83 FR 13522 - Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

Page Range		13522-13522
FR Document		2018-06324

Federal Register, Volume 83 Issue 61 (Thursday, March 29, 2018)

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13522]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06324]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Insys 
Manufacturing LLC

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 on or before May 29, 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 
December 7, 2017, Insys Manufacturing LLC, 2700 Oakmont Drive, Round 
Rock, Texas 78665 applied to be registered as a bulk manufacturer the 
following basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Marihuana..........................            7360  I
Tetrahydrocannabinols..............            7370  I
------------------------------------------------------------------------

    The company plans to manufacture bulk synthetic active 
pharmaceutical ingredients (APIs) for product development and 
distribution to its customers. No other activity for these drug codes 
are authorized for this registration.

    Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06324 Filed 3-28-18; 8:45 am]
 BILLING CODE 4410-09-P

13522 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices

issuance of the proposed registration on Dated: March 15, 2018. customers. No other activity for these
or before April 30, 2018. Such persons Susan A. Gibson, drug codes are authorized for this
may also file a written request for a Deputy Assistant Administrator. registration.
hearing on the application on or before [FR Doc. 2018–06320 Filed 3–28–18; 8:45 am] Dated: March 15, 2018.
April 30, 2018. BILLING CODE 4410–09–P
Susan A. Gibson,
ADDRESSES: Written comments should Deputy Assistant Administrator.
be sent to: Drug Enforcement [FR Doc. 2018–06324 Filed 3–28–18; 8:45 am]
Administration, Attention: DEA Federal DEPARTMENT OF JUSTICE
BILLING CODE 4410–09–P
Register Representative/DRW, 8701 Drug Enforcement Administration
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be [Docket No. DEA–392]
DEPARTMENT OF JUSTICE
sent to: Drug Enforcement
Administration, Attn: Administrator, Bulk Manufacturer of Controlled
Substances Application: Insys Drug Enforcement Administration
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for hearing Manufacturing LLC
[Docket No. DEA–392]
should also be sent to: (1) Drug ACTION: Notice of application.
Enforcement Administration, Attn: Bulk Manufacturer of Controlled
Hearing Clerk/LJ, 8701 Morrissette DATES: Registered bulk manufacturers of Substances Application: National
Drive, Springfield, Virginia 22152; and the affected basic classes, and Center for Natural Products Research
(2) Drug Enforcement Administration, applicants therefore, may file written NIDA MPROJECT
Attn: DEA Federal Register comments on or objections to the
Representative/DRW, 8701 Morrissette issuance of the proposed registration on
Drive, Springfield, Virginia 22152. ACTION: Notice of application.
or before May 29, 2018.
Comments and requests for hearings on ADDRESSES: Written comments should
applications to import narcotic raw be sent to: Drug Enforcement DATES: Registered bulk manufacturers of
material are not appropriate. 72 FR 3417 Administration, Attention: DEA Federal the affected basic classes, and
(January 25, 2007). Register Representative/DRW, 8701 applicants therefore, may file written
Morrissette Drive, Springfield, Virginia comments on or objections to the
SUPPLEMENTARY INFORMATION:
22152. issuance of the proposed registration on
The Attorney General has delegated or before May 29, 2018.
his authority under the Controlled SUPPLEMENTARY INFORMATION: The
Substances Act to the Administrator of Attorney General has delegated his ADDRESSES: Written comments should
the Drug Enforcement Administration authority under the Controlled be sent to: Drug Enforcement
(DEA), 28 CFR 0.100(b). Authority to Substances Act to the Administrator of Administration, Attention: DEA Federal
exercise all necessary functions with the Drug Enforcement Administration Register Representative/DRW 8701
respect to the promulgation and (DEA), 28 CFR 0.100(b). Authority to Morrissette Drive, Springfield, Virginia
implementation of 21 CFR part 1301, exercise all necessary functions with 22152.
incident to the registration of respect to the promulgation and
implementation of 21 CFR part 1301, SUPPLEMENTARY INFORMATION: The
manufacturers, distributors, dispensers, Attorney General has delegated his
importers, and exporters of controlled incident to the registration of
manufacturers, distributors, dispensers, authority under the Controlled
substances (other than final orders in Substances Act to the Administrator of
connection with suspension, denial, or importers, and exporters of controlled
substances (other than final orders in the Drug Enforcement Administration
revocation of registration) has been
connection with suspension, denial, or (DEA), 28 CFR 0.100(b). Authority to
redelegated to the Assistant
revocation of registration) has been exercise all necessary functions with
Administrator of the DEA Diversion
redelegated to the Assistant respect to the promulgation and
Control Division (‘‘Assistant
Administrator of the DEA Diversion implementation of 21 CFR part 1301,
Administrator’’) pursuant to section 7 of
Control Division (‘‘Assistant incident to the registration of
28 CFR part 0, appendix to subpart R.
Administrator’’) pursuant to section 7 of manufacturers, distributors, dispensers,
In accordance with 21 CFR importers, and exporters of controlled
28 CFR part 0, appendix to subpart R.
1301.34(a), this is notice that on In accordance with 21 CFR substances (other than final orders in
February 2, 2018, Siegfried USA, LLC, 1301.33(a), this is notice that on connection with suspension, denial, or
33 Industrial Park Road, Pennsville, NJ December 7, 2017, Insys Manufacturing revocation of registration) has been
08070 applied to be registered as an LLC, 2700 Oakmont Drive, Round Rock, redelegated to the Assistant
importer of the following basic classes Texas 78665 applied to be registered as Administrator of the DEA Diversion
of controlled substances: a bulk manufacturer the following basic Control Division (‘‘Assistant
classes of controlled substances: Administrator’’) pursuant to section 7 of
Controlled sub- 28 CFR part 0, appendix to subpart R.
Drug code Schedule
stance
Controlled sub- In accordance with 21 CFR
Drug code Schedule
Opium, raw ....... 9600 II stance
1301.33(a), this is notice that on October
Poppy Straw 9670 II 18, 2017, National Center for Natural
sradovich on DSK3GMQ082PROD with NOTICES

Marihuana ......... 7360 I
Concentrate. Products Research NIDA MPROJECT,
Tetrahydrocann- 7370 I
abinols. University of Mississippi, 135 Coy
The company plans to import the Waller Complex, P.O. Box 1848,
listed controlled substances to The company plans to manufacture University, Mississippi 38677–1848
manufacture bulk active bulk synthetic active pharmaceutical applied to be registered as a bulk
pharmaceuticals ingredients (API) for ingredients (APIs) for product manufacturer of the following basic
distribution to its customers. development and distribution to its classes of controlled substances:

VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\29MRN1.SGM 29MRN1

Document Created: 2018-03-29 00:25:42
Document Modified: 2018-03-29 00:25:42

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 on or before May 29, 2018.
FR Citation		83 FR 13522

83 FR 13522 - Bulk Manufacturer of Controlled Substances Application: Insys Manufacturing LLC

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration