[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)] [Rules and Regulations] [Page 31027] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-15466] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Neomycin Sulfate Soluble Powder
Agency
Food and Drug Administration, HHS.
Action
Final rule.
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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 Wade Jones Co., Inc. The ANADA provides for the use of a generic neomycin sulfate soluble powder in drinking water and milk for cattle (excluding veal calves), swine, sheep, and goats for the treatment and control of colibacillosis.
EFFECTIVE DATE: June 19, 1996.
For Further Information Contact
Melanie R. Berson, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1643.
Supplementary Information
Wade Jones Co., Inc., Hwy. 71 North, Lowell, AK 72745, filed ANADA 200-130, which provides for the use of neomycin sulfate soluble powder in drinking water and milk for cattle (excluding veal calves), swine, sheep, and goats for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate. ANADA 200-130 is approved as a generic copy of the Upjohn Co.'s NADA 11-315. The ANADA is approved as of May 8, 1996, and the regulations are amended in 21 CFR 520.1484(b) and (c)(3) to reflect the approval. The basis for approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of part 20 (21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.24(d)(1)(i) 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.
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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b).
2. Section 520.1484 is amended by revising paragraph (b) and the last sentence of paragraph (c)(3) to read as follows:
Sec. 520.1484 Neomycin sulfate soluble powder.
* * * * * (b) Sponsors. See Nos. 000009, 000069, 047864, 050604, and 059130 in Sec. 510.600(c) of this chapter. (c) * * * (3) * * * Discontinue treatment prior to slaughter as follows: For sponsors 000009, 000069, 047864, and 050604--cattle (not for use in veal calves), 1 day; sheep, 2 days; swine and goats, 3 days.
Dated: June 10, 1996. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 96-15466 Filed 6-18-96; 8:45 am] BILLING CODE 4160-01-F