88 FR 229 pg. 83578 - Importer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC
Type: NOTICEVolume: 88Number: 229Page: 83578
Page: 83578Docket number: [Docket No. DEA-1298]
FR document: [FR Doc. 2023-26342 Filed 11-29-23; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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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.
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):
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Dimethyltryptamine | 7435 | I |
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