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Home » 2023 Issues » 88 FR (11/30/2023) » 2023-26343. Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC

  2023-26343. Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC  

  • Start Preamble

    AGENCY:

    Drug Enforcement Administration, Justice.

    ACTION:

    Notice of application.

    SUMMARY:

    Pharmaron Manufacturing Services (US) 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.

    Start Printed Page 83578

    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 29, 2024. Such persons may also file a written request for a hearing on the application on or before January 29, 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.

    End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    In accordance with 21 CFR 1301.33(a), this is notice that on October 23, 2023, Pharmaron Manufacturing Services (US) LLC, 498 Washington Street, Coventry, Rhode Island 02816, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

    Controlled substanceDrug codeSchedule
    Dimethyltryptamine7435I

    The company plans to bulk manufacture the listed controlled substance for the purpose of producing material for clinical trials. No other activities for this drug code are authorized for this registration.

    Start Signature

    Claude Redd,

    Acting Deputy Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2023–26343 Filed 11–29–23; 8:45 am]

    BILLING CODE 4410–09–P

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Document Information

Published:
11/30/2023
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2023-26343
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 29, 2024. Such persons may also file a written request for a hearing on the application on or before January 29, 2024.
Pages:
83577-83578 (2 pages)
Docket Numbers:
Docket No. DEA-1299
PDF File:
2023-26343.pdf