Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc., 95647-95648 [2016-31283]

Download as PDF 95647 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices Controlled substance Drug code Meperidine ............................................................................................................................................................... Meperidine intermediate-B ....................................................................................................................................... Methadone ............................................................................................................................................................... Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................... Morphine .................................................................................................................................................................. Thebaine .................................................................................................................................................................. Oxymorphone .......................................................................................................................................................... Alfentanil .................................................................................................................................................................. Remifentanil ............................................................................................................................................................. Sufentanil ................................................................................................................................................................. Carfentanil ................................................................................................................................................................ Tapentadol ............................................................................................................................................................... Fentanyl ................................................................................................................................................................... The company plans to manufacture bulk controlled substances for use in product development of analytical reference standards, for distribution to its customers. Drug Enforcement Administration [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: ACTION: [FR Doc. 2016–31285 Filed 12–27–16; 8:45 am] Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement SUMMARY: BILLING CODE 4410–09–P Company sradovich on DSK3GMQ082PROD with NOTICES Rhodes Technologies ........................................................... Bellwyck Clinical Services .................................................... Cerilliant Corporation ............................................................ Noramco, Inc ........................................................................ Cody Laboratories, Inc ......................................................... AMRI Rensselaer, Inc .......................................................... ALMAC Clinical Services Incorp (ACSI) .............................. Fresenius Kabi USA, LLC .................................................... Akorn, Inc ............................................................................. Actavis Laboratories FL, Inc ................................................ Unither Manufacturing LLC .................................................. Cambrex Charles City .......................................................... United States Pharmacopeial Convention ........................... R & D Systems, Inc .............................................................. Catalent CTS, LLC ............................................................... VerDate Sep<11>2014 18:54 Dec 27, 2016 Jkt 241001 The companies listed below applied to be registered as importers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted and no requests for hearing were submitted for these notices. FR docket The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of the listed registrants to import the applicable basic classes of schedule I or II 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 each company’s maintenance of effective controls against diversion by inspecting and testing each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing each company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the DEA has II. II. II. II. II. II. II. II. II. II. II. II. II. Administration (DEA) as importers of various classes of schedule I or II controlled substances. DEPARTMENT OF JUSTICE Importer of Controlled Substances Registration Dated: December 20, 2016. Louis J. Milione, Assistant Administrator. 9230 9233 9250 9273 9300 9333 9652 9737 9739 9740 9743 9780 9801 Schedule 81 81 81 81 81 81 81 81 81 81 81 81 81 81 81 FR FR FR FR FR FR FR FR FR FR FR FR FR FR FR 46956 54603 57933 57932 54602 54603 54602 54601 57935 54602 61250 63222 63220 64509 66081 Published ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ ........................................................................ granted a registration as an importer for schedule I or II controlled substances to the above listed persons. Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016–31273 Filed 12–27–16; 8:45 am] July 19, 2016. August 16, 2016. August 24, 2016. August 24, 2016. August 16, 2016. August 16, 2016. August 16, 2016. August 16, 2016. August 24, 2016. August 16, 2016. September 6, 2016. September 14, 2016. September 14, 2016. September 20, 2016. September 26, 2016. 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 February 27, 2017. DATES: Drug Enforcement Administration Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: ADDRESSES: BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc. ACTION: PO 00000 Notice of application. Frm 00093 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28DEN1.SGM 28DEN1 95648 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices 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 September 5, 2016, Johnson Matthey Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Amphetamine ................................................................................................................................................................... Methylphenidate .............................................................................................................................................................. Codeine ........................................................................................................................................................................... Oxycodone ....................................................................................................................................................................... Diphenoxylate .................................................................................................................................................................. Hydrocodone ................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Methadone ....................................................................................................................................................................... Methadone intermediate .................................................................................................................................................. Morphine .......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Opium tincture ................................................................................................................................................................. The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. Thebaine (9333) will be used to manufacture other controlled substances for sale in bulk to its customers. Dated: December 20, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016–31283 Filed 12–27–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for State or Federal Workers’ Compensation Information ACTION: Notice. The Department of Labor (DOL) is submitting the Office of Workers’ Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, ‘‘Request for State or Federal Workers’ Compensation Information,’’ to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). DATES: Submit comments on or before January 27, 2017. ADDRESSES: A copy of this ICR with applicable supporting documentation; including a description of the likely sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:54 Dec 27, 2016 Jkt 241001 respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http:// www.reginfo.gov/public/do/ PRAViewICR?ref_nbr=201607-1240-002 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or sending an email to DOL_PRA_PUBLIC@dol.gov. Submit comments about this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL–OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503, Fax: 202–395–6881 (this is not a toll-free number), email: OIRA_ submission@omb.eop.gov. Commenters are encouraged, but not required, to send a courtesy copy of any comments to the U.S. Department of LaborOASAM, Office of the Chief Information Officer, Attn: Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210, email: DOL_PRA_PUBLIC@dol.gov. FOR FURTHER INFORMATION CONTACT: Contact Michel Smyth by telephone at 202–693–4129 (this is not a toll-free number) or by email at DOL_PRA_ PUBLIC@dol.gov. Authority: 44 U.S.C. 3507(a)(1)(D). This ICR seeks approval under the PRA for revisions to the Request for State or Federal Workers’ Compensation Information (Form CM–905) information collection. Form CM–905 collects information to process a claim under the Black Lung Benefits Act (30 U.S.C. 901 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 2010 1100 1724 9050 9143 9170 9193 9230 9250 9254 9300 9333 9630 Schedule I II II II II II II II II II II II II et seq.). The information collected helps determine compensation benefits awarded for pneumoconiosis. The information collection has been classified as a revision, because the OWCP proposes to make a series of cosmetic and minor changes to Form CM–905. The changes provide clearer language, so that Federal/State workers’ compensation officials clearly understand which portion of the form they should complete and what information to provide. Other changes update the form to reflect current organizational structure within the DOL. For additional substantive information about this ICR, see the related notice published in the Federal Register on July 27, 2016 (81 FR 49270). This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1240–0032. The current approval for this collection is scheduled to expire on December 31, 2016; however, the DOL notes that existing information collection requirements submitted to the OMB receive a monthto-month extension while they undergo E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95647-95648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31283]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Johnson 
Matthey Inc.

ACTION: Notice of application.

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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 
1301.33(a) on or before February 27, 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 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

[[Page 95648]]

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 
September 5, 2016, Johnson Matthey Inc., Pharmaceuticals Materials, 900 
River Road, Conshohocken, Pennsylvania 19428, applied to be registered 
as a bulk manufacturer of the following basic classes of controlled 
substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..........            2010  I
Amphetamine........................            1100  II
Methylphenidate....................            1724  II
Codeine............................            9050  II
Oxycodone..........................            9143  II
Diphenoxylate......................            9170  II
Hydrocodone........................            9193  II
Meperidine.........................            9230  II
Methadone..........................            9250  II
Methadone intermediate.............            9254  II
Morphine...........................            9300  II
Thebaine...........................            9333  II
Opium tincture.....................            9630  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution and sale to its customers. Thebaine (9333) 
will be used to manufacture other controlled substances for sale in 
bulk to its customers.

    Dated: December 20, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31283 Filed 12-27-16; 8:45 am]
 BILLING CODE 4410-09-P