[Federal Register Volume 64, Number 127 (Friday, July 2, 1999)]
[Rules and Regulations]
[Pages 35923-35924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16836]



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  Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules 
and Regulations  

[[Page 35923]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


Animal Drugs, Feeds, and Related Products; Diclazuril

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 Schering-Plough Animal Health Corp. The NADA provides 
for the use of a Type A medicated article containing diclazuril for use 
in manufacturing a Type C medicated feed indicated for the prevention 
of coccidiosis in broiler chickens.

EFFECTIVE DATE: July 2, 1999.
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: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed NADA 140-951, which provides for 
the use of a Type A medicated article containing 0.2 percent of 
diclazuril (ClinacoxTM) for use in manufacturing a Type C 
medicated feed indicated for the prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis 
(mivati), and E. maxima. Because diclazuril is effective against E. 
maxima later in its life cycle, subclinical intestinal lesions may be 
present for a short time after infection. Diclazuril was shown in 
studies to reduce lesion scores and improve performance and health of 
birds challenged with E. maxima. The NADA is approved as of April 21, 
1999, and the regulations are amended in 21 CFR part 558 by adding 
Sec. 558.198 to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    Also, the regulations are amended in 21 CFR part 556 by adding 
Sec. 556.175 to establish tolerances for diclazuril residues in the 
edible tissues of chickens and to establish an acceptable daily intake 
(ADI) for total diclazuril residues. The ADI represents the total 
amount of drug residue that can safely be consumed by humans every day.
    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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity for the use of diclazuril in chicken 
feed beginning April 21, 1999, because no active ingredient (including 
any ester or salt of the active ingredient) has been approved in any 
other application.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    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

21 CFR Part 556

    Animal drugs, Foods.

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 parts 556 and 
558 are amended as follows:

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

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

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

    2. Section 556.175 is added to subpart B to read as follows:

Sec. 556.175  Diclazuril.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
diclazuril is 25 micrograms per kilogram of body weight per day.
    (b) Tolerances. (1) Chickens: Tolerances are established for 
residues of parent diclazuril at 0.5 part per million (ppm) in muscle, 
3 ppm in liver, and 1 ppm in skin/fat.
    (2) [Reserved]

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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

    4. Section 558.198 is added to subpart B to read as follows:

Sec. 558.198  Diclazuril.

    (a) Approvals. Type A medicated article: 0.2 percent of diclazuril 
to 000061 in Sec. 510.600(c) of this chapter.
    (b) Related tolerances. See Sec. 556.175 of this chapter.
    (c) [Reserved]
    (d) Conditions of use. It is used in broiler chickens as follows:
    (1) Amount. 1 part per million (ppm).
    (2) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis 
(mivati), and E. maxima. Because diclazuril is effective against E. 
maxima later in its life cycle, subclinical intestinal lesions may be 
present for a short time after infection. Diclazuril was shown in 
studies to reduce lesion scores and

[[Page 35924]]

improve performance and health of birds challenged with E. maxima.
    (3) Limitations. Feed continuously. Not for use in hens producing 
eggs for human food.

    Dated: June 4, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-16836 Filed 7-1-99; 8:45 am]
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