Importer of Controlled Substances Application: Mylan Inc., 10382-10383 [2023-03395]

Download as PDF 10382 ACTION: Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices Notice of application. activities for these drug codes are authorized for this registration. Veranova, L.P. 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. SUMMARY: 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 April 18, 2023. Such persons may also file a written request for a hearing on the application on or before April 18, 2023. DATES: The Drug Enforcement Administration (DEA) 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. ADDRESSES: In accordance with 21 CFR 1301.33(a), this is notice that on January 5, 2023 Veranova, L.P., 25 Patton Road, Devens, Massachusetts 01434–3803, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance lotter on DSK11XQN23PROD with NOTICES1 Amphetamine ............... Methylphenidate ........... Nabilone ....................... Hydrocodone ................ Levorphanol .................. Thebaine ....................... Alfentanil ....................... Remifentanil .................. Sufentanil ...................... Drug code Schedule 1100 1724 7379 9193 9220 9333 9737 9739 9740 II II II II II II II II II The company plans to bulk manufacture the above controlled substances in order to support manufacturing and analytical testing activities at its other DEA-registered manufacturing facility. No other VerDate Sep<11>2014 17:13 Feb 16, 2023 Jkt 259001 Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–03410 Filed 2–16–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE In accordance with 21 CFR 1301.34(a), this is notice that on November 16, 2023, Avant Biopharmaceuticals, 7220 Trade Street, San Diego, California 92121, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Controlled substance Drug Enforcement Administration [Docket No. DEA–1141] Importer of Controlled Substances Application: Avant Biopharmaceuticals Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Avant Biopharmaceuticals 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 20, 2023. Such persons may also file a written request for a hearing on the application on or before March 20, 2023. 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. SUMMARY: PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 Marihuana Extract ........ Marihuana ..................... Tetrahydrocannabinols Psilocybin ..................... Psilocyn ........................ Drug code 7350 7360 7370 7437 7438 Schedule I I I I I The company plans to import the listed controlled substances for analytical or scientific purposes. 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. 2023–03400 Filed 2–16–23; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 1140] Importer of Controlled Substances Application: Mylan Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Mylan Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental 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 March 20, 2023. Such persons may also file a written request for a hearing on the application on or before March 20, 2023. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, SUMMARY: E:\FR\FM\17FEN1.SGM 17FEN1 10383 Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices 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 2, 2022, 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 lotter on DSK11XQN23PROD with NOTICES1 Amphetamine ............... Methylphenidate ........... Oxycodone ................... Hydromorphone ............ Methadone .................... Morphine ....................... Fentanyl ........................ Drug code Schedule 1100 1724 9143 9150 9250 9300 9801 II II II II II II II The company plans to import bulk active pharmaceutical ingredients for internal testing purposes only and finished dosage forms for analytical testing and distribution for clinical trials. No other activity for these drug codes 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 the Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–03395 Filed 2–16–23; 8:45 am] BILLING CODE P VerDate Sep<11>2014 17:13 Feb 16, 2023 Jkt 259001 following basic class(es) of controlled substance(s). DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled substance [Docket No. DEA–1138] Importer of Controlled Substances Application: Persist Al Formulations Corp Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Persist Al Formulations Corp 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 20, 2023. Such persons may also file a written request for a hearing on the application on or before March 20, 2023. 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 19, 2022, Persist AI Formulations Corp, 1100 Main Street, Suite 300–PB, Woodland, California 95695–3513, applied to be registered as an importer of the SUMMARY: PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 Psilocybin ..................... Drug code 7437 Schedule I The company plans to import the listed controlled substance as bulk material for research and development activities. 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. 2023–03386 Filed 2–16–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Modification to Partial Consent Decree Under the Clean Water Act On February 13, 2023, the Department of Justice lodged a proposed Modification to Partial Consent Decree with the United States District Court for the Middle District of Pennsylvania in the lawsuit entitled United States and Commonwealth of Pennsylvania Department of Environmental Protection v. Capital Region Water and the City of Harrisburg, PA, Civil Action No. 1:15–cv–00291–CCC. The United States and the Pennsylvania Department of Environmental Protection (‘‘PADEP’’) jointly filed this lawsuit in February 2015 against Capital Region Water (‘‘CRW’’) and the City of Harrisburg alleging violations of the Clean Water Act and the Pennsylvania Clean Streams Law. The complaint sought injunctive relief and civil penalties for alleged unpermitted discharges from the sewer system in Harrisburg, failure to prepare a Long-Term Control Plan in compliance with EPA’s 1994 Combined Sewer Overflow Control Policy (‘‘CSO Policy’’), and failure to comply with other requirements of sewer and stormwater National Pollutant Discharge Elimination System (‘‘NPDES’’) permits. At the same time, the United States and PADEP also lodged a Partial Consent Decree that required CRW to perform injunctive relief to address the alleged E:\FR\FM\17FEN1.SGM 17FEN1

Agencies

[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10382-10383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03395]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1140]


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 Supplemental 
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 March 20, 2023. 
Such persons may also file a written request for a hearing on the 
application on or before March 20, 2023.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal,

[[Page 10383]]

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 2, 2022, 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 bulk active pharmaceutical ingredients 
for internal testing purposes only and finished dosage forms for 
analytical testing and distribution for clinical trials. No other 
activity for these drug codes 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 the Food and Drug 
Administration-approved or non-approved finished dosage forms for 
commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-03395 Filed 2-16-23; 8:45 am]
BILLING CODE P
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