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 Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for a revision to the labeling of cephapirin benzathine intramammary infusion administered to dairy cows entering their dry period for the treatment of mastitis.
This rule is effective March 7, 2008.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 108-114 that revises labeling of CEFA-DRI (cephapirin benzathine) Intramammary Infusion administered to dairy cows entering their dry period for the treatment of mastitis. The application is approved as of February 7, 2008, and the regulations are amended in 21 CFR 526.363 to reflect the approval, an editorial change, and a current format.
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 526End 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 526—INTRAMAMMARY DOSAGE FORMSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 526.363, at the end of paragraph (d)(2), add “, including penicillin-resistant strains”; and in the second sentence of paragraph (d)(3), remove “use” and add in its place “used”.End Amendment Part Start Signature
Dated: February 27, 2008.
Director, Center for Veterinary Medicine.
[FR Doc. E8-4473 Filed 3-6-08; 8:45 am]
BILLING CODE 4160-01-S