New Animal Drugs; Masitinib, 6326-6327 [2011-2519]
Download as PDF
<![CDATA[
6326
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations
mail: tomasz.rakowski@faa.gov; phone: 781–
238–7735; fax: 781–238–7199.
Paperwork Reduction Act Burden Statement
(5) A federal agency may not conduct or
sponsor, and a person is not required to
respond to, nor shall a person be subject to
a penalty for failure to comply with a
collection of information subject to the
requirements of the Paperwork Reduction
Act unless that collection of information
displays a current valid OMB Control
Number. The OMB Control Number for this
information collection is 2120–0056. Public
reporting for this collection of information is
estimated to be approximately 5 minutes per
response, including the time for reviewing
instructions, completing and reviewing the
collection of information. All responses to
this collection of information are mandatory.
Comments concerning the accuracy of this
burden and suggestions for reducing the
burden should be directed to the FAA at: 800
Independence Ave., SW., Washington, DC
20591, Attn: Information Collection
Clearance Officer, AES–200.
Definitions
(v) For the purposes of this AD, an EGT
above redline is a confirmed overtemperature indication that is not a result of
EGT system error.
(w) For the purposes of this AD, a shift in
the smoothed EGT trending data is a shift in
a rolling average of EGT that can be
confirmed by a corresponding shift in the
trending of fuel flow or fan speed/core speed
(N1/N2) relationship. You can find further
guidance about evaluating EGT trend data in
GE Company Service Rep Tip 373
‘‘Guidelines For Parameter Trend
Monitoring.’’
(bb) The Manager, Engine Certification
Office, has the authority to approve
alternative methods of compliance for this
AD if requested using the procedures found
in 14 CFR 39.19.
Related Information
(cc) Contact Tomasz Rakowski, Aerospace
Engineer, Engine Certification Office, FAA,
Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA
01803; phone: 781–238–7735; fax: 781–238–
7199; e-mail: tomasz.rakowski@faa.gov, for
more information about this AD.
Material Incorporated by Reference
(dd) You must use GE Service Bulletin No.
CF6–50–SB 72–1312, Revision 1, dated
October 18, 2010, to do the ultrasonic
inspections required by this AD.
(1) The Director of the Federal Register
approved the incorporation by reference of
this service bulletin in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
(2) Contact General Electric Company, GE–
Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215, telephone (513) 552–
3272; fax (513) 552–3329; e-mail:
geae.aoc@ge.com for a copy of this service
information.
(3) You may review copies at the FAA,
New England Region, 12 New England
Executive Park, Burlington, MA. For
information on the availability of this
material at the FAA, call 781–238–7125.
(4) You may also review copies of the
service information that is incorporated by
reference at the National Archives and
Records Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030, or go
to: https://www.archives.gov/federal-register/
cfr/ibr-locations.html.
jdjones on DSK8KYBLC1PROD with RULES
Previous Credit
(x) A borescope inspection performed
before the effective date of this AD using AD
2010–06–15, Amendment 39–16240 (75 FR
12661, March 17, 2010) or AD 2010–12–10,
Amendment 39–16331 (75 FR 32649, June 9,
2010) within the last 75 cycles, satisfies the
initial borescope inspection requirement in
paragraph (f)(1) of this AD.
(y) A UI performed before the effective date
of this AD using GE SB No. CF6–50–SB 72–
1312, dated August 9, 2010 or GE SB No.
CF6–50–SB 72–1312 Revision 1, dated
October 18, 2010, satisfies the inspection
requirement in paragraph (n) of this AD.
(z) An engine core vibration survey
performed before the effective date of this AD
using GE SB No. CF6–50–SB 72–1313, dated
August 9, 2010 or GE SB No. CF6–50–SB 72–
1313 Revision 1, dated October 18, 2010,
within the last 350 cycles, satisfies the initial
survey requirement in paragraph (o) of this
AD.
Issued in Burlington, Massachusetts, on
January 14, 2011.
Peter A. White,
Acting Manager, Engine & Propeller
Directorate, Aircraft Certification Service.
Alternative Methods of Compliance
(AMOCs)
(aa) AMOCs previously approved for AD
2010–06–15, Amendment 39–16240 (75 FR
12661, March 17, 2010) are not approved for
this AD. However, AMOCs previously
approved for AD 2010–12–10, Amendment
39–16331 (75 FR 32649, June 9, 2010) are
approved for this AD.
ACTION:
VerDate Mar<15>2010
14:40 Feb 03, 2011
Jkt 223001
[FR Doc. 2011–2387 Filed 2–3–11; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 516
[Docket No. FDA–2011–N–0003]
New Animal Drugs; Masitinib
AGENCY:
Food and Drug Administration,
HHS.
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
conditional approval of an application
for a new animal drug intended for a
minor use filed by AB Science. The
application for conditional approval
SUMMARY:
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
provides for the veterinary prescription
use of masitinib mesylate tablets in
dogs.
DATES: This rule is effective February 4,
2011.
FOR FURTHER INFORMATION CONTACT: Lisa
M. Troutman, Center for Veterinary
Medicine (HFV–116), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8322,
e-mail: lisa.troutman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: AB
Science, 3 Avenue George V, 75008
Paris, France, filed an application for
conditional approval (141–308) that
provides for veterinary prescription use
of KINAVET–CA1 (masitinib mesylate)
Tablets for the treatment of recurrent
(post-surgery) or nonresectable Grade II
or III cutaneous mast cell tumors in dogs
that have not previously received
radiotherapy and/or chemotherapy
except corticosteroids. In accordance
with the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as
amended by the Minor Use and Minor
Species Animal Health Act of 2004
(MUMS Act), this drug is conditionally
approved as of December 15, 2010, and
the regulations in part 516 (21 CFR part
516) are amended by adding new
§ 516.1318.
In addition, AB Science has not been
previously listed in the animal drug
regulations as a sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to add
entries for this firm.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support conditional approval of this
application may be seen in the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m.,
Monday through Friday.
The Agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
KINAVET–CA1 (masitinib mesylate)
Tablets for the intended uses
conditionally approved by FDA under
application number 141–308 qualifies
for 7 years of exclusive marketing rights
beginning on the date of conditional
approval. This new animal drug
qualifies for exclusive marketing rights
under section 573(c) of the FD&C Act
(21 U.S.C. 360ccc–2(c)) because it has
E:\FR\FM\04FER1.SGM
04FER1
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations
been declared a designated new animal
drug by FDA under section 573(a) of the
FD&C Act.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in
5 U.S.C. 801–808.
List of Subjects
PART 516—NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for 21 CFR
part 516 continues to read as follows:
■
Authority: 21 U.S.C. 360ccc–1, 360ccc–2,
371.
4. Add § 516.1318 to subpart E to read
as follows:
■
§ 516.1318
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 516
Administrative practice and
procedure, Animal drugs, Confidential
business information, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510 and 516 are amended as
follows:
PART 510—NEW ANIMAL DRUGS
Masitinib.
(a) Specifications. Each tablet
contains 50 or 150 milligrams (mg)
masitinib mesylate.
(b) Sponsor. See No. 052913 in
§ 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1)
Amount. 12.5 mg/kilograms (5.7 mg/lb)
of body weight daily.
(2) Indications for use. For the
treatment of recurrent (post-surgery) or
nonresectable Grade II or III cutaneous
mast cell tumors in dogs that have not
previously received radiotherapy and/or
chemotherapy except corticosteroids.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. It is a violation
of Federal law to use this product other
than as directed in the labeling.
Dated: January 28, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
[FR Doc. 2011–2519 Filed 2–3–11; 8:45 am]
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
BILLING CODE 4160–01–P
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘AB Science’’; and in the table
in paragraph (c)(2), numerically add an
entry for ‘‘052913’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
Department of the Army, Corps of
Engineers
33 CFR Part 334
*
Firm name and address
DEPARTMENT OF DEFENSE
Restricted Area, Potomac River,
Marine Corps Base Quantico,
Quantico, VA
Drug labeler
code
AGENCY:
ACTION:
*
*
*
AB Science, 3 Avenue
George V, 75008 Paris,
France ...............................
*
*
*
*
*
*
(2) * * *
jdjones on DSK8KYBLC1PROD with RULES
Drug labeler
code
Firm name and address
*
*
*
*
*
052913 ........ AB Science, 3 Avenue George
V, 75008 Paris, France.
*
VerDate Mar<15>2010
*
*
14:40 Feb 03, 2011
*
Jkt 223001
*
Final rule.
The U.S. Army Corps of
Engineers (Corps) is amending its
regulations to establish a restricted area
in the waters of the Potomac River
extending offshore from the Marine
Corps Air Facility (MCAF) at Marine
Corps Base Quantico (MCB Quantico),
located in Quantico, Virginia. The
restricted area will address current
security needs at MCB Quantico,
including the protection of military
assets at MCAF which includes the
Presidential Helicopter Squadron
(HMX–1). The restricted area will also
protect public health by preventing
vessels from disturbing a planned
SUMMARY:
052913
*
U.S. Army Corps of Engineers,
DoD.
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
6327
environmental remediation area that is
located to the northeast of MCAF.
DATES: Effective date: March 7, 2011.
ADDRESSES: Headquarters, U.S. Army
Corps of Engineers, Operations and
Regulatory Community of Practice, 441
G Street, NW., Washington, DC 20314–
1000.
FOR FURTHER INFORMATION CONTACT: Mr.
David Olson, Headquarters, Operations
and Regulatory Community of Practice,
Washington, DC at 202–761–4922 or by
e-mail at david.b.olson@usace.army.mil
or Mr. Steve Elinsky, U.S. Army Corps
of Engineers, Baltimore District,
Regulatory Branch, at 410–962–4503 or
by e-mail at
steve.elinsky@usace.army.mil.
SUPPLEMENTARY INFORMATION: Pursuant
to its authorities in Section 7 of the
Rivers and Harbors Act of 1917 (40 Stat.
266; 33 U.S.C. 1) and Chapter XIX of the
Army Appropriations Act of 1919 (40
Stat. 892; 33 U.S.C. 3), the Corps is
amending its regulations to establish a
restricted area in the waters of the
Potomac River extending offshore from
the MCAF at MCB Quantico, located in
Quantico, Virginia. The restricted area
will address current security needs at
MCB Quantico, including the protection
of military assets at MCAF which
includes the Presidential Helicopter
Squadron (HMX–1). The restricted area
will also protect public health by
preventing vessels from disturbing a
planned environmental remediation
area that is located to the northeast of
MCAF.
The proposed rule was published in
the August 31, 2010, edition of the
Federal Register (75 FR 53264) and the
docket number was COE–2010–0032. In
September 2010, the Corps Baltimore
and Norfolk districts issued public
notices soliciting comments on the
proposal from all known interested
parties. The districts received three
comments.
One commenter indicated that this
action does not require essential fish
habitat (EFH) conservation measures to
protect EFH. Another commenter said
that the proposed undertaking would
have no effect on historic resources in
Maryland. One commenter stated that
the establishment of the restricted area
would not impact recreation nor would
it adversely affect any documented
state-listed plant or animal species in
Virginia.
None of these comments warrant
changes to the rule text. However, to
provide clarity in the final rule, the
following changes were made to the rule
text:
1. The provisions concerning the
timing of the restrictions stated in
E:\FR\FM\04FER1.SGM
04FER1
]]>Agencies
[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Rules and Regulations]
[Pages 6326-6327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2519]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 516
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Masitinib
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect conditional approval of an application for
a new animal drug intended for a minor use filed by AB Science. The
application for conditional approval provides for the veterinary
prescription use of masitinib mesylate tablets in dogs.
DATES: This rule is effective February 4, 2011.
FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8322, e-mail:
lisa.troutman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: AB Science, 3 Avenue George V, 75008 Paris,
France, filed an application for conditional approval (141-308) that
provides for veterinary prescription use of KINAVET-CA1 (masitinib
mesylate) Tablets for the treatment of recurrent (post-surgery) or
nonresectable Grade II or III cutaneous mast cell tumors in dogs that
have not previously received radiotherapy and/or chemotherapy except
corticosteroids. In accordance with the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), as amended by the Minor Use and Minor
Species Animal Health Act of 2004 (MUMS Act), this drug is
conditionally approved as of December 15, 2010, and the regulations in
part 516 (21 CFR part 516) are amended by adding new Sec. 516.1318.
In addition, AB Science has not been previously listed in the
animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support conditional
approval of this application may be seen in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday
through Friday.
The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
KINAVET-CA1 (masitinib mesylate) Tablets for the intended uses
conditionally approved by FDA under application number 141-308
qualifies for 7 years of exclusive marketing rights beginning on the
date of conditional approval. This new animal drug qualifies for
exclusive marketing rights under section 573(c) of the FD&C Act (21
U.S.C. 360ccc-2(c)) because it has
[[Page 6327]]
been declared a designated new animal drug by FDA under section 573(a)
of the FD&C Act.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and
516 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``AB Science''; and in the table in paragraph (c)(2),
numerically add an entry for ``052913'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
AB Science, 3 Avenue George V, 75008 Paris, France...... 052913
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
052913.............................. AB Science, 3 Avenue George V,
75008 Paris, France.
* * * * *
------------------------------------------------------------------------
PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
0
3. The authority citation for 21 CFR part 516 continues to read as
follows:
Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.
0
4. Add Sec. 516.1318 to subpart E to read as follows:
Sec. 516.1318 Masitinib.
(a) Specifications. Each tablet contains 50 or 150 milligrams (mg)
masitinib mesylate.
(b) Sponsor. See No. 052913 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. 12.5 mg/kilograms (5.7
mg/lb) of body weight daily.
(2) Indications for use. For the treatment of recurrent (post-
surgery) or nonresectable Grade II or III cutaneous mast cell tumors in
dogs that have not previously received radiotherapy and/or chemotherapy
except corticosteroids.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.
Dated: January 28, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-2519 Filed 2-3-11; 8:45 am]
BILLING CODE 4160-01-P
