[Federal Register Volume 59, Number 71 (Wednesday, April 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8821]


[[Page Unknown]]

[Federal Register: April 13, 1994]


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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; Semduramicin

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 the approval of a new animal drug 
application (NADA) filed by Pfizer, Inc. The NADA provides for making a 
semduramicin Type A medicated article used to make a Type C medicated 
broiler chicken feed for the prevention of coccidiosis.
EFFECTIVE DATE: April 13, 1994.

FOR FURTHER INFORMATION CONTACT: Thomas Letonja, Center for Veterinary 
Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1656.
SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed NADA 140-940, which provides for making a 5.13 percent 
AviaxTM (semduramicin sodium) Type
A medicated article (equivalent to 50 gram (g) of semduramicin per 
kilogram or 22.7 g per pound (g/lb)) used to make a 25 parts per 
million semduramicin Type C medicated broiler chicken feed. The feed is 
used for the prevention of coccidiosis caused by Eimeria tenella, E. 
acervulina, E. maxima, E. brunetti, E. necatrix, and E. mivati/E. mitis 
in broiler chickens.
    The NADA is approved as of March 10, 1994, and the regulations are 
amended in part 558 (21 CFR part 558) by revising Sec. 558.4(d) and 
adding new Sec. 558.555 to reflect the approval. The basis for approval 
is discussed in the freedom of information summary.
    Semduramicin is a Category I drug which, as provided in Sec. 558.4 
as amended, does not require a medicated feed application (form FDA 
1900) for making a Type C medicated feed. The maximum concentration of 
semduramicin permitted in a Type B medicated feed is 2.25 g/lb (0.05 
percent).
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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), rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, from 9 a.m. to 
4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and 
Cosmetic Act, this approval qualifies for 5 years marketing exclusivity 
beginning March 10, 1994, because no active ingredient (including any 
ester or salt thereof) has been approved in any other application under 
section 512(b)(1) of the act.
    FDA has carefully considered the potential environmental effects of 
this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Docket's Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

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 558.4 is amended in paragraph (d) in the ``Category I'' 
table by alphabetically adding a new entry for ``Semduramicin'' to read 
as follows:


Sec. 558.4  Medicated feed applications.

 * * * * *
    (d) * * *

                               CATEGORY I                               
------------------------------------------------------------------------
                   Assay limits    Type B maximum  Assay limits percent1
     Drug        percent1 type A       (200x)            type B/C2      
------------------------------------------------------------------------
                                 *******                                
Semduramicin...  94-102.........  2.25 g/lb (0.50                85-110 
                                   %).                                  
                                 *******                                
                                                                        
------------------------------------------------------------------------
\1\Percent of labeled amount.                                           
\2\Values given represent ranges for either Type B or Type C medicated  
  feeds. For those drugs that have two range limits, the first set is   
  for a Type B medicated feed and the second set is for a Type C        
  medicated feed. These values (ranges) have been assigned in order to  
  provide for the possibity of dilution of a Type B medicated feed with 
  lower assay limits to make Type C medicated feed.                     

 * * * * *
    3. New Sec. 558.555 is added to subpart B to read as follows:


Sec.  558.555  Semduramicin.

    (a) Approvals. Type A medicated article containing 5.13 percent 
semduramicin sodium (equivalent to 50 grams semduramicin per kilogram 
or 22.7 grams per pound) to 000069 in Sec. 510.600(c) of this chapter.
    (b) Conditions of use. (1) Broilers:
    (i) Amount. Semduramicin: 25 parts per million.
    (ii) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, 
and E. mivati/E. mitis.
    (iii) Limitations. Do not feed to laying hens. Reduced average 
daily gains may result from exceeding the levels of semduramicin 
recommended in the feeding directions.
    (2) [Reserved]

    Dated: April 6, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-8821 Filed 4-12-94; 8:45 am]
BILLING CODE 4160-01-F