[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Rules and Regulations]
[Pages 38474-38476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19025]


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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, Decoquinate, and Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the

[[Page 38475]]

animal drug regulations to reflect approval of a new animal drug 
application (NADA) filed by Alpharma Inc. The NADA provides for using 
approved bacitracin methylene disalicylate, decoquinate, and roxarsone 
Type A medicated articles to make combination drug Type C medicated 
broiler chicken feeds.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1638.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of NADA 141-100 that provides for 
combining approved Type A medicated articles containing BMD 
(10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) bacitracin 
methylene disalicylate) with Deccox (6 percent or 27.2 g/lb 
decoquinate), and 3-Nitro (45.4, 90, or 227 g/lb roxarsone) 
to make Type C medicated broiler feeds containing 50 g/ton (g/t) 
bacitracin methylene disalicylate, 27.2 g/t decoquinate, and 22.7 to 
45.4 g/t roxarsone. The Type C medicated broiler feeds are used as an 
aid in the prevention of necrotic enteritis, for the prevention of 
coccidiosis, and for increased rate of weight gain, improved feed 
efficiency, and improved pigmentation in broiler chickens. The NADA is 
approved as of June 2, 1998, and the regulations are amended in 21 CFR 
558.76(d)(3) and 558.195(d) by adding new entries, and 558.530(d)(5)(x) 
is revised 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.
    This approval is for use of single ingredient Type A medicated 
articles to make combination drug Type C medicated feeds. One 
ingredient, roxarsone, is a Category II drug as defined in 21 CFR 
558.3(b)(1)(ii). Prior to enactment of the Animal Drug Availability Act 
of 1996 (Pub. L. 104-250) (ADAA), an approved medicated feed 
application (MFA) was required for feed mills to make Type C medicated 
feeds from Type A medicated articles containing Category II drugs. The 
ADAA revised the Federal Food, Drug, and Cosmetic Act to replace the 
requirement for MFA's with a requirement for feed mill licenses.
    The agency has determined under 21 CFR 25.33(a)(2) 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: 21 U.S.C. 360b, 371.

    2. Section 558.76 is amended by adding paragraph (d)(3)(xv) to read 
as follows:


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (xv) Decoquinate and roxarsone as in Sec. 558.195.
    3. Section 558.195 is amended in the table in paragraph (d) by 
adding an entry for ``27.2 (0.003 pct)'' following the entry for 
``Bacitracin 10 to 50'' and before the entry for ``Chlortetracycline 
100 to 200'' to read as follows:


Sec. 558.195  Decoquinate.

* * * * *
    (d) * * *

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                                    Combination in      Indications for                                         
  Decoquinate in grams per ton       grams per ton            use             Limitations           Sponsor     
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
27.2 (0.003 pct)................  Bacitracin          Broiler chickens;   Feed continuously   046573            
                                   methylene           for prevention of   as sole ration.                      
                                   disalicylate 50     coccidiosis         Withdraw 5 days                      
                                   and roxarsone       caused by Eimeria   before slaughter.                    
                                   22.7-45.4.          tenella, E.         Do not feed to                       
                                                       necatrix, E.        laying chickens.                     
                                                       mivati, E.          Not for use in                       
                                                       acervulina, E.      breeder chickens.                    
                                                       maxima, E.          Use as sole                          
                                                       brunetti; as an     source of organic                    
                                                       aid in the          arsenic. Poultry                     
                                                       prevention of       should have                          
                                                       necrotic            access to                            
                                                       enteritis caused    drinking water at                    
                                                       or complicated by   all times. Drug                      
                                                       Clostridium spp.    overdosage or                        
                                                       or other            lack of drinking                     
                                                       organisms           water may result                     
                                                       susceptible to      in leg weakness                      
                                                       bacitracin; for     or paralysis.                        
                                                       increased rate of   Decoquinate,                         
                                                       weight gain,        bacitracin                           
                                                       improved feed       methylene                            
                                                       efficiency, and     disalicylate, and                    
                                                       improved            roxarsone, as                        
                                                       pigmentation.       provided by No.                      
                                                                           046573 in Sec.                       
                                                                           510.600(c) of                        
                                                                           this chapter.                        
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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    3. Section 558.530 is amended by removing and reserving paragraph 
(c), and by revising paragraph (d)(5)(x) to read as follows:


Sec.  558.530  Roxarsone.

* * * * *

[[Page 38476]]

    (c) [Reserved]
    (d) * * *
    (5) * * *
    (x) Decoquinate alone or in combination as in Sec. 558.195.
* * * * *

    Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19025 Filed 7-16-98; 8:45 am]
BILLING CODE 4160-01-F