Importers Notice of Application - 2020
[Federal Register Volume 85, Number 57 (Tuesday, March 24, 2020)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06167]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-605]
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|
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,
[FR Doc. 2020-06167 Filed 3-23-20; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).