2020-06167. Importer of Controlled Substances Application: Sharp (Bethlehem), LLC

ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 23, 2020. Such persons may also file a written request for a hearing on the application on or before April 23, 2020.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a hearing should also 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.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on January 28, 2020, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020-8024 applied to be registered as an importer of the following basic class(es) of controlled substances:

Controlled substance	Drug code	Schedule
Gamma Hydroxybutyric Acid	2010	I
3,4-Methylenedioxymethamphetamine	7405	I
Psilocybin	7437	I

The company plans to import the listed controlled substances for clinical trials. Approval of permit applications will occur only when the registrant's activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.

Dated: March 12, 2020.

William T. McDermott,

Assistant Administrator.