Document ID: FDA-2011-N-0003-0023
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Amprolium
Posted Date: 2011-07-12T04:00Z

[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Rules and Regulations]
[Page 40808]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17465]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Amprolium

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an original abbreviated new 
animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The 
original ANADA provides for the use of amprolium soluble powder for the 
treatment of coccidiosis in chickens and turkeys.

DATES: This rule is effective July 12, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-488 for the use of 
AMPROMED-P (amprolium) for poultry, a water-soluble powder used for the 
treatment of coccidiosis in chickens and turkeys. Cross Vetpharm Group 
Ltd.'s AMPROMED-P for Poultry is approved as a generic copy of 
Huvepharma AD's AMPROL 128 (amprolium) 20% Soluble Powder, approved 
under NADA 33-165. The ANADA is approved as of May 23, 2011, and the 
regulations in 21 CFR 520.100 are amended 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 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.
    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. In Sec.  520.100, paragraph (b)(4) is revised to read as follows:

Sec.  520.100  Amprolium.

* * * * *
    (b) * * *
    (4) No. 061623 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (d)(1) and (d)(2) of this section.
* * * * *

    Dated: June 30, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-17465 Filed 7-11-11; 8:45 am]
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