[Federal Register Volume 64, Number 246 (Thursday, December 23, 1999)]
[Rules and Regulations]
[Pages 72026-72027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33281]


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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; 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 for medicated feed applications to add an entry 
stating the maximum Type B level and assay limits for diclazuril Type B 
and C medicated feeds. The Federal Register document that reflected 
approval of Schering-Plough Animal Health Corp.'s new animal drug 
application (NADA) for use of diclazuril Type A medicated articles for 
making Type C medicated broiler feeds failed to provide that entry.

Dates: This regulation is effective December 23, 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: In the Federal Register of July 2, 1999 (64 
FR 35923), FDA published a final rule that reflected the approval of 
Schering-Plough Animal Health Corp.'s NADA 141-951. The NADA provides 
for use of a Type A medicated article containing 0.2 percent of 
diclazuril (CLINACOXTM ) to make Type C broiler feeds used 
for the prevention of coccidiosis. The final rule added 21 CFR 556.175 
and 558.198 to reflect the approval, but failed to amend Sec. 558.4 (21 
CFR 558.4) to add an entry stating the maximum Type B level and assay 
limits for diclazuril Type B and C medicated feeds. At this time, 
Sec. 558.4 is amended in paragraph (d) in the table ``Category I'' 
accordingly.
    As provided in 21 CFR part 20 and 514.11(e)(2)(ii), a freedom of 
information summary of safety and effectiveness data and information 
required to support approval of the application was placed on file in 
the Dockets Management Branch, Food and Drug Administration, upon 
publication of the approval.
    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.

[[Page 72027]]

List of Subjects 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 558.4 is amended by adding an entry alphabetically to 
the Category I table in paragraph (d) to read as follows:

Sec. 558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                               CATEGORY I
------------------------------------------------------------------------
                                                          Assay limits
       Drug           Assay limits     Type B maximum   percent \1\ type
                    percent \1\ type       (200x)            B/C \2\
---------------------------A--------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
Diclazuril         90-110             182 g/t (0.02%)   85-115/70-120
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated
  feeds. For those drug that have two range limits, the first set is for
  a Type B medicated feed and the second set is for a Type C medicated
  feed. These values (ranges) have been assigned in order to provide for
  the possibility of dilution of a Type B medicated feed with lower
  assay limits to make Type C medicated feed.

* * * * *

    Dated: December 14, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 99-33281 Filed 12-22-99; 8:45 am]
BILLING CODE 4160-01-F