3980 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 

Controlled substance Schedule 

Methylphenidate (1724) ................ II 

Levorphanol (9220) ...................... II 

Noroxymorphone (9668) .............. II 

Tapentadol (9780) ........................ II 

The company plans to import the 

listed substances for analytical research, 

testing, and clinical trials. This 

authorization does not extend to the 

import of a finished FDA approved or 

non-approved dosage form for 

commercial distribution in the United 

States. 

The company plans to import an 

intermediate form of tapentadol (9780) 

to bulk manufacture tapentadol for 

distribution to its customers. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01309 Filed 1–23–15; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Mylan Pharmaceuticals, 

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 February 25, 2015. Such 

persons may also file a written request 

for a hearing on the application 

pursuant to 21 CFR 1301.43 on or before 

February 25, 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 pt. 0, subpt. R, App. 

In accordance with 21 CFR 

1301.34(a), this is notice that on October 

6, 2014, Mylan Pharmaceuticals, Inc., 

781 Chestnut Ridge Road, Morgantown, 

West Virginia 26505, applied to be 

registered as an importer of the 

following basic classes of controlled 

substances: 

Controlled substance Schedule 

Amphetamine (1100) .................... II 

Methylphenidate (1724) ................ II 

Oxycodone (9143) ........................ II 

Hydromorphone (9150) ................ II 

Methadone (9250) ........................ II 

Morphine (9300) ........................... 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 domesticallymanufactured FDF to foreign markets. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01310 Filed 1–23–15; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Noramco, 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 February 25, 2015. Such 

persons may also file a written request 

for a hearing on the application 

pursuant to 21 CFR 1301.43 on or before 

February 25, 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. Comments 

and request for hearings on applications 

to import narcotic raw material are not 

appropriate. 72 FR 3417 (January 27, 

2007). 

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 pt. 0, subpt. R, App. 

In accordance with 21 CFR 

1301.34(a), this is notice that on August 

26, 2014, Noramco, Inc., 500 Swedes 

Landing Road, Wilmington, Delaware 

19801–4417, applied to be registered as 

an importer of the following basic 

classes of controlled substances: 

Controlled substance Schedule 

Phenylacetone (8501) .................. II 

Opium, raw (9600) ....................... II 

Poppy Straw Concentrate (9670) II 

Tapentadol (9780) ........................ II 

The company plans to import raw 

Opium (9600) and Poppy Straw 

concentrate (9670) to bulk manufacture 

other controlled substances for 

distribution to its customers. The 

company plans to import an 

intermediate form of tapentadol (9780) 

to bulk manufacture tapentadol (9780) 

for distribution to its customers. The 

company plans to import Phenylacetone 

(8501) in bulk for the manufacture of a 

controlled substance. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01311 Filed 1–23–15; 8:45 am] 

BILLING CODE P 


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