Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research NIDA MPROJECT, 13522-13523 [2018-06323]
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13522
Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
issuance of the proposed registration on
or before April 30, 2018. Such persons
may also file a written request for a
hearing on the application on or before
April 30, 2018.
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 request 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.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR 3417
(January 25, 2007).
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
customers. No other activity for these
drug codes are authorized for this
registration.
[FR Doc. 2018–06320 Filed 3–28–18; 8:45 am]
BILLING CODE 4410–09–P
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
[FR Doc. 2018–06324 Filed 3–28–18; 8:45 am]
ADDRESSES:
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
February 2, 2018, Siegfried USA, LLC,
33 Industrial Park Road, Pennsville, NJ
08070 applied to be registered as an
importer of the following basic classes
of controlled substances:
sradovich on DSK3GMQ082PROD with NOTICES
Controlled substance
Opium, raw .......
Poppy Straw
Concentrate.
Drug code
9600
9670
19:09 Mar 28, 2018
[Docket No. DEA–392]
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Insys
Manufacturing LLC
ACTION:
II
II
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:
DATES:
Jkt 244001
Controlled substance
Drug code
Marihuana .........
Tetrahydrocannabinols.
7360
7370
Schedule
I
I
The company plans to manufacture
bulk synthetic active pharmaceutical
ingredients (APIs) for product
development and distribution to its
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Drug Enforcement Administration
[Docket No. DEA–392]
Notice of application.
Schedule
The company plans to import the
listed controlled substances to
manufacture bulk active
pharmaceuticals ingredients (API) for
distribution to its customers.
VerDate Sep<11>2014
BILLING CODE 4410–09–P
Drug Enforcement Administration
Bulk Manufacturer of Controlled
Substances Application: National
Center for Natural Products Research
NIDA MPROJECT
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 May 29, 2018.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
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 October
18, 2017, National Center for Natural
Products Research NIDA MPROJECT,
University of Mississippi, 135 Coy
Waller Complex, P.O. Box 1848,
University, Mississippi 38677–1848
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29MRN1.SGM
29MRN1
Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
Controlled substance
Drug code
Marihuana Extract.
Marihuana .........
Tetrahydrocannabinols.
Schedule
7350
I
7360
7370
I
I
The company plans to bulk
manufacture the listed controlled
substances to make available to the
National Institute on Drug Abuse
(NIDA) a supply of bulk marihuana for
distribution to research investigators in
support of the national research
program needs. No other activities for
these drug codes are authorized for this
registration.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
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
February 18, 2015, S&B Pharma, Inc.,
DBA NORAC Pharma, 405 S. Motor
Avenue, Azusa, CA 91702 applied for
renewal of their registration as an
importer of the following basic classes
of controlled substances:
[FR Doc. 2018–06323 Filed 3–28–18; 8:45 am]
BILLING CODE 4410–09–P
4-Anilino-N-phenethyl-4piperidine (ANPP).
Tapentadol ......................
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: S&B Pharma, 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 April 30, 2018. Such persons
may also file a written request for a
hearing on the application on or before
April 30, 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 request 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
sradovich on DSK3GMQ082PROD with NOTICES
DATES:
VerDate Sep<11>2014
19:09 Mar 28, 2018
Drug
code
Controlled substance
Jkt 244001
Schedule
8333
II
9780
II
The company plans to import the
controlled substances in bulk for the
manufacture of other controlled
substances for its customers. Tapentadol
(9780) will be imported in Intermediate
form to bulk manufacture Tapentadol
for distribution to its customers. No
other activity for these drug codes will
be allowed.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On March 23, 2018, the Department of
Justice lodged a proposed consent
decree with the United States District
Court for the District of North Dakota in
the lawsuit entitled United States of
America v. XTO Energy Inc., Civil
Action No. 1:18–cv–00060.
The lawsuit seeks injunctive relief
and civil penalties for violations of the
Clean Air Act and the Federal
Implementation Plan for Oil and Natural
Gas Well Production Facilities; Fort
Berthold Indian Reservation at well
pads owned and operated by XTO
Energy Inc. (‘‘XTO’’) on the Fort
Berthold Indian Reservation in North
Dakota. The violations relate to alleged
failures to adequately design, operate,
Fmt 4703
Sfmt 4703
To submit
comments:
Send them to:
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ–ENRD, P.O. Box
7611, Washington, DC
20044–7611.
By mail .........
DEPARTMENT OF JUSTICE
Frm 00055
and maintain storage tank vapor control
systems, resulting in emissions of
volatile organic compounds (‘‘VOC’’)
and other pollutants to the atmosphere.
The proposed consent decree covers
all 20 of XTO’s well pads on the Fort
Berthold Indian Reservation. The
proposed decree requires XTO to
perform injunctive relief, including
conducting engineering evaluations of
the vapor control systems at each of the
well pads to ensure that they are
adequately sized and designed. XTO
must also complete one environmental
mitigation project, estimated to cost at
least $425,000, and pay a $320,000 civil
penalty. Entering into and fully
complying with the proposed consent
decree would release XTO from past
civil liability at the tanks systems as
associated vapor control systems for
violations of the Fort Berthold FIP
relating to VOC emissions from storage
tanks.
The publication of this notice opens
a period for public comment on the
consent decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States of America v. XTO Energy
Inc., D.J. Ref. No. 90–5–2–1–11656. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
By email .......
[FR Doc. 2018–06322 Filed 3–28–18; 8:45 am]
PO 00000
13523
During the public comment period,
the consent decree may be examined
and downloaded at this Justice
Department website: https://
www.justice.gov/enrd/consent-decrees.
We will provide a paper copy of the
consent decree upon written request
and payment of reproduction costs.
Please mail your request and payment
to: Consent Decree Library, U.S. DOJ—
ENRD, P.O. Box 7611, Washington, DC
20044–7611.
Please enclose a check or money order
for $17.00 (25 cents per page
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Pages 13522-13523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06323]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: National
Center for Natural Products Research NIDA MPROJECT
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.
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
October 18, 2017, National Center for Natural Products Research NIDA
MPROJECT, University of Mississippi, 135 Coy Waller Complex, P.O. Box
1848, University, Mississippi 38677-1848 applied to be registered as a
bulk manufacturer of the following basic classes of controlled
substances:
[[Page 13523]]
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana Extract.................. 7350 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances to make available to the National Institute on Drug Abuse
(NIDA) a supply of bulk marihuana for distribution to research
investigators in support of the national research program needs. No
other activities for these drug codes are authorized for this
registration.
Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-06323 Filed 3-28-18; 8:45 am]
BILLING CODE 4410-09-P
