Legal Status
Legal Status
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
A Rule by the Food and Drug Administration on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- Publication Date:
- 03/31/2006
- Agencies:
- Food and Drug Administration
- Dates:
- This rule is effective March 31, 2006.
- Effective Date:
- 03/31/2006
- Document Type:
- Rule
- Document Citation:
- 71 FR 16221
- Page:
- 16221-16222 (2 pages)
- CFR:
- 21 CFR 522
- Document Number:
- 06-3118
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Published Document
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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 an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the veterinary prescription use of flunixin meglumine injectable solution for the control of inflammation in horses and cattle.
DATES:
This rule is effective March 31, 2006.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Christopher Melluso, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: christopher.melluso@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-387 for the use of Flunixin Injectable Solution by veterinary Start Printed Page 16222prescription for the control of inflammation in horses and cattle. Cross Vetpharm Group's Flunixin Injectable Solution is approved as a generic copy of Schering-Plough Animal Health's BANAMINE (flunixin) Solution, approved under NADA 101-479. The ANADA is approved as of March 2, 2006, and the regulations in 21 CFR 522.970 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.
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.
The agency 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 SubjectsList of Subjects in 21 CFR Part 522
End List of Subjects Start Amendment PartTherefore, 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 PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 360b.
End Authority2. 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”.
End Amendment Part Start SignatureDated: March 13, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3118 Filed 3-30-06; 8:45 am]
BILLING CODE 4160-01-S