[Federal Register Volume 66, Number 7 (Wednesday, January 10, 2001)]
[Rules and Regulations]
[Pages 1832-1834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-628]


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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, 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 new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient decoquinate, monensin, and tylosin Type A medicated 
articles to make three-way combination drug Type B and Type C medicated 
feeds used for prevention of coccidiosis, improved feed efficiency, and 
reduction of incidence of liver abscesses in growing-finishing cattle 
fed in confinement for slaughter.

DATES: This rule is effective January 10, 2001.

[[Page 1833]]


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 141-149 that provides for use of 
DECCOX (27.2 gram per pound (g/lb) decoquinate), 
Rumensin (20, 30, 45, 60, 80, or 90.7 g/lb monensin activity 
as monensin sodium) and TYLAN (10, 40, or 100 g/lb tylosin 
phosphate) Type A medicated articles to make three-way combination Type 
B and Type C medicated feeds for use in growing-finishing cattle fed in 
confinement for slaughter. The Type C medicated feeds contain 13.6 to 
27.2 g/ton decoquinate, 5 to 30 g/ton monensin, and 8 to 10 g/ton 
tylosin, and are used for the prevention of coccidiosis caused by 
Eimeria bovis and E. zuernii, improved feed efficiency, and reduction 
of incidence of liver abscesses caused by Fusobacterium necrophorum and 
Actinomyces pyogenes. The NADA is approved as of November 16, 2000, and 
the regulations in 21 CFR 558.195 and 558.625 are being 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 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 after ``Monensin 5 to 30'' 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; plus   Cattle fed in confinement for slaughter;  Feed only to cattle fed in confinement    046573
                     tylosin 8 to 10          for prevention of coccidiosis caused by   for slaughter. Feed continuously as the
                                              Eimeria bovis and E. zuernii, improved    sole ration to provide 22.7 mg of
                                              feed efficiency, and reduction of         decoquinate per 100 lb body weight per
                                              incidence of liver abscesses caused by    day, 50 to 360 mg of monensin per head
                                              Fusobacterium necrophorum and             per day, and 60 to 90 mg of tylosin per
                                              Actinomyces pyogenes.                     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 and tylosin as tylosin phosphate
                                                                                        provided by 000986 in Sec.  510.600(c)
                                                                                        of this chapter.
                   *                  *                  *                  *                  *                  *                  *
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 1834]]

Sec. 558.355  [Amended]

    3. Section 558.355 Monensin is amended in paragraph (f)(7) by 
adding ``alone or with tylosin'' after ``decoquinate''.

    4. Section 558.625 is amended by redesignating paragraphs (f)(2)(i) 
through (f)(2)(v) as (f)(2)(ii) through (f)(2)(vi), and by adding 
paragraph (f)(2)(i) to read as follows:


Sec. 558.625  Tylosin.

* * * * *
    (f) * * *
    (2) * * *
    (i) Decoquinate and monensin as in Sec. 558.195.
* * * * *

    Dated: December 26, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-628 Filed 1-9-01; 8:45 am]
BILLING CODE 4160-01-F