Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC, 52510 [2015-21520]

Download as PDF 52510 Federal Register / Vol. 80, No. 168 / Monday, August 31, 2015 / Notices [Docket No. DEA–392] 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 27, 2015, Catalent Pharma Solutions, LLC, 10381 Decatur Road, Philadelphia, Pennsylvania 19114 applied to be registered as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for a clinical trial study. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under to 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. Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. 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 April 24, 2015, Alltech Associates, Inc., 2051 Waukegan Road, Deerfield, Illinois 60015 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Schedule Gamma Hydroxybutyric Acid (2010). Lysergic acid diethylamide (7315) Heroin (9200) ............................... Meperidine (9230) ........................ I I I II The company plans to import these controlled substances for the manufacture of reference standards. Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–21470 Filed 8–28–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ACTION: Controlled substance [FR Doc. 2015–21520 Filed 8–28–15; 8:45 am] Notice of application. BILLING CODE 4410–09–P 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 September 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 2015. DATES: 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 tkelley on DSK3SPTVN1PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 16:19 Aug 28, 2015 Jkt 235001 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). 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 July 16, 2014, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601, applied to be registered as an importer of the following basic classes of controlled substances: Phenylacetone (8501) .................. Thebaine (9333) ........................... Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ Schedule II II II II DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Noramco, 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 30, 2015. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 30, 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 DATES: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 The company plans to import thebaine (9333) analytical reference standards 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. The company plans to import phenylacetone (8501) and poppy straw concentrate (9670) to manufacture other controlled substances. Dated: August 21, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–21545 Filed 8–28–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Cambrex Charles City ACTION: E:\FR\FM\31AUN1.SGM Notice of application. 31AUN1

Agencies

[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Page 52510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21520]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, LLC

ACTION: Notice of application.

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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 September 30, 2015. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 30, 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 July 
27, 2015, Catalent Pharma Solutions, LLC, 10381 Decatur Road, 
Philadelphia, Pennsylvania 19114 applied to be registered as an 
importer of hydromorphone (9150), a basic class of controlled substance 
listed in schedule II.
    The company plans to import the above listed controlled substance 
for a clinical trial study. Approval of permit applications will occur 
only when the registrant's business activity is consistent with what is 
authorized under to 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.

    Dated: August 21, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-21520 Filed 8-28-15; 8:45 am]
BILLING CODE 4410-09-P

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