9556 Federal Register / Vol. 90, No. 29 / Thursday, February 13, 2025 / Notices 

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 December 30, 2024, 

Maridose LLC, 74 Orion Street, Unit 7, 

Brunswick, Maine 04011, applied to be 

registered as a bulk manufacturer 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 

The company plans to bulk 

manufacture the listed controlled 

substances to supply the Drug 

Enforcement Administration-registered 

researchers for their approval studies. 

No other activities for these drug codes 

are authorized for this registration. 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2025–02596 Filed 2–12–25; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1486] 

Importer of Controlled Substances 

Application: Mylan Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Mylan 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 submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before March 17, 2025. Such 

persons may also file a written request 

for a hearing on the application on or 

before March 17, 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 December 10, 2024, 

Mylan Inc., 3711 Collins Ferry Road, 

Morgantown, West Virginia 26505– 

2362, applied to be registered as an 

importer of the following basic class(es) 

of controlled substance(s): 

Controlled substance Drug 

code Schedule 

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

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

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

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

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

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

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

The company plans to import the 

listed controlled substances as bulk 

active pharmaceutical ingredients for 

internal testing purposes only and 

finished dosage forms for analytical 

testing and distribution for clinical trials 

to support foreign market participation. 

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. 2025–02594 Filed 2–12–25; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1490] 

Importer of Controlled Substances 

Application: Janssen Pharmaceuticals 

Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Janssen Pharmaceuticals 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 submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before March 17, 2025. Such 

persons may also file a written request 

for a hearing on the application on or 

before March 17, 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 


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