[Federal Register Volume 66, Number 176 (Tuesday, September 11, 2001)] [Rules and Regulations] [Pages 47076-47077] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 01-22668] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Lasalocid 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 Alpharma, Inc. The supplemental NADA provides for an increased daily dosage of lasalocid in pasture cattle. DATES: This rule is effective September 11, 2001. FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0223. SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 96-298 that provides for the use of BOVATEC(lasalocid sodium) Premix in cattle. The supplemental NADA provides for an increased daily dosage of lasalocid in pasture cattle. The supplemental NADA is approved as of July 25, 2001, and the regulations are amended in 21 CFR 558.311 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this supplemental application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) 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. This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. 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 558.311 is amended by adding paragraph (d)(7); in the table in paragraph (e)(1) by revising paragraphs (e)(1)(ix) and (e)(1)(xii); by revising paragraphs (e)(2)(iii) and (e)(3)(iii); and in paragraphs (e)(2)(iv) and (e)(3)(iv) by removing ``200'' and adding in its place ``300'' to read as follows: Sec. 558.311 Lasalocid. * * * * * (d) * * * (7) Each use in a free-choice Type C cattle feed as in paragraph (e)(1)(xii) of this section must be the subject of an approved NADA or supplemental NADA as provided in Sec. 510.455 of this chapter. (e)(1) * * * ---------------------------------------------------------------------------------------------------------------- Lasalocid sodium activity in Combination in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ix)............................. Pasture cattle Feed continuously at a 046573 (slaughter, stocker, rate of not less than feeder cattle, and 60 mg or more than dairy and beef 300 mg of lasalocid replacement heifers): per head per day when for increased rate of on pasture; the drug weight gain. Intakes must be contained in of lasalocid in at least 1 pound of excess of 200 mg/head/ feed. day have not been shown to be more effective than 200 mg/ head/day. [[Page 47077]] * * * * * * * (xii)............................ Pasture cattle Feed continuously on a 046573 (slaughter, stocker, free-choice basis at feeder cattle, and a rate of not less dairy and beef than 60 mg or more replacement heifers): than 300 mg of for increased rate of lasalocid per head weight gain. Intakes per day. of lasalocid in excess of 200 mg/head/ day have not been shown to be more effective than 200 mg/ head/day. ................................ Pasture cattle Feed continuously on a 021930 (slaughter, stocker, free-choice basis at feeder cattle, and a rate of not less dairy and beef than 60 mg or more replacement heifers): than 200 mg of for increased rate of lasalocid per head weight gain. per day. * * * * * * * ---------------------------------------------------------------------------------------------------------------- (2) * * * * * * * * (iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day. * * * * * (3) * * * (iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day. * * * * * Dated: August 24, 2001. Claire M. Lathers, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 01-22668 Filed 9-10-01; 8:45 am] BILLING CODE 4160-01-S