71 FR 62 pgs. 16221-16222 - Implantation or Injectable Dosage Form New Animal Drugs;Flunixin
Type: RULEVolume: 71Number: 62Pages: 16221 - 16222
FR document: [FR Doc. 06-3118 Filed 3-30-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;Flunixin
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) isamending the animal drug regulations to reflect approval of an abbreviatednew animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. TheANADA provides for the veterinary prescription use of flunixin meglumineinjectable solution for the control of inflammation in horses andcattle.
DATES:
This rule is effective March 31, 2006.
FOR FURTHER INFORMATION CONTACT:
Christopher Melluso,Center for Veterinary Medicine (HFV-104), Food and DrugAdministration, 7500 Standish Pl., Rockville, MD 20855,301-827-0169, e-mail: christopher.melluso@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland,filed ANADA 200-387 for the use of Flunixin Injectable Solution byveterinary prescription for the control of inflammation in horses andcattle. Cross Vetpharm Group's Flunixin Injectable Solution is approved asa generic copy of Schering-Plough Animal Health's BANAMINE (flunixin)Solution, approved under NADA 101-479. The ANADA is approved as ofMarch 2, 2006, and the regulations in 21 CFR 522.970 are amended to reflectthe approval. The basis of approval is discussed in the freedom ofinformation summary.
In accordance with the freedom of information provisions of 21 CFR part20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness dataand information submitted to support approval of this application may beseen in the Division of Dockets Management (HFA-305), Food and DrugAdministration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(1) that this action isof a type that does not individually or cumulatively have a significanteffect on the human environment. Therefore, neither an environmentalassessment 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 5U.S.C. 801-808.
List of Subjects in 21 CFR Part 522
Animaldrugs.
Therefore, under the Federal Food,Drug, and Cosmetic Act and under authority delegated to the Commissioner ofFood and Drugs and redelegated to the Center for Veterinary Medicine, 21CFR part 522 is amended as follows:
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMALDRUGS
1. The authority citation for 21 CFR part 522 continues to read asfollows:
Authority:
21 U.S.C. 360b.
§ 522.970 [Amended]
2. Section 522.970 is amended in paragraphs (b)(2) and (e)(2)(iii)by removing "and 059130" and by adding in its place"059130, and 061623".
Dated: March 13, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3118 Filed 3-30-06; 8:45 am]
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