[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)]
[Rules and Regulations]
[Pages 53701-53702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25623]



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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 use of decoquinate Type A medicated articles to make Type 
C medicated feeds for young sheep for the prevention of certain forms 
of coccidiosis.

EFFECTIVE DATE: October 17, 1995.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary 

[[Page 53702]]
Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Rhone-Poulenc, Inc., 500 Northridge Rd., 
suite 620, Atlanta, GA 30350, filed supplemental NADA 39-417, which 
provides for use of Deccox (decoquinate) Type A medicated 
article to make a Type C medicated feed for young sheep for the 
prevention of coccidiosis caused by Eimeria bakuensis, E. crandallis, 
E. ovinoidalis, and E. parva.
    The supplemental NADA is approved as of August 28, 1995, and the 
regulations are amended in 21 CFR 558.195 to reflect the approval. The 
basis of approval is discussed in the freedom of information summary.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 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, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
     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 for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning August 28, 1995, because the supplemental NADA contains 
reports of new clinical or field investigations (other than 
bioequivalence or residue studies) essential to approval and conducted 
or sponsored by the applicant. Marketing exclusivity applies only to 
the use for which the supplemental NADA is approved.
    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.

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 in paragraph (d) in the table by 
numerically adding a new entry to read as follows:


Sec. 558.195  Decoquinate.

-* * * * *
     (d) * * *

                                                                                                                
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                                    Combination in grams                                                        
  Decoquinate in grams per ton            per ton          Indications for use       Limitations        Sponsor 
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
 13.6 (0.0015 pct)..............  .......................  Young sheep; for     Feed Type C feed at       011526
                                                            the prevention of    a rate to provide              
                                                            coccidiosis caused   22.7 mg per 100 lb             
                                                            by Eimeria           of body weight                 
                                                            ovinoidalis, E.      (0.5 mg per kg)                
                                                            crandallis, E.       per day. Feed at               
                                                            parva, E.            least 28 days                  
                                                            bakuensis.           during periods of              
                                                                                 exposure to                    
                                                                                 coccidiosis or                 
                                                                                 when it is likely              
                                                                                 to be a hazard. Do             
                                                                                 not feed to sheep              
                                                                                 producing milk for             
                                                                                 food.                          
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    Dated: October 5, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-25623 Filed 10-16-95; 8:45 am]
BILLING CODE 4160-01-F