Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc., 58027 [2017-26507]

Download as PDF 58027 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices throughout and that the above-quota tariff rate decrease by five percentage points during each year of the remedy period. Chairman Schmidtlein and Commissioner Williamson additionally recommend an in-quota tariff rate of 20 percent ad valorem, which would decrease to 18 percent in the second year of the remedy period and 15 percent in the third year of the period, in addition to the current rate of duty. Vice Chairman Johanson and Commissioner Broadbent do not recommend an additional in-quota tariff rate for large residential washers. The Commissioners also unanimously recommend that the President impose a separate TRQ on imports of covered parts of large residential washers for a duration of three years. For U.S. imports of covered parts that exceed 50,000 units, they recommend a tariff rate of 50 percent ad valorem, in addition to the current rate of duty. They recommend that the in-quota volume increase by 20,000 units in each year of the remedy period, and that the above-quota tariff rate decrease by five percentage points each year. They do not recommend an 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 .............................................................. Above-Quota Tariff Rate ............................................................ In-Quota Tariff Rate (Schmidtlein & Williamson) ....................... In-Quota Tariff Rate (Johanson & Broadbent) ........................... 1.2 million units .............. 50% ................................ 20% ................................ 0% .................................. 1.2 million units .............. 45% ................................ 18% ................................ 0% .................................. 1.2 million units. 40%. 15%. 0%. 70,000 units ................... 45% ................................ 0% .................................. 90,000 units. 40%. 0%. Covered Parts: TRQ sradovich on DSK3GMQ082PROD with NOTICES In-Quota Volume Level .............................................................. Above-Quota Tariff Rate ............................................................ In-Quota Tariff Rate ................................................................... Having made negative findings with respect to imports from Canada and Mexico under section 311(a) of the North American Free Trade Agreement Implementation Act, the Commissioners recommend that imports from Canada and Mexico be excluded from the above TRQs and increased rates of duty. The Commissioners also recommend that the above TRQs and increased rates of duty not apply to imports from Australia, Colombia, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Israel, Jordan, Korea, Nicaragua, Panama, Peru, and Singapore, or to imports from the beneficiary countries under the Caribbean Basin Economic Recovery Act. Availability of the public version of the report. The public version of the Commission’s report containing the Commission’s injury determination, its remedy recommendations, an explanation of the basis for its injury determination and remedy recommendations, and a summary of the information obtained in the investigation is contained in Large Residential Washers, Inv. No. TA–201– 076, USITC Publication 4745, December 2017. By order of the Commission. Issued: December 4, 2017. Katherine M. Hiner, Supervisory Attorney. [FR Doc. 2017–26451 Filed 12–7–17; 8:45 am] BILLING CODE 7020–02–P VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 50,000 units ................... 50% ................................ 0% .................................. DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc. ACTION: Notice of application. 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. DATES: 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00081 Fmt 4703 Sfmt 9990 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 Methylphenidate ....... Oxycodone ................ Hydromorphone ........ Hydrocodone ............ Oripavine .................. Thebaine ................... Oxymorphone ........... Tapentadol ................ Fentanyl .................... Drug code 1724 9143 9150 9193 9330 9333 9652 9780 9801 Schedule II II II II II II II II 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 E:\FR\FM\08DEN1.SGM 08DEN1

Agencies

[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Page 58027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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