24984 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Application; Clinical Supplies 

Management, Inc. 

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 

November 13, 2011, 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 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 May 29, 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: April 17, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2012–10047 Filed 4–25–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Application; Catalent Pharma 

Solutions, Inc. 

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) 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, Catalent Pharma Solutions, Inc., 

10381 Decatur Road, Philadelphia, 

Pennsylvania 19114, made application 

to the Drug Enforcement Administration 

(DEA) to be registered as an importer of 

Noroxymorphone (9668), a basic class of 

controlled substance listed in schedule 

II. 

The company plans to import the 

listed controlled substance in finished 

dosage form for clinical trials. 

The import of the above listed basic 

class of controlled substance 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 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 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 May 29, 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: April 17, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2012–10046 Filed 4–25–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Application; Rhodes 

Technologies 

This is notice that on February 24, 

2011, Rhodes Technologies, 498 

Washington Street, Coventry, Rhode 

Island 02816, made application by 

renewal to the Drug Enforcement 

Administration (DEA) for registration as 

an importer of the following basic 

classes of controlled substances in 

schedule II: 

Drug Schedule 

Opium, Raw (9600) ...................... II 

Poppy Straw Concentrate (9670) II 

The company plans to import the 

listed controlled substances in order to 

bulk manufacture controlled substances 

in Active Pharmaceutical Ingredient 

(API) form. The company distributes the 

manufactured APIs in bulk form to its 

customers. 

Comments and requests for hearings 

on applications to import narcotic raw 

material are not appropriate. 72 FR 3417 

(2007). 

As noted in a previous notice 

published in the Federal Register on 

September 23, 1975, 40 FR 43745, all 

applicants for registration to import a 

basic class of any controlled substance 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24985 

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: April 17, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2012–10043 Filed 4–25–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Application; Almac Clinical 

Services, Inc., (ACSI) 

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 March 

5, 2012, Almac Clinical Services, Inc., 

(ACSI), 25 Fretz Road, Souderton, 

Pennsylvania 18964, 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 

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

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

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

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

The company plans to import small 

quantities of the listed controlled 

substances in dosage form to conduct 

clinical trials. 

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 May 29, 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 the 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: April 17, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2012–10053 Filed 4–25–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Registration; Hospira Inc. 

By Notice dated December 5, 2011, 

and published in the Federal Register 

on December 12, 2011, 76 FR 77253, 

Hospira Inc., 1776 North Centennial 

Drive, McPherson, Kansas 67460–1247, 

made application by renewal to the 

Drug Enforcement Administration 

(DEA) to be registered as an importer of 

Remifentanil (9739), a basic class of 

controlled substance listed in schedule 

II. 

The company plans to import 

Remifentanil for use in dosage form 

manufacturing. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 952(a), 

and determined that the registration of 

Hospira Inc. to import the basic class of 

controlled substance is consistent with 

the public interest, and with United 

States obligations under international 

treaties, conventions, or protocols in 

effect on May 1, 1971, at this time. DEA 

has investigated Hospira Inc. to ensure 

that the company’s registration is 

consistent with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 952(a) 

and 958(a), and in accordance with 21 

CFR 1301.34, the above named company 

is granted registration as an importer of 

the basic class of controlled substance 

listed. 

Dated: April 17, 2012. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2012–10048 Filed 4–25–12; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Registration; ISP Freetown 

Fine Chemicals 

By Notice dated October 8, 2010, and 

published in the Federal Register on 

October 20, 2010, 75 FR 64743, ISP 

Freetown Fine Chemicals, 238 South 

Main Street, Assonet, Massachusetts 

02702, made application by renewal to 

the Drug Enforcement Administration 

(DEA) to be registered as an importer of 

Phenylacetone (8501), a basic class of 

controlled substance listed in schedule 

II. 

The company plans to import the 

controlled substance to manufacture 

amphetamine. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 952(a), 

and determined that the registration of 

ISP Freetown Fine Chemicals to import 

the basic class of controlled substance is 

consistent with the public interest, and 

with United States obligations under 

international treaties, conventions, or 

protocols in effect on May 1, 1971, at 

this time. DEA has investigated ISP 

Freetown Fine Chemicals to ensure that 

the company’s registration is consistent 

with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 952(a) 

and 958(a), and in accordance with 21 

CFR 1301.34, the above named company 

is granted registration as an importer of 

the basic class of controlled substance 

listed. 


tkelley on DSK3SPTVN1PROD with NOTICES