Importer of Controlled Substances Application: Catalent Centers, LLC, 43569-43570 [2017-19833]

Download as PDF Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices Register pursuant to Section 6(b) of the Act on June 28, 2017 (82 FR 29328). DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals LLC BILLING CODE P DEPARTMENT OF JUSTICE [Docket No. DEA–392] [FR Doc. 2017–19791 Filed 9–15–17; 8:45 am] DEPARTMENT OF JUSTICE Drug Enforcement Administration Patricia A. Brink, Director of Civil Enforcement, Antitrust Division. Importer of Controlled Substances Application: Catalent Centers, LLC ACTION: Notice of application. sradovich on DSKBBY8HB2PROD with NOTICES Notice Pursuant to the National Cooperative Research and Production Act of 1993—fd.Io Project, Inc. Notice is hereby given that, on August 24, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 et seq. (‘‘the Act’’), fd.io Project, Inc. (‘‘fd.io’’) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act’s provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, ARM Ltd., Cambridge, UNITED KINGDOM; Linaro Limited, Cambridge, UNITED KINGDOM; Rubicon Communications LLC dba Netgate, Austin, TX; and CENGN (Centre of Excellence in Next Generation Networks), Ottawa, CANADA, have been added as parties to this venture. Also, Brocade Communications Systems, Inc., San Jose, CA, has withdrawn as a party to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and fd.io intends to file additional written notifications disclosing all changes in membership. On May 4, 2016, fd.io filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the Federal Register pursuant to Section 6(b) of the Act on June 9, 2016 (81 FR 37211). The last notification was filed with the Department on May 30, 2017. A notice was published in the Federal Register pursuant to Section 6(b) of the Act on June 28, 2017 (82 FR 29329). 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 1301.33(a) on or before November 17, 2017. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on August 16, 2017, AMPAC Fine Chemicals LLC, Highway 50 and Hazel Avenue, Building 05001, Rancho Cordova, California 95670 applied to be registered as a bulk manufacturer of levomethorphan (9210), a basic class of controlled substance in schedule II. The company plans to manufacture the listed controlled substance as an intermediate in the bulk manufacture of other controlled substances for distribution to its customers. SUPPLEMENTARY INFORMATION: Patricia A. Brink, Director of Civil Enforcement, Antitrust Division. Dated: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19789 Filed 9–15–17; 8:45 am] [FR Doc. 2017–19831 Filed 9–15–17; 8:45 am] BILLING CODE 4410–11–P BILLING CODE 4410–09–P 18:59 Sep 15, 2017 Jkt 241001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 October 18, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 18, 2017. DATES: Antitrust Division VerDate Sep<11>2014 43569 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: The Attorney General has delegated his 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 Assistant Administrator of the DEA Diversion Control Division (‘‘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 25, 2017, Catalent Centers, LLC, 10245 Hickman Mills Drive, Kansas City, Missouri 64137 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: E:\FR\FM\18SEN1.SGM 18SEN1 43570 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices Controlled substance Gamma Hydroxybutyric Acid ... Marihuana Extract .................... Marihuana ................................ Drug code 2010 7350 7360 Schedule Drug Enforcement Administration I I I [Docket No. DEA–392] The company plans to import finished dosage unit products containing gammahydroxybutryic acid and cannabis extracts for clinical trial studies. These cannabis extracts compounds are listed under drug code 7350. No other activity for these drug codes is authorized for this registration. 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. Dated: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19833 Filed 9–15–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Specgx LLC 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 1301.33(a) on or before November 17, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of DATES: 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 Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on August 9, 2017, Specgx LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: sradovich on DSKBBY8HB2PROD with NOTICES Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Tetrahydrocannabinols .................................................................................................................................................... Codeine-N-oxide .............................................................................................................................................................. Dihydromorphine ............................................................................................................................................................. Difenoxin .......................................................................................................................................................................... Morphine-N-oxide ............................................................................................................................................................ Normorphine .................................................................................................................................................................... Norlevorphanol ................................................................................................................................................................ Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ............................................................................... Butyryl Fentanyl ............................................................................................................................................................... Amphetamine ................................................................................................................................................................... Methamphetamine ........................................................................................................................................................... Lisdexamfetamine ............................................................................................................................................................ Methylphenidate .............................................................................................................................................................. Nabilone ........................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Diphenoxylate .................................................................................................................................................................. Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Levorphanol ..................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Methadone ....................................................................................................................................................................... Methadone intermediate .................................................................................................................................................. Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. Morphine .......................................................................................................................................................................... Oripavine ......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Opium tincture ................................................................................................................................................................. Opium, powdered ............................................................................................................................................................ Oxymorphone .................................................................................................................................................................. Noroxymorphone ............................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Remifentanil ..................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... Tapentadol ....................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... VerDate Sep<11>2014 16:54 Sep 15, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\18SEN1.SGM 18SEN1 2010 7370 9053 9145 9168 9307 9313 9634 9821 9822 1100 1105 1205 1724 7379 8333 9050 9120 9143 9150 9170 9180 9193 9220 9230 9250 9254 9273 9300 9330 9333 9630 9639 9652 9668 9737 9739 9740 9780 9801 Schedule I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II

Agencies

[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43569-43570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19833]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent Centers, 
LLC

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 in accordance with 21 CFR 
1301.34(a) on or before October 18, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before October 18, 2017.

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

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 
25, 2017, Catalent Centers, LLC, 10245 Hickman Mills Drive, Kansas 
City, Missouri 64137 applied to be registered as an importer of the 
following basic classes of controlled substances:

[[Page 43570]]



------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...............    2010  I
Marihuana Extract.......................    7350  I
Marihuana...............................    7360  I
------------------------------------------------------------------------

    The company plans to import finished dosage unit products 
containing gamma-hydroxybutryic acid and cannabis extracts for clinical 
trial studies.
    These cannabis extracts compounds are listed under drug code 7350. 
No other activity for these drug codes is authorized for this 
registration. 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.

    Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-19833 Filed 9-15-17; 8:45 am]
 BILLING CODE 4410-09-P