Bulk Manufacturer of Controlled Substances Application: Organix, Inc., 539 [2017-28180]

Download as PDF 539 Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices SOUTH DAKOTA manufacturer of the following basic classes of controlled substances: Miner County Wheeler Hotel, 101 N. Main St., MINNESOTA Ramsey County Church of St. Casimir—Catholic, 937 E. Jessamine Ave., St. Paul, AD83000939 Authority: 60.13 of 36 CFR part 60 Dated: December 13, 2017. J. Paul Loether, Chief, National Register of Historic Places/ National Historic Landmarks Program and Keeper, National Register of Historic Places. [FR Doc. 2017–28467 Filed 1–3–18; 8:45 am] BILLING CODE 4312–52–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Organix, 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 on or before March 5, 2018. 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 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 September 6, 2017, Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801 applied to be registered as a bulk ethrower on DSK3G9T082PROD with NOTICES DATES: VerDate Sep<11>2014 16:16 Jan 03, 2018 Jkt 244001 Drug code Controlled substance Additional documentation has been received for the following resource: Gamma Hydroxybutyric Acid. Lysergic acid diethylamide. Marihuana ....................... Tetrahydrocannabinols ... Dimethyltryptamine ......... Psilocybin ....................... Psilocyn .......................... Heroin ............................. Morphine ......................... Schedule 2010 I 7315 I 7360 7370 7435 7437 7438 9200 9300 I I I I I I II The company plans to manufacture reference standards for distribution to its research and forensic customers. In reference to drug code 7360 (marihuana) and 7370 (THC) the company plans to manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration. Dated: December 20, 2017. Demetra Ashley, Acting Assistant Administrator. DC:llll llllllllllll DCX:llll llllllllllll Return to ODW—Mike Lewis DCX:llll llllllllllll DR:llll llllllllllll DRX:llll llllllllllll DRW:llll lllllllllll DRW Policy Analyst:llll llll DRG:llll llllllllllll DRG/A:llll llllllllll DRGR Unit Chief:llll llllll DRQ:llll lllllllllll DRGR Staff Coordinatorllll lll DRGR–L.Mckoyllll10/25/2017 NOA—ORGANIX INC Document#: DRGR–17–0306 DFN: 010.02.A1 General Correspondence DFN: 301–04 Federal Register Files [FR Doc. 2017–28180 Filed 1–3–18; 8:45 am] BILLING CODE 4410–09–P Controlled substance DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sharp (Bethlehem), 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 DATES: PO 00000 Frm 00041 Fmt 4703 issuance of the proposed registration on or before February 5, 2018. Such persons may also file a written request for a hearing on the application pursuant on or before February 5, 2018. 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 June 15, 2017, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020 applied to be registered as an importer of the following basic classes of controlled substances: Sfmt 4703 3,4-Methylenedioxy methamphetamine. Psilocybin ....................... Drug code Schedule 7405 I 7437 I The company plans to import the listed controlled substances for clinical trials. No other activity for these drug codes is authorized for this registration. Approval of permits 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- E:\FR\FM\04JAN1.SGM 04JAN1

Agencies

[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)]
[Notices]
[Page 539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28180]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Organix, 
Inc.

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 on or before March 5, 2018.

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 
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 
September 6, 2017, Organix, Inc., 240 Salem Street, Woburn, 
Massachusetts 01801 applied to be registered as a bulk manufacturer of 
the following basic classes of controlled substances:

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............    2010  I
Lysergic acid diethylamide.............    7315  I
Marihuana..............................    7360  I
Tetrahydrocannabinols..................    7370  I
Dimethyltryptamine.....................    7435  I
Psilocybin.............................    7437  I
Psilocyn...............................    7438  I
Heroin.................................    9200  I
Morphine...............................    9300  II
------------------------------------------------------------------------

    The company plans to manufacture reference standards for 
distribution to its research and forensic customers. In reference to 
drug code 7360 (marihuana) and 7370 (THC) the company plans to 
manufacture these drugs as synthetic. No other activities for these 
drug codes are authorized for this registration.

    Dated: December 20, 2017.
Demetra Ashley,
Acting Assistant Administrator.

DC:____----------------------------------------------------------------

DCX:____---------------------------------------------------------------

Return to ODW--Mike Lewis

DCX:____---------------------------------------------------------------

DR:____----------------------------------------------------------------

DRX:____---------------------------------------------------------------

DRW:____---------------------------------------------------------------

DRW Policy Analyst:____------------------------------------------------

DRG:____---------------------------------------------------------------

DRG/A:____-------------------------------------------------------------

DRGR Unit Chief:____---------------------------------------------------

DRQ:____---------------------------------------------------------------

DRGR Staff Coordinator____---------------------------------------------

DRGR-L.Mckoy____10/25/2017

NOA--ORGANIX INC
Document#: DRGR-17-0306

DFN: 010.02.A1 General Correspondence

DFN: 301-04 Federal Register Files

[FR Doc. 2017-28180 Filed 1-3-18; 8:45 am]
 BILLING CODE 4410-09-P
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