Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for use of amprolium solution to make medicated drinking water or as a drench for the prevention or treatment of coccidiosis in calves.
This rule is effective September 27, 2006.
John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827-0169, e-mail:
IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200–389 that provides for the use of Amprolium 9.6% Oral Solution to make medicated drinking water or as a drench for the prevention or treatment of coccidiosis in calves. IVX Animal Health's Amprolium 9.6% Oral Solution is approved as a generic copy of Merial Ltd.'s CORID (amprolium) 9.6% Solution approved under NADA 13–149. The ANADA is approved as of September 6, 2006, and the regulations are amended in 21 CFR 520.100 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.
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.
Animal drugs.
21 U.S.C. 360b.
(a)
(2) Each gram of powder contains 200 mg amprolium (20 percent).
(3) Each ounce (28.4 grams) of crumbles contains 355 mg amprolium (1.25 percent).
(b)
(1) No. 050604 for use of products described in paragraph (a) of this section as in paragraph (e) of this section.
(2) No. 051311 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section.
(3) No. 059130 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(2) of this section.
(c)
(d)
(e)
(i)
(ii)
(iii)
(2)
(i)
(B) As an aid in the treatment of coccidiosis caused by
(ii)