[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Rules and Regulations]
[Pages 38750-38751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19177]


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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 Zoalene

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 new animal drug application 
(NADA) filed by Alpharma Inc. The NADA provides for using approved 
bacitracin methylene disalicylate and zoalene Type A medicated articles 
to make Type C medicated turkey feeds.

EFFECTIVE DATE: July 20, 1998.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1600.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, is sponsor of NADA 141-085 which provides for 
combining approved BMD<Register> (10, 25, 30, 40, 50, 60, or 75 gram 
per pound (g/lb) bacitracin methylene disalicylate), and 
Zoamix<Register> (113.5 g/lb zoalene) Type A medicated articles to make 
Type C medicated feeds for growing turkeys containing 4 to 50 g per ton 
(g/t) bacitracin methylene disalicylate and 113.5 to 170.3 g/t zoalene. 
The Type C medicated turkey feed is used for prevention and control of 
coccidiosis, and for increased rate of weight gain and improved feed 
efficiency. The NADA is approved as of June 3, 1998, and the 
regulations are amended in 21 CFR 558.76(d)(3) by adding paragraph 
(d)(3)(xv), and in 21 CFR 558.680(c), in the table, in item (iii) by 
adding an entry 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.
    FDA 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) Zoalene alone or in combination as in Sec. 558.680.
    3. Section 558.680 is amended in the table in paragraph (c)(1) in 
item (iii) by alphabetically adding an entry for ``Bacitracin methylene 
disalicylate 4-50'' to read as follows:


Sec. 558.680  Zoalene.

* * * * *
    (c) * * *
    (1) * * *

                                                                                                                
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    Zoalene in grams/ton       Combination in grams/ton       Indications for use             Limitations       
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
(iii) 113.5-170.3 (0.0125-                                                                                      
 0.01875%)                                                                                                      

[[Page 38751]]

                                                                                                                
                             Bacitracin methylene         Turkeys; prevention and     For turkeys grown for meat
                              disalicylate 4-50.           control of coccidiosis,     purposes only, not to be 
                                                           and increased rate of       fed to laying birds, feed
                                                           weight gain and improved    continuously as sole     
                                                           feed efficiency.            ration until 14 to 16    
                                                                                       weeks of age.            
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
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* * * * *

    Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19177 Filed 7-17-98; 8:45 am]
BILLING CODE 4160-01-F