9536 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

SUMMARY: S&B Pharma, Inc. has applied 

to be registered as an importer of basic 

class(es) of controlled substance(s). 

Refer to SUPPLEMENTARY 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 18, 2021. Such persons 

may also file a written request for a 

hearing on the application on or before 

March 18, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing must 

be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

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 18, 2020, 

S&B Pharma, Inc., 405 S Motor Avenue, 

Azusa, California 91702–3232, applied 

to be registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

4-Anilino-NPhenethyl-4- 

Piperdine (ANPP).

8333 II 

Tapentadol ................ 9780 II 

The company plans to import 

intermediate forms of Tapentadol (9780) 

for further manufacturing prior to 

distribution to its customers. The 

company plans to import ANPP (8333) 

to bulk manufacture other controlled 

substances for distribution to its 

customers. 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. 2021–02979 Filed 2–12–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–780] 

Bulk Manufacturer of Controlled 

Substances Application: Bulk 

Manufacturer of Marihuana: North Star 

Holdings California, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is providing 

notice of an application it has received 

from an entity applying to be registered 

to manufacture in bulk basic class(es) of 

controlled substances listed in schedule 

I. DEA intends to evaluate this and other 

pending applications according to its 

regulations governing the program of 

growing marihuana for scientific and 

medical research under DEA 

registration. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefor, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before April 19, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. To ensure proper handling of 

comments, please reference Docket No. 

DEA–780 in all correspondence, 

including attachments. 

SUPPLEMENTARY INFORMATION: The 

Controlled Substances Act (CSA) 

prohibits the cultivation and 

distribution of marihuana except by 

persons who are registered under the 

CSA to do so for lawful purposes. In 

accordance with the purposes specified 

in 21 CFR 1301.33(a), DEA is providing 

notice that the entity identified below 

has applied for registration as a bulk 

manufacturer of schedule I controlled 

substances. In response, registered bulk 

manufacturers of the affected basic 

class(es), and applicants therefor, may 

file written comments on or objections 

of the requested registration, as 

provided in this notice. This notice does 

not constitute any evaluation or 

determination of the merits of the 

application submitted. 

The applicant plans to manufacture 

bulk active pharmaceutical ingredients 

(APIs) for product development and 

distribution to DEA registered 

researchers. If the application for 

registration is granted, the registrant 

would not be authorized to conduct 

other activity under this registration 

aside from those coincident activities 

specifically authorized by DEA 

regulations. DEA will evaluate the 

application for registration as a bulk 

manufacturer for compliance with all 

applicable laws, treaties, and 

regulations and to ensure adequate 

safeguards against diversion are in 

place. 

As this applicant has applied to 

become registered as a bulk 

manufacturer of marihuana, the 

application will be evaluated under the 

criteria of 21 U.S.C. 823(a). DEA will 

conduct this evaluation in the manner 

described in the rule published at 85 FR 

82333 on December 18, 2020, and 

reflected in DEA regulations at 21 CFR 

part 1318. 

In accordance with 21 CFR 

1301.33(a), DEA is providing notice that 

on January 15, 2021, North Star 

Holdings California, LLC, 69375 Ramon 

Road, Cathedral City, California 92234, 

applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substances: 

Controlled substance Drug 

code Schedule 

Marihuana Extract ........ 7350 I 

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

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–02980 Filed 2–12–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–778] 

Importer of Controlled Substances 

Application: Noramco Coventry, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Noramco Coventry, LLC has 

applied to be registered as an importer 

of basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9537 

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 18, 2021. Such persons 

may also file a written request for a 

hearing on the application on or before 

March 18, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing must 

be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

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 January 14, 2021, 

Noramco Coventry LLC, 498 

Washington Street, Coventry, Rhode 

Island 02816, applied to be registered as 

an importer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

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

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

Oxycodone ............................ 9143 II 

Hydromorphone .................... 9150 II 

Hydrocodone ......................... 9193 II 

Morphine ............................... 9300 II 

Opium, raw ........................... 9600 II 

Oxymorphone ....................... 9652 II 

Poppy Straw Concentrate ..... 9670 II 

The company (formerly known as 

Rhodes Technologies) plans to import 

Opium, raw (9600), and Poppy Straw 

Concentrate (9670) in order to bulk 

manufacture controlled substances in 

Active Pharmaceutical Ingredient (API) 

form. The company distributes the 

manufactured APIs in bulk to its 

customers. The company plans to 

import the other listed controlled 

substances for internal reference 

standards use only. The comparisons of 

foreign reference standards to the 

company’s domestically manufactured 

API will allow the company to export 

domestically manufactured API to 

foreign markets. 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. 2021–02971 Filed 2–12–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–774] 

Bulk Manufacturer of Controlled 

Substances Application: Bulk 

Manufacturer of Marihuana: Mountain 

Trading LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is providing 

notice of an application it has received 

from an entity applying to be registered 

to manufacture in bulk basic class(es) of 

controlled substances listed in schedule 

I. DEA intends to evaluate this and other 

pending applications according to its 

regulations governing the program of 

growing marihuana for scientific and 

medical research under DEA 

registration. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefor, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before April 19, 2021. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. To ensure proper handling of 

comments, please reference Docket No. 

DEA–774 in all correspondence, 

including attachments. 

SUPPLEMENTARY INFORMATION: The 

Controlled Substances Act (CSA) 

prohibits the cultivation and 

distribution of marihuana except by 

persons who are registered under the 

CSA to do so for lawful purposes. In 

accordance with the purposes specified 

in 21 CFR 1301.33(a), DEA is providing 

notice that the entity identified below 

has applied for registration as a bulk 

manufacturer of schedule I controlled 

substances. In response, registered bulk 

manufacturers of the affected basic 

class(es), and applicants therefor, may 

file written comments on or objections 

of the requested registration, as 

provided in this notice. This notice does 

not constitute any evaluation or 

determination of the merits of the 

application submitted. 

The applicant plans to manufacture 

bulk active pharmaceutical ingredients 

(APIs) for product development and 

distribution to DEA-registered 

researchers. If the application for 

registration is granted, the registrant 

would not be authorized to conduct 

other activity under this registration 

aside from those coincident activities 

specifically authorized by DEA 

regulations. DEA will evaluate the 

application for registration as a bulk 

manufacturer for compliance with all 

applicable laws, treaties, and 

regulations and to ensure adequate 

safeguards against diversion are in 

place. 

As this applicant has applied to 

become registered as a bulk 

manufacturer of marihuana, the 

application will be evaluated under the 

criteria of 21 U.S.C. 823(a). DEA will 

conduct this evaluation in the manner 

described in the rule published at 85 FR 

82333 on December 18, 2020, and 

reflected in DEA regulations at 21 CFR 

part 1318. 

In accordance with 21 CFR 

1301.33(a), DEA is providing notice that 

on November 30, 2018, Mountain 

Trading LLC, 6 South 89 Street West, 

Billings, Montana 59106, applied to be 

registered as a manufacturer, and on 

January 14, 2021, the application was 

changed from a manufacturer to a bulk 

manufacturer, of the following basic 

class(es) of controlled substances: 

Controlled substance Drug 

code Schedule 

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

Tetrahydrocannabinols 7370 I 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–02970 Filed 2–12–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–787] 

Importer of Controlled Substances 

Application: Sigma Aldrich Co., LLC. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Sigma Aldrich Co. LLC. has 

applied to be registered as an importer 


khammond on DSKJM1Z7X2PROD with NOTICES