[Federal Register Volume 63, Number 160 (Wednesday, August 19, 1998)]
[Rules and Regulations]
[Pages 44385-44386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22227]


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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 and Chlortetracycline

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 single ingredient bacitracin methylene 
disalicylate (BMD) and chlortetracycline (CTC) Type A medicated 
articles to make Type B medicated feeds used to make Type C medicated 
swine feeds.

EFFECTIVE DATE: August 19, 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 141-059 that provides 
for combining approved BMD (10, 25, 30, 40, 50, 60, or 75 
grams per pound (g/lb) BMD) and CTC (50, 65, or 70 g/lb CTC) 
Type A medicated articles to make Type B medicated feed. The Type B 
medicated feed containing 1 to 3 g/lb BMD and 40 g/lb CTC is used to 
make Type C medicated swine feed containing 10 to 30 g per ton (g/t) 
BMD and 400 g/t CTC. The Type C medicated swine feeds are used for 
treatment of bacterial enteritis caused by Escherichia coli and 
Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella 
multocida susceptible to CTC, and for increased rate of weight gain and 
improved feed efficiency. The supplemental NADA is approved as of June 
24, 1998, and the regulations are amended in the table in 21 CFR 
558.76(d)(1) 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 this 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.
    The agency has determined under 21 CFR 25.33(a)(3) 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 
the 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 the table in paragraph (d)(1) by 
revising entry (iv) to read as follows:

Sec. 558.76   Bacitracin methylene disalicylate.

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

                                                                                                                
----------------------------------------------------------------------------------------------------------------
      Bacitracin methylene          Combination in      Indications for                                         
  disalicylate in grams per ton      grams per ton            use             Limitations           Sponsor     
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
(iv) 10 to 30...................    ................  Swine: for          For growing and     000004 and 046573 
                                                       increased rate of   finishing swine.                     
                                                       weight gain and                                          
                                                       improved feed                                            
                                                       efficiency.                                              

[[Page 44386]]

                                                                                                                
                                  Chlortetracycline   Swine; for          Feed for not more   000004 and 046573 
                                   approximately       increased rate of   than 14 days to                      
                                   400, varying with   weight gain and     provide 10                           
                                   body weight and     improved feed       milligrams of                        
                                   food consumption    efficiency; for     chlortetracycline                    
                                   to provide 10       treatment of        per pound of body                    
                                   milligrams per      bacterial           weight per day;                      
                                   pound of body       enteritis caused    as                                   
                                   weight per day.     by Escherichia      chlortetracycline                    
                                                       coli and            provided by Nos.                     
                                                       Salmonella          000004 and 046573                    
                                                       choleraesuis and    in Sec.                              
                                                       bacterial           510.600(c) of                        
                                                       pneumonia caused    this chapter.                        
                                                       by Pasteurella      Type C feed may                      
                                                       multocida           be prepared from                     
                                                       susceptible to      Type B feed                          
                                                       chlortetracycline.  containing 1 to 3                    
                                                                           grams per pound                      
                                                                           BMD with 400                         
                                                                           grams per pound                      
                                                                           CTC, to 046573 in                    
                                                                           Sec.  510.600(c).                    
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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* * * * *

    Dated: August 1, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-22227 Filed 8-18-98; 8:45 am]
BILLING CODE 4160-01-F