Document ID: FDA-2008-N-0039-0060
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Amprolium
Posted Date: 2008-08-06T04:00Z

[Federal Register: August 6, 2008 (Volume 73, Number 152)]
[Rules and Regulations]               
[Page 45610-45611]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au08-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

 
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

[[Page 45611]]

animal drug regulations to reflect approval of a supplemental new 
animal drug application (NADA) filed by Phibro Animal Health. The 
supplemental NADA provides for label revisions associated with a 
previous change of sponsorship and other minor changes for amprolium 
concentrate solution to make medicated drinking water for chickens and 
turkeys for the treatment of coccidiosis. The product approval is being 
codified for the first time.

DATES: This rule is effective August 6, 2008.

FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: 
donald.prater@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Phibro Animal Health, 65 Challenger Rd., 3d 
floor, Ridgefield Park, NJ 07660, filed a supplement to NADA 13-663 
that provides for the use of COCCIPROL (amprolium) 9.6% Oral Solution 
to make medicated drinking water for chickens and turkeys for the 
treatment of coccidiosis. The supplemental NADA provides for label 
revisions associated with a previous change of sponsorship and other 
minor changes. The supplemental NADA is approved as of July 8, 2008, 
and the regulations are amended in 21 CFR 520.100 to reflect the 
approval. The product approval is being codified for the first time. 
Also, Sec.  520.100 is revised to reflect current pathogen spelling.
    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 Subject 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. In Sec.  520.100, revise paragraph (b), remove paragraph (d), 
redesignate paragraph (e) as paragraph (d), and revise new paragraphs 
(d)(2)(i)(A) and (d)(2)(i)(B) to read as follows:

Sec.  520.100  Amprolium.

* * * * *
    (b) Sponsors. See sponsors in 510.600(c) of this chapter.
    (1) No. 016592 for use of products described in paragraph (a) of 
this section as in paragraph (d) of this section.
    (2) Nos. 051311 and 066104 for use of product described in 
paragraph (a)(1) of this section as in paragraph (d)(1) of this 
section.
    (3) No. 059130 for use of product described in paragraph (a)(1) of 
this section as in paragraph (d)(2) of this section.
* * * * *
    (d) * * *
    (2) * * *
    (i) * * * (A) As an aid in the prevention of coccidiosis caused by 
Eimeria bovis and E. zurnii, administer 5 mg per kilogram (mg/kg) body 
weight for 21 days during periods of exposure or when experience 
indicates that coccidiosis is likely to be a hazard.
    (B) As an aid in the treatment of coccidiosis caused by E. bovis 
and E. zurnii, administer 10 mg/kg body weight for 5 days.
* * * * *

    Dated: July 28, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-18093 Filed 8-5-08; 8:45 am]

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