Oral Dosage Form New Animal Drugs; Fenbendazole Suspension, 17770 [E9-8822]
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Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Rules and Regulations
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[FR Doc. E9–8801 Filed 4–16–09; 8:45 am]
BILLING CODE 0000–00–P
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337,
e-mail: melanie.berson@fda.hhs.gov.
Intervet,
Inc., P.O. Box 318, 29160 Intervet Lane,
Millsboro, DE 19966, filed a supplement
to NADA 104–494 that provides for use
of PANACUR (fenbendazole)
Suspension 10% in horses for the
control of various internal parasites. The
supplemental NADA provides for a
revised human food safety warning on
product labeling. The supplemental
NADA is approved as of March 25,
2009, and the regulations are amended
in 21 CFR 520.905a 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(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.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 520
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Animal drugs.
[Docket No. FDA–2009–N–0665]
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:
Oral Dosage Form New Animal Drugs;
Fenbendazole Suspension
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
■
Food and Drug Administration
21 CFR Part 520
AGENCY:
Food and Drug Administration,
1. The authority citation for 21 CFR
part 520 continues to read as follows:
■
HHS.
ACTION:
Final rule.
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
Intervet, Inc. The supplemental NADA
provides for a revised human food
safety warning for use of fenbendazole
suspension in horses.
DATES: This rule is effective April 17,
2009.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Authority: 21 U.S.C. 360b.
dwashington3 on PROD1PC60 with RULES
SUMMARY:
VerDate Nov<24>2008
15:01 Apr 16, 2009
Jkt 217001
2. Amend § 520.905a as follows:
a. Revise paragraph (a);
■ b. Remove paragraph (e);
■ c. Redesignate paragraph (d) as
paragraph (e);
■ d. Add new paragraph (d); and
■ e. Revise newly redesignated
paragraphs (e)(1)(i), (e)(1)(iii), (e)(2)(i),
(e)(2)(iii), (e)(3)(i), (e)(3)(ii) , and
(e)(4)(i).
The revisions and addition are to read
as follows:
■
■
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
§ 520.905a
Fenbendazole suspension.
(a) Specifications. Each milliliter of
suspension contains 100 milligrams
(mg) fenbendazole.
*
*
*
*
*
(d) Special considerations—(1) See
§ 500.25 of this chapter.
(2) Fenbendazole suspension 10
percent and approved forms of
trichlorfon, when used concomitantly
for treating the indications provided in
paragraph (e) of this section and for
treating infections of stomach bot as
provided in § 520.2520, have been
shown to be compatible and not to
interfere with one another.
(e) * * *
(1) * * *
(i) Amount. Administer orally 5 mg
per kilogram (/kg) (2.3 mg per pound (/
lb)) for the control of large strongyles,
small strongyles, and pinworms; 10 mg/
kg for the control of ascarids.
*
*
*
*
*
(iii) Limitations. Administer by dose
syringe or suitable plastic syringe. Do
not use in horses intended for human
consumption.
(2) * * *
(i) Amount. Administer orally 5 mg/
kg of body weight (2.3 mg/lb).
*
*
*
*
*
(iii) Limitations. Retreatment may be
needed after 4 to 6 weeks. Cattle must
not be slaughtered within 8 days
following last treatment.
(3) * * *
(i) Amount. Administer orally 10 mg/
kg of body weight.
(ii) Indications for use. For the
removal and control of stomach worm
(4th stage inhibited larvae/type II
ostertagiasis), Ostertagia ostertagi, and
tapeworm, Moniezia benedeni.
*
*
*
*
*
(4) * * *
(i) Amount. Administer orally 5 mg/
kg of body weight (2.3 mg/lb).
*
*
*
*
*
Dated: April 9, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E9–8822 Filed 4–16–09; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\17APR1.SGM
17APR1
]]>Agencies
[Federal Register Volume 74, Number 73 (Friday, April 17, 2009)]
[Rules and Regulations]
[Page 17770]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8822]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2009-N-0665]
Oral Dosage Form New Animal Drugs; Fenbendazole Suspension
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 Intervet, Inc. The supplemental NADA
provides for a revised human food safety warning for use of
fenbendazole suspension in horses.
DATES: This rule is effective April 17, 2009.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed a supplement to NADA 104-494 that
provides for use of PANACUR (fenbendazole) Suspension 10% in horses for
the control of various internal parasites. The supplemental NADA
provides for a revised human food safety warning on product labeling.
The supplemental NADA is approved as of March 25, 2009, and the
regulations are amended in 21 CFR 520.905a 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(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 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. 520.905a as follows:
0
a. Revise paragraph (a);
0
b. Remove paragraph (e);
0
c. Redesignate paragraph (d) as paragraph (e);
0
d. Add new paragraph (d); and
0
e. Revise newly redesignated paragraphs (e)(1)(i), (e)(1)(iii),
(e)(2)(i), (e)(2)(iii), (e)(3)(i), (e)(3)(ii) , and (e)(4)(i).
The revisions and addition are to read as follows:
Sec. 520.905a Fenbendazole suspension.
(a) Specifications. Each milliliter of suspension contains 100
milligrams (mg) fenbendazole.
* * * * *
(d) Special considerations--(1) See Sec. 500.25 of this chapter.
(2) Fenbendazole suspension 10 percent and approved forms of
trichlorfon, when used concomitantly for treating the indications
provided in paragraph (e) of this section and for treating infections
of stomach bot as provided in Sec. 520.2520, have been shown to be
compatible and not to interfere with one another.
(e) * * *
(1) * * *
(i) Amount. Administer orally 5 mg per kilogram (/kg) (2.3 mg per
pound (/lb)) for the control of large strongyles, small strongyles, and
pinworms; 10 mg/kg for the control of ascarids.
* * * * *
(iii) Limitations. Administer by dose syringe or suitable plastic
syringe. Do not use in horses intended for human consumption.
(2) * * *
(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
* * * * *
(iii) Limitations. Retreatment may be needed after 4 to 6 weeks.
Cattle must not be slaughtered within 8 days following last treatment.
(3) * * *
(i) Amount. Administer orally 10 mg/kg of body weight.
(ii) Indications for use. For the removal and control of stomach
worm (4th stage inhibited larvae/type II ostertagiasis), Ostertagia
ostertagi, and tapeworm, Moniezia benedeni.
* * * * *
(4) * * *
(i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
* * * * *
Dated: April 9, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E9-8822 Filed 4-16-09; 8:45 am]
BILLING CODE 4160-01-S
