Manufacturer of Controlled Substances Registration: Apertus Pharmaceuticals, 2910-2911 [2016-00778]
Download as PDF
<![CDATA[
2910
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
Dated: January 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
Controlled substance
[FR Doc. 2016–00789 Filed 1–15–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: American
Radiolabeled Chemicals, Inc.
ACTION:
Notice of registration.
American Radiolabeled
Chemicals, Inc. applied to be registered
as a manufacturer of certain basic
classes of controlled substances. The
Drug Enforcement Administration
(DEA) grants American Radiolabeled
Chemicals, Inc. registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated October 2, 2015, and published in
the Federal Register on October 13,
2015, 80 FR 61469, American
Radiolabeled Chemicals, Inc., 101 Arc
Drive, Saint Louis, Missouri 63146
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of American
Radiolabeled Chemicals, 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, 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 following basic
classes of controlled substances:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Ibogaine (7260) ............................
Lysergic acid diethylamide (7315)
Tetrahydrocannabinols (7370) .....
VerDate Sep<11>2014
17:50 Jan 15, 2016
I
I
I
I
Jkt 238001
Dimethyltryptamine (7435) ...........
1-[1-(2Thienyl)cyclohexyl]piperidine
(7470).
Dihydromorphine (9145) ...............
Heroin (9200) ...............................
Normorphine (9313) .....................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Amobarbital (2125) .......................
Phencyclidine (7471) ....................
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Metazocine (9240) ........................
Methadone (9250) ........................
Dextropropoxyphene, bulk (nondosage forms) (9273).
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Phenazocine (9715) .....................
Carfentanil (9743) .........................
Fentanyl (9801) ............................
Schedule
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
small quantities of the listed controlled
substances as radiolabeled compounds
for biochemical research.
Dated: January 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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).
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
1301.34(a), this is notice that on
November 12, 2015, Siegfried USA,
LLC, 33 Industrial Park Road,
Pennsville, New Jersey 08070 applied to
be registered as an importer of the
following basic classes of controlled
substances:
[FR Doc. 2016–00779 Filed 1–15–16; 8:45 am]
BILLING CODE 4410–09–P
Controlled substance
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Siegfried USA, 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
issuance of the proposed registration in
accordance with 21 CFR 1301.34(a) on
or before February 18, 2016. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
February 18, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
DATES:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Schedule
II
II
The company plans to import the
listed controlled substances to
manufacture bulk active
pharmaceuticals ingredients (API) for
distribution to its customer.
Dated: January 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–00783 Filed 1–15–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Apertus
Pharmaceuticals
ACTION:
E:\FR\FM\19JAN1.SGM
Notice of registration.
19JAN1
2911
Federal Register / Vol. 81, No. 11 / Tuesday, January 19, 2016 / Notices
Apertus Pharmaceuticals
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Apertus Pharmaceuticals
registration as a manufacturer of those
controlled substances.
DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION:
ACTION:
SUMMARY:
By notice dated October 2, 2015, and
published in the Federal Register on
October 13, 2015, 80 FR 61470, Apertus
Pharmaceuticals, 331 Consort Drive,
Ballwin, Missouri 63011 applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Apertus
Pharmaceuticals 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, 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 following basic
classes of controlled substances:
Controlled Substance
Schedule
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Remifentanil (9739) ......................
I
I
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
In reference to drug codes 7360
marihuana and 7370
tetrahydrocannabinols the company
plans to bulk manufacture both as
synthetic substances. No other activity
for these drug codes is authorized for
this registration.
Dated: January 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–00778 Filed 1–15–16; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
17:50 Jan 15, 2016
Jkt 238001
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Rhodes
Technologies
Notice of registration.
Rhodes Technologies applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Rhodes
Technologies registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated August 21, 2015, and published in
the Federal Register on August 31,
2015, 80 FR 52511, Rhodes
Technologies, 498 Washington Street,
Coventry, Rhode Island 02816 applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. No comments or objections
were submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Rhodes Technologies
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, 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 following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Tetrahydrocannabinols (7370) .....
Dihydromorphine (9145) ...............
Methylphenidate (1724) ................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Schedule
I
I
II
II
II
II
II
II
II
II
II
II
II
II
Controlled substance
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
II
II
The company plans to manufacture
the listed controlled substances in bulk
for conversion and sale to dosage form
manufacturers.
In reference to drug code 7370 the
company plans to bulk manufacture
synthetic tetrahydrocannabinols. No
other activity for this drug code is
authorized for this registration.
Dated: January 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–00781 Filed 1–15–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1121–0321]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Revision of a
Currently Approved Collection:
National Institute of Justice
Compliance Testing Program
Office of Justice Programs,
Department of Justice.
ACTION: 60-day notice.
AGENCY:
The Department of Justice
(DOJ), Office of Justice Programs,
National Institute of Justice (NIJ), will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
DATES: Comments are encouraged and
will be accepted for 60 days until March
21, 2016.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact:
Michael O’Shea (202) 305–7954,
National Institute of Justice (NIJ), Office
of Justice Programs, U.S. Department of
Justice, 810 Seventh Street NW.,
Washington, DC 20531 or
Jamie.phillips@usdoj.gov.
SUMMARY:
Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2910-2911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00778]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Apertus
Pharmaceuticals
ACTION: Notice of registration.
-----------------------------------------------------------------------
[[Page 2911]]
SUMMARY: Apertus Pharmaceuticals applied to be registered as a
manufacturer of certain basic classes of controlled substances. The
Drug Enforcement Administration (DEA) grants Apertus Pharmaceuticals
registration as a manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION:
By notice dated October 2, 2015, and published in the Federal
Register on October 13, 2015, 80 FR 61470, Apertus Pharmaceuticals, 331
Consort Drive, Ballwin, Missouri 63011 applied to be registered as a
manufacturer of certain basic classes of controlled substances. No
comments or objections were submitted for this notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of Apertus Pharmaceuticals 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, 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 following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled Substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
Remifentanil (9739)........................ II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers. In reference to
drug codes 7360 marihuana and 7370 tetrahydrocannabinols the company
plans to bulk manufacture both as synthetic substances. No other
activity for these drug codes is authorized for this registration.
Dated: January 11, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-00778 Filed 1-15-16; 8:45 am]
BILLING CODE 4410-09-P
