Document ID: FDA-2009-N-0665-0010
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Amprolium - Final Rule
Posted Date: 2009-03-11T04:00Z

[Federal Register: March 11, 2009 (Volume 74, Number 46)]
[Rules and Regulations]               
[Page 10483-10484]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr09-10]                         

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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; Amprolium

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides 
for the use of generic amprolium concentrate solution to make medicated 
drinking water for chickens and turkeys for the treatment of 
coccidiosis.

DATES:  This rule is effective March 11, 2009.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th

[[Page 10484]]

Street Ter., St. Joseph, MO 64503, filed ANADA 200-463 that provides 
for the use of Amprolium 9.6% Oral Solution to make medicated drinking 
water for chickens and turkeys for the treatment of coccidiosis. IVX 
Animal Health, Inc.'s Amprolium 9.6% Oral Solution is approved as a 
generic copy of Huvepharma, AD's AMPROVINE 9.6% Solution, approved 
under NADA 13-149. The ANADA is approved as of February 12, 2009, and 
the regulations are amended in 21 CFR 520.100 to reflect the approval.
    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 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

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

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2. In Sec.  520.100, revise paragraph (b)(3) to read as follows:

Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (3) No. 059130 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d) of this section.
* * * * *

    Dated: February 27, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-5131 Filed 3-10-09; 8:45 am]

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