82 FR 58027 - Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 235 (December 8, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 58027-58027 | |
| FR Document | 2017-26507 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Page 58027] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26507] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, 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 February 6, 2018. 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 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 1301.33(a), this is notice that on September 19, 2017, Janssen Pharmaceutical, Inc., Buildings 1-5 & 7-14, 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Methylphenidate.................................. 1724 II Oxycodone........................................ 9143 II Hydromorphone.................................... 9150 II Hydrocodone...................................... 9193 II Oripavine........................................ 9330 II Thebaine......................................... 9333 II Oxymorphone...................................... 9652 II Tapentadol....................................... 9780 II Fentanyl......................................... 9801 II ------------------------------------------------------------------------ The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: November 17, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-26507 Filed 12-7-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 58027
throughout and that the above-quota in addition to the current rate of duty. of covered parts that exceed 50,000
tariff rate decrease by five percentage Vice Chairman Johanson and units, they recommend a tariff rate of 50
points during each year of the remedy Commissioner Broadbent do not percent ad valorem, in addition to the
period. Chairman Schmidtlein and recommend an additional in-quota tariff current rate of duty. They recommend
Commissioner Williamson additionally rate for large residential washers. that the in-quota volume increase by
recommend an in-quota tariff rate of 20 The Commissioners also unanimously 20,000 units in each year of the remedy
percent ad valorem, which would recommend that the President impose a period, and that the above-quota tariff
decrease to 18 percent in the second separate TRQ on imports of covered rate decrease by five percentage points
year of the remedy period and 15 parts of large residential washers for a each year. They do not recommend an
percent in the third year of the period, duration of three years. For U.S. imports in-quota tariff rate for covered parts.
SUMMARY OF COMMISSIONERS’ RECOMMENDED ACTIONS LARGE RESIDENTIAL WASHERS
Year 1 Year 2 Year 3
Large Residential Washers: TRQ
In-Quota Volume Level .............................................................. 1.2 million units .............. 1.2 million units .............. 1.2 million units.
Above-Quota Tariff Rate ............................................................ 50% ................................ 45% ................................ 40%.
In-Quota Tariff Rate (Schmidtlein & Williamson) ....................... 20% ................................ 18% ................................ 15%.
In-Quota Tariff Rate (Johanson & Broadbent) ........................... 0% .................................. 0% .................................. 0%.
Covered Parts: TRQ
In-Quota Volume Level .............................................................. 50,000 units ................... 70,000 units ................... 90,000 units.
Above-Quota Tariff Rate ............................................................ 50% ................................ 45% ................................ 40%.
In-Quota Tariff Rate ................................................................... 0% .................................. 0% .................................. 0%.
Having made negative findings with DEPARTMENT OF JUSTICE Administrator of the DEA Diversion
respect to imports from Canada and Control Division (‘‘Assistant
Mexico under section 311(a) of the Drug Enforcement Administration Administrator’’) pursuant to section 7 of
North American Free Trade Agreement 28 CFR part 0, appendix to subpart R.
[Docket No. DEA–392]
Implementation Act, the Commissioners In accordance with 21 CFR
recommend that imports from Canada Bulk Manufacturer of Controlled 1301.33(a), this is notice that on
and Mexico be excluded from the above Substances Application: Janssen September 19, 2017, Janssen
TRQs and increased rates of duty. The Pharmaceutical, Inc. Pharmaceutical, Inc., Buildings 1–5 & 7–
Commissioners also recommend that the 14, 1440 Olympic Drive, Athens,
above TRQs and increased rates of duty ACTION: Notice of application. Georgia 30601 applied to be registered
not apply to imports from Australia, as a bulk manufacturer of the following
Colombia, Costa Rica, the Dominican DATES: Registered bulk manufacturers of
the affected basic classes, and basic classes of controlled substances:
Republic, El Salvador, Guatemala,
Honduras, Israel, Jordan, Korea, applicants therefore, may file written
Drug
Nicaragua, Panama, Peru, and comments on or objections to the Controlled substance code Schedule
issuance of the proposed registration in
Singapore, or to imports from the
accordance with 21 CFR 1301.33(a) on Methylphenidate ....... 1724 II
beneficiary countries under the
or before February 6, 2018. Oxycodone ................ 9143 II
Caribbean Basin Economic Recovery
ADDRESSES: Written comments should Hydromorphone ........ 9150 II
Act.
be sent to: Drug Enforcement Hydrocodone ............ 9193 II
Availability of the public version of Administration, Attention: DEA Federal Oripavine .................. 9330 II
the report. The public version of the Register Representative/DRW, 8701 Thebaine ................... 9333 II
Commission’s report containing the Morrissette Drive, Springfield, Virginia Oxymorphone ........... 9652 II
Commission’s injury determination, its 22152. Tapentadol ................ 9780 II
remedy recommendations, an Fentanyl .................... 9801 II
SUPPLEMENTARY INFORMATION: The
explanation of the basis for its injury
Attorney General has delegated his
determination and remedy authority under the Controlled The company plans to manufacture
recommendations, and a summary of Substances Act to the Administrator of the above-listed controlled substances
the information obtained in the the Drug Enforcement Administration in bulk for distribution to its customers.
investigation is contained in Large (DEA), 28 CFR 0.100(b). Authority to Dated: November 17, 2017.
Residential Washers, Inv. No. TA–201– exercise all necessary functions with Demetra Ashley,
076, USITC Publication 4745, December respect to the promulgation and
2017. Acting Assistant Administrator.
implementation of 21 CFR part 1301,
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2017–26507 Filed 12–7–17; 8:45 am]
By order of the Commission. incident to the registration of
Issued: December 4, 2017. manufacturers, distributors, dispensers, BILLING CODE 4410–09–P
importers, and exporters of controlled
Katherine M. Hiner,
substances (other than final orders in
Supervisory Attorney. connection with suspension, denial, or
[FR Doc. 2017–26451 Filed 12–7–17; 8:45 am] revocation of registration) has been
BILLING CODE 7020–02–P redelegated to the Assistant
VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 PO 00000 Frm 00081 Fmt 4703 Sfmt 9990 E:\FR\FM\08DEN1.SGM 08DEN1](https://thefederalregister.org/doc/82_FR_58262/page/1.svg)
Document Created: 2017-12-08 01:43:36
Document Modified: 2017-12-08 01:43:36
| 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 February 6, 2018. | |
| FR Citation | 82 FR 58027 |
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