[Federal Register: December 5, 2002 (Volume 67, Number 234)]
[Rules and Regulations]
[Page 72369-72370]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de02-7]
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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; Salinomycin and Tylosin
Phosphate
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 new animal drug application
(NADA) filed by Elanco Animal Health. The NADA provides for use of
approved, single-ingredient salinomycin and tylosin phosphate Type A
medicated articles to make two-way combination Type C medicated feeds
used as an aid in the prevention of coccidiosis, and for increased rate
of weight gain and improved feed efficiency in broiler chickens.
DATES: This rule is effective December 5, 2002.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1600, e-mail:
candres@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA
141-198 that provides for use of BIO-COX (30 or 60 grams per pound (g/
lb) salinomycin activity) and TYLAN (10, 40, or 100 g/lb tylosin
phosphate) Type A medicated articles to make two-way combination Type C
medicated broiler chicken feeds. The combination Type C medicated feeds
contain 40 to 60 g/ton salinomycin and 4 to 50 g/ton tylosin phosphate
and are used for the prevention of coccidiosis caused by Eimeria
tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E.
mivati, and for increased rate of weight gain and improved feed
efficiency in broiler chickens. The NADA is approved as of September 4,
2002, and the regulations in 21 CFR 558.550 and 558.625 are being
amended 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 21 CFR 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.
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 558.550 is amended by adding paragraph (d)(1)(xxii) to
read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(d) * * *
(1) * * *
(xxii) Amount per ton. Salinomycin, 40 to 60 grams; plus tylosin, 4
to 50 grams.
(A) Indications for use. As an aid in the prevention of coccidiosis
caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E.
brunetti, and E. mivati, and for increased rate of weight gain and
improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as
sole ration. Do not feed to laying hens. Not approved for use with
pellet binders. May be fatal if accidentally fed to adult turkeys or
horses. Salinomycin as provided by 046573; tylosin phosphate as
provided by 000986 in Sec. 510.600(c) of this chapter.
* * * * *
[[Page 72370]]
3. Section 558.625 is amended by adding paragraph (f)(2)(viii) to
read as follows:
Sec. 558.625 Tylosin.
* * * * *
(f) * * *
(2) * * *
(viii) Salinomycin as in Sec. 558.550.
Dated: November 21, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-30784 Filed 12-4-02; 8:45 am]
BILLING CODE 4160-01-S