Importer of Controlled Substances Application: Mylan Technologies Inc., 64564 [2019-25405]

Download as PDF 64564 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices is notice that on October 4, 2019, S & B Pharma, Inc., DBA Norac Pharma, 405 South Motor Avenue, Azusa, California 91702–3232 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Gamma Hydroxybutyric Acid ................................................................................................................................... Telrahydrocannabinois ............................................................................................................................................. Amphetamine ........................................................................................................................................................... Methamphetamine ................................................................................................................................................... Lisdexamfetamine .................................................................................................................................................... Methylphenidate ....................................................................................................................................................... Pentobarbital ............................................................................................................................................................ 4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................. Tapentadol ............................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to manufacture the listed controlled substances in bulk for use in product development and for commercial sales to its customers. In reference to drug code 7360 (marihuana) and 7370 (tetrahydrocannabinois), the company plans to bulk manufacture both as synthetic substances. No other activity for these dug codes is authorized for this registration. Dated: November 5, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–25402 Filed 11–21–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–549] Importer of Controlled Substances Application: Mylan Technologies 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 on or before December 23, 2019. Such persons may also file a written request for a hearing on the application on or before December 23, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 DATES: In accordance with 21 CFR 1301.34(a), this is notice that on October 16, 2019, Mylan Technologies Inc., 110 Lake Street, Saint Albans, Vermont 054780 applied to be registered as an importer of the following basic classes of controlled substances: Drug code khammond on DSKJM1Z7X2PROD with NOTICES DEPARTMENT OF JUSTICE Dated: November 8, 2019. William T. McDermott, Assistant Administrator. DATES: [FR Doc. 2019–25405 Filed 11–21–19; 8:45 am] BILLING CODE 4410–09–P Jkt 250001 Drug Enforcement Administration [Docket No. DEA–540] Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals 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 on or before January 21, 2020. PO 00000 Frm 00112 Fmt 4703 1724 9801 In accordance with 21 CFR 1301.33(a), this is notice that on May 17, 2019, Chattem Chemicals, 3801 Saint Elmo Avenue, Chattanooga, Tennessee 37409 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Drug code Sfmt 4703 II II Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. Gamma Hydroxybutyric Acid ................................................................................................................................... Marihuana ................................................................................................................................................................ Tetrahydrocannabinols ............................................................................................................................................ 16:57 Nov 21, 2019 Schedule ADDRESSES: Controlled substance VerDate Sep<11>2014 I I II II II II II II II II SUPPLEMENTARY INFORMATION: Methylphenidate ....................................................................................................................................................... Fentanyl ................................................................................................................................................................... ACTION: 7360 7370 1100 1105 1205 1724 2270 8333 9780 9801 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: 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. Controlled substance The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to allow the company to export domestically manufactured FDF to foreign markets. Schedule E:\FR\FM\22NON1.SGM 22NON1 2010 7360 7370 Schedule I I I

Agencies

[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Page 64564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25405]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-549]


Importer of Controlled Substances Application: Mylan Technologies 
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 on or before December 23, 2019. 
Such persons may also file a written request for a hearing on the 
application on or before December 23, 2019.

ADDRESSES: 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: 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on October 16, 2019, Mylan Technologies Inc., 110 Lake 
Street, Saint Albans, Vermont 054780 applied to be registered as an 
importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Methylphenidate.........................            1724              II
Fentanyl................................            9801              II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to allow the company to export domestically manufactured FDF to foreign 
markets.

    Dated: November 8, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-25405 Filed 11-21-19; 8:45 am]
 BILLING CODE 4410-09-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.