Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 3981 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Registration: Cody Laboratories, Inc. 

ACTION: Notice of registration. 

SUMMARY: Cody Laboratories, Inc. 

applied to be registered as an importer 

of certain basic classes of controlled 

substances. The DEA grants Cody 

Laboratories, Inc. registration as an 

importer of those controlled substances. 

SUPPLEMENTARY INFORMATION: By notice 

dated August 27, 2014, and published in 

the Federal Register on September 4, 

2014, 79 FR 52762, Cody Laboratories, 

Inc., 601 Yellowstone Avenue, Cody, 

Wyoming 82414–9321, applied to be 

registered as an importer of certain basic 

classes of controlled substances. No 

comments or objections were submitted 

to this notice. Comments and requests 

for hearings on applications to import 

narcotic raw material are not 

appropriate. 72 FR 3417 (January 25, 

2007). 

The Drug Enforcement 

Administration (DEA) has considered 

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

958(a) and determined that the 

registration of Cody Laboratories, 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. The DEA investigated the 

company’s maintenance of effective 

controls against diversion by inspecting 

and testing the company’s physical 

security systems, verifying the 

company’s compliance with state and 

local laws, and reviewing 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: 

Controlled substance Schedule 

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

Poppy Straw Concentrate 

(9670) ................................ II 

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

The company plans to import narcotic 

raw materials for manufacturing and 

further distribution to its customers. 

The company is registered with the DEA 

as a manufacturer of several controlled 

substances that are manufactured from 

poppy straw concentrate. 

The company plans to import an 

intermediate form of tapentadol (9780) 

to bulk manufacture tapentadol for 

distribution to its customers. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01317 Filed 1–23–15; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Registration: Catalent CTS, LLC 

ACTION: Notice of registration. 

SUMMARY: Catalent CTS, LLC applied to 

be registered as an importer of certain 

basic classes of controlled substances. 

The DEA grants Catalent CTS, LLC 

registration as an importer of those 

controlled substances. 

SUPPLEMENTARY INFORMATION: 

By notice dated June 10, 2014, and 

published in the Federal Register on 

June 17, 2014, 79 FR 34551, Catalent 

CTS, LLC, 10245 Hickman Mills Drive, 

Kansas City, Missouri 64137, applied to 

be registered as an importer of certain 

basic classes of controlled substances. 

One comment of objection was received 

on this registration and a request for a 

hearing was received on September 3, 

2014. The objection was resolved. 

Comments and requests for hearings on 

applications to import narcotic raw 

material are not appropriate. 72 FR 

3417, (January 25, 2007). 

The Drug Enforcement 

Administration (DEA) has considered 

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

958(a) and determined that the 

registration of Catalent CTS, LLC 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. The DEA investigated the 

company’s maintenance of effective 

controls against diversion by inspecting 

and testing the company’s physical 

security systems, verifying the 

company’s compliance with state and 

local laws, and reviewing 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: 

Controlled substance Schedule 

Marihuana (7360) ................. I 

Poppy Straw Concentrate 

(9670) ................................ II 

The company plans to import a 

finished pharmaceutical product 

containing cannabis extracts in dosage 

form for a clinical trial study. 

This compound is listed under drug 

code 7360. No other activity for this 

drug code is authorized for this 

registration. 

In addition, the company plans to 

import an ointment for the treatment of 

wounds which contain trace amounts of 

the controlled substances normally 

found in poppy straw concentrate for 

packaging and labeling to be used in 

clinical trials. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01316 Filed 1–23–15; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Bulk Manufacturer of Controlled 

Substances Application: IRIX 

Manufacturing, Inc. 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.33(a) on 

or before March 27, 2015. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/ODW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. Request for hearings should be 

sent to: Drug Enforcement 

Administration, Attention: Hearing 

Clerk/LJ, 8701 Morrissette Drive, 

Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, and 

dispensers of controlled substances 


emcdonald on DSK67QTVN1PROD with NOTICES
3982 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices 

(other than final orders in connection 

with suspension, denial, or revocation 

of registration) has been redelegated to 

the Deputy Assistant Administrator of 

the DEA Office of Diversion Control 

(‘‘Deputy Assistant Administrator’’) 

pursuant to section 7 of 28 CFR pt. 0, 

subpt. R, App. 

In accordance with 21 CFR 

1301.33(a), this is notice that on August 

14, 2014, IRIX Manufacturing, Inc., 309 

Delaware Street, Building 1106, 

Greenville, South Carolina 29605, 

applied to be registered as a bulk 

manufacturer of noroxymorphone 

(9668), a basic class of controlled 

substance listed in schedule II. 

The company plans to manufacture 

the listed controlled substance as API 

for clinical trials. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01314 Filed 1–23–15; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Bulk Manufacturer of Controlled 

Substances Application: Siemens 

Healthcare Diagnostics, Inc. 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.33(a) on 

or before March 27, 2015. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/ODW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. Request for hearings should be 

sent to: Drug Enforcement 

Administration, Attention: Hearing 

Clerk/LJ, 8701 Morrissette Drive, 

Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, and 

dispensers of controlled substances 

(other than final orders in connection 

with suspension, denial, or revocation 

of registration) has been redelegated to 

the Deputy Assistant Administrator of 

the DEA Office of Diversion Control 

(‘‘Deputy Assistant Administrator’’) 

pursuant to section 7 of 28 CFR pt. 0, 

subpart. R, App. 

In accordance with 21 CFR 

1301.33(a), this is notice that on 

November 19, 2014, Siemens Healthcare 

Diagnostics, Inc., Attn: RA, 100 GBC 

Drive, Mailstop 514, Newark, Delaware 

19702, applied to be registered as a bulk 

manufacturer of the following basic 

classes of controlled substances: 

Controlled substance Schedule 

Tetrahydrocannabinols (7370) ...... I 

Ecgonine (9180) ........................... II 

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

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

The company plans to produce the 

listed controlled substances in bulk to 

be used in the manufacture of reagents 

and drug calibrator controls which are 

DEA exempt products. 

In reference to drug code 7370 the 

company plans to bulk manufacture a 

synthetic tetrahydrocannabinol. No 

other activity for this drug code is 

authorized for this registration. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01315 Filed 1–23–15; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Manufacturer of Controlled 

Substances Registration: Pharmacore, 

Inc. 

ACTION: Notice of registration. 

SUMMARY: Pharmacore, Inc. applied to 

be registered as a manufacturer of a 

basic class of controlled substance. The 

DEA grants Pharmacore, Inc. registration 

as a manufacturer of this controlled 

substance. 

SUPPLEMENTARY INFORMATION: By notice 

dated May 28, 2014, and published in 

the Federal Register on June 3, 2014, 79 

FR 31987, Pharmacore, Inc., 4180 

Mendenhall Oaks Parkway, High Point, 

North Carolina 27265, applied to be 

registered as a manufacturer of a certain 

basic class of controlled substance. No 

comments or objections were submitted 

to this notice. 

The Drug Enforcement 

Administration (DEA) has considered 

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

determined that the registration of 

Pharmacore, Inc. to manufacture this 

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. The 

DEA investigated the company’s 

maintenance of effective controls 

against diversion by inspecting and 

testing the company’s physical security 

systems, verifying the company’s 

compliance with state and local laws, 

and reviewing the company’s 

background and history. 

Therefore, pursuant to 21 U.S.C. 

823(a), and in accordance with 21 CFR 

1301.33, the above-named company is 

granted registration as a bulk 

manufacturer of Noroxymorphone 

(9668), a basic class of controlled 

substance listed in schedule II. 

The company plans to manufacture 

the listed controlled substance as an 

active pharmaceutical ingredient (API) 

for clinical trials. 

Dated: January 9, 2015. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2015–01298 Filed 1–23–15; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Manufacturer of Controlled 

Substances Registration: Lin Zhi 

International, Inc. 

ACTION: Notice of registration. 

SUMMARY: Lin Zhi International, Inc., 

applied to be registered as a 

manufacturer of certain basic classes of 

controlled substances. The DEA grants 

Lin Zhi International, Inc. registration as 

a manufacturer of those controlled 

substances. 

SUPPLEMENTARY INFORMATION: By notice 

dated May 28, 2014, and published in 

the Federal Register on June 4, 2014, 79 

FR 32321, Lin Zhi International, Inc., 

670 Almanor Avenue, Sunnyvale, 

California 94085, applied to be 

registered as a manufacturer of certain 

basic classes of controlled substances. 

No comments or objections were 

submitted to this notice. 

The Drug Enforcement 

Administration (DEA) has considered 

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

determined that the registration of Lin 

Zhi International, Inc. to manufacture 

the basic classes of controlled 


emcdonald on DSK67QTVN1PROD with NOTICES