The eRulemaking Program

05/06/2024 | Press release | Distributed by Public on 05/06/2024 07:53

Bulk App-Research Triangle-(2024-09783) DEA1349

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1349]

Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute

Agency

Drug Enforcement Administration, Justice.

Action

Notice of application.

Summary

Research Triangle Institute 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.

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 July 5, 2024. Such persons may also file a written request for a hearing on the application on or before July 5, 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.

Supplementary Information

In accordance with 21 CFR 1301.33(a), this is notice that on March 11, 2024, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Building, Room 106, Research Triangle Park, North Carolina 27709-2194, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled substance Drug code Schedule
Tetrahydrocannabinols 7370 I

The company plans to bulk manufacture the listed controlled substance synthetically for distribution to its customers for research and as analytical reference standards. No other activities for this drug code are authorized for this registration.

Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-09783 Filed 5-3-24; 8:45 am]
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