Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices 47961 

respond/reply: It is estimated that 2500 

respondents will complete a 4-hour 

form. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: The total hour burden to 

complete the forms is 10,000 annual 

burden hours. 

If additional information is required 

contact: Lynn Bryant, Department 

Clearance Officer, United States 

Department of Justice, Policy and 

Planning Staff, Justice Management 

Division, Suite 1600, Patrick Henry 

Building, 601 D Street, NW., 

Washington, DC 20530. 

Dated: September 14, 2009. 

Lynn Bryant, 

Department Clearance Officer, PRA, United 

States Department of Justice. 

[FR Doc. E9–22450 Filed 9–17–09; 8:45 am] 

BILLING CODE 4410–18–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 May 8, 

2009, DDN/Obergfel LLC., 1560–A S. 

Baker Avenue, Ontario, California 

91761, 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 in bulk for distribution to 

dosage form manufacturers. 

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 19, 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: September 14, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–22502 Filed 9–17–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Registration 

By Notice dated June 22, 2009, and 

published in the Federal Register on 

June 26, 2009, (74 FR 30621), Noramco, 

Inc., Division of Ortho-McNeil, Inc., 500 

Swedes Landing Road, Wilmington, 

Delaware 19801, made application by 

letter to the Drug Enforcement 

Administration (DEA) to be registered as 

an importer of Tapentadol (9780), a 

basic class of controlled substance listed 

in schedule II. 

The company plans to import an 

intermediate of the basic class listed for 

the bulk manufacture of Tapentadol 

which it will distribute 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 

Noramco, 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 Noramco, 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: September 14, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. E9–22506 Filed 9–17–09; 8:45 am] 

BILLING CODE 4410–09–M 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Importer of Controlled Substances; 

Notice of Registration 

By Notice dated June 15, 2009, and 

published in the Federal Register on 

June 23, 2009, (74 FR 29719), Aptuit 

(Allendale) Inc., 75 Commerce Drive, 

Allendale, New Jersey 07401, 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 

Lisdexamfetamine (1205) ............. II 

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

The company plans to import the 

basic classes of controlled substances 

for clinical trials and research. 

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 

Aptuit (Allendale), 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 Aptuit 

(Allendale), 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 


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