Importer of Controlled Substances Application: Akorn, Inc., 54327 [2015-22625]

Download as PDF 54327 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 21 CFR 1301.43 on or before October 9, 2015. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). ADDRESS: 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 July 22, 2015, Chattem Chemicals, Inc., 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Schedule Lhorne on DSK5TPTVN1PROD with NOTICES Methamphetamine (1105) ............ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ II II II II II II The company plans to import the listed controlled substances to bulk manufacture other controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacturer tapentadol (9780) for distribution to its customers. The company plans to import Phenylacetone (8501) in bulk for the manufacture of a controlled substance. VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 Dated: September 1, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. Dated: September 1, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–22624 Filed 9–8–15; 8:45 am] [FR Doc. 2015–22625 Filed 9–8–15; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration [Docket No. DEA–392] [Docket No. DEA–392] Importer of Controlled Substances Application: Akorn, Inc. Manufacturer of Controlled Substances Registration: PCASNanosyn, LLC ACTION: Notice of application. ACTION: Registered bulk manufacturers of the affected basic class, 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 October 9, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 9, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 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 14, 2015, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substance listed in schedule II. The company plans to import remifentanil in dosage form for distribution. DATES: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Notice of registration. PCAS-Nanosyn, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants PCASNanosyn, LLC registration as a manufacturer of those controlled substances. SUMMARY: SUPPLEMENTARY INFORMATION: By notice dated May 15, 2015, and published in the Federal Register on May 21, 2015, 80 FR 29336, PCASNanosyn, LLC, 3331–B Industrial Drive, Santa Rosa, California 95403 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of PCAS-Nanosyn, LLC to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances: Controlled substance Oxycodone (9143) ........................ Oripavine (9330) ........................... Oxymorphone (9652) ................... Fentanyl (9801) ............................ Schedule II II II II The company is a contract manufacturer. At the request of the company’s customers, it manufacturers E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Page 54327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22625]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Akorn, Inc.

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic class, 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 October 9, 2015. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before October 9, 2015.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODXL, 
8701 Morrissette Drive, Springfield, Virginia 22152. Request for 
hearings should be sent to: Drug Enforcement Administration, Attention: 
Hearing Clerk/LJ, 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 
14, 2015, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 
applied to be registered as an importer of remifentanil (9739), a basic 
class of controlled substance listed in schedule II.
    The company plans to import remifentanil in dosage form for 
distribution.

    Dated: September 1, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-22625 Filed 9-8-15; 8:45 am]
 BILLING CODE 4410-09-P