16262 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Notices 

a registration under this Section to a 

bulk manufacturer of a controlled 

substance in schedule I or II, and prior 

to issuing a regulation under 21 U.S.C. 

952(a) (2) authorizing the importation of 

such a substance, provide 

manufacturers holding registrations for 

the bulk manufacture of the substance 

an opportunity for a hearing. 

Therefore, in accordance with 21 CFR 

1301.34(a), this is notice that on October 

7, 2011, Mylan Technologies Inc., 110 

Lake Street, Saint Albans, Vermont 

05478, made application by renewal to 

the Drug Enforcement Administration 

(DEA) to be registered as an importer of 

the following basic classes of controlled 

substances: 

Drug 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 domesticallymanufactured FDF to foreign markets. 

Any bulk manufacturer who is 

presently, or is applying to be, 

registered with DEA to manufacture 

such basic classes of controlled 

substances may file comments or 

objections to the issuance of the 

proposed registration and may, at the 

same time, file a written request for a 

hearing on such application pursuant to 

21 CFR 1301.43, and in such form as 

prescribed by 21 CFR 1316.47. 

Any such written comments or 

objections should be addressed, in 

quintuplicate, to the Drug Enforcement 

Administration, Office of Diversion 

Control, Federal Register Representative 

(ODL), 8701 Morrissette Drive, 

Springfield, Virginia 22152; and must be 

filed no later than April 19, 2012. 

This procedure is to be conducted 

simultaneously with, and independent 

of, the procedures described in 21 CFR 

1301.34(b), (c), (d), (e), and (f). As noted 

in a previous notice published in the 

Federal Register on September 23, 1975, 

40 FR 43745–46, all applicants for 

registration to import a basic class of 

any controlled substance in schedule I 

or II are, and will continue to be, 

required to demonstrate to the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, that the requirements 

for such registration pursuant to 21 

U.S.C. 958(a); 21 U.S.C. 823(a); and 21 

CFR 1301.34(b), (c), (d), (e), and (f) are 

satisfied. 

Dated: March 8, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2012–6699 Filed 3–19–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Application 

Pursuant to 21 U.S.C. 958(i), the 

Attorney General shall, prior to issuing 

a registration under this Section to a 

bulk manufacturer of a controlled 

substance in schedule I or II, and prior 

to issuing a regulation under 21 U.S.C. 

952(a)(2) authorizing the importation of 

such a substance, provide 

manufacturers holding registrations for 

the bulk manufacture of the substance 

an opportunity for a hearing. 

Therefore, in accordance with 21 CFR 

1301.34(a), this is notice that on January 

5, 2012, Capricorn Pharma Inc., 6900 

English Muffin Way, Unit A, Frederick, 

Maryland 21703, made application to 

the Drug Enforcement Administration 

(DEA) to be registered as an importer of 

Fentanyl (9801), a basic class of 

controlled substance listed in schedule 

II. 

The company plans to import the 

listed controlled substance 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. 

In reference to the import of Fentanyl 

(9801), the authorization for the import 

of this basic class of controlled 

substance, if approved, would be 

granted only for analytical 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. 

Any bulk manufacturer who is 

presently, or is applying to be, 

registered with DEA to manufacture 

such basic classes of controlled 

substances may file comments or 

objections to the issuance of the 

proposed registration and may, at the 

same time, file a written request for a 

hearing on such application pursuant to 

21 CFR 1301.43, and in such form as 

prescribed by 21 CFR 1316.47. 

Any such written comments or 

objections should be addressed, in 

quintuplicate, to the Drug Enforcement 

Administration, Office of Diversion 

Control, Federal Register Representative 

(ODL), 8701 Morrissette Drive, 

Springfield, Virginia 22152; and must be 

filed no later than April 19, 2012. 

This procedure is to be conducted 

simultaneously with, and independent 

of, the procedures described in 21 CFR 

1301.34(b), (c), (d), (e), and (f). As noted 

in a previous notice published in the 

Federal Register on September 23, 1975, 

40 FR 43745–46, all applicants for 

registration to import a basic class of 

any controlled substance in schedules I 

or II are, and will continue to be, 

required to demonstrate to the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, that the requirements 

for such registration pursuant to 21 

U.S.C. 958(a); 21 U.S.C. 823(a); and 21 

CFR 1301.34(b), (c), (d), (e), and (f) are 

satisfied. 

Dated: March 8, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2012–6697 Filed 3–19–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances, 

Notice of Registration; Johnson 

Matthey, Inc., Pharmaceutical Materials 

By Notice dated December 2, 2011, 

and published in the Federal Register 

on December 12, 2011, 76 FR 77253, 

Johnson Matthey, Inc., Pharmaceutical 

Materials, 2003 Nolte Drive, West 

Deptford, New Jersey 08066–1742, made 

application by renewal to the Drug 

Enforcement Administration (DEA) to 

be registered as an importer of the 

following basic classes of controlled 

substances: 

Drug Schedule 

Coca Leaves (9040) ..................... II 

Thebaine (9333) ........................... II 

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

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

Poppy Straw Concentrate (9670) II 

The company plans to import the 

listed controlled substances as raw 

materials, to be used in the manufacture 

of bulk controlled substances, for 

distribution to its customers. In regard 


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