E7-21054. Oral Dosage Form New Animal Drugs; Phenylbutazone Paste

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 supplemental new animal drug application (NADA) filed by Luitpold Pharmaceuticals, Inc. The supplemental NADA provides for a revised human food safety warning for phenylbutazone paste, used in horses for relief of inflammatory conditions associated with the musculoskeletal system.

DATES:

This rule is effective October 25, 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: [e-mail].

SUPPLEMENTARY INFORMATION:

Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967, filed a supplement to NADA 140-958 that provides for use of EQUIPHEN (phenylbutazone) Paste in horses for relief of inflammatory conditions associated with the musculoskeletal system. The supplemental NADA provides for a revised human food safety warning on product labeling. The supplemental NADA is approved as of September 26, 2007, and the regulations are amended in 21 CFR 520.1720c to reflect the approval.

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.

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.

§ 520.1720c

[Amended]

2. In § 520.1720c, in paragraph (c)(3), remove “Not for use in horses intended for food.” and add in its place “Do not use in horses intended for human consumption.”

Dated: October 17, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.