2019-02881. Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute

ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 25, 2019. Such persons may also file a written request for a hearing on the application on or before March 25, 2019.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.34(a), this is notice that on June 25, 2018, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Bldg., Room 106, Research Triangle Park, North Carolina 27709, re-applied to be registered as a bulk manufacturer of small quantities of Tetrahydrocannabinols (7370), a basic class of a controlled substance listed in schedule I.

The company will manufacture via synthesis Tetrahydrocannabinols (7370), for use by researchers as Active Pharmaceutical Ingredients (API) for clinical trials.

Dated: January 29, 2019.

John J. Martin,

Assistant Administrator.