Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices 2457 

Virginia 22152. All requests for a 

hearing should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/OALJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DPW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on December 15, 2020, 

Medi-Physics, Inc. dba GE Healthcare, 

3350 North Ridge Avenue, Arlington 

Heights, Illinois 60004–1412, applied to 

be registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Cocaine ........................ 9041 II 

The company plans to import small 

quantities of Ioflupane, in the form of 

three separate analogues of Cocaine, to 

validate production and quality control 

systems, for a reference standard, and 

for producing material for a future 

investigational new drug submission. 

Supplies of this particular controlled 

substance are not available in the form 

needed within the current domestic 

supply of the United States. No other 

activity for this drug code is authorized 

for this registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–00353 Filed 1–11–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–756] 

Bulk Manufacturer of Controlled 

Substances Application: Cedarburg 

Pharmaceuticals 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Cedarburg Pharmaceuticals 

has applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplemental Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before March 15, 2021. Such persons 

may also file a written request for a 

hearing on the application on or before 

March 15, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on October 16, 2020, 

Cedarburg Pharmaceuticals 870 Badger 

Circle, Grafton, Wisconsin 53024, 

applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Tetrahydrocannabinols 7370 I 

3, 4- 

Methylenedioxymethamphetamine.

7405 I 

Dimethyltryptamine ....... 7435 I 

Psilocybin ..................... 7437 I 

Methylphenidate ........... 1724 II 

Nabilone ....................... 7379 II 

4-Anilino-N-phenethyl-4- 

piperidine (ANPP).

8333 II 

Fentanyl ........................ 9801 II 

The company plans to manufacture 

bulk active pharmaceutical ingredients 

(API) for distribution to its customers. In 

reference to the drug code 7370 

(Tetrahydrocannabinols), the company 

plans to bulk manufacture as synthetic. 

No other activity for this drug code is 

authorized for this registration. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–00351 Filed 1–11–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–765] 

Bulk Manufacturer of Controlled 

Substances Application: Organix, Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Organix, Inc. has applied to 

be registered as a bulk manufacturer of 

basic class(es) of controlled 

substance(s). Refer to Supplemental 

Information listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before March 15, 2021. Such persons 

may also file a written request for a 

hearing on the application on or before 

March 15, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on September 22, 2020, 

Organix, Inc., 240 Salem Street, 

Woburn, Massachusetts 01801, applied 

to be registered as an bulk manufacturer 

of the following basic class(es) of 

controlled substance(s): 

Controlled substance Drug code Schedule 

Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I 

Lysergic acid diethylamide .............................................................................................................................................. 7315 I 

Marihuana ........................................................................................................................................................................ 7360 I 

Tetrahydrocannabinols .................................................................................................................................................... 7370 I 

5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. 7431 I 

Bufotenine ........................................................................................................................................................................ 7433 I 

Dimethyltryptamine .......................................................................................................................................................... 7435 I 

Psilocybin ......................................................................................................................................................................... 7437 I 

Psilocyn ........................................................................................................................................................................... 7438 I 

Heroin .............................................................................................................................................................................. 9200 I 


khammond on DSKJM1Z7X2PROD with NOTICES