46228 Federal Register / Vol. 74, No. 172 / Tuesday, September 8, 2009 / Notices 

Drug Schedule 

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

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

Benzoylecgonine (9180) ............... II 

Ethylmorphine (9190) ................... II 

Meperidine (9230) ........................ II 

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

Dextropropoxyphene, bulk (nondosage forms).

(9273) ........................................... II 

Morphine (9300) ........................... II 

Oripavine (9330) ........................... II 

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

Levo-alphacetylmethadol (9648) .. II 

Oxymorphone (9652) ................... II 

Poppy Straw Concentrate (9670) II 

Fentanyl (9801) ............................ II 

The company plans to import small 

quantities of the listed controlled 

substances for the manufacture of 

analytical reference standards. 

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 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 October 8, 2009. 

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 listed 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: August 28, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–21543 Filed 9–4–09; 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 Title 21 

Code of Federal Regulations (CFR), 

1301.34(a), this is notice that on July 8, 

2009, Clinical Supplies Management, 

Inc., 342 42nd Street South, Fargo, 

North Dakota 58103, made application 

by renewal to the Drug Enforcement 

Administration (DEA) to be registered as 

an importer of Sufentanil (9740), a basic 

class of controlled substance listed in 

schedule II. 

The company plans to import the 

listed controlled substance with the sole 

purpose of packaging, labeling, and 

distributing to customers which are 

qualified clinical sites conducting 

clinical trials under the auspices of an 

FDA-approved clinical study. 

Any bulk manufacturer who is 

presently, or is applying to be, 

registered with DEA to manufacture 

such basic class of controlled substance 

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 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, VA 22152; and must be 

filed no later than October 8, 2009. 

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: August 28, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–21541 Filed 9–4–09; 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 Title 21 

Code of Federal Regulations (CFR), 

1301.34(a), this is notice that on July 2, 

2009, GE Healthcare, 3350 North Ridge 

Avenue, Arlington Heights, Illinois 

60004–1412, made application by 

renewal to the Drug Enforcement 

Administration (DEA) to be registered as 

an importer of Cocaine (9041), a basic 

class of controlled substance listed in 

schedule II. 

The company plans to import small 

quantities of ioflupane, in the form of 

three separate analogues of Cocaine, to 

validate production and quality control 

systems, for a reference standard, and 

for producing material for a future 

investigational new drug (IND) 

submission. 

Any bulk manufacturer who is 

presently, or is applying to be, 

registered with DEA to manufacture 

such basic class of controlled substance 

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 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, VA. 22152; and must be 

filed no later than October 8, 2009. 


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