Oral Dosage Form New Animal Drugs; Oxfendazole Suspension, 10595-10596 [E7-4205]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations
generally for congressional review of
agency rules. A reporting requirement is
triggered in instances where NCUA
issues a final rule as defined by Section
551 of the APA. 5 U.S.C. 551. NCUA has
requested a SBREFA determination from
the Office of Management and Budget,
which is pending. As required by
SBREFA, NCUA will file the
appropriate reports with Congress and
the General Accounting Office so that
the final rule may be reviewed.
List of Subjects
12 CFR Part 745
Credit unions, Share insurance.
12 CFR Part 747
Administrative practice and
procedure, Bank deposit insurance,
Claims, Credit unions, Equal access to
justice, Investigations, Lawyers,
Penalties.
I Accordingly, NCUA adopts as final
the interim rule amending 12 CFR parts
745 and 747.
By the National Credit Union
Administration Board on March 1, 2007.
Mary F. Rupp,
Secretary of the Board.
[FR Doc. E7–4225 Filed 3–8–07; 8:45 am]
BILLING CODE 7535–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs;
Fenbendazole Paste
AGENCY:
Food and Drug Administration,
HHS.
erjones on PRODPC74 with RULES
ACTION:
Final rule.
15:24 Mar 08, 2007
List of Subjects in 21 CFR Part 520
Animal drugs.
I 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 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
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of two supplemental new
animal drug applications (NADAs) filed
by Intervet, Inc. The supplemental
NADAs provide for a revised human
food safety warning for fenbendazole
paste, used for the control of various
internal parasites in horses and cattle.
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, 301 827 7540, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
VerDate Aug<31>2005
Millsboro, DE 19966, filed a supplement
to NADA 120–648 that provides for use
of PANACUR (fenbendazole) Paste in
horses for the control of various internal
parasites, and to NADA 132–872 that
provides for use of SAFE-GUARD
(fenbendazole) Paste in cattle for the
control of various internal parasites. The
supplemental NADAs provide for a
revised human food safety warning on
product labeling. The supplemental
NADAs are approved as of February 8,
2007, and the regulations are amended
in 21 CFR 520.905c to reflect the
approval and a current format.
Approval of these supplemental
NADAs did not require review of
additional safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
FDA 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.
Jkt 211001
Authority: 21 U.S.C. 360b.
2. Amend § 520.905c as follows:
a. Revise paragraph (a);
b. Redesignate paragraph (d) as
paragraph (e);
I c. Add new paragraph (d); and
I d. Revise newly redesignated
paragraph (e).
The revisions, redesignation, and
addition read as follows:
I
I
I
§ 520.905c
For control of large strongyles
(Strongylus edentatus, S. equinus, S.
vulgaris), small strongyles, pinworms
(Oxyuris equi), and ascarids (Parascaris
equorum): 2.3 mg per pound (/lb) of
body weight, or for foals and weanlings
(less than 18 months of age), 4.6 mg/lb
of body weight. Retreatment at intervals
of 6 to 8 weeks may be required.
(B) For control of arteritis caused by
the fourth-stage larvae of S. vulgaris: 4.6
mg/lb of body weight daily for 5 days.
Treatment should be initiated in the
spring and repeated in 6 months.
(C) For treatment of encysted mucosal
cyathostome (small strongyle) larvae
including early third-stage (hypobiotic),
late third-stage, and fourth-stage larvae:
4.6 mg/lb of body weight daily for 5
consecutive days.
(D) Fenbendazole paste 10 percent
may be used concomitantly with
approved forms of trichlorfon for the
indications provided in paragraph
(e)(1)(i)(A) of this section and for
treating infections of stomach bots as
provided in § 520.2520.
(ii) Limitations. Do not use in horses
intended for human consumption.
(2) Cattle—(i) Amount. 2.3 mg/lb of
body weight. Re-treatment may be
needed after 4 to 6 weeks.
(ii) Indications for use. For the
removal and control of lungworms
(Dictyocaulus viviparus), stomach
worms (Haemonchus contortus,
Ostertagia ostertagi, Trichostrongylus
axei), and intestinal worms
(Bunostomum phlebotomum,
Nematodirus helvetianus, Cooperia
punctata, C. oncophora,
Trichostrongylus colubriformis, and
Oesophagostomum radiatum).
(iii) Limitations. Cattle must not be
slaughtered within 8 days following last
treatment.
Dated: February 28, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–4204 Filed 3–8–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Fenbendazole paste.
(a) Specifications. Each gram of paste
contains 100 milligrams (mg)
fenbendazole (10 percent).
*
*
*
*
*
(d) Special considerations. See
§ 500.25 of this chapter.
(e) Conditions of use—(1) Horses—(i)
Indications for use and amounts—(A)
PO 00000
10595
Frm 00003
Fmt 4700
Sfmt 4700
Oral Dosage Form New Animal Drugs;
Oxfendazole Suspension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
E:\FR\FM\09MRR1.SGM
09MRR1
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
Frm 00004
Fmt 4700
Sfmt 4700
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
]]>Agencies
[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Rules and Regulations]
[Pages 10595-10596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4205]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Oxfendazole Suspension
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
[[Page 10596]]
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, e-mail:
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.
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. Amend Sec. 520.1630 as follows:
0
a. Redesignate paragraph (d) as paragraph (e);
0
b. Add new paragraph (d);
0
c. Revise the introductory text in newly redesignated paragraphs (e)(1)
and (e)(2); and
0
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:
Sec. 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 Sec. 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
