[Federal Register Volume 88, Number 215 (Wednesday, November 8, 2023)]
[Notices]
[Page 77108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24614]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1287]
Importer of Controlled Substances Application: Noramco
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Noramco has applied to be registered as an importer of basic
class(es) of controlled substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
December 8, 2023. Such persons may also file a written request for a
hearing on the application on or before December 8, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should also be
sent to: Drug Enforcement Administration, Attn: Administrator, 8701
Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on October 4, 2023, Noramco, 500 Swedes Landing Road,
Wilmington, Delaware 19801-4417, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
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Drug
Controlled substance code Schedule
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Gamma Hydroxybutyric Acid.............. 2010 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Nabilone............................... 7379 II
Phenylacetone.......................... 8501 II
Opium, Raw............................. 9600 II
Opium Extracts......................... 9610 II
Opium Fluid Extract.................... 9620 II
Opium Tincture......................... 9630 II
Opium Powdered......................... 9639 II
Opium Granulated....................... 9640 II
Opium Poppy/Poppy Straw................ 9650 II
Noroxymorphone......................... 9668 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. The company plans to import an
intermediate form of Tapentadol (9780) to bulk manufacture Tapentadol
for distribution to its customers. In reference to drug codes 7360
(Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to
import a synthetic cannabidiol and a synthetic Tetrahydrocannabinol. No
other activity for these drug codes is authorized for this
registration.
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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-24614 Filed 11-7-23; 8:45 am]
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