96-7679. New Animal Drugs for Use in Animal Feeds; Nicarbazin; Technical Amendment

[Federal Register Volume 61, Number 62 (Friday, March 29, 1996)]
[Rules and Regulations]
[Pages 14021-14022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7679]



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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; Nicarbazin; 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 regarding the use of nicarbazin in Type C broiler 
feeds. Because of incorrect amendatory instructions in a final rule 
that appeared in the Federal Register of June 5, 1995 (60 FR 29483), 
certain uses of nicarbazin combination Type C broiler feeds were 
removed from the regulations. This document corrects those errors.
EFFECTIVE DATE: March 29, 1996

FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center For Veterinary 
Medicine (HFV-238), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1739.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 5, 1995 (60 
FR 29483), the animal drug regulations were amended to codify Merck 
Research Laboratories, Division of Merck & Co.'s NADA 98-378 for use of 
single ingredient nicarbazin and bacitracin methylene disalicylate Type 
A articles to make combination drug Type C medicated broiler feeds. The 
document published with incorrect amendatory language resulting in the 
removal of certain approved uses of the drug from the regulation. FDA 
is correcting these errors.
    -Publication of this document constitutes final action on these 
changes under the Administrative Procedures Act (5 U.S.C. 553). Notice 
and public procedures on these corrections is unnecessary because FDA 
is merely republishing previously approved regulations.

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 558.366 is amended in the table in paragraph (c) by 
alphabetically adding two new entries to read as follows:


Sec. 558.366  Nicarbazin.

* * * * *
    (c) *    *    *

                                                                                                                
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                                   Combination in                                                               
  Nicarbazin in grams per ton       grams per ton      Indications for use         Limitations         Sponsor  
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  *                    *                    *                    *                    *                    *    
                                                             *                                                  
                                 Roxarsone 22.7      do....................  Feed continuously as         000006
                                  (0.0025).                                   sole ration from time             
                                                                              chicks are placed on              
                                                                              litter until past the             
                                                                              time when coccidiosis             
                                                                              is ordinarily a                   
                                                                              hazard; as sole                   
                                                                              source of organic                 
                                                                              arsenic; do not use a             
                                                                              treatment for                     
                                                                              coccidiosis; do not               
                                                                              use in flushing                   
                                                                              mashes; do not feed               
                                                                              to laying hens;                   
                                                                              withdraw 5 days                   
                                                                              before slaughter.                 
                                 Rosarsone 22.7      do....................  do....................       000006
                                  (0.0025) plus                                                                 
                                  lincomycin 2                                                                  
                                  (0.0004).                                                                     
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[[Page 14022]]


    Dated: March 14, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-7679 Filed 3-28-96; 8:45 am]
BILLING CODE 4160-01-F