Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices 19595 

Dated: April 17, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–9782 Filed 4–28–09; 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 

§ 1301.34(a), this is notice that on March 

10, 2009, Almac Clinical Services Inc. 

(ACSI), 2661 Audubon Road, Audubon, 

Pennsylvania 19403, has made 

application by renewal to the Drug 

Enforcement Administration (DEA) to 

be registered as an importer of the basic 

classes of controlled substances listed in 

schedule II: 

Drug Schedule 

Oxycodone (9143) ........................ 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 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, 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 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, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–9780 Filed 4–28–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Registration 

By Notice dated January 30, 2009, and 

published in the Federal Register on 

February 6, 2009 (74 FR 6309), 

Mallinckrodt Inc., 3600 North Second 

Street, St. Louis, Missouri 63147, made 

application by renewal to the Drug 

Enforcement Administration (DEA) to 

be registered as an importer of the basic 

classes of controlled substances listed in 

schedule II: 

Drug Schedule 

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

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

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

Poppy Straw (9650) ..................... II 

Poppy Straw Concentrate (9670) II 

The company plans to import the 

listed controlled substances for the 

manufacture of controlled substances in 

bulk for distribution to its customers. 

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 

Mallinckrodt Inc. to import the basic 

classes of controlled substances 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 

Mallinckrodt 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 classes of controlled 

substances listed. 

Dated: April 17, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–9789 Filed 4–28–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Registration 

By Notice dated December 22, 2008, 

and published in the Federal Register on 

December 31, 2008 (73 FR 80431), Norac 

Inc., 405 S. Motor Avenue, P.O. Box 

577, Azusa, California 91702–3232, 

made application by renewal to the 

Drug Enforcement Administration 

(DEA) to be registered as a bulk 

manufacturer of Tetrahydrocannabinols 

(7370), a basic class of controlled 

substance listed in schedule I. 

The company plans to manufacture 

the listed controlled substance in bulk 

for formulation into the pharmaceutical 

controlled substance Marinol® for sale 

to its customers. 

No comments or objections have been 

received. DEA has considered the 

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

determined that the registration of 

Norac Inc. to manufacture the listed 

basic class of controlled substance is 

consistent with the public interest at 

this time. DEA has investigated Norac 

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. 823, 

and in accordance with 21 CFR 1301.33, 

the above named company is granted 

registration as a bulk manufacturer of 

the basic class of controlled substance 

listed. 


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