[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Page 49663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23328]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Galephar 
Pharmaceutical Research, Inc.

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 November 27, 2017. 
Such persons may also file a written request for a hearing on the 
application on or before November 27, 2017.

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 
requests 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 August 
2, 2017, Galephar Pharmaceutical Research, Inc., #100 Carr 198, 
Industrial Park, Juncos, Puerto Rico 00777-3873 applied to be 
registered as an importer of hydromorphone (9150), a basic class of 
controlled substance in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, research and analytical 
purposes.
    The import of this class of controlled substance will be granted 
only for analytical testing, research, and clinical trials. This 
authorization does not extend to the import of a finished FDA approved 
or non-approved dosage form for commercial sale.

    Dated: October 18, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-23328 Filed 10-25-17; 8:45 am]
 BILLING CODE 4410-09-P