[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Page 83578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26342]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1298]


Importer of Controlled Substances Application: Pharmaron 
Manufacturing Services (US) LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Pharmaron Manufacturing Services (US) LLC 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 
January 2, 2024. Such persons may also file a written request for a 
hearing on the application on or before January 2, 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 October 30, 2023, Pharmaron Manufacturing Services 
(US) LLC, 498 Washington Street, Conventry, Rhode Island 02816, applied 
to be registered as an importer of the following basic class(es) of 
controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Dimethyltryptamine......................    7435  I
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    The company purpose of importing Dimethyltryptamine (7435) is to 
conduct process and analytical technology transfer, further process, 
and analytical development as needed and subsequently manufacture/
produce an Active Pharmaceutical Ingredient under Good Manufacturing 
Practices at the US Pharmaron site (Pharmaron Manufacturing Services 
(US) LLC in Coventry, Rhode Island. No other activity for this drug 
code 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 non-approved finished 
dosage forms for commercial sale.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-26342 Filed 11-29-23; 8:45 am]
BILLING CODE 4410-09-P