[Federal Register Volume 60, Number 107 (Monday, June 5, 1995)]
[Rules and Regulations]
[Pages 29483-29484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13635]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Nicarbazin and 
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 codify a previously approved new animal drug 
application (NADA) held by Merck Research Laboratories, Division of 
Merck & Co., Inc. The NADA provides for use of nicarbazin and 
bacitracin methylene disalicylate in Type C broiler feeds for 
prevention of certain forms of coccidiosis and for increased rate of 
weight gain and improved feed efficiency.

EFFECTIVE DATE: June 5, 1995.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1623.

SUPPLEMENTARY INFORMATION:  Merck Research Laboratories, Division of 
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, is sponsor of NADA 
98-378 which provides for the use of approved nicarbazin and bacitracin 
methylene disalicylate Type A medicated articles to make Type C 
medicated broiler feeds containing 113.5 grams per ton (g/t) nicarbazin 
with 30 g/t bacitracin methylene disalicylate. The NADA was approved by 
letter of March 15, 1955, for prevention of certain forms of 
coccidiosis and for increased rate of weight gain and improved feed 
efficiency. This document amends the regulations in 21 CFR 558.76(d) 
and in the table in 21 CFR 558.366(c) to reflect the approval.
    Also, the table in Sec. 558.366(c) contains two entries in the 
first column for ``113.5 (0.0125 pct).'' The second entry in the first 
column is unnecessary, and is being removed at this time. In addition, 
the entry for ``113.5 (0.0125)'' contains an outdated footnote to the 
approval for use of 113.5 g/t nicarbazin. Because the National Academy 
of Sciences/National Research Council (NAS/NRC) status was changed by 
enactment of the Generic Animal Drug and Patent Term Restoration Act of 
1988, the footnote is hereby removed.
    NADA 98-378 provides for use of nicarbazin and bacitracin methylene 
disalicylate Type A medicated articles to make Type C medicated feeds. 
Nicarbazin is a Category II drug which, as provided in 21 CFR 558.4, 
requires an approved Form FDA 1900 for making Type C medicated feeds. 
Therefore, use of nicarbazin Type A medicated articles in making Type C 
medicated feeds as in this NADA requires an approved Form FDA 1900.
    Because this NADA was approved prior to July 1, 1975, the freedom 
of information (FOI) summary specified in 21 CFR part 20 and 21 CFR 
514.11(e)(2)(ii) is not required.
    The agency has determined under 21 CFR 25.24(d)(1)(i) 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: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).

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


Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) * * *
    (v) Nicarbazin as in Sec. 558.366.
* * * * *
    3. Section 558.366 is amended in the table in paragraph (c) by 
removing footnote ``1'' for the entry ``113.5 (0.0125 pct),'' by 
removing the second entry ``113.5 (0.0125 pct),'' and by adding a new 
item before the entry for ``Lincomycin 2 (0.00044 pct),'' to read as 
follows:


Sec.  558.366  Nicarbazin.

* * * * *
    (c) * * *

                                                                                                                
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Nicarbazin in grams per   Combination in grams                                                                  
          ton                   per ton            Indications for use            Limitations          Sponsor  
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                               *                                                
                         Bacitracin methylene   Broiler chickens; aid in   ......do................       000006
                          disalicylate 30        preventing outbreaks of                                        
                                                 cecal (Eimeria tenella)                                        
                                                 and intestinal (E.                                             
                                                 acervulina, E. maxima,                                         
                                                 E. necatrix, and E.                                            
                                                 brunetti) coccidiosis;                                         
                                                 for increased rate of                                          
                                                 weight gain and improved                                       
                                                 feed efficiency.                                               
  *                    *                    *                    *                    *                    *    
                                                               *                                                
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    [[Page 29484]] Dated: May 24, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13635 Filed 6-2-95; 8:45 am]
BILLING CODE 4160-01-F