[Federal Register Volume 84, Number 52 (Monday, March 18, 2019)]
[Notices]
[Page 9837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05000]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Sharp (Bethlehem),
LLC
ACTION: Notice of application.
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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 April 17, 2019. Such
persons may also file a written request for a hearing on the
application on or before April 17, 2019.
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
requests 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: 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
January 04, 2019, Sharp (Bethlehem), LLC, 2400 Baglyos Circle,
Bethlehem, Pennsylvania 18020 applied to be registered as an importer
of the following basic classes of controlled substances:
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Drug
Controlled substance code Schedule
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Gamma Hydroxybutyric Acid................ 2010 I
3,4-Methylenedioxymethamphe- tamine...... 7405 I
Psilocybin............................... 7437 I
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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
to 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 5, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-05000 Filed 3-15-19; 8:45 am]
BILLING CODE 4410-09-P