[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)] [Rules and Regulations] [Pages 34168-34169] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-16686] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Gentamicin Sulfate Oral Solution 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 Med-Pharmex, Inc. The ANADA provides for the use of gentamicin sulfate oral solution for the control and treatment of colibacillosis in weanling swine and for the control and treatment of swine dysentery caused by Treponema hyodysenteriae. EFFECTIVE DATE: June 25, 1997. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209. SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767, has filed ANADA 200-190, which provides for the control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for the control and treatment of swine dysentery associated with T. hyodysenteriae. [[Page 34169]] ANADA 200-190 is approved as a generic copy of Schering-Plough Animal Health's Garasin(gentamicin sulfate) oral solution in NADA 91-191. The ANADA is approved as of May 27, 1997, and the regulations are amended in 21 CFR 520.1044a(b) 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 21 CFR part 20 and 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). Sec. 520.1044a [Amended] 2. Section 520.1044a Gentamicin sulfate oral solution is amended in paragraph (b) by removing ``No. 000061'' and adding in its place ``Nos. 000061 and 051259''. Dated: June 12, 1997. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 97-16686 Filed 6-24-97; 8:45 am] BILLING CODE 4160-01-F