[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]
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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.
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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
