Food and Drug Administration, HHS.
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 a new pouch size of oxytetracycline hydrochloride soluble powder used to make medicated drinking water for swine.
This rule is effective July 21, 2003.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed a supplement to ANADA 200-144 that provides for a new pouch size of TETROXY (oxytetracycline HCl) Soluble Powder used to make medicated drinking water for administration to swine. The supplemental application is approved as of April 21, 2003, and the regulations are amended in 21 CFR 520.1660d 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 Subjects
List of Subjects in 21 CFR Part 520
- Animal drugs
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, 21 CFR part 520 is amended as follows:End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation for 21 CFR part 520 continues to read as follows:End Amendment Part
2. Section 520.1660d Oxytetracycline hydrochloride soluble powder is amended in paragraph (a)(9) by removing “and 19.75 oz” and by adding in its place “, 19.75 oz, and 3.91 lb”.End Amendment Part Start Signature
Dated: July 8, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 03-18351 Filed 7-18-03; 8:45 am]
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