Oral Dosage Form New Animal Drugs; Firocoxib Paste, 5788 [06-993]
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5788
Federal Register / Vol. 71, No. 23 / Friday, February 3, 2006 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Firocoxib Paste
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC71 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Merial Ltd.
The NADA provides for veterinary
prescription use of firocoxib oral paste
in horses for the control of pain and
inflammation associated with
osteoarthritis.
DATES: This rule is effective February 3,
2006.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION: Merial
Ltd., 3239 Satellite Blvd., Bldg. 500,
Duluth, GA 30096–4640, filed NADA
141–253 for veterinary prescription use
of EQUIOXX (firocoxib) oral paste for
the control of pain and inflammation
associated with osteoarthritis in horses.
The NADA is approved as of December
30, 2005, and 21 CFR part 520 is
amended by adding new § 520.930 to
reflect the approval. The basis of
approval is discussed in the freedom of
information summary.
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 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.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning
December 30, 2005.
The agency has determined under 21
CFR 25.33(d)(1) 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
VerDate Aug<31>2005
16:47 Feb 02, 2006
Jkt 208001
nor an environmental impact statement
is required.
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 in 21 CFR Part 520
Animal drugs.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 520 is amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Revise the section heading of
§ 520.928 to read as follows:
I
§ 520.928
*
I
Firocoxib tablets.
*
*
*
*
3. Add § 520.930 to read as follows:
§ 520.930
Firocoxib paste.
(a) Specifications. Each milligram
(mg) of paste contains 0.82 mg firocoxib.
(b) Sponsors. See No. 050604 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. 0.1 mg per kilogram (0.045 mg
per pound) body weight daily for up to
14 days.
(2) Indications for use. For the control
of pain and inflammation associated
with osteoarthritis.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
Dated: January 18, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06–993 Filed 2–2–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[CGD05–06–009]
RIN 1625–AA00
Security Zone; Choptank River,
Cambridge, MD
AGENCY:
PO 00000
Coast Guard, DHS.
Frm 00012
Fmt 4700
Sfmt 4700
ACTION:
Temporary final rule.
SUMMARY: The Coast Guard is
establishing a temporary security zone
from February 9 through February 12,
2006, encompassing certain waters of
the Choptank River. This action is
necessary to ensure the safety of persons
and property, and prevent terrorist acts
or incidents during the U.S. House
Republican Issues Conference. This rule
prohibits vessels and people from
entering the security zone and requires
vessels and persons in the security zone
to depart the security zone, unless
specifically exempt under the
provisions in this rule or granted
specific permission from the Coast
Guard Captain of the Port Baltimore.
DATES: This rule is effective from 7 a.m.
eastern standard time on February 9,
2006 through 7 a.m. eastern standard
time on February 12, 2006.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket CGD05–06–
009 and are available for inspection or
copying at Commander, Coast Guard
Sector Baltimore, 2401 Hawkins Point
Road, Baltimore, Maryland 21226–1791,
between 9 a.m. and 4 p.m., Monday
through Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Mr.
Ronald Houck, Waterways Management
Division, at Commander, Coast Guard
Sector Baltimore, 2401 Hawkins Point
Road, Baltimore, Maryland 21226–1791,
telephone number (410) 576–2674.
SUPPLEMENTARY INFORMATION:
Regulatory Information
We did not publish a notice of
proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists
for not publishing an NPRM and for
making this rule effective less than 30
days after publication in the Federal
Register. The Coast Guard is
establishing this security zone to
support the United States Capitol Police
Dignitary Protection Division, the lead
federal agency coordinating security for
the U.S. House Republican Issues
Conference, in their efforts to coordinate
security operations and establish a
secure environment for this highly
visible and publicized event. This
temporary security zone of short
duration is necessary to provide for the
security of a large gathering of highranking United States officials, their
families and staff. Additionally, the
publication of an NPRM is contrary to
the public interest as our nation
continues its heightened security
posture. Therefore, immediate action is
E:\FR\FM\03FER1.SGM
03FER1
]]>Agencies
[Federal Register Volume 71, Number 23 (Friday, February 3, 2006)]
[Rules and Regulations]
[Page 5788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-993]
[[Page 5788]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Firocoxib Paste
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by Merial Ltd. The NADA provides for veterinary
prescription use of firocoxib oral paste in horses for the control of
pain and inflammation associated with osteoarthritis.
DATES: This rule is effective February 3, 2006.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.gov.
SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA 30096-4640, filed NADA 141-253 for veterinary
prescription use of EQUIOXX (firocoxib) oral paste for the control of
pain and inflammation associated with osteoarthritis in horses. The
NADA is approved as of December 30, 2005, and 21 CFR part 520 is
amended by adding new Sec. 520.930 to reflect the approval. The basis
of approval is discussed in the freedom of information summary.
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 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.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning December 30, 2005.
The agency has determined under 21 CFR 25.33(d)(1) 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.
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 in 21 CFR Part 520
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Revise the section heading of Sec. 520.928 to read as follows:
Sec. 520.928 Firocoxib tablets.
* * * * *
0
3. Add Sec. 520.930 to read as follows:
Sec. 520.930 Firocoxib paste.
(a) Specifications. Each milligram (mg) of paste contains 0.82 mg
firocoxib.
(b) Sponsors. See No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. 0.1 mg per kilogram
(0.045 mg per pound) body weight daily for up to 14 days.
(2) Indications for use. For the control of pain and inflammation
associated with osteoarthritis.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Dated: January 18, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-993 Filed 2-2-06; 8:45 am]
BILLING CODE 4160-01-S
