Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc., 71474 [2019-27952]

Download as PDF 71474 Federal Register / Vol. 84, No. 248 / Friday, December 27, 2019 / Notices The company plans to import the listed controlled substances to manufacture bulk active pharmaceutical ingredients (API) for distribution to its customers. Dated: December 10, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–27953 Filed 12–26–19; 8:45 am] Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: ADDRESSES: BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–552] Importer of Controlled Substances Application: Myoderm ACTION: 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 27, 2020. Such persons may also file a written request for a hearing on the application on or before January 27, 2020. DATES: Notice of application. 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. In accordance with 21 CFR 1301.34(a), this is notice that on October 14, 2019, Myoderm, 48 East Main Street, Norristown, Pennsylvania 19401–4915 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Amphetamine ........................................................................................................................................................... Lisdexamfetamine .................................................................................................................................................... Methylphenidate ....................................................................................................................................................... Nabilone ................................................................................................................................................................... Oxycodone ............................................................................................................................................................... Hydromorphone ....................................................................................................................................................... Hydrocodone ............................................................................................................................................................ Morphine .................................................................................................................................................................. Oxymorphone .......................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to import the listed controlled substances for clinical trials, research, and analytical purposes. 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 nonapproved finished dosage forms for commercial sale. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. [FR Doc. 2019–27952 Filed 12–26–19; 8:45 am] ADDRESSES: Drug Enforcement Administration Controlled substance BILLING CODE 4410–09–P [Docket No. DEA–566] jbell on DSKJLSW7X2PROD with NOTICES Dated: December 10, 2019. William T. McDermott, Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2019–27954 Filed 12–26–19; 8:45 am] ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written DATES: VerDate Sep<11>2014 18:44 Dec 26, 2019 Jkt 250001 SUPPLEMENTARY INFORMATION: Methylphenidate ....... Hydromorphone ........ Hydrocodone ............ Oripavine .................. Thebaine ................... Tapentadol ................ Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals Inc. 1100 1205 1724 7379 9143 9150 9193 9300 9652 9801 comments on or objections to the issuance of the proposed registration on or before February 25, 2020. In accordance with 21 CFR 1301.33(a), this is notice that on October 9, 2019, Janssen Pharmaceuticals 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: Dated: November 13, 2019. William T. McDermott, Acting Assistant Administrator. Schedule Drug code 1724 9150 9193 9330 9333 9780 Frm 00127 Fmt 4703 Sfmt 4703 BILLING CODE 4410–09–P DEPARTMENT OF LABOR Employment and Training Administration Notice To Ensure State Workforce Agencies Are Aware of the Revised Schedule of Remuneration for the Unemployment Compensation for ExService Members (UCX) Program That Reflects the Military Pay Increase Effective January 1, 2020 Employment and Training Administration, Labor. ACTION: Notice. AGENCY: Schedule II II II II II II The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. PO 00000 II II II II II II II II II II Each year, the Department of Defense issues a Schedule of Remuneration used by states for UCX purposes. States must use the schedule to determine Federal military wages for UCX ‘‘first claims’’ only when the Federal Claims Control Center (FCCC) responds to a request for information indicating that there is no Copy 5 of the SUMMARY: E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Page 71474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27952]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-566]


Bulk Manufacturer of Controlled Substances Application: Janssen 
Pharmaceuticals 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 February 25, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on October 9, 2019, Janssen Pharmaceuticals 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
Hydromorphone.........................       9150  II
Hydrocodone...........................       9193  II
Oripavine.............................       9330  II
Thebaine..............................       9333  II
Tapentadol............................       9780  II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers.

    Dated: December 10, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-27952 Filed 12-26-19; 8:45 am]
BILLING CODE 4410-09-P
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