[Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)] [Rules and Regulations] [Pages 8373-8374] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-4512] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Bambermycins 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 a supplemental new animal drug application (NADA) filed by Hoechst-Roussel Agri-Vet Co. The supplement provides for using liquid bambermycins Type B medicated feeds to make Type C medicated feeds for cattle fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency. EFFECTIVE DATE: February 25, 1997. FOR FURTHER INFORMATION CONTACT: Russell G. Arnold, Center for Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1674. SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Route 202-206, P.O. Box 2500, Somerville, NJ 08876-1258, filed supplemental NADA 141- 034 that provides for using 10-gram per pound (g/lb) Flavomycin(bambermycins) Type A medicated articles to make 40 to 800 g/ton liquid Type B medicated feeds, the liquid Type B feeds used to make dry Type C medicated feeds. The Type C feeds containing 1 to 4 g/ton bambermycins are for cattle fed in confinement for slaughter to provide 10 to 20 milligrams bambermycins per head per day for increased rate of weight gain and improved feed efficiency. The regulations are amended in Sec. 558.95 (21 CFR 558.95) by adding new paragraph (a)(5), by redesignating paragraph (b) as paragraph (d), and by revising newly redesignated paragraph (d)(4)(i)(b) to reflect the approval. Furthermore, use of liquid Type B feeds to make Type C feeds requires publication of specifications and expiration information. New Sec. 558.95(b) is established to reflect the Type B feed specifications and expiration information. In the interest of issuing uniform regulations in the future, new Sec. 558.95(c) is also established at this time and reserved for future use. Approval of this supplement did not require submission of additional safety or efficacy data. A freedom of information (FOI) summary as in 21 CFR part 20 and 514.11(e)(2)(ii) is not required. An FOI summary submitted to support approval of the original application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, from 9 a.m. to 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 approval for food producing animals does not qualify for marketing exclusivity because the supplement does not contain substantial evidence of effectiveness of the drug involved, any studies of animal safety or human food safety studies (other than bioequivalence or residue studies) required for approval of the supplement and conducted or sponsored by the applicant. The agency has determined under 21 CFR 25.24(d)(1)(iii) 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). 2. Section 558.95 is amended by adding new paragraph (a)(5), by redesignating paragraph (b) as paragraph (d), by adding new paragraph (b), by adding and reserving paragraph (c), and by adding a new fourth sentence to newly redesignated paragraph (d)(4)(i)(b), to read as follows: Sec. 558.95 Bambermycins. (a) * * * (5) 10 grams of activity per pound to 012799 in Sec. 510.600(c) of this chapter to make 40 to 800 gram/ton Type B feeds for use as in paragraph (d)(4)(i) of this section. (b) Special considerations. (1) Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent. (2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture. (c) [Reserved] (d) * * * (4) * * * (i) * * * [[Page 8374]] (b) * * * Liquid Type B feeds containing bambermycins may be used in the preparation of dry complete ration Type C feeds. * * * * * Dated: February 10, 1997. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 97-4512 Filed 2-24-97; 8:45 am] BILLING CODE 4160-01-F