Bulk Manufacturer of Controlled Substances Application: Invizyne Technologies, Inc., 4336-4337 [2024-01135]

Download as PDF 4336 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 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. In accordance with 21 CFR 1301.34(a), this is notice that on December 5, 2023, 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): SUPPLEMENTARY INFORMATION: Controlled substance Amphetamine .................. Methylphenidate .............. Oxycodone ...................... Hydromorphone ............... Methadone ...................... Morphine .......................... Fentanyl ........................... Drug code Schedule 1100 1724 9143 9150 9250 9300 9801 II II II II II II II khammond on DSKJM1Z7X2PROD with NOTICES The company plans to import the above 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 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 Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2024–01136 Filed 1–22–24; 8:45 am] BILLING CODE P VerDate Sep<11>2014 17:41 Jan 22, 2024 Jkt 262001 following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Drug Enforcement Administration Controlled substance [Docket No. DEA–1317] Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Mylan 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 February 22, 2024. Such persons may also file a written request for a hearing on the application on or before February 22, 2024. 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 6, 2023 Mylan Pharmaceuticals, Inc., 2898 Manufacturers Road, Greensboro, North Carolina 27406–4600, applied to be registered as an importer of the SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Remifentanil .................... Drug code Schedule 9739 II The company plans to import the above listed controlled substances in finished dosage form for commercial distribution to its customers. 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. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2024–01137 Filed 1–22–24; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 1315] Bulk Manufacturer of Controlled Substances Application: Invizyne Technologies, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Invizyne Technologies, Inc. has applied to be registered as a bulk manufacturer 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 submit electronic comments on or objections to the issuance of the proposed registration on or before March 25, 2024. Such persons may also file a written request for a hearing on the application on or before March 25, 2024. 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 SUMMARY: E:\FR\FM\23JAN1.SGM 23JAN1 Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices 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 17, 2023, Invizyne Technologies, Inc., 750 Royal Oaks Drive, Suite 106, Monrovia, California 91016–6357, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Tetrahydrocannabinols .... Drug code Schedule I 7370 II The company plans to bulk manufacture the listed controlled substance for the internal use intermediates or for sale to its customers. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for this drug code is authorized for this registration. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2024–01135 Filed 1–22–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE 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. In accordance with 21 CFR 1301.34(a), this is notice that on December 14, 2023, Medi-Physics Inc. DBA GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004–1412 applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug Enforcement Administration Controlled substance [Docket No. DEA–1313] Schedule 9041 9180 II II Importer of Controlled Substances Application: Medi-Physics Inc. DBA GE Healthcare Cocaine ........................... Ecgonine .......................... Drug Enforcement Administration, Justice. ACTION: Notice of application. The company plans to import derivatives of the listed controlled substances to be used for the manufacture of a diagnostic product and reference standards. 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. AGENCY: Medi-Physics Inc. DBA GE Healthcare 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 February 22, 2024. Such persons may also file a written request for a hearing on the application on or before February 22, 2024. ADDRESSES: The Drug Enforcement Administration requires that all SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Drug code VerDate Sep<11>2014 17:41 Jan 22, 2024 Jkt 262001 I I Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2024–01133 Filed 1–22–24; 8:45 am] BILLING CODE 4410–09–P PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 4337 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 1314] Importer of Controlled Substances Application: Myonex Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Myonex 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. 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 February 22, 2024. Such persons may also file a written request for a hearing on the application on or before February 22, 2024. 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 20, 2023, Myonex Inc., 100 Progress Drive, Horsham, Pennsylvania 19044, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4336-4337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01135]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 1315]


Bulk Manufacturer of Controlled Substances Application: Invizyne 
Technologies, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Invizyne Technologies, Inc. has applied to be registered as a 
bulk manufacturer 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 submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
March 25, 2024. Such persons may also file a written request for a 
hearing on the application on or before March 25, 2024.

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

[[Page 4337]]

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 17, 2023, Invizyne Technologies, Inc., 750 
Royal Oaks Drive, Suite 106, Monrovia, California 91016-6357, applied 
to be registered as a bulk manufacturer of the following basic 
class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols...................    7370  I
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substance for the internal use intermediates or for sale to its 
customers. In reference to drug code 7370 (Tetrahydrocannabinols), the 
company plans to bulk manufacture this drug as synthetic. No other 
activities for this drug code is authorized for this registration.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-01135 Filed 1-22-24; 8:45 am]
BILLING CODE 4410-09-P
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