Food and Drug Administration, HHS.
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.
This rule is effective October 25, 2007.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects in 21 CFR Part 520End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
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.”End Amendment Part Start Signature
Dated: October 17, 2007.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21054 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S