80 FR 8902 - Importer of Controlled Substances Application: Mylan Technologies, 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 | 8902-8902 | |
| FR Document | 2015-03493 |
[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)] [Notices] [Page 8902] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03493] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Mylan Technologies, 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 March 23, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before March 23, 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 1301.34(a), this is notice that on November 13, 2014, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Methylphenidate (1724)..................... II Fentanyl (9801)............................ II ------------------------------------------------------------------------ The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets. Dated: February 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-03493 Filed 2-18-15; 8:45 am] BILLING CODE 4410-09-P
![8902 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices
Dated: February 11, 2015. Controlled substance Schedule manufacturers, distributors, dispensers,
Joseph T. Rannazzisi, importers, and exporters of controlled
Deputy Assistant Administrator. Amphetamine (1100) .................... II substances (other than final orders in
[FR Doc. 2015–03489 Filed 2–18–15; 8:45 am] Methylphenidate (1724) ................ II connection with suspension, denial, or
Codeine (9050) ............................. II revocation of registration) has been
BILLING CODE 4410–09–P
Oxycodone (9143) ........................ II redelegated to the Deputy Assistant
Diphenoxylate (9170) ................... II
Hydrocodone (9193) ..................... II
Administrator of the DEA Office of
DEPARTMENT OF JUSTICE Meperidine (9230) ........................ II Diversion Control (‘‘Deputy Assistant
Methadone (9250) ........................ II Administrator’’) pursuant to section 7 of
Drug Enforcement Administration Methadone intermediate (9254) ... II 28 CFR part 0, appendix to subpart R.
[Docket No. DEA–392] Morphine (9300) ........................... II In accordance with 21 CFR
Thebaine (9333) ........................... II 1301.34(a), this is notice that on
Bulk Manufacturer of Controlled November 13, 2014, Mylan
Substances Application: Johnson The company plans to manufacture Technologies, Inc., 110 Lake Street,
Matthey, Inc. the listed controlled substances in bulk Saint Albans, Vermont 05478, applied
for distribution and sale to its to be registered as an importer of the
ACTION: Notice of application. customers. following basic classes of controlled
The Thebaine (9333) will be used to substances:
DATES: Registered bulk manufacturers of manufacture other controlled substances
the affected basic classes, and for sale in bulk to its customers. Controlled substance Schedule
applicants therefore, may file written
Dated: February 11, 2015.
comments on or objections to the Methylphenidate (1724) ................ II
issuance of the proposed registration in Joseph T. Rannazzisi, Fentanyl (9801) ............................ II
accordance with 21 CFR 1301.33(a) on Deputy Assistant Administrator.
or before April 20, 2015. [FR Doc. 2015–03491 Filed 2–18–15; 8:45 am] The company plans to import the
ADDRESSES: Written comments should BILLING CODE 4410–09–P listed controlled substances in finished
be sent to: Drug Enforcement dosage form (FDF) from foreign sources
Administration, Attention: DEA Federal for analytical testing and clinical trials
Register Representative/ODW, 8701 DEPARTMENT OF JUSTICE in which the foreign FDF will be
Morrissette Drive, Springfield, Virginia compared to the company’s own
Drug Enforcement Administration domestically-manufactured FDF. This
22152. Request for hearings should be
sent to: Drug Enforcement [Docket No. DEA–392] analysis is required to allow the
Administration, Attention: Hearing company to export domestically-
Clerk/LJ, 8701 Morrissette Drive, Importer of Controlled Substances manufactured FDF to foreign markets.
Springfield, Virginia 22152. Application: Mylan Technologies, Inc.
Dated: February 11, 2015.
SUPPLEMENTARY INFORMATION: The ACTION: Notice of application. Joseph T. Rannazzisi,
Attorney General has delegated his Deputy Assistant Administrator.
authority under the Controlled DATES: Registered bulk manufacturers of [FR Doc. 2015–03493 Filed 2–18–15; 8:45 am]
Substances Act to the Administrator of the affected basic classes, and BILLING CODE 4410–09–P
the Drug Enforcement Administration applicants therefore, may file written
(DEA), 28 CFR 0.100(b). Authority to comments on or objections to the
exercise all necessary functions with issuance of the proposed registration in DEPARTMENT OF JUSTICE
respect to the promulgation and accordance with 21 CFR 1301.34(a) on
implementation of 21 CFR part 1301, or before March 23, 2015. Such persons Drug Enforcement Administration
incident to the registration of may also file a written request for a
manufacturers, distributors, dispensers, hearing on the application pursuant to [Docket No. DEA–392]
importers, and exporters of controlled 21 CFR 1301.43 on or before March 23,
substances (other than final orders in Importer of Controlled Substances
2015.
connection with suspension, denial, or Registration: United States
ADDRESSES: Written comments should
revocation of registration) has been Pharmacopeial Convention
be sent to: Drug Enforcement
redelegated to the Deputy Assistant Administration, Attention: DEA Federal ACTION: Notice of registration.
Administrator of the DEA Office of Register Representative/ODW, 8701
Diversion Control (‘‘Deputy Assistant Morrissette Drive, Springfield, Virginia SUMMARY: United States Pharmacopeial
Administrator’’) pursuant to section 7 of 22152. Request for hearings should be Convention applied to be registered as
28 CFR part 0, appendix to subpart R. sent to: Drug Enforcement an importer of certain basic classes of
In accordance with 21 CFR Administration, Attention: Hearing controlled substances. The DEA grants
1301.33(a), this is notice that on Clerk/LJ, 8701 Morrissette Drive, United States Pharmacopeial
September 3, 2014, Johnson Matthey, Springfield, Virginia 22152. Convention registration as an importer
Inc., Pharmaceuticals Materials, 900 of those controlled substances.
SUPPLEMENTARY INFORMATION: The
River Road, Conshohocken,
Attorney General has delegated his SUPPLEMENTARY INFORMATION: By notice
Pennsylvania 19428, applied to be
emcdonald on DSK67QTVN1PROD with NOTICES
authority under the Controlled dated August 11, 2014, and published in
registered as a bulk manufacturer of the
Substances Act to the Administrator of the Federal Register on August 20,
following basic classes of controlled
the Drug Enforcement Administration 2014, 79 FR 49341, United States
substances:
(DEA), 28 CFR 0.100(b). Authority to Pharmacopeial Convention, 12601
Controlled substance Schedule exercise all necessary functions with Twinbrook Parkway, Rockville,
respect to the promulgation and Maryland 20852, applied to be
Gamma Hydroxybutyric Acid I implementation of 21 CFR part 1301, registered as an importer of certain basic
(2010). incident to the registration of classes of controlled substances. No
VerDate Sep<11>2014 16:58 Feb 18, 2015 Jkt 235001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\19FEN1.SGM 19FEN1](https://thefederalregister.org/doc/80_FR_8935/page/1.svg)
Document Created: 2018-02-16 11:12:19
Document Modified: 2018-02-16 11:12:19
| 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 March 23, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before March 23, 2015. | |
| FR Citation | 80 FR 8902 |
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