[Federal Register Volume 60, Number 127 (Monday, July 3, 1995)]
[Rules and Regulations]
[Pages 34460-34461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16091]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Decoquinate; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to clarify the conditions of use in the approved new 
animal drug application (NADA) for Type C decoquinate cattle feed. This 
amendment was requested by the sponsor, Rhone-Poulenc, Inc.

EFFECTIVE DATE: July 3, 1995.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1644.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 3, 1976 
(41 FR 53002), FDA published a document reflecting approval of 
supplemental NADA 39-417V filed by Hess and Clark, Division of Rhodia, 
Inc., Ashland, OH, proposing safe and effective use of a 6 percent 
decoquinate premix for manufacturing a cattle feed used as an aid in 
the prevention of coccidiosis. The supplemental NADA amended 
Sec. 558.195(g)(2) (21 CFR 558.195(g)(2)) in the table to reflect the 
approval.
    In the Federal Register of September 30, 1986, FDA published a 
document reflecting a change of sponsor of NADA 39-417 Deccox 
(decoquinate) from Hess & Clark, Inc., to Rhone Poulenc, Inc. The new 
sponsor of decoquinate, Rhone-Poulenc, Inc., P.O. Box 125, Black Horse 
Lane, Monmouth Junction, NJ 08852, informed FDA that the regulation for 
use of Type C decoquinate cattle feed that reflects the conditions of 
use in its approved NADA were incorrect. Section 558.195(d) in the 
table in the entry for ``22.7 mg per 100 lb * * *'' provides the 
feeding level for the cattle feed. This information usually is provided 
in the ``Limitations'' column. The firm requested that the entry be 
revised to place the concentration of active ingredient in the 
``Decoquinate in grams per ton'' column and the feeding level in the 
``Limitations'' column. FDA concurs 

[[Page 34461]]
with the firm's request and is amending the regulations accordingly. In 
addition, Sec. 558.195(c)(2) provides status of this product for the 
National Academy of Sciences/National Research Council. The status is 
outdated based upon the Generic Animal Drug and Patent Term Restoration 
Act of 1988, therefore, Sec. 558.195(c)(2) is removed and reserved.

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 removing and reserving paragraph 
(c)(2), and in the table in paragraph (d) by removing the entry for 
``22.7 mg per 100 lb of body weight per day (0.5 mg per kilogram)'' and 
adding a new entry in numerical order to read as follows:


Sec. 558.195   Decoquinate.

* * * * *
    (d) * * *

                                                                                                                
----------------------------------------------------------------------------------------------------------------
  Decoquinate in grams    Combination in grams                                                                  
        per ton                 per ton            Indications for use            Limitations          Sponsor  
----------------------------------------------------------------------------------------------------------------
13.6 to 27.2 (0.0015 to  .....................  Cattle; for the            Feed Type C feed at a                
 0.003 pct).              ...............        prevention of              rate to provide 22.7 mg             
                                                 coccidiosis in             per 100 lb of body                  
                                                 ruminating and             weight (0.5 mg per kg)              
                                                 nonruminating calves and   per day. May be                     
                                                 cattle caused by Eimeria   prepared from dry or                
                                                 bovis and E. zumii.        liquid Type B feed                  
                                                                            containing 0.0125 to                
                                                                            0.5 pct decoquinate.                
                                                                            Liquid Type B feed must             
                                                                            have a pH range of 5.0              
                                                                            to 6.5 and contain a                
                                                                            suspending agent to                 
                                                                            maintain a viscosity of             
                                                                            not less tha 500                    
                                                                            centipoises. Feed at                
                                                                            least 28 days during                
                                                                            periods of exposure to              
                                                                            coccidiosis or when it              
                                                                            is likely to be a                   
                                                                            hazard. Do not feed to              
                                                                            cows producing milk for             
                                                                            food.                               
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    Dated: June 23, 1995.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 95-16091 Filed 6-30-95; 8:45 am]
BILLING CODE 4160-01-F