[Federal Register Volume 65, Number 251 (Friday, December 29, 2000)]
[Rules and Regulations]
[Pages 82912-82913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33217]


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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; Decoquinate and 
Monensin

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 Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient decoquinate and monensin Type A medicated articles to 
make two-way combination drug Type B and Type C medicated feeds used 
for prevention of coccidiosis and improved feed efficiency in cattle 
fed in confinement for slaughter.

DATES: This rule is effective December 29, 2000.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-148 that provides for use of 
DECCOX (27.2 gram per pound (g/lb) decoquinate) and 
Rumensin (20, 30, 45, 60, 80, or 90.7 g/lb monensin activity 
as monensin sodium) Type A medicated articles to make two-way 
combination Type B and Type C medicated feeds. The Type C medicated 
feeds contain 13.6 to 27.2 
g/ton decoquinate and 5 to 30 g/ton monensin, and are used for 
prevention of coccidiosis caused by Eimeria bovis and E. zuernii, and 
improved feed efficiency in cattle fed in confinement for slaughter. 
The NADA is approved as of November 16, 2000, and the regulations in 21 
CFR 558.195 and 558.355 are amended 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

[[Page 82913]]

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 558.195 is amended in the table in paragraph (d) by 
adding an entry following ``13.6 to 27.2 (0.0015 to 0.003 pct)'' and 
before ``Chlortetracycline approximately 400'' to read as follows:


Sec. 558.195  Decoquinate.

* * * * *
    (d) * * *

 
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Decoquinate in      Combination in grams
   grams per ton            per ton                     Indications for use                           Limitations                        Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
                       *                  *                  *                  *                  *              *                *
                    Monensin 5 to 30         Cattle fed in confinement for slaughter;  Feed only to cattle fed in confinement    046573
                                              for prevention of coccidiosis caused by   for slaughter. Feed continuously as the
                                              Eimeria bovis and E. zuernii, and         sole ration to provide 22.7 mg of
                                              improved feed efficiency.                 decoquinate per 100 lb body weight per
                                                                                        day and 50 to 360 mg of monensin per
                                                                                        head per day. Feed at least 28 days
                                                                                        during period of exposure to
                                                                                        coccidiosis or when it is likely to be
                                                                                        a hazard. Do not feed to animals
                                                                                        producing milk for food. Also see
                                                                                        (c)(1) of this paragraph and Sec.
                                                                                        558.355(d)(8). Monensin as monensin
                                                                                        sodium provided by 000986 in Sec.
                                                                                        510.600(c) of this chapter.
                       *                  *                  *                  *                  *              *                *
--------------------------------------------------------------------------------------------------------------------------------------------------------


    3. Section 558.355 is amended by adding paragraph (f)(7) to read as 
follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (7) Monensin may also be used in combination with decoquinate as in 
Sec. 558.195.

    Dated: December 20, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-33217 Filed 12-28-00; 8:45 am]
BILLING CODE 4160-01-F