | |
| FR Citation | 80 FR 22554 |
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