Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin, 10596-10597 [E7-4206]
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10596
Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations
erjones on PRODPC74 with RULES
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Fort
Dodge Animal Health, Division of
Wyeth. The supplemental NADA
provides for over-the-counter (OTC)
marketing status for oral use of
oxfendazole suspension in cattle.
DATES: This rule is effective March 9,
2007.
FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, 800 Fifth St. NW., Fort Dodge,
IA 50501, filed a supplement to NADA
140–854 for SYNANTHIC (oxfendazole)
Bovine Dewormer Suspension,
approved for oral use in cattle for the
removal of various internal parasites.
The supplemental NADA provides for
OTC marketing status. The
supplemental application is approved as
of January 29, 2007, and the regulations
are amended in 21 CFR 520.1630 to
reflect the approval and a current
format. 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.
The agency 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 Parts 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:
VerDate Aug<31>2005
15:24 Mar 08, 2007
Jkt 211001
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
1. The authority citation for 21 CFR
part 520 continues to read as follows:
Food and Drug Administration
I
Authority: 21 U.S.C. 360b.
2. Amend § 520.1630 as follows:
I a. Redesignate paragraph (d) as
paragraph (e);
I b. Add new paragraph (d);
I c. Revise the introductory text in
newly redesignated paragraphs (e)(1)
and (e)(2); and
I d. Revise paragraph (a) and newly
redesignated paragraphs (e)(1)(i),
(e)(1)(iii), (e)(2)(i), and (e)(2)(iii).
The redesignation, addition, and
revisions read as follows:
I
§ 520.1630
Oxfendazole suspension.
(a) Specifications. Each milliliter of
suspension contains:
(1) 90.6 milligrams (mg) oxfendazole
(9.06 percent).
(2) 225.0 mg oxfendazole (22.5
percent).
*
*
*
*
*
(d) Special considerations. See
§ 500.25 of this chapter. If labeled for
administration by stomach tube: Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(e) Conditions of use—(1) Horses. Use
the product described in paragraph
(a)(1) of this section as follows:
(i) Amount. 10 mg per kilogram (/kg)
of body weight by stomach tube or dose
syringe. Horses maintained on premises
where reinfection is likely to occur
should be retreated in 6 to 8 weeks.
*
*
*
*
*
(iii) Limitations. Withholding feed or
water prior to use is unnecessary.
Administer drug with caution to sick or
debilitated horses. Do not use in horses
intended for human consumption.
(2) Cattle. Use the products described
in paragraphs (a)(1) and (a)(2) of this
section as follows:
(i) Amount. 4.5 mg/kg of body weight
by dose syringe. Treatment may be
repeated in 4 to 6 weeks.
*
*
*
*
*
(iii) Limitations. Cattle must not be
slaughtered until 7 days after treatment.
Do not use in lactating dairy cattle.
Dated: February 21, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–4205 Filed 3–8–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
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Fmt 4700
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21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Enrofloxacin
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 new animal
drug application (NADA) filed by Bayer
HealthCare LLC. The supplemental
NADA provides for changing scientific
nomenclature for a bovine respiratory
pathogen on labeling for enrofloxacin
injectable solution.
DATES: This rule is effective March 9,
2007.
Joan
C. Gotthardt, Center for Veterinary
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bayer
HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201, filed a supplement
to NADA 141 068 for BAYTRIL 100
(enrofloxacin) Injectable Solution used
for the treatment of bovine respiratory
disease associated with several bacterial
pathogens. The supplemental NADA
provides for changing a pathogen name
from Pasteurella haemolytica to
Mannheimia haemolytica on product
labeling. The supplemental NADA is
approved as of February 15, 2007, and
the regulations in 21 CFR 522.812 are
amended to reflect the approval and a
current format.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
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.
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.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations
List of Subjects in 21 CFR Part 522
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: 21 U.S.C. 360b.
erjones on PRODPC74 with RULES
Food and Drug Administration
2. Revise § 522.812 to read as follows:
§ 522.812
Dated: February 28, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–4206 Filed 3–8–07; 8:45 am]
BILLING CODE 4160–01–S
I
I
not use in calves to be processed for
veal. The effect of enrofloxacin on
bovine reproductive performance,
pregnancy, and lactation have not been
determined.
21 CFR Part 524
Enrofloxacin.
(a) Specifications. Each milliliter (mL)
of solution contains:
(1) 22.7 milligrams (mg) enrofloxacin
or
(2) 100 mg enrofloxacin.
(b) Sponsor. See No. 000859 in
§ 510.600(c) of this chapter.
(c) Related tolerance. See § 556.228 of
this chapter.
(d) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
Federal law prohibits the extra-label use
of this drug in food-producing animals.
(e) Conditions of use—(1) Dogs. Use
the product described in paragraph
(a)(1) of this section as follows:
(i) Amount. 2.5 mg per kilogram (/kg)
of body weight (1.13 mg per pound) as
a single, intramuscular, initial dose
followed by use of tablets twice daily for
2 to 3 days beyond cessation of clinical
signs to a maximum of 10 days.
(ii) Indications for use. For the
management of diseases associated with
bacteria susceptible to enrofloxacin.
(2) Cattle. Use the product described
in paragraph (a)(2) of this section as
follows:
(i) Amount. Single-dose therapy: 7.5
to 12.5 mg/kg of body weight (3.4 to 5.7
mL per 100 pounds) by subcutaneous
injection. Multiple-day therapy: 2.5 to
5.0 mg/kg of body weight (1.1 to 2.3 mL
per 100 pounds) by subcutaneous
injection once daily for 3 to 5 days.
(ii) Indications for use. For the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, and
Haemophilus somnus.
(iii) Limitations. Animals intended for
human consumption must not be
slaughtered within 28 days from the last
treatment. Do not use in cattle intended
for dairy production. A withdrawal
period has not been establishedfor this
product in pre-ruminating calves. Do
VerDate Aug<31>2005
15:24 Mar 08, 2007
Jkt 211001
Ophthalmic and Topical Dosage Form
New Animal Drugs; Imidacloprid and
Moxidectin
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 two new animal drug
applications (NADAs) filed by Bayer
HealthCare LLC. The NADAs provide
for the topical use by veterinary
prescription of topical solutions
containing imidacloprid and two
strengths of moxidectin, one for use on
dogs and the other for use on cats, for
the prevention of heartworm disease,
the treatment of flea infestations, and
the treatment and control of several
internal parasites.
DATES: This rule is effective March 9,
2007.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV-110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855; tel: 301–827–
7540; e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bayer
HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee
Mission, KS 66201, filed NADA 141–
251 that provides for veterinary
prescription use of ADVANTAGE
MULTI (imidacloprid 10% and
moxidectin 2.5%) for Dogs, a topical
solution used for the prevention of
heartworm disease, the treatment of flea
infestations, and the treatment and
control of several internal parasites.
Bayer HealthCare LLC also filed NADA
141–254 that provides for veterinary
prescription use of ADVANTAGE
MULTI (imidacloprid 10% and
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10597
moxidectin 1%) for Cats, a topical
solution used for the prevention of
heartworm disease, the treatment of flea
infestations, and the treatment and
control of ear mites and several internal
parasites. NADA 141–251 is approved
as of December 20, 2006, and NADA
141–254 is approved as of January 19,
2007. Accordingly, the regulations are
amended in part 524 (21 CFR part 524)
by adding § 524.1146 to reflect these
approvals.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii),
summaries of safety and effectiveness
data and information submitted to
support approval of these applications
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 under NADA 141–251
qualifies for 3 years of marketing
exclusivity beginning December 20,
2006, and this approval under NADA
141–254 qualifies for 3 years of
marketing exclusivity beginning January
19, 2007.
The agency has determined under 21
CFR 25.33(d)(1) that these actions are of
a type that do 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 524
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 524 is amended as follows:
I
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 524 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
I
2. Add § 524.1146 to read as follows:
E:\FR\FM\09MRR1.SGM
09MRR1
]]>Agencies
[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Rules and Regulations]
[Pages 10596-10597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Enrofloxacin
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 new animal drug
application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA
provides for changing scientific nomenclature for a bovine respiratory
pathogen on labeling for enrofloxacin injectable solution.
DATES: This rule is effective March 9, 2007.
FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:
joan.gotthardt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement
to NADA 141 068 for BAYTRIL 100 (enrofloxacin) Injectable Solution used
for the treatment of bovine respiratory disease associated with several
bacterial pathogens. The supplemental NADA provides for changing a
pathogen name from Pasteurella haemolytica to Mannheimia haemolytica on
product labeling. The supplemental NADA is approved as of February 15,
2007, and the regulations in 21 CFR 522.812 are amended to reflect the
approval and a current format.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
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.
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.
[[Page 10597]]
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. Revise Sec. 522.812 to read as follows:
Sec. 522.812 Enrofloxacin.
(a) Specifications. Each milliliter (mL) of solution contains:
(1) 22.7 milligrams (mg) enrofloxacin or
(2) 100 mg enrofloxacin.
(b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter.
(c) Related tolerance. See Sec. 556.228 of this chapter.
(d) Special considerations. Federal law restricts this drug to use
by or on the order of a licensed veterinarian. Federal law prohibits
the extra-label use of this drug in food-producing animals.
(e) Conditions of use--(1) Dogs. Use the product described in
paragraph (a)(1) of this section as follows:
(i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per
pound) as a single, intramuscular, initial dose followed by use of
tablets twice daily for 2 to 3 days beyond cessation of clinical signs
to a maximum of 10 days.
(ii) Indications for use. For the management of diseases associated
with bacteria susceptible to enrofloxacin.
(2) Cattle. Use the product described in paragraph (a)(2) of this
section as follows:
(i) Amount. Single-dose therapy: 7.5 to 12.5 mg/kg of body weight
(3.4 to 5.7 mL per 100 pounds) by subcutaneous injection. Multiple-day
therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL per 100 pounds)
by subcutaneous injection once daily for 3 to 5 days.
(ii) Indications for use. For the treatment of bovine respiratory
disease (BRD) associated with Mannheimia haemolytica, Pasteurella
multocida, and Haemophilus somnus.
(iii) Limitations. Animals intended for human consumption must not
be slaughtered within 28 days from the last treatment. Do not use in
cattle intended for dairy production. A withdrawal period has not been
established for this product in pre-ruminating calves. Do not use in
calves to be processed for veal. The effect of enrofloxacin on bovine
reproductive performance, pregnancy, and lactation have not been
determined.
Dated: February 28, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E7-4206 Filed 3-8-07; 8:45 am]
BILLING CODE 4160-01-S
