[Federal Register Volume 60, Number 9 (Friday, January 13, 1995)] [Rules and Regulations] [Pages 3079-3080] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-898] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Salinomycin In Combination AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approval of three abbreviated new animal drug applications (ANADA's) filed by Hoechst-Roussel Agri-Vet Co. The ANADA's provide for using approved Type A medicated articles to make Type C medicated broiler feeds containing salinomycin with chlortetracycline and roxarsone, or salinomycin with chlortetracycline, or salinomycin with oxytetracycline. EFFECTIVE DATE: January 13, 1995. 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: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, Somerville, NJ 08876-1258, filed the following ANADA's: ANADA 200-091, salinomycin with chlortetracycline and roxarsone, which provides for using approved single ingredient Type A medicated articles to make Type C medicated broiler feeds containing 40 to 60 grams per ton (g/t) salinomycin sodium activity, chlortetracycline calcium complex equivalent to 500 g/t chlortetracycline hydrochloride, and 45.4 g/t roxarsone for prevention of coccidiosis and as an aid in reduction of mortality due to certain Escherichia coli infections. ANADA 200-095, salinomycin with chlortetracycline, which provides for using approved single ingredient Type A medicated articles to make Type C medicated broiler feeds containing 40 to 60 g/t salinomycin sodium activity with [[Page 3080]] chlortetracycline calcium complex equivalent to 500 g/t chlortetracycline hydrochloride for prevention of coccidiosis and as an aid in the reduction of mortality due to certain E. coli infections. ANADA 200-096, salinomycin with oxytetracycline, which provides for using approved single ingredient Type A medicated articles to make Type C medicated broiler feeds containing 40 to 60 g/t salinomycin sodium activity with 500 g/t oxytetracycline for prevention of coccidiosis and as an aid in the reduction of mortality due to airsacculitis caused by certain strains of E. coli. ANADA's 200-091 and 200-095 are approved as generic copies of American Cyanamid's NADA's 140-867 and 140-859. ANADA 200-096 is approved as a generic copy of Pfizer's NADA 140-448. ANADA 200-091 is approved as of January 13, 1995. ANADA's 200-095 and 200-096 are approved as of November 25, 1994. The regulations are amended in Secs. 558.450 and 558.550 (21 CFR 558.450 and 558.550) to reflect the approvals. These approvals are for use of Type A medicated articles to make Type C medicated feeds. Roxarsone is a Category II drug which, as in 21 CFR 558.4, requires an approved Form FDA 1900 for making a Type C medicated feed. Use of salinomycin, chlortetracycline, and roxarsone to make Type C medicated feeds as in ANADA 200-091 requires an approved Form FDA 1900. FDA has published several documents amending Sec. 558.550(a) to create paragraphs (a)(1) and (a)(2) and add a series of amendments to paragraph (a)(2). At this time, FDA is editorially amending the regulation following addition of these approvals to simplify the text. In addition, FDA provided for the use of 45 and 45.4 g/t of roxarsone in this regulation. Those used at 45 g/t are amended to read 45.4 g/t. 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 these applications may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 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)(ii) 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 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. 558.450 [Amended] 2. Section 558.450 Oxytetracycline is amended in paragraph (d)(1), in table 1, under the heading ``Sponsor,'' in entry (v) for ``Salinomycin 40 to 60,'' by removing ``000069'' and adding in its place ``000069, 012799''. 3. Section 558.550 is amended by revising paragraph (a)(2) and by amending paragraph (b)(1)(ii)(a) and (b)(1)(xv)(a) by removing ``45'' and adding in its place ``45.4'' to read as follows: Sec. 558.550 Salinomycin. (a) * * * (2) To 012799 for use as in paragraphs (b)(1)(i), (b)(1)(iii) through (b)(1)(xvi), and (b)(3)(i) through (b)(3)(iii) of this section. * * * * * Dated: January 4, 1995. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 95-898 Filed 1-12-95; 8:45 am] BILLING CODE 4160-01-F