Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 50903 

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 July 1, 2021, Amethyst Exploration, 

LLC., 4210 Jewell Road, Sparta, Georgia 

31087, 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 

Tetrahydrocannabinols .. 7370 I 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2021–19629 Filed 9–10–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–899] 

Bulk Manufacturer of Controlled 

Substances Application: Eli-Elsohly 

Laboratories 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Eli-Elsohly Laboratories has 

applied to be registered as a bulk 

manufacturer 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 November 12, 2021. Such 

persons may also file a written request 

for a hearing on the application on or 

before November 12, 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 August 5, 2021, EliElsohly Laboratories, 5 Industrial Park 

Drive, Oxford, Mississippi 38655, 

applied to be registered as an bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substances Drug 

code Schedule 

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

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

Tetrahydrocannabinols .. 7370 I 

Amphetamine ................ 1100 II 

Methamphetamine ......... 1105 II 

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

Codeine ......................... 9050 II 

Dihydrocodeine .............. 9120 II 

Ecgonine ........................ 9180 II 

Thebaine ........................ 9333 II 

The company plans to manufacture 

the listed controlled substances for 

product development and reference 

standards. In reference to drug codes 

7360 (Marihuana) and 7370 

(Tetrahydrocannabinols), the company 

plans to isolate these controlled 

substances from procured 7350 

(Marihuana Extract). In reference to 

drug code 7360, no cultivation activities 

are authorized for this registration. In 

reference to drug code 9333 (Thebaine), 

the company plans to manufacture a 

Thebaine derivative. No other activities 

for these drug codes are authorized for 

this registration. 

Brian S. Bresser, 

Acting Assistant Administrator. 

[FR Doc. 2021–19679 Filed 9–10–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–897] 

Importer of Controlled Substances 

Application: Aurobindo Pharma USA, 

Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Aurobindo Pharma USA, 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 October 13, 2021. Such 

persons may also file a written request 

for a hearing on the application on or 

before October 13, 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 July 20, 2021, 

Aurobindo Pharma USA, Inc., 6 

Wheeling Road, Dayton, New Jersey 

08810–1526, applied to be registered as 

an importer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Remifentanil ................... 9739 II 

The company plans to import 

Remifentanil (9739) in bulk form for 

research and development. 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. 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2021–19631 Filed 9–10–21; 8:45 am] 

BILLING CODE P 


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