[Federal Register Volume 66, Number 233 (Tuesday, December 4, 2001)]
[Rules and Regulations]
[Pages 62916-62917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-29983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs for Use in Animal Feeds; 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 supplemental new animal drug 
application (NADA) filed by Schering-Plough Animal Health Corp. The 
NADA provides for use of the approved diclazuril Type A medicated 
article to make Type B and Type C medicated feeds used for prevention 
of coccidiosis in growing turkeys. Also, tolerances for diclazuril 
residues in turkey liver, muscle, and skin with adherent fat are being 
established.

DATES: This rule is effective December 4, 2001.

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., P.O. Box 3182, Union, NJ 07083, filed a supplement to NADA 
140-951 that provides for use of CLINACOX (0.2 percent diclazuril) Type 
A medicated article to make Type B and Type C medicated turkey feeds 
used for the prevention of coccidiosis caused by Eimeria adenoeides, E. 
gallopavonis, and E. meleagrimitis. The NADA is approved as of 
September 21, 2001, and the regulations are being amended in 
Secs. 556.175 and 558.198 (21 CFR 556.175 and 558.198) to reflect the 
approval. In addition, Sec. 556.175 is being redesignated as 
Sec. 556.185 to place it in alphabetical order in 21 CFR part 556. The 
basis of 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 each 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.

[[Page 62917]]

    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning September 21, 2001, 
because the application contains substantial evidence of the 
effectiveness of the drug involved, any studies of animal safety or, in 
the case of food-producing animals, human food safety studies (other 
than bioequivalence or residue studies) required for approval of the 
application and conducted or sponsored by the applicant.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA'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, Food.

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.


Sec. 556.175  [Redesignated as Sec. 556.185]

    2. Section 556.175 is redesignated as Sec. 556.185 and is amended 
by revising paragraph (b)(1) and by adding paragraph (b)(2) to read as 
follows:


Sec. 556.185  Diclazuril.

* * * * *
    (b) Tolerances--(1) Chickens--(i) Liver. The tolerance for parent 
diclazuril (the marker residue) is 3 parts per million (ppm).
    (ii) Muscle. The tolerance for parent diclazuril (the marker 
residue) is 0.5 ppm.
    (iii) Skin/fat. The tolerance for parent diclazuril (the marker 
residue) is 1 ppm.
    (2) Turkeys--(i) Liver. The tolerance for parent diclazuril (the 
marker residue) is 3 ppm.
    (ii) Muscle. The tolerance for parent diclazuril (the marker 
residue) is 0.5 ppm.
    (iii) Skin/fat. The tolerance for parent diclazuril (the marker 
residue) is 1 ppm.

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 amended in paragraph (b) by removing 
``556.175'' and by adding in its place ``556.185''; and in paragraph 
(d)(1) by adding a heading and by revising the introductory text, and 
by adding paragraph (d)(2) to read as follows:


Sec. 558.198  Diclazuril.

* * * * *
    (d) Conditions of use--(1) Chickens. For chickens it is used as 
follows:
* * * * *
    (2) Turkeys. For turkeys it is used as follows:

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                                 Combination grams/
      Diclazuril grams/ton              ton           Indications for use      Limitations          Sponsor
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(i) 0.91 (1 ppm)...............   ................  Growing turkeys: For    Feed continuously  000061
                                                     the prevention of       as the sole
                                                     coccidiosis caused by   ration. Do not
                                                     E. adenoeides, E.       feed to breeding
                                                     gallopavonis and E.     turkeys. Not for
                                                     meleagrimitis..         use in hens
                                                                             producing eggs
                                                                             for human
                                                                             consumption..
(ii) [Reserved]................   ................   .....................   ................
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    Dated: November 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-29983 Filed 12-3-01; 8:45 am]
BILLING CODE 4160-01-S