[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)] [Rules and Regulations] [Page 14356] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-7699] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Bambermycins; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulation for bambermycins to correct several cross-references in that regulation. In approving a new animal drug application (NADA) filed by Hoechst Roussel Vet, FDA failed to amend certain cross- references to conform to amendments in the approval document and to provide certain other cross-references. This document provides for those conforming amendments and cross-references. EFFECTIVE DATE: March 25, 1998. FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1739. SUPPLEMENTARY INFORMATION: In amending the bambermycins regulation to reflect approval of Hoechst Roussel Vet's NADA 141-034 (use of bambermycins Type A medicated articles to make Type C medicated cattle feeds), FDA amended Sec. 558.95 (21 CFR 558.95) by redesignating paragraph (b) as paragraph (d) (see 62 FR 8373, February 25, 1997), but failed to amend the cross-references in paragraph (a). Furthermore, in approving NADA 141-034 to establish several added uses in Sec. 558.95(b)(4) (currently Sec. 558.95(d)(4)) (see 59 FR 15624, April 4, 1994 and 61 FR 43654, August 26, 1996), FDA failed to provide reference in paragraph (a)(5) to uses in paragraphs (b)(4)(ii) and (b)(4)(iii) (current paragraphs (d)(4)(ii) and (d)(4)(iii)). Section 558.95 is amended by revising paragraph (a), by revising the cross- references to paragraphs (d)(1), (d)(2), (d)(3), and (d)(4), as appropriate, and by expanding those references in paragraph (a)(5) to reflect all uses in paragraph (d)(4). 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: 21 U.S.C. 360b, 371. 2. Section 558.95 is amended by revising paragraph (a) to read as follows: Sec. 558.95 Bambermycins. (a) Approvals. To sponsors identified by drug labeler codes in Sec. 510.600(c) of this chapter for use of bambermycins Type A medicated articles as bambermycins activity per pound in paragraph (d) of this section as follows: (1) To 012799: 2, 4, and 10 grams for use as in paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of this section. (2) To 012799: 0.4 gram for use as in paragraph (d)(2) of this section. (3) To 011490: 0.4 and 2 grams for use as in paragraph (d)(2) of this section. (4) To 012286, 016968, and 017790: 0.4 and 2 grams for use as in paragraph (d)(2) and 2 grams for use as in paragraph (d)(3) of this section. (5) To 012799: 10 grams to make 40 to 800 grams per ton Type B feed for use as in paragraph (d)(4) of this section. * * * * * Dated: March 12, 1998. Andrew J. Beaulieau, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 98-7699 Filed 3-24-98; 8:45 am] BILLING CODE 4160-01-F