[Federal Register Volume 62, Number 25 (Thursday, February 6, 1997)] [Rules and Regulations] [Pages 5525-5526] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-3015] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Amoxicillin Bolus and 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 codify two previously approved supplemental new animal drug applications (NADA's) filed by Pfizer, Inc. The supplemental NADA's provide for the use of amoxicillin boluses and soluble powder in preruminating calves including veal calves. EFFECTIVE DATE: February 6, 1997. FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1623. SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017, is sponsor of NADA 55-087 Amoxi-Bol(amoxicillin trihydrate) bolus and NADA 55-088 Amoxi-Sol (amoxicillin trihydrate) soluble powder which provide for treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves. Use is by or on the order of a licensed veterinarian. These supplemental NADA's were approved on October 7, 1993, but the regulations were inadvertently not amended at that time to reflect these approvals. The regulations are now being amended in Secs. 520.88d(d) and 520.88e(d) (21 CFR 520.88d(d) and 520.88e(d)) to reflect the approvals. In addition, the term ``nonruminating'' is being changed to ``preruminating'' to better describe the type of animal being treated. The supplemental approvals provided for further clarification of the class of animals indicated for treatment. No additional safety or effectiveness data were required. Therefore, a freedom of information (FOI) summary is not 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 520.88d is amended by revising the heading for paragraph (d), paragraph (d)(2), and the third sentence in paragraph (d)(3) to read as follows: Sec. 520.88d Amoxicillin trihydrate soluble powder. * * * * * (d) Conditions of use. Preruminating calves including veal calves-- * * * * * (2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves. [[Page 5526]] (3) * * * For use in preruminating calves including veal calves only, not for use in other animals which are raised for food production. * * * 3. Section 520.88e is amended by revising the heading for paragraph (d), paragraph (d)(2), and the first sentence in paragraph (d)(3) to read as follows: Sec. 520.88e Amoxicillin trihydrate boluses. * * * * * (d) Conditions of use. Preruminating calves including veal calves-- * * * * * (2) Indications for use. Treatment of bacterial enteritis when due to susceptible Escherichia coli in preruminating calves including veal calves. (3) Limitations. For oral use in preruminating calves including veal calves only, not for use in other animals which are raised for food production. * * * Dated: January 27, 1997. Robert C. Livingston, Director, Office of New Animal Drug Evaluation Center for Veterinary Medicine [FR Doc. 97-3015 Filed 2-5-97; 8:45 am] BILLING CODE 4160-01-F