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

###### Food and Drug Administration

          - 21 CFR Part 520

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Final rule.

# SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the veterinary prescription use of diclazuril oral pellets in horses for the treatment of equine protozoal myeloencephalitis.

# DATES:

This rule is effective April 27, 2007.

# FOR FURTHER INFORMATION CONTACT:

                        Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:                         *melanie.berson@fda.hhs.gov*.                    

# SUPPLEMENTARY INFORMATION:

                    Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed NADA 141-268 for the veterinary prescription use of PROTAZIL (1.56% diclazuril) Antiprotozoal Pellets in horses for the treatment of equine protozoal myeloencephalitis (EPM) caused by                     *Sarcocystis neurona*. The NADA is approved as of March 29, 2007, and the regulations in 21 CFR part 520 are amended by adding new § 520.606 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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning March 29, 2007.

The agency has determined under 21 CFR 25.33(d)(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                               ( print page 20943)                            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. Add § 520.606 to read as follows: 

§ 520.606

                        (a)                         *Specifications*. Each 100 grams (g) of pellets contain 1.56 g diclazuril.                    

                        (b)                         *Sponsor*. See No. 000061 in § 510.600(c) of this chapter.                    

                        (c)                         *Conditions of use in horses*                        —(1)                         *Amount*. Administer 1 milligram (mg) per kilogram (0.45 mg per pound) of body weight in the daily grain ration for 28 days.                    

                        (2)                         *Indications for use*. For the treatment of equine protozoal myeloencephalitis (EPM) caused by                         *Sarcocystis neurona*.                    

                        (3)                         *Limitations*. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.                    

Dated: April 13, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

[FR Doc. E7-8041 Filed 4-26-07; 8:45 am]

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