[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27633-27634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12682]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Bellwyck Clinical
Services
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 July 13, 2018. Such
persons may also file a written request for a hearing on the
application on or before July 13, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
request for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DRW, 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 April
4, 2018, Bellwyck Clinical Services, 8946 Global Way, West Chester, OH
45069 applied to be registered as an importer of the following basic
classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Amphetamine.................... 1100 II
Methylphenidate................ 1724 II
Oxycodone...................... 9143 II
------------------------------------------------------------------------
[[Page 27634]]
The company plans to import the listed controlled substances in
dosage form to conduct 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: June 6, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-12682 Filed 6-12-18; 8:45 am]
BILLING CODE 4410-09-P