Food and Drug Administration, HHS.Start Printed Page 6994
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in dairy cattle for control of pyrexia associated with acute bovine mastitis.
This rule is effective February 12, 2009.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed supplemental ANADA 200-387 that provides for veterinary prescription use of FLUNAZINE (flunixin meglumine) Injectable Solution intravenously in dairy cattle for control of pyrexia associated with acute bovine mastitis. The supplemental ANADA is approved as of December 18, 2008, and the regulations are amended in 21 CFR 522.970 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.Start List of Subjects
List of Subject in 21 CFR Part 522End 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 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. In § 522.970, revise paragraphs (b)(2) and (b)(4) to read as follows:End Amendment Part
(b) * * *
(2) See No. 057561 for use as in paragraphs (e)(1), (e)(2)(i)(A), (e)(2)(ii)(A), and (e)(2)(iii) of this section.
(4) See Nos. 055529, 059130, and 061623 for use as in paragraphs (e)(1) and (e)(2) of this section.
Dated: February 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E9-2941 Filed 2-11-09; 8:45 am]
BILLING CODE 4160-01-S