80 FR 57389 - Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 184 (September 23, 2015)

Page Range		57389-57389
FR Document		2015-24123

Federal Register, Volume 80 Issue 184 (Wednesday, September 23, 2015)

[Federal Register Volume 80, Number 184 (Wednesday, September 23, 2015)]
[Notices]
[Page 57389]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24123]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Chemtos, 
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 
1301.33(a) on or before November 23, 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 1301.33(a), this is notice that on May 
28, 2015, Chemtos, LLC, 14101 W. Highway 290, Building 2000B, Austin, 
Texas 78737-9331 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Amphetamine (1100).........................  II
Methamphetamine (1105).....................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Nabilone (7379)............................  II
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Etorphine HCI (9059).......................  II
Dihydrocodeine (9120)......................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Ecgonine (9180)............................  II
Ethylmorphine (9190).......................  II
Hydrocodone (9193).........................  II
Levomethorphan (9210)......................  II
Levorphanol (9220).........................  II
Isomethadone (9226)........................  II
Meperidine (9230)..........................  II
Meperidine intermediate-A (9232)...........  II
Meperidine intermediate-B (9233)...........  II
Meperidine intermediate-C (9234)...........  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Morphine (9300)............................  II
Thebaine (9333)............................  II
Dihydroetorphine (9334)....................  II
Levo-alphacetylmethadol (9648).............  II
Oxymorphone (9652).........................  II
Racemethorphan (9732)......................  II
Racemorphan (9733).........................  II
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances in bulk for distribution to its customers for use 
as reference standards.

    Dated: September 16, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-24123 Filed 9-22-15; 8:45 am]
 BILLING CODE 4410-09-P

Federal Register / Vol. 80, No. 184 / Wednesday, September 23, 2015 / Notices 57389

The company plans to import the In accordance with 21 CFR also file a written request for a hearing
listed substances for analytical research, 1301.33(a), this is notice that on May 28, on the application pursuant to 21 CFR
testing, and clinical trials. This 2015, Chemtos, LLC, 14101 W. Highway 1301.43 on or before October 23, 2015.
authorization does not extend to the 290, Building 2000B, Austin, Texas ADDRESSES: Written comments should
import of a finished FDA approved or 78737–9331 applied to be registered as be sent to: Drug Enforcement
non-approved dosage form for a bulk manufacturer of the following Administration, Attention: DEA Federal
commercial distribution in the United basic classes of controlled substances: Register Representative/ODXL, 8701
States. Morrissette Drive, Springfield, Virginia
The company plans to import an Controlled substance Schedule 22152. Request for hearings should be
intermediate form of tapentadol (9780) sent to: Drug Enforcement
to bulk manufacture tapentadol for Marihuana (7360) ......................... I
Amphetamine (1100) .................... II Administration, Attention: Hearing
distribution to its customers. Methamphetamine (1105) ............ II Clerk/LJ, 8701 Morrissette Drive,
Dated: September 16, 2015. Lisdexamfetamine (1205) ............. II Springfield, Virginia 22152.
Joseph T. Rannazzisi, Methylphenidate (1724) ................ II SUPPLEMENTARY INFORMATION: The
Nabilone (7379) ............................ II Attorney General has delegated her
Deputy Assistant Administrator.
Phenylacetone (8501) .................. II
[FR Doc. 2015–24121 Filed 9–22–15; 8:45 am] Cocaine (9041) ............................. II
authority under the Controlled
BILLING CODE 4410–09–P Codeine (9050) ............................. II Substances Act to the Administrator of
Etorphine HCI (9059) ................... II the Drug Enforcement Administration
Dihydrocodeine (9120) ................. II (DEA), 28 CFR 0.100(b). Authority to
DEPARTMENT OF JUSTICE Oxycodone (9143) ........................ II exercise all necessary functions with
Hydromorphone (9150) ................ II respect to the promulgation and
Drug Enforcement Administration Ecgonine (9180) ........................... II implementation of 21 CFR part 1301,
Ethylmorphine (9190) ................... II incident to the registration of
[Docket No. DEA–392] Hydrocodone (9193) ..................... II
Levomethorphan (9210) ............... II
manufacturers, distributors, dispensers,
Levorphanol (9220) ...................... II importers, and exporters of controlled
Bulk Manufacturer of Controlled substances (other than final orders in
Isomethadone (9226) ................... II
Substances Application: Chemtos, Meperidine (9230) ........................ II connection with suspension, denial, or
LLC Meperidine intermediate-A (9232) II revocation of registration) has been
Meperidine intermediate-B (9233) II redelegated to the Deputy Assistant
ACTION: Notice of application. Meperidine intermediate-C (9234) II Administrator of the DEA Office of
Methadone (9250) ........................ II Diversion Control (‘‘Deputy Assistant
DATES: Registered bulk manufacturers of Methadone intermediate (9254) ... II
the affected basic classes, and Administrator’’) pursuant to section 7 of
Morphine (9300) ........................... II
applicants therefore, may file written Thebaine (9333) ........................... II 28 CFR part 0, appendix to subpart R.
comments on or objections to the Dihydroetorphine (9334) ............... II In accordance with 21 CFR
issuance of the proposed registration in Levo-alphacetylmethadol (9648) .. II 1301.34(a), this is notice that on June
accordance with 21 CFR 1301.33(a) on Oxymorphone (9652) ................... II 16, 2015, Fresenius Kabi USA, LLC,
Racemethorphan (9732) .............. II 3159 Staley Road, Grand Island, New
or before November 23, 2015. Racemorphan (9733) ................... II York 14072 applied to be registered as
ADDRESSES: Written comments should
an importer of remifentanil (9739), a
be sent to: Drug Enforcement The company plans to manufacture basic class of controlled substance listed
Administration, Attention: DEA Federal small quantities of the listed controlled in schedule II.
Register Representative/ODXL, 8701 substances in bulk for distribution to its The company plans to import the
Morrissette Drive, Springfield, Virginia customers for use as reference listed controlled substance for product
22152. Request for hearings should be standards. development and preparation of
sent to: Drug Enforcement Dated: September 16, 2015. stability batches.
Administration, Attention: Hearing
Joseph T. Rannazzisi, Dated: September 16, 2015.
Clerk/LJ, 8701 Morrissette Drive,
Deputy Assistant Administrator. Joseph T. Rannazzisi,
Springfield, Virginia 22152.
[FR Doc. 2015–24123 Filed 9–22–15; 8:45 am] Deputy Assistant Administrator.
SUPPLEMENTARY INFORMATION: The
BILLING CODE 4410–09–P [FR Doc. 2015–24118 Filed 9–22–15; 8:45 am]
Attorney General has delegated her
authority under the Controlled BILLING CODE 4410–09–P
Substances Act to the Administrator of DEPARTMENT OF JUSTICE
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to Drug Enforcement Administration DEPARTMENT OF JUSTICE
exercise all necessary functions with
[Docket No. DEA–392] Drug Enforcement Administration
respect to the promulgation and
implementation of 21 CFR part 1301, Importer of Controlled Substances
incident to the registration of [Docket No. DEA–392]
Application: Fresenius Kabi USA, LLC
manufacturers, distributors, dispensers,
Importer of Controlled Substances
importers, and exporters of controlled ACTION: Notice of application. Registration: Rhodes Technologies
mstockstill on DSK4VPTVN1PROD with NOTICES

substances (other than final orders in
connection with suspension, denial, or DATES: Registered bulk manufacturers of ACTION: Notice of registration.
revocation of registration) has been the affected basic class, and applicants
redelegated to the Deputy Assistant therefore, may file written comments on SUMMARY: Rhodes Technologies applied
Administrator of the DEA Office of or objections to the issuance of the to be registered as an importer of certain
Diversion Control (‘‘Deputy Assistant proposed registration in accordance basic classes of controlled substances.
Administrator’’) pursuant to section 7 of with 21 CFR 1301.34(a) on or before The Drug Enforcement Administration
28 CFR part 0, appendix to subpart R. October 23, 2015. Such persons may (DEA) grants Rhodes Technologies

VerDate Sep<11>2014 18:00 Sep 22, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\23SEN1.SGM 23SEN1

Document Created: 2015-12-15 09:44:39
Document Modified: 2015-12-15 09:44:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
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 1301.33(a) on or before November 23, 2015.
FR Citation		80 FR 57389

80 FR 57389 - Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 80, Issue 184 (September 23, 2015)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration