Implantation or Injectable Dosage Form New Animal Drugs; Flunixin, 15564 [06-3006]
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15564
Federal Register / Vol. 71, No. 60 / Wednesday, March 29, 2006 / Rules and Regulations
used to sweeten this food, unlike sugars,
does not promote tooth decay.
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Dated: March 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06–3007 Filed 3–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Flunixin
AGENCY:
Food and Drug Administration,
HHS.
hsrobinson on PROD1PC68 with RULES
ACTION:
Final rule.
List of Subjects in 21 CFR Part 522
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental abbreviated
new animal drug application (ANADA)
filed by Norbrook Laboratories, Ltd. The
supplemental ANADA provides for the
veterinary prescription use of flunixin
meglumine solution by intravenous
injection in lactating dairy cattle for
control of fever associated with bovine
respiratory disease and endotoxemia,
and for control of inflammation in
endotoxemia.
DATES: This rule is effective March 29,
2006.
FOR FURTHER INFORMATION CONTACT:
Christopher Melluso, Center for
Veterinary Medicine (HFV–104), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301–827–
0169, e-mail:
christopher.melluso@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed
supplemental ANADA 200–308 that
provides for veterinary prescription use
of Flunixin Injection intravenously in
lactating dairy cattle for control of fever
associated with bovine respiratory
disease and endotoxemia, and for
control of inflammation in endotoxemia.
The supplemental ANADA is approved
as of March 1, 2006, and the regulations
are amended in 21 CFR 522.970 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
VerDate Aug<31>2005
15:34 Mar 28, 2006
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.
FDA has determined under 21 CFR
25.33(a)(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.
Jkt 208001
Animal drugs.
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 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
2. Section 522.970 is amended by
revising paragraph (e)(2)(iii) to read as
follows:
I
§ 522.970
Flunixin.
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(e) * * *
(2) * * *
(iii) Limitations. Do not slaughter for
food use within 4 days of last treatment.
A withdrawal period has not been
established for use in preruminating
calves. Do not use in calves to be
processed for veal. For Nos. 000061,
055529, and 059130: Do not use in dry
dairy cows. Milk that has been taken
during treatment and for 36 hours after
the last treatment must not be used for
food. For No. 057561: Not for use in
lactating or dry dairy cows.
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Dated: March 20, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–3006 Filed 3–28–06; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 706
Certifications and Exemptions Under
the International Regulations for
Preventing Collisions at Sea, 1972
Department of the Navy, DOD.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Department of the Navy
is amending its certifications and
exemptions under the International
Regulations for Preventing Collisions at
Sea, 1972 (72 COLREGS), to reflect that
the Deputy Assistant Judge Advocate
General (Admiralty and Maritime Law)
has determined that USS THE
SULLIVANS (DDG 68) is a vessel of the
Navy which, due to its special
construction and purpose, cannot fully
comply with certain provisions of the 72
COLREGS without interfering with its
special function as a naval ship. The
intended effect of this rule is to warn
mariners in waters where 72 COLREGS
apply.
DATES: Effective Date: March 1, 2006.
FOR FURTHER INFORMATION CONTACT:
Commander Gregg A. Cervi, JAGC, U.S.
Navy, Deputy Assistant Judge Advocate
General (Admiralty and Maritime Law),
Office of the Judge Advocate General,
Department of the Navy, 1322 Patterson
Ave., SE., Suite 3000, Washington Navy
Yard, DC 20374–5066, telephone 202–
685–5040.
SUPPLEMENTARY INFORMATION: Pursuant
to the authority granted in 33 U.S.C.
1605, the Department of the Navy
amends 32 CFR Part 706. This
amendment provides notice that the
Deputy Assistant Judge Advocate
General (Admiralty and Maritime Law),
under authority delegated by the
Secretary of the Navy, has certified that
USS THE SULLIVANS (DDG 68) is a
vessel of the Navy which, due to its
special construction and purpose,
cannot fully comply with the following
specific provisions of 72 COLREGS
without interfering with its special
function as a naval ship: Annex I,
paragraph 3(a), pertaining to the
horizontal distance between the forward
and after masthead lights. The Deputy
Assistant Judge Advocate General
(Admiralty and Maritime Law) has also
certified that the lights involved are
located in closest possible compliance
with the applicable 72 COLREGS
requirements. All other previously
certified deviations from the 72
COLREGS not affected by this
amendment remain in effect.
E:\FR\FM\29MRR1.SGM
29MRR1
]]>Agencies
[Federal Register Volume 71, Number 60 (Wednesday, March 29, 2006)]
[Rules and Regulations]
[Page 15564]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3006]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
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 supplemental abbreviated new
animal drug application (ANADA) filed by Norbrook Laboratories, Ltd.
The supplemental ANADA provides for the veterinary prescription use of
flunixin meglumine solution by intravenous injection in lactating dairy
cattle for control of fever associated with bovine respiratory disease
and endotoxemia, and for control of inflammation in endotoxemia.
DATES: This rule is effective March 29, 2006.
FOR FURTHER INFORMATION CONTACT: Christopher Melluso, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail:
christopher.melluso@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, filed supplemental ANADA 200-308 that
provides for veterinary prescription use of Flunixin Injection
intravenously in lactating dairy cattle for control of fever associated
with bovine respiratory disease and endotoxemia, and for control of
inflammation in endotoxemia. The supplemental ANADA is approved as of
March 1, 2006, and the regulations are amended in 21 CFR 522.970 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.
FDA has determined under 21 CFR 25.33(a)(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 522
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. Section 522.970 is amended by revising paragraph (e)(2)(iii) to read
as follows:
Sec. 522.970 Flunixin.
* * * * *
(e) * * *
(2) * * *
(iii) Limitations. Do not slaughter for food use within 4 days of
last treatment. A withdrawal period has not been established for use in
preruminating calves. Do not use in calves to be processed for veal.
For Nos. 000061, 055529, and 059130: Do not use in dry dairy cows. Milk
that has been taken during treatment and for 36 hours after the last
treatment must not be used for food. For No. 057561: Not for use in
lactating or dry dairy cows.
* * * * *
Dated: March 20, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-3006 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S
