Manufacturer of Controlled Substances Registration: Organix, Inc., 52764-52765 [2014-21060]
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Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–392]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Chattem
Chemicals, Inc.
Importer of Controlled Substances
Registration: Akorn, Inc.
ACTION:
ACTION:
Notice of registration.
Akorn, Inc., applied to be
registered as an importer of a certain
basic class of controlled substance. The
DEA grants Akorn, Inc., registration as
an importer of this controlled substance.
SUMMARY:
By notice
dated May 28, 2014, and published in
the Federal Register on June 4, 2014, 79
FR 32317, Akorn, Inc., 1222 W. Grand
Avenue, Decatur, Illinois 62522, applied
to be registered as an importer of a
certain basic class of controlled
substance. No comments or objections
were reviewed for this notice.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the
registration of Akorn, Inc., to import the
basic class of controlled substance 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 the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above named
company is granted registration as an
importer of Remifentanil (9739), a basic
class of controlled substance listed in
schedule II.
The company plans to import
Remifentanil in bulk for use in dosage
form manufacturing.
SUPPLEMENTARY INFORMATION:
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[FR Doc. 2014–21063 Filed 9–3–14; 8:45 am]
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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 3, 2014.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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 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, and
dispensers 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 pt. 0,
subpt. R, App.
In accordance with 21 CFR
1301.33(a), this is notice that on June
23, 2014, Chattem Chemicals, Inc., 3801
St. Elmo Avenue, Chattanooga,
Tennessee 37409, applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
DATES:
Controlled substance
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
VerDate Mar<15>2010
Notice of application.
Jkt 232001
Gamma
Hydroxybutyric
Acid
(2010).
4-Methoxyamphetamine (7411) ...
Dihydromorphine (9145) ...............
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
PO 00000
Frm 00140
Fmt 4703
Sfmt 4703
Schedule
I
I
I
II
II
II
II
II
II
II
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Meperidine intermediate-A (9232)
Meperidine intermediate-B (9233)
Meperidine intermediate-C (9234)
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers. Regarding (9640) the
company plans to manufacture another
controlled substance for sale to its
customers.
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014–21062 Filed 9–3–14; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Organix, Inc.
ACTION:
Notice of registration.
Organix, Inc. applied to be
registered as a manufacturer of certain
basic classes of narcotic and nonnarcotic controlled substances. The DEA
grants Organix, Inc. registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated April 21, 2014, and published in
the Federal Register on April 28, 2014,
79 FR 23376, Organix, Inc., 240 Salem
Street, Woburn, Massachusetts 01801,
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections have been received.
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823(a) and
determined that the registration of
Organix, Inc. to manufacture the basic
classes of controlled substances is
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 79, No. 171 / Thursday, September 4, 2014 / Notices
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 the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances listed:
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Lysergic acid diethylamide (7315)
Heroin (9200) ...............................
Morphine (9300) ...........................
I
I
I
II
Controlled substance
The company plans to manufacture
reference standards for distribution to
its research and forensics customers.
Marihuana (7360) .......................
Tetrahydrocannabinols (7370) ....
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
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DEPARTMENT OF JUSTICE
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: National
Center for Natural Products Research
(NIDA MProject), Inc.
Notice of registration.
National Center for Natural
Products Research (NIDA MProject), Inc.
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The DEA grants
National Center for Natural Products
Research (NIDA MProject), Inc.,
registration as a manufacturer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated November 5, 2013, and published
in the Federal Register on November 18,
2013, 78 FR 69132, National Center for
Natural Products Research (NIDA
MProject), Inc., University of
Mississippi, 135 Coy Waller Complex,
University, Mississippi 38677, applied
to be registered as a manufacturer of
certain basic classes of controlled
substances.
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VerDate Mar<15>2010
18:14 Sep 03, 2014
Jkt 232001
I
I
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Drug Enforcement Administration
SUMMARY:
Schedule
The company plans to cultivate
marihuana in support of the National
Institute on Drug Abuse for research
approved by the Department of Health
and Human Services.
No comments or objections have been
received.
[FR Doc. 2014–21060 Filed 9–3–14; 8:45 am]
ACTION:
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823(a) and
determined that the registration of
National Center for Natural Products
Research (NIDA MProject), Inc., to
manufacture the 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 the company’s maintenance
of effective controls against diversion by
inspecting and testing the company’s
physical security systems, verified the
company’s compliance with state and
local laws, and reviewed the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances listed:
[FR Doc. 2014–21077 Filed 9–3–14; 8:45 am]
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NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[Notice: (14–091)]
NASA Federal Advisory Committees
National Aeronautics and
Space Administration.
ACTION: Annual invitation for public
nominations by U.S. citizens for service
on NASA Federal advisory committees.
AGENCY:
NASA announces its annual
invitation for public nominations for
service on NASA Federal advisory
committees. U.S. citizens may submit
self-nominations for consideration as
potential members of NASA’s Federal
advisory committees. NASA’s Federal
advisory committees have member
vacancies from time to time throughout
the year, and NASA will consider selfnominations to fill such intermittent
SUMMARY:
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vacancies. NASA is committed to
selecting members to serve on its
Federal advisory committees based on
their individual expertise, knowledge,
experience, and current/past
contributions to the relevant subject
area.
DATE: The deadline for NASA receipt of
all public nominations is October 1,
2014.
ADDRESSES: Self-nominations from
interested U.S. citizens must be sent
electronically to NASA in letter form, be
signed, and must include the name of
specific NASA Federal advisory
committee of interest for NASA
consideration. Self-nomination letters
are limited to specifying interest in only
one (1) NASA Federal advisory
committee per year. The following
additional information is required to be
attached to each self-nomination letter
(i.e., cover letter): (1) Professional
resume (one-page maximum); (2)
professional biography (one-page
maximum). Please submit the selfnomination package as a single package
containing cover letter and both
required attachments to hq-nasanoms@
mail.nasa.gov. All public selfnomination packages must be submitted
electronically via email to NASA; paperbased documents sent through postal
mail (hard-copies) will not be accepted.
Note: Nomination letters that are
noncompliant with inclusion of the
three (3) mandatory documents listed
above will not receive further
consideration by NASA.
FOR FURTHER INFORMATION CONTACT: To
view charters and obtain further
information on NASA’s Federal
advisory committees, please visit the
NASA Advisory Committee
Management Division Web site noted
below. For any questions, please contact
Ms. Marla King, Advisory Committee
Specialist, Advisory Committee
Management Division, Office of
International and Interagency Relations,
NASA Headquarters, Washington, DC
20546, (202) 358–1148.
SUPPLEMENTARY INFORMATION: NASA’s
six (6) currently chartered Federal
advisory committees are listed below.
The individual charters may be found at
the NASA Advisory Committee
Management Division’s Web site at
https://oiir.hq.nasa.gov/acmd.html:
• Aerospace Safety Advisory Panel—
The Aerospace Safety Advisory Panel
provides advice and recommendations
to the NASA Administrator and the
Congress on matters related to safety,
and performs such other duties as the
NASA Administrator may request.
• Applied Sciences Advisory
Committee—The Applied Sciences
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]]>Agencies
[Federal Register Volume 79, Number 171 (Thursday, September 4, 2014)]
[Notices]
[Pages 52764-52765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21060]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Organix, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Organix, Inc. applied to be registered as a manufacturer of
certain basic classes of narcotic and non-narcotic controlled
substances. The DEA grants Organix, Inc. registration as a manufacturer
of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated April 21, 2014, and
published in the Federal Register on April 28, 2014, 79 FR 23376,
Organix, Inc., 240 Salem Street, Woburn, Massachusetts 01801, applied
to be registered as a manufacturer of certain basic classes of
controlled substances. No comments or objections have been received.
The Drug Enforcement Administration (DEA) has considered the
factors in 21 U.S.C. 823(a) and determined that the registration of
Organix, Inc. to manufacture the basic classes of controlled substances
is
[[Page 52765]]
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 the company's maintenance of
effective controls against diversion by inspecting and testing the
company's physical security systems, verifying the company's compliance
with state and local laws, and reviewing the company's background and
history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21
CFR 1301.33, the above-named company is granted registration as a bulk
manufacturer of the basic classes of controlled substances listed:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)........... I
Lysergic acid diethylamide (7315).......... I
Heroin (9200).............................. I
Morphine (9300)............................ II
------------------------------------------------------------------------
The company plans to manufacture reference standards for
distribution to its research and forensics customers.
Dated: August 27, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-21060 Filed 9-3-14; 8:45 am]
BILLING CODE 4410-09-P
