[Federal Register Volume 64, Number 11 (Tuesday, January 19, 1999)]
[Rules and Regulations]
[Page 2855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1037]


-----------------------------------------------------------------------

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) filed by 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 (80 grams per pound (g/lb) monensin sodium) and 
Tylan (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. 99-1037 Filed 1-15-99; 8:45 am]
BILLING CODE 4160-01-F