Bulk Manufacturer of Controlled Substances Registration, 95641 [2016-31280]

Download as PDF 95641 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices Lower Ferry Road, Ewing, New Jersey 08618–1414 applied to be registered as a bulk manufacturer of the following basic classes controlled substances: Controlled substance Drug code Pentobarbital .................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Remifentanil ..................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... The company plans to initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually up FDA approval to produce commercial size batches for distribution to dosage form manufacturers. Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. Drug Enforcement Administration [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: Bulk Manufacturer of Controlled Substances Registration Notice of registration. Registrants listed below have applied for and been granted registration by the Drug Enforcement Company FR docket National Center for Natural Products Research (NIDA MPROJECT) .............. Cambrex Charles City ....................................................................................... Chemtos, LLC .................................................................................................... Stepan Company ............................................................................................... Chattem Chemicals ........................................................................................... The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable 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 each of the 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. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed persons. Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. 80 81 81 81 81 FR FR FR FR FR 78766 46956 54604 54849 57932 Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Synthcon, 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 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. DATES: BILLING CODE 4410–09–P The Attorney General has delegated her authority under the Controlled Published ............................................ ............................................ ............................................ ............................................ ............................................ DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: [FR Doc. 2016–31280 Filed 12–27–16; 8:45 am] sradovich on DSK3GMQ082PROD with NOTICES The companies listed below applied to be registered as manufacturers of various basic classes of controlled substances. Information on previously published notices is listed in the table below. No comments or objections were submitted for these notices. SUMMARY: BILLING CODE 4410–09–P Drug code 3-Fluoro-N-methylcathinone (3–FMC) ............................................................................................................................. Cathinone ........................................................................................................................................................................ Methcathinone ................................................................................................................................................................. 4-Fluoro-N-methylcathinone (4–FMC) ............................................................................................................................. Pentedrone (a-methylaminovalerophenone) ................................................................................................................... 18:54 Dec 27, 2016 Jkt 241001 PO 00000 Frm 00087 Fmt 4703 December 17, 2015. July 19, 2016. August 16, 2016. August 17, 2016. August 24, 2016. 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 December 16, 2015, Synthcon, LLC, 770 Wooten Road, Unit 101, Colorado Springs, Colorado 80915 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance VerDate Sep<11>2014 II II II II Administration (DEA) as bulk manufacturers of various classes of controlled substances. DEPARTMENT OF JUSTICE ACTION: [FR Doc. 2016–31282 Filed 12–27–16; 8:45 am] 2270 8333 9739 9801 Schedule Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1 1233 1235 1237 1238 1246 Schedule I I I I I

Agencies

[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Page 95641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31280]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Registration

ACTION: Notice of registration.

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SUMMARY: Registrants listed below have applied for and been granted 
registration by the Drug Enforcement Administration (DEA) as bulk 
manufacturers of various classes of controlled substances.

SUPPLEMENTARY INFORMATION: The companies listed below applied to be 
registered as manufacturers of various basic classes of controlled 
substances. Information on previously published notices is listed in 
the table below. No comments or objections were submitted for these 
notices.

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                 Company                             FR docket                          Published
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National Center for Natural Products       80 FR 78766.................  December 17, 2015.
 Research (NIDA MPROJECT).
Cambrex Charles City.....................  81 FR 46956.................  July 19, 2016.
Chemtos, LLC.............................  81 FR 54604.................  August 16, 2016.
Stepan Company...........................  81 FR 54849.................  August 17, 2016.
Chattem Chemicals........................  81 FR 57932.................  August 24, 2016.
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    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of these registrants to manufacture 
the applicable 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 each of the 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. 823(a), and in accordance with 21 
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer 
to the above listed persons.

    Dated: December 19, 2016.
Louis J. Milione,
Assistant Administrator.
[FR Doc. 2016-31280 Filed 12-27-16; 8:45 am]
 BILLING CODE 4410-09-P