[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64159-64160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27037]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Noramco 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 January 14, 2019.
Such persons may also file a written request for a hearing on the
application on or before January 14, 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
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/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
[[Page 64160]]
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
14, 2018, Noramco Inc., 500 Swedes Landing Road, Wilmington, Delaware
19801-4417 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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Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Nabilone............................... 7379 II
Phenylacetone.......................... 8501 II
Opium, raw............................. 9600 II
Poppy Straw Concentrate................ 9670 II
Tapentadol............................. 9780 II
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The company plans to import phenylacetone (8501), and poppy straw
concentrate (9670) to bulk manufacture other controlled substances for
distribution to its customers. In reference to drug codes 7360
(marihuana) and 7370 (THC), the company plans to import a synthetic
cannabidiol and a synthetic tetrahydrocannabinol. No other activity for
these drug codes is authorized for this registration. Placement of
these drug codes onto the company's registration does not translate
into automatic approval of subsequent permit applications to import
controlled substances.
Approval of permit applications will occur only when the
registrant's business 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: December 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-27037 Filed 12-12-18; 8:45 am]
BILLING CODE 4410-09-P