68 FR 139 pg. 42968 - New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder
Type: RULEVolume: 68Number: 139Page: 42968
FR document: [FR Doc. 03-18351 Filed 7-18-03; 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 520
New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder
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 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.
DATES:
This rule is effective July 21, 2003.
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: lluther@cvm.fda.gov.
SUPPLEMENTARY 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.
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:
PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 520.1660d [Amended]
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".
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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