Animal drugs, feeds, and related products: New drug applications— Monensin and tylosin,

[Federal Register: January 19, 1999 (Volume 64, Number 11)]

[Rules and Regulations]

[Page 2855]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19ja99-21]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal Feeds; Monensin and Tylosin

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) filedby Elanco Animal Health, A Division of Eli Lilly and Co. The supplemental NADA provides for use of monensin and tylosin Type A medicated articles for making Type B and C cattle feeds, the Type C cattle feed to be fed at a range of 60 to 90 milligrams of tylosin per head per day (mg/hd/day) rather than the currently approved 90 mg/hd/day.

EFFECTIVE DATE: January 19, 1999.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0217.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, filed supplemental NADA 104-646 that provides for combining Rumensin‹Register› (80 grams per pound (g/lb) monensin sodium) and Tylan‹Register› (40 or 100 g/lb tylosin phosphate) Type A medicated articles to make Type B and C medicated cattle feeds. The Type C medicated cattle feeds are to be fed to cattle fed in confinement for slaughter at 50 to 360 mg/hd/day monensin and 60 to 90 mg/hd/day tylosin for improved feed efficiency and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces pyogenes. The tylosin feeding level is the same as currently approved under 21 CFR 558.625(f)(1)(i)(c) for use of tylosin Type C cattle feeds. The supplemental NADA is approved as of November 19, 1998, and the regulations are amended in 21 CFR 558.355(f)(3)(ii)(b) to reflect the approval.

A summary of 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)(2) 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: 21 U.S.C. 360b, 371.

   Sec. 558.355 [Amended]

2. Section 558.355 Monensin is amended in paragraph (f)(3)(ii)(b) by removing ``90'' and adding in its place ``60 to 90.''

   Dated: December 17, 1998. Andrew J. Beaulieu, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

   [FR Doc. 99-1037Filed1-15-99; 8:45 am]

   BILLING CODE 4160-01-F