Importer of Controlled Substances Registration: Mylan Pharmaceuticals, Inc., 38471-38472 [2015-16453]
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Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
under 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDA
approved or non-approved finished
dosage forms for commercial sale.
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances:
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
The company plans to manufacture
the listed controlled substances in bulk
for distribution and sale to its
customers.
In reference to Amphetamine (1100),
the company plans to acquire the listed
controlled substance in bulk from a
domestic source in order to manufacture
other controlled substances in bulk for
distribution to its customers.
[FR Doc. 2015–16448 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Euticals, Inc.
ACTION:
Notice of registration.
Controlled substance
Gamma
Hydroxybutyric
Acid
(2010).
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Phenylacetone (8501) ..................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Oripavine (9330) ...........................
Tapentadol (9780) ........................
Schedule
I
II
II
II
II
II
II
II
II
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16454 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
Euticals, Inc. applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Euticals, Inc. registration
as a manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated January 9, 2015, and published in
the Federal Register on January 26,
2015, 80 FR 3978, Euticals, Inc., 2460
W. Bennett Street, Springfield, Missouri
65807–1229 applied to be registered as
a manufacturer of certain basic classes
of controlled substances. No comments
or objections were submitted to this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Euticals, 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
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SUMMARY:
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14:37 Jul 02, 2015
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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
February 4, 2015, Navinta, LLC, 1499
Lower Ferry Road, Ewing, New Jersey
08618–1414 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
Controlled substance
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Fentanyl (9801) ............................
Schedule
II
II
The company plans initially to
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval, then
eventually upon FDA approval to
produce commercial size batches for
distribution to dosage form
manufacturers.
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Navinta, LLC
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16441 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
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 1301.33(a) on
or before September 4, 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 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
DATES:
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Sfmt 4703
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Mylan Pharmaceuticals,
Inc.
ACTION:
Notice of registration.
Mylan Pharmaceuticals, Inc.
applied to be registered as an importer
of certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Mylan
Pharmaceuticals, Inc. registration as an
importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated March 20, 2015, and published in
the Federal Register on March 27, 2015,
80 FR 16436, Mylan Pharmaceuticals,
Inc., 3711 Collins Ferry Road,
Morgantown, West Virginia 26505
applied to be registered as an importer
SUMMARY:
E:\FR\FM\06JYN1.SGM
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38472
Federal Register / Vol. 80, No. 128 / Monday, July 6, 2015 / Notices
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, 952(a) and 958(a) and
determined that the registration of
Mylan Pharmaceuticals, Inc. to import
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.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
importer of the basic classes of
controlled substances:
Controlled substance
Schedule
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Levorphanol (9220) ......................
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Remifentanil (9739) ......................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances in finished
dosage form (FDF) from foreign sources
for analytical testing and clinical trials
in which the foreign FDF will be
compared to the company’s own
domestically-manufactured FDF. This
analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16453 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Lhorne on DSK7TPTVN1PROD with NOTICES
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Noramco,
Inc.
ACTION:
Notice of registration.
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14:37 Jul 02, 2015
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Noramco, Inc. applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
The Drug Enforcement Administration
(DEA) grants Noramco, Inc. registration
as a manufacturer of those controlled
substances.
SUMMARY:
By notice
dated September 26, 2014, and
published in the Federal Register on
October 7, 2014, 79 FR 60498, Noramco,
Inc., Olympic Drive, Athens, Georgia
30601 applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted to this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Noramco, 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 basic classes of
controlled substances listed:
SUPPLEMENTARY INFORMATION:
Controlled substance
Gamma
Hydroxybutyric
Acid
(2010).
Codeine-N-oxide (9053) ...............
Dihydromorphine (9145) ...............
Morphine-N-oxide (9307) .............
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium tincture (9630) ..................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Sufentanil (9740) ..........................
Carfentanil (9743) .........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
I
I
I
I
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 to its customers.
PO 00000
Frm 00046
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Sfmt 4703
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–16455 Filed 7–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–NEW]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Approval of a
New Collection Request for Emergency
or Term Access to National Security
Information Form (FD–1116)
Federal Bureau of
Investigation, DOJ.
ACTION: 30-day notice.
AGENCY:
The Department of Justice
(DOJ), Federal Bureau of Investigation
(FBI), Security Division (SecD) 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.
The proposed information collection
was previously published in the FR 80
23290, April 27, 2015, allowing for a 60
day comment period.
DATES: Comments are encouraged and
will be accepted for an additional 30
days until August 5, 2015.
FOR FURTHER INFORMATION CONTACT: If
you have 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 the Office of Management and
Budget, Office of Information and
Regulatory Affairs, Attention
Department of Justice Desk Officer,
Washington, DC 20503. Additionally,
comments may be submitted via email
to OIRA_submissions@omb.eop.gov.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
Evaluate the accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used;
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Notices]
[Pages 38471-38472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16453]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Mylan
Pharmaceuticals, Inc.
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Mylan Pharmaceuticals, Inc. applied to be registered as an
importer of certain basic classes of controlled substances. The Drug
Enforcement Administration (DEA) grants Mylan Pharmaceuticals, Inc.
registration as an importer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated March 20, 2015, and
published in the Federal Register on March 27, 2015, 80 FR 16436, Mylan
Pharmaceuticals, Inc., 3711 Collins Ferry Road, Morgantown, West
Virginia 26505 applied to be registered as an importer
[[Page 38472]]
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, 952(a) and
958(a) and determined that the registration of Mylan Pharmaceuticals,
Inc. to import 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. 952(a) and 958(a), and in
accordance with 21 CFR 1301.34, the above-named company is granted
registration as an importer of the basic classes of controlled
substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Morphine (9300)............................ II
Oxymorphone (9652)......................... II
Remifentanil (9739)........................ II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to import the listed controlled substances in
finished dosage form (FDF) from foreign sources for analytical testing
and clinical trials in which the foreign FDF will be compared to the
company's own domestically-manufactured FDF. This analysis is required
to allow the company to export domestically-manufactured FDF to foreign
markets.
Dated: June 25, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-16453 Filed 7-2-15; 8:45 am]
BILLING CODE 4410-09-P
