[Federal Register Volume 65, Number 172 (Tuesday, September 5, 2000)]
[Rules and Regulations]
[Pages 53581-53582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22572]


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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 
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 monensin 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, for increased rate of 
weight gain, and improved feed efficiency in broiler chickens. 
Technical corrections are also being made.

DATES: This rule is effective September 5, 2000.

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.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
141-164 that provides for use of Coban (44, 45, or 60 grams 
per pound (g/lb) of monensin activity as monensin sodium) and 
Tylan (10 g/lb of tylosin phosphate) Type A medicated 
articles to make combination Type C medicated broiler chicken feeds. 
The combination Type C medicated feeds contain 90 to 110 g/ton monensin 
and 4 to 50 g/ton tylosin phosphate and are used as an aid in the 
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. 
acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate 
of weight gain, and improved feed efficiency in broiler chickens. The 
NADA is approved as of July 3, 2000, and the regulations in 21 CFR 
558.355 are amended to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    Also, 21 CFR 558.625 is being revised by updating the address for 
Dockets Management Branch in paragraph (a) and by moving paragraph 
(f)(1)(vi)(e) to precede paragraph (f)(2), correcting a sequence error 
in the format of this paragraph.
    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.
    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

[[Page 53582]]

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)(1)(xxviii) to 
read as follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (1) * * *
    (xxviii) Amount per ton. Monensin, 90 to 110 grams, plus tylosin 
phosphate, 4 to 50 grams.
    (a) Indications for use. As an aid in the prevention of coccidiosis 
caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. 
mivati, and E. maxima, for increased rate of weight gain, and improved 
feed efficiency.
    (b) Limitations. Feed continuously as sole ration. In the absence 
of coccidiosis, the use of monensin with no withdrawal period may limit 
feed intake resulting in reduced weight gain. Do not feed to laying 
chickens. As monensin sodium and tylosin phosphate provided by No. 
000986 in Sec. 510.600(c) of this chapter.
* * * * *


Sec. 558.625  [Amended]

    3. Section 558.625Tylosin is amended in paragraph (a) by removing 
``rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857,'' and by adding in 
its place ``5630 Fishers Lane, rm. 1061, Rockville, MD 20852,'' and by 
redesignating paragraph (f)(2)(v)(e) as paragraph (f)(1)(vi)(e).

    Dated: August 23, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-22572 Filed 9-1-00; 8:45 am]
BILLING CODE 4160-01-F