[Federal Register Volume 63, Number 147 (Friday, July 31, 1998)]
[Rules and Regulations]
[Pages 40824-40825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20466]


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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; Bacitracin Methylene 
Disalicylate

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 Alpharma Inc. The supplemental NADA 
provides for using approved bacitracin methylene disalicylate (BMD) 
Type A medicated articles to make a Type C medicated feed for 
replacement chickens.

EFFECTIVE DATE: July 31, 1998.
FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1652.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed supplemental NADA 46-592 that provides 
for using approved BMD<Register> (10, 25, 30, 40, 50, 60, or 75 grams 
(g) per pound BMD) Type A medicated articles to make Type C medicated 
replacement chicken feed. A Type C feed containing 50 g per ton (/t) 
BMD is fed continuously as an aid in the prevention of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to BMD. A Type C feed containing 100 to 200 g/t BMD is fed 
for 5 to 7 days, or as long as clinical signs persist, as an aid in the 
control of necrotic enteritis caused or complicated by Clostridium spp. 
or other organisms susceptible to BMD. The supplemental NADA is 
approved as of June 22, 1998, and the regulations in 21 CFR 
558.76(d)(1) are amended in the table in items (vi) and (ix) to add new 
entries to reflect the approval. The basis for 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 the 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.
    FDA has determined under 21 CFR 25.33(a)(1) that these actions are 
of a type that do 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: 21 U.S.C. 360b, 371.
    2. Section 558.76 is amended in paragraph (d)(1) in the table in 
items (vi) and (ix) by adding new entries to read as follows:

Sec. 558.76   Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (1) * * *

[[Page 40825]]



                                                                                                                
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      Bacitracin methylene          Combination in      Indications for                                         
  disalicylate in grams per ton      grams per ton            use             Limitations           Sponsor     
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
(vi) *  *  *....................                                                                                
                                  ..................   Replacement         Feed continuously   046573           
                                                       chickens; as an     as sole ration..                     
                                                       aid in the                                               
                                                       prevention of                                            
                                                       necrotic                                                 
                                                       enteritis caused                                         
                                                       or complicated by                                        
                                                       Clostridium spp.                                         
                                                       or other                                                 
                                                       organisms                                                
                                                       susceptible to                                           
                                                       bacitracin.                                              
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
(ix) *  *  *....................                                                                                
                                  ..................   Replacement         Feed continuously   046573           
                                                       chickens; as an     as sole ration.                      
                                                       aid in the          Start at first                       
                                                       control of          clinical signs of                    
                                                       necrotic            disease, vary                        
                                                       enteritis caused    dosage based on                      
                                                       or complicated by   severity of                          
                                                       Clostridium spp.    infection,                           
                                                       or other            administer                           
                                                       organisms           continuously for                     
                                                       susceptible to      5 to 7 days or as                    
                                                       bacitracin.         long as clinical                     
                                                                           signs persist,                       
                                                                           then reduce                          
                                                                           medication to                        
                                                                           prevention level                     
                                                                           (50 g/t).                            
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: July 10, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-20466 Filed 7-30-98; 8:45 am]
BILLING CODE 4160-01-F