[Federal Register Volume 62, Number 82 (Tuesday, April 29, 1997)]
[Rules and Regulations]
[Pages 23128-23129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10986]


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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

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 Rhone-Poulenc, Inc. The supplemental NADA 
provides for certain revisions in the Type C medicated feed fed for 
prevention of coccidiosis in cattle, sheep, and goats.

EFFECTIVE DATE: April 29, 1997.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Rhone-Poulenc, Inc., P.O. Box 125, Black 
Horse Lane, Monmouth Junction, NJ 66210, filed supplemental NADA 39-
417, which provides for use of 6 percent decoquinate Type A medicated 
article to make 0.06 to 0.6 percent decoquinate Type B feeds to make 
0.0015 to 0.059 percent decoquinate Type C medicated feed for cattle, 
sheep, and goats for prevention of coccidiosis. The supplemental NADA 
is approved as of

[[Page 23129]]

March 7, 1997, and the regulations are amended in 21 CFR 558.195(c) and 
(d) to reflect the approval.
    The supplemental NADA does not contain added safety or 
effectiveness data. Therefore, a freedom of information (FOI) summary 
for the supplemental approval is not required. An FOI summary for the 
currently approved application may be seen in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857, between 9 a.m. to 4 p.m., Monday through 
Friday.
    The agency has determined under 21 CFR 25.24(d)(1)(iii) 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 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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

    2. Section 558.195 is amended by adding new paragraph (c)(2) and in 
the table in paragraph (d) a new entry for ``13.6 to 535.7 (0.0015 to 
0.059 pct)'' to read as follows:

Sec. 558.195  Decoquinate.

* * * * *
    (c)  * * *
    (2) Type A medicated articles containing 6 percent decoquinate may 
be used to make dry or liquid Type B cattle (including veal calf), 
sheep, and goat feeds as in paragraph (d) of this section.
    (d)  * * *


                                                                                                                
----------------------------------------------------------------------------------------------------------------
 Decoquinate in     Combination in                                                                              
  grams per ton     grams per ton     Indications for use               Limitations                   Sponsor   
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
13.6 to 535.7                        Cattle: prevention    Feed Type C feed (including dry milk   011526        
 (0.0015 to                           of coccidiosis in     replacer) to provide 22.7 mg per 100                
 0.059 pct)                           ruminating and        lb body weight (0.5 mg per kg) per                  
                                      nonruminating         day. May be prepared from dry Type B                
                                      calves (including     feed containing 0.06 to 0.6 pct                     
                                      veal calves) and      decoquinate or liquid Type B feed                   
                                      cattle caused by      containing 0.0125 to 0.05 pct                       
                                      Eimeria bovis and     decoquinate. The liquid Type B feed                 
                                      E. zurnii.            must have pH 5.0 to 6.5 and contain                 
                                                            a suspending agent to maintain a                    
                                                            viscosity of not less than 500                      
                                                            centipoises. 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.                            
                                     Young sheep:          do                                     do            
                                      prevention of                                                             
                                      coccidiosis caused                                                        
                                      by Eimeria                                                                
                                      ovinoidalis, E.                                                           
                                      parva, E.                                                                 
                                      bakuensis, E.                                                             
                                      crandallis.                                                               
                                     Young goats:          do                                     do            
                                      prevention of                                                             
                                      coccidiosis caused                                                        
                                      by Eimeria                                                                
                                      christenseni, E.                                                          
                                      ninakohlyakimovae.                                                        
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: April 8, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-10986 Filed 4-28-97; 8:45 am]
BILLING CODE 4160-01-F