Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices 60865 

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

958(a) and determined that the 

registration of Alkermes Gainesville LLC 

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. 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 Noroxymorphone (9668), a 

basic class of controlled substance listed 

in schedule II. 

The company plans to import the 

above listed controlled substance for 

analytical research and testing. 

The import of the above listed basic 

class of controlled substance would be 

granted only for analytical testing and 

clinical testing. 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. 

Dated: October 1, 2014. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2014–24032 Filed 10–7–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Manufacturer of Controlled 

Substances Registration: Austin 

Pharma, LLC 

ACTION: Notice of registration. 

SUMMARY: Austin Pharma, LLC applied 

to be registered as a manufacturer of 

certain basic classes of controlled 

substances. The DEA grants Austin 

Pharma, LLC 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 32322, Austin Pharma, LLC, 811 

Paloma Drive, Suite C, Round Rock, 

Texas 78665–2402, 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 

Austin Pharma, LLC to manufacture 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. 

823(a), and in accordance with 21 CFR 

1301.33, the above-named company is 

granted registration as a bulk 

manufacturer of the basic classes of 

controlled substances: 

Controlled substance Schedule 

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

Tetrahydrocannabinols (7370) ..... I 

The company plans to manufacture 

bulk synthetic active pharmaceutical 

ingredients (APIs) for distribution and 

new product development to its 

customers. The company plans to bulk 

manufacture a synthetic 

tetrahydrocannabinol. 

In reference to drug code 7360, the 

company plans to manufacture a 

synthetic cannabinol in bulk for sale to 

its customers. The controlled substance 

will be further synthesized to bulk 

manufacture a synthetic 

tetrahydrocannabinol (7370). No other 

activity for this drug code is authorized 

for this registration. 

Dated: October 2, 2014. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2014–24018 Filed 10–7–14; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Manufacturer of Controlled 

Substances Registration: Siemens 

Healthcare Diagnostics, Inc. 

ACTION: Notice of registration. 

SUMMARY: Siemens Healthcare 

Diagnostics, Inc., applied to be 

registered as a manufacturer of certain 

basic classes of controlled substances. 

The DEA grants Siemens Healthcare 

Diagnostics, Inc. registration as a 

manufacturer of those controlled 

substances. 

SUPPLEMENTARY INFORMATION: By notice 

dated May 2, 2014, and published in the 

Federal Register on May 15, 2014, 79 

FR 27936, Siemens Healthcare 

Diagnostics, Inc., Attn: RA, 100 GBC 

Drive, Mailstop 514, Newark, Delaware 

19702, 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 

Siemens Healthcare Diagnostics, Inc., to 

manufacture 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. 

823(a), and in accordance with 21 CFR 

1301.33, the above-named company is 

granted registration as a bulk 

manufacturer of the basic classes of 

controlled substances listed: 

Controlled substance Schedule 

Tetrahydrocannabinols (7370) ..... I 

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

Morphine (9300) ........................... 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: October 1, 2014. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator. 

[FR Doc. 2014–24035 Filed 10–7–14; 8:45 am] 

BILLING CODE 4410–09–P 


asabaliauskas on DSK5VPTVN1PROD with NOTICES