Importer of Controlled Substances Application: Mylan Inc., 9556 [2025-02594]

Download as PDF 9556 Federal Register / Vol. 90, No. 29 / Thursday, February 13, 2025 / Notices 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): ADDRESSES: Controlled substance Marihuana Extract ........... Marihuana ........................ Tetrahydrocannabinols .... I Drug code Schedule 7350 7360 7370 I I I 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 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): DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration [Docket No. DEA–1486] Amphetamine .................. Methylphenidate .............. Oxycodone ...................... Hydromorphone ............... Methadone ...................... Morphine .......................... Fentanyl ........................... Importer of Controlled Substances Application: Mylan Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. ddrumheller on DSK120RN23PROD with NOTICES1 AGENCY: 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 SUMMARY: VerDate Sep<11>2014 16:39 Feb 12, 2025 Jkt 265001 Drug code Schedule 1100 1724 9143 9150 9250 9300 9801 II II II II II II 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. PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: 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 SUMMARY: E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 90, Number 29 (Thursday, February 13, 2025)]
[Notices]
[Page 9556]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02594]


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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):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             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 non-approved 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
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