[Federal Register Volume 64, Number 40 (Tuesday, March 2, 1999)]
[Rules and Regulations]
[Page 10103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556


Oral Dosage Form New Animal Drugs; Decoquinate

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 adding a dry powder 
containing decoquinate to whole milk to be fed to calves for prevention 
of coccidiosis. Also, the regulations are amended to codify an 
acceptable daily intake (ADI) for decoquinate residues.

EFFECTIVE DATE: March 2, 1999.)

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7575.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-060 that provides for adding 
an 0.8 percent decoquinate medicated powder to whole milk to be fed to 
ruminating and nonruminating calves including veal calves for 
prevention of coccidiosis caused by Eimeria bovis and E. zurni. The 
NADA is approved as of January 14, 1999, and the regulations are 
amended by adding 21 CFR 520.534 to reflect the approval.
     In addition, FDA is codifying the ADI for decoquinate previously 
established in Alpharma Inc.'s NADA 39-417 in 21 CFR 556.170.
    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)(1) 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

21 CFR Part 520

     Animal drugs.

21 CFR Part 556

     Animal drugs, Foods.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under the authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 
556 are amended as follows:

PART 520-- ORAL DOSAGE FORM NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

     2. Section 520.534 is added to read as follows:

Sec. 520.534   Decoquinate.

     (a)  Specifications. The drug is a powder containing 0.8 percent 
decoquinate.
     (b) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter.
     (c)  Related tolerances. See Sec. 556.170 of this chapter.
     (d)  Conditions of use.  Replacement calves--(1) Amount. Feed 22.7 
milligrams per 100 pounds of body weight (0.5 milligram per kilogram) 
per day.
     (2)  Indications for use. For the prevention of coccidiosis in 
ruminating and nonruminating calves, including veal calves, caused by 
Eimeria bovis and E. zuernii.
     (3)  Limitations. Feed in whole milk at the rate of 22.7 
milligrams per 100 pounds body weight daily (0.5 milligram per 
kilogram) for at least 28 days.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

     3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

     4. Section 556.170 is revised to read as follows:


Sec. 556.170  Decoquinate.

    (a)  Acceptable daily intake (ADI). The ADI for total residues of 
decoquinate is 75 micrograms per kilogram of body weight per day.
    (b)  Tolerances. Tolerances are established for residues of 
decoquinate in the uncooked, edible tissues of chickens, cattle, and 
goats as follows:
    (1) 1 part per million (ppm) in skeletal muscle.
     (2) 2 ppm in other tissues.

    Dated: February 19, 1999.
 Stephen F. Sundlof,
 Director, Center for Veterinary Medicine.
[FR Doc. 99-5031 Filed 3-1-99; 8:45 am]
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