Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 520
          - [Docket No. FDA-2009-N-0665]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Final rule; technical amendment.

# 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                           ( print 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

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

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

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

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

§ 520.100

(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]

BILLING CODE 4160-01-S