Importer of Controlled Substances Application: Cody Laboratories, Inc., 54602 [2016-19435]

Download as PDF 54602 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices In accordance with 21 CFR 1301.34(a), this is notice that on June 29, 2016, ALMAC Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of the following basic classes of controlled substances: development and preparation of stability batches. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19434 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: ALMAC Clinical Services Incorp (ACSI) 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 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. asabaliauskas on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 Schedule Oxycodone (9143) ................ Hydromorphone (9150) ........ Morphine (9300) ................... Tapentadol (9780) ................ Fentanyl (9801) .................... II II II II II The company plans to import the listed controlled substances in dosage form for clinical trial only. 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 non-approved finished dosage forms for commercial sale. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19439 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Cody Laboratories, 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 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 Attn: DEA Federal Register Representative/ODW, 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on May 18, 2016, Cody Laboratories, Inc., 601 Yellowstone Avenue, Barry Baldwin, Controlled Substances Manager, Cody, Wyoming 82414–9321 applied to be registered as an importer of the following basic classes of controlled substances: Schedule Phenylacetone (8501) .......... Poppy Straw Concentrate (9670) ................................ Tapentadol (9780) ................ II II II The company plans to import narcotic raw materials to manufacture bulk controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacture tapentadol for distribution to its customers. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19435 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Actavis Laboratories FL., 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 DATES: E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Page 54602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19435]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Cody Laboratories, 
Inc.

ACTION: Notice of application.

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SUMMARY: 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 
1301.34(a) on or before September 15, 2016. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 15, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/ODW, 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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on May 
18, 2016, Cody Laboratories, Inc., 601 Yellowstone Avenue, Barry 
Baldwin, Controlled Substances Manager, Cody, Wyoming 82414-9321 
applied to be registered as an importer of the following basic classes 
of controlled substances:

------------------------------------------------------------------------
                  Controlled substance                       Schedule
------------------------------------------------------------------------
Phenylacetone (8501)....................................              II
Poppy Straw Concentrate (9670)..........................              II
Tapentadol (9780).......................................              II
------------------------------------------------------------------------

    The company plans to import narcotic raw materials to manufacture 
bulk controlled substances for distribution to its customers. The 
company plans to import an intermediate form of tapentadol (9780), to 
bulk manufacture tapentadol for distribution to its customers.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-19435 Filed 8-15-16; 8:45 am]
 BILLING CODE 4410-09-P