97070 Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on November 5, 2024, 

Kinetochem LLC, 96 Market Street, 

Suite 102, Georgetown, Texas 78626– 

3618, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled 

substance 

Drug 

code Schedule 

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

Tetrahydrocannabinols.7370 I 

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

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

The company plans to bulk 

manufacture the listed controlled 

substances as Active Pharmaceutical 

Ingredients to its customers as well as 

for research and clinical trials. In 

reference to drug codes 7360 

(Marihuana), and 7370 

(Tetrahydrocannabinols) the company 

plans to bulk manufacture these drug 

codes as synthetic. No other activities 

for these drug codes are authorized for 

this registration. 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2024–28715 Filed 12–5–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1464] 

Bulk Manufacturer of Controlled 

Substances Application: Navinta LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Navinta LLC 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 submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before February 4, 2025. Such 

persons may also file a written request 

for a hearing on the application on or 

before February 4, 2025. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on October 14, 2024, 

Navinta LLC, 1499 Lower Ferry Road, 

Ewing, New Jersey 08618–1414, applied 

to be registered as a bulk manufacturer 

of the following basic class(es) of 

controlled substance(s): 

Controlled substance Drug 

code Schedule 

Levomethorphan .............. 9210 II 

Levorphanol ..................... 9220 II 

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

The company plans to bulk 

manufacture the listed controlled 

substances for validation purposes as 

part of the Food Administration 

approval process before distributing to 

their customers. No other activities for 

these drug codes are authorized for this 

registration. 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2024–28719 Filed 12–5–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1465] 

Importer of Controlled Substances 

Application: Organic Standards 

Solutions International, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Organic Standards Solutions 

International, 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. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants, therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before January 6, 2025. Such 

persons may also file a written request 

for a hearing on the application on or 

before January 6, 2025. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. All 

requests for a hearing must 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. All requests for a hearing should 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on November 6, 2024, 

Organic Standards Solutions 

International, LLC, 7290 Investment 

Drive, Unit B, North Charleston, South 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 235 / Friday, December 6, 2024 / Notices 97071 

Carolina 29418–8305, applied to be 

registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

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

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

Tetrahydrocannabinols .... 7370 I 

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

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

The company plans to import the 

listed controlled substances to produce 

analytical reference standards for sale 

and distribution to its customers. Drug 

codes 7350 (Marihuana Extract) and 

7360 (Marihuana) will be used for the 

manufacture of cannabidiol only. In 

reference to drug code 7370 

(Tetrahydrocannabinols) the company 

plans to import a synthetic version of 

this controlled substance. No other 

activities for these drug codes are 

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. 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2024–28717 Filed 12–5–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1462] 

Importer of Controlled Substances 

Application: Noramco 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Noramco 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 submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before January 6, 2025. Such 

persons may also file a written request 

for a hearing on the application on or 

before January 6, 2025. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. All 

requests for a hearing must 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. All requests for a hearing should 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on October 9, 2024, 

Noramco, 500 Swedes Landing Road, 

Wilmington, Delaware 19801–4417, 

applied to be registered as an importer 

of the following basic class(es) of 

controlled substance(s): 

Controlled substance Drug 

code Schedule 

Gamma Hydroxybutyric 

Acid.

2010 I 

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

Tetrahydrocannabinols .... 7370 I 

Methadone-Intermediate 9254 II 

Opium, Raw ..................... 9600 II 

Opium Extracts ................ 9610 II 

Opium Fluid Extract ......... 9620 II 

Opium Tincture ................ 9630 II 

Opium, Powdered ............ 9639 II 

Opium, Granulated .......... 9640 II 

Opium Poppy/Poppy 

Straw.

9650 II 

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

Poppy Straw Concentrate 9670 II 

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

The company plans to import Poppy 

Straw Concentrate (9670) to bulk 

manufacture other controlled substances 

for distribution to its customers. The 

company plans to import an 

intermediate form of Tapentadol (9780) 

to bulk manufacture Tapentadol for 

distribution to its customers. In 

reference to drug codes 7360 

(Marihuana) and 7370 

(Tetrahydrocannabinols), the company 

plans to import a synthetic cannabidiol 

and a synthetic Tetrahydrocannabinol. 

No other activities for these drug codes 

are 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. 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2024–28728 Filed 12–5–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Notice of Lodging of Proposed 

Consent Decree Under the Clean Air 

Act 

On December 2, 2024, the Department 

of Justice lodged a proposed Consent 

Decree with the United States District 

Court for the Western District of 

Missouri in the lawsuit entitled United 

States of America v. BCP Ingredients, 

Inc. Civ. No. 3:24–cv–5094 (W.D. Mo.). 

The Complaint seeks injunctive relief 

and civil penalties for alleged violations 

of section 112(r) of the Federal Clean 

Air Act (‘‘CAA’’), 42 U.S.C. 7412(r)(7), 

and its implementing regulations set 

forth at 40 CFR part 68, resulting from 

a release of ethylene oxide (‘‘EtO’’) at a 

chemical manufacturing and repackaging facility owned and operated 

by BCP Ingredients, Inc. (‘‘BCP’’) in 

Verona, Missouri. Under the proposed 

Consent Decree resolving these alleged 

violations, BCP will pay a civil penalty 

of $300,000 to the United States, install 

an additional state-of-the-art EtO 

scrubber to reduce EtO emissions at its 

facility, and share a copy of its final 

audit completion report from a 2022 

third party audit. BCP also will be 

required to perform three Supplemental 

Environmental Projects totaling 

$350,000: (1) donation of two vehicles 

to a local healthcare provider to provide 

mobile health services to communities 

near BCP’s facility; (2) provision of at 

least 1,000 medical visits to be 

administered by the same local 

healthcare provider using the vehicles 

BCP will donate for the first SEP; and 

(3) donation of emergency response 

equipment to a fire department near 

BCP’s facility. 

The publication of this notice opens 

a period for public comment on the 

proposed Consent Decree. Comments 


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