82 FR 6645 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6645-6645 | |
| FR Document | 2017-01103 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Notices] [Page 6645] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01103] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. 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 in accordance with 21 CFR 1301.33(a) on or before March 20, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 1301.33(a), this is notice that on July 12, 2016, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Marihuana............................. 7360 I Codeine-N-oxide....................... 9053 I Dihydromorphine....................... 9145 I Hydromorphinol........................ 9301 I Morphine-N-oxide...................... 9307 I Amphetamine........................... 1100 II Methylphenidate....................... 1724 II Phenylacetone......................... 8501 II Codeine............................... 9050 II Dihydrocodeine........................ 9120 II Oxycodone............................. 9143 II Hydromorphone......................... 9150 II Hydrocodone........................... 9193 II Morphine.............................. 9300 II Oripavine............................. 9330 II Thebaine.............................. 9333 II Opium extracts........................ 9610 II Opium fluid extract................... 9620 II Opium tincture........................ 9630 II Opium, powdered....................... 9639 II Opium, granulated..................... 9640 II Oxymorphone........................... 9652 II Noroxymorphone........................ 9668 II Tapentadol............................ 9780 II ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. In reference to drug code 7360, the company plans to manufacture a synthetic version of cannabidiol in bulk for sale to its customers, who are final dosage form manufacturers. No other activity for this drug code is authorized for this registration. Dated: January 11, 2017. Louis J. Milione, Assistant Administrator. [FR Doc. 2017-01103 Filed 1-18-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6645
and replacement parts for customers failed to establish the existence of a exercise all necessary functions with
that purchased their covered products domestic industry that practices the respect to the promulgation and
prior to the date the exclusion order mask patents. RID at 1. No petitions for implementation of 21 CFR part 1301,
becomes final; and (2) cease and desist review were received. incident to the registration of
orders prohibiting domestic respondents Having examined the record of this manufacturers, distributors, dispensers,
BMC Medical Co., Ltd., 3B Medical, Inc. investigation, the Commission has importers, and exporters of controlled
from conducting any of the following determined to review in-part the RID for substances (other than final orders in
activities in the United States: the limited purpose of modifying pages connection with suspension, denial, or
Importing, selling, marketing, 20–21 and 24 of the RID. The revocation of registration) has been
advertising, distributing, transferring Commission does not adopt the RID’s redelegated to the Assistant
(except for exportation), and soliciting statements that ‘‘the amount a Administrator of the DEA Diversion
U.S. agents or distributors for, sleep- complainant spends to purchase
disordered breathing treatment systems Control Division (‘‘Assistant
components manufactured in the United
and components thereof covered by Administrator’’) pursuant to section 7 of
States is immaterial to the economic
claims 1, 9, 32, 89, and 92 of the ’527 28 CFR part 0, appendix to subpart R.
prong analysis’’ (RID at 20–21) or that
patent; claims 19, 21, 29, 32, and 36 of evidence of payments to domestic In accordance with 21 CFR
the ’392 patent; claims 32, 33, 34, and suppliers is ‘‘per se insufficient to 1301.33(a), this is notice that on July 12,
53 of the ’267 patent; claims 30, 37, and include in the quantitative analysis.’’ 2016, Noramco, Inc., 500 Swedes
38 of the ’060 patent; and claims 1, 3, RID at 24. The Commission has Landing Road, Wilmington, Delaware
5, 11, 28, 30, 31, and 56 of the ’883 determined to otherwise not review the 19801–4417 applied to be registered as
patent. RID. The Commission has determined to a bulk manufacturer of the following
On February 18, 2015, ResMed filed a vacate the suspended remedial orders. basic classes of controlled substances:
notice of appeal in the U.S. Court of The investigation is terminated.
Appeals for the Federal Circuit, seeking The authority for the Commission’s Drug
review of the Commission’s Controlled substance Schedule
determination is contained in section code
determination as to the ’453 patent 337 of the Tariff Act of 1930, as
(Appeal No. 2015–1360). On April 14, amended (19 U.S.C. 1337), and in Part Marihuana ................. 7360 I
2015, BMC filed a notice of appeal in 210 of the Commission’s Rules of Codeine-N-oxide ....... 9053 I
the Federal Circuit, seeking review of Practice and Procedure (19 CFR part Dihydromorphine ...... 9145 I
the Commission’s domestic industry 210). Hydromorphinol ........ 9301 I
determination as well as the Morphine-N-oxide ..... 9307 I
Commission’s finding that prior art does By order of the Commission. Amphetamine ........... 1100 II
not render the asserted claims of the Issued: January 12, 2017. Methylphenidate ....... 1724 II
’267 patent invalid for obviousness Lisa R. Barton, Phenylacetone .......... 8501 II
(Appeal No. 2015–1576). The Court Secretary to the Commission. Codeine .................... 9050 II
consolidated the two appeals on April [FR Doc. 2017–01143 Filed 1–18–17; 8:45 am] Dihydrocodeine ......... 9120 II
23, 2015. BILLING CODE 7020–02–P
Oxycodone ............... 9143 II
On March 16, 2016, the parties jointly Hydromorphone ........ 9150 II
moved to dismiss ResMed’s appeal as to Hydrocodone ............ 9193 II
the ’453 patent. On March 17, 2016, the DEPARTMENT OF JUSTICE
Morphine ................... 9300 II
Commission moved to remand BMC’s Oripavine .................. 9330 II
appeal in light of intervening domestic Drug Enforcement Administration Thebaine ................... 9333 II
industry precedent in Lelo Inc. v. Opium extracts ......... 9610 II
International Trade Commisson, 789 [Docket No. DEA–392] Opium fluid extract ... 9620 II
F.3d 879 (Fed. Cir. 2015). On March 29, Opium tincture .......... 9630 II
Bulk Manufacturer of Controlled Opium, powdered ..... 9639 II
2016, the Court granted the motion to
Substances Application: Noramco, Inc. Opium, granulated .... 9640 II
dismiss ResMed’s appeal. On April 22,
2016, the Court granted the Oxymorphone ........... 9652 II
ACTION: Notice of application.
Commission’s remand motion. Noroxymorphone ...... 9668 II
On May 12, 2016, the Commission Tapentadol ................ 9780 II
DATES: Registered bulk manufacturers of
issued a notice suspending the remedial the affected basic classes, and
orders in place during the pendency of applicants therefore, may file written The company plans to manufacture
the remand proceedings. 81 FR 31254– comments on or objections to the the above-listed controlled substances
55 (May 18, 2016). The Commission also issuance of the proposed registration in in bulk for distribution to its customers.
issued an order asking the parties to accordance with 21 CFR 1301.33(a) on In reference to drug code 7360, the
comment on further proceedings. On or before March 20, 2017. company plans to manufacture a
June 8, 2016, the parties submitted synthetic version of cannabidiol in bulk
ADDRESSES: Written comments should
initial comments. The parties filed for sale to its customers, who are final
be sent to: Drug Enforcement
responses on July 15, 2016. On August
Administration, Attention: DEA Federal dosage form manufacturers. No other
16, 2016, the Commission issued an
Register Representative/DRW, 8701 activity for this drug code is authorized
order remanding the investigation to the
Morrissette Drive, Springfield, Virginia for this registration.
ALJ to: (1) Apply the Federal Circuit’s
mstockstill on DSK3G9T082PROD with NOTICES
22152.
intervening domestic industry Dated: January 11, 2017.
precedent in Lelo to the existing record SUPPLEMENTARY INFORMATION: The Louis J. Milione,
(as to the mask patents, the only patents Attorney General has delegated her Assistant Administrator.
remaining); and (2) issue an RID on authority under the Controlled
[FR Doc. 2017–01103 Filed 1–18–17; 8:45 am]
remand as to violation. Substances Act to the Administrator of
BILLING CODE 4410–09–P
On November 10, 2016, the ALJ the Drug Enforcement Administration
issued the RID finding that ResMed (DEA), 28 CFR 0.100(b). Authority to
VerDate Sep<11>2014 21:20 Jan 18, 2017 Jkt 241001 PO 00000 Frm 00164 Fmt 4703 Sfmt 9990 E:\FR\FM\19JAN1.SGM 19JAN1](https://thefederalregister.org/doc/82_FR_6657/page/1.svg)
Document Created: 2018-02-01 15:15:39
Document Modified: 2018-02-01 15:15:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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 in accordance with 21 CFR 1301.33(a) on or before March 20, 2017. | |
| FR Citation | 82 FR 6645 |
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