New Animal Drugs for Use in Animal Feeds; Chlortetracycline

Hoffmann-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110, filed a supplement to NADA 48-761, Aureomycin (chlortetracycline) mineral, Type C cattle feed containing 4 grams CTC per lb. The supplement provides for free-choice feeding to grazing beef cattle weighing over 700 lb at 0.0125 to 0.05 lb of Type C feed per 100 lb of body weight per day (0.5 to 2.0 milligrams (mg) CTC per lb of body weight per day) for control of active infections of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. The supplement is approved as of July 10, 1996, and the regulations are amended in 21 CFR 558.128(c)(4) to reflect the approval. The basis of approval is discussed in the freedom of information summary. With approval of this supplement, cattle may be fed 0.5 to 2.0 mg CTC per head per day. To provide for safe use at the upper limit, a withdrawal time of 4 days prior to slaughter is provided. Use of Type A medicated articles to make free-choice CTC Type C medicated feeds requires an approved Form FDA 1900 as in 21 CFR 510.455. 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. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning July 10, 1996, because the supplemental application contains reports of new clinical or field investigations (other than bioequivalence or residue studies) or human food safety studies (other than bioequivalence or residue studies) essential to the approval and conducted or sponsored by the applicant. The 3 years of marketing exclusivity applies only to the new claim for which the supplement was approved. The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds. 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 558 is amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.128 [Amended]

2. Section 558.128 Chlortetracycline is amended in paragraph (c)(4) by removing the phrase ``daily minimum intake of 0.5 milligram of chlortetracycline per pound of body weight to aid in the prevention of anaplasmosis'' and adding in its place ``daily intake of 0.5 to 2.0 milligrams of chlortetracycline per pound of body weight to aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; discontinue use 4 days prior to slaughter''.

Dated: May 31, 1996. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 96-17315 Filed 7-9-96; 8:45 am] BILLING CODE 4160-01-F