[Federal Register Volume 63, Number 191 (Friday, October 2, 1998)]
[Rules and Regulations]
[Page 52969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26425]
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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 Bacitracin
Methylene Disalicylate
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 & Co. The supplemental NADA provides for using approved single
ingredient monensin and bacitracin methylene disalicylate (BMD) Type A
medicated articles to make an additional approved combination for a
monensin/BMD Type C medicated turkey feed.
EFFECTIVE DATE: October 2, 1998.
FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed
supplemental NADA 140-937 that provides for combining approved
Coban (45 and 60 grams per pound (g/lb) monensin) and
BMD (25, 30, 40, 50, 60, or 75 g/lb BMD) Type A medicated
articles to make Type C medicated turkey feeds containing 54 to 90 g/
ton (t) monensin and 200 g/t BMD. The monensin/BMD Type C turkey feeds
are used for the prevention of coccidiosis caused by Eimeria adenoides,
E. meleagrimitis, and E. gallopavonis, and as an aid in the control of
transmissible enteritis complicated by organisms susceptible to BMD.
The supplemental NADA is approved as of August 13, 1998, and 21 CFR
558.355(f)(2)(iii) is added to reflect the approval. The basis for
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 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.
2. Section 558.355 is amended by adding paragraph (f)(2)(iii) to
read as follows:
Sec. 558.355 Monensin.
* * * * *
(f) * * *
(2) * * *
(iii) Amount per ton. Monensin, 54 to 90 grams, and bacitracin
methylene disalicylate, 200 grams.
(a) Indications for use. For the prevention of coccidiosis caused
by Eimeria adenoides, E. meleagrimitis, and E. gallopavonis, and as an
aid in the control of transmissible enteritis complicated by organisms
susceptible to bacitracin methylene disalicylate.
(b) Limitations. For growing turkeys only; as monensin sodium; feed
continuously as sole ration. Do not allow horses, other equines, mature
turkeys or guinea fowl access to feed containing monensin. Ingestion of
monensin by horses and guinea fowl has been fatal. Some strains of
turkey coccidia may be monensin tolerant or resistant. Monensin may
interfere with development of immunity to turkey coccidiosis.
Bacitracin methylene disalicylate as provided by No. 046573 in
Sec. 510.600(c) of this chapter.
* * * * *
Dated: September 20, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-26425 Filed 10-1-98; 8:45 am]
BILLING CODE 4160-01-F
