Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 33359 

ACTION: Notice of application. 

SUMMARY: Cambrex Charles City 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 August 23, 2021. Such persons 

may also file a written request for a 

hearing on the application on or before 

August 23, 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 May 6, 2021, Cambrex 

Charles City, 1205 11th Street, Charles 

City, Iowa 50616–3466, applied to be 

registered as a bulk manufacturer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Gamma Hydroxybutyric 

Acid ............................. 2010 I 

Tetrahydrocannabinols ... 7370 I 

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

Lisdexamfetamine ........... 1205 II 

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

ANPP (4-Anilino-Nphenethyl-4-piperidine) 8333 II 

Phenylacetone ................ 8501 II 

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

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

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

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

Methadone ...................... 9250 II 

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

Oripavine ........................ 9330 II 

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

Opium extracts ............... 9610 II 

Opium fluid extract ......... 9620 II 

Opium tincture ................ 9630 II 

Opium, powdered ........... 9639 II 

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

Noroxymorphone ............ 9668 II 

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

The company plans to manufacture 

the above-listed controlled substances 

in bulk for conversion to other 

controlled substances and sales to its 

customers for dosage form development, 

clinical trials and use in stability 

qualification studies. In reference to 

drug code 7370 

(Tetrahydrocannabinols), the company 

plans to bulk manufacture this drug as 

synthetic. No other activities for these 

drug codes are authorized for this 

registration. 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–13252 Filed 6–23–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–858] 

Bulk Manufacturer of Controlled 

Substances Application: Bulk 

Manufacturer of Marihuana: Annac 

Medical Center LC 

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 August 23, 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–858 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). In addition 

to seeking to produce marihuana 

extract, this applicant is separately 

seeking to cultivate marihuana. See 

Notice of Application, Bulk 

Manufacturers of Marihuana, 84 FR 

44920, 44922 (Aug. 27, 2019). 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 April 14, 2021, Annac Medical 

Center, LC, 5172 West Patrick Lane, 

Suite 100, Las Vegas, Nevada 89117– 

8911, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substances: 

Controlled substance Drug 

code Schedule 

Tetrahydrocannabinols ... 7370 I 

William T. McDermott, 

Assistant Administrator. 

[FR Doc. 2021–13249 Filed 6–23–21; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Notice of Lodging of Proposed 

Consent Decree Under the Oil 

Pollution Act 

On June 17, 2021, the Department of 

Justice lodged a proposed Consent 

Decree with the United States District 

Court for the Western District of 

Louisiana in the lawsuit entitled United 

States of America and Louisiana v. 

CITGO Petroleum Corp., Civil Action 

No. 2:21–cv–1705. The United States is 


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