[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Rules and Regulations]
[Pages 54193-54194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25972]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Lasalocid

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 two supplemental new animal 
drug applications (NADA's) filed by Hoffmann-La Roche, Inc. One 
supplemental NADA provides for the addition of certain lasalocid-
containing Type A medicated articles to dry, powdered milk replacer 
before reconstitution. The reconstituted Type C medicated feed is used 
to control coccidiosis in nonveal calves. Additionally, FDA is amending 
the regulations to reflect approval of another supplemental NADA which 
modifies the lasalocid feeding directions for control of coccidiosis in 
cattle.

EFFECTIVE DATE: October 20, 1995.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., Nutley, NJ 07110, 
is the sponsor of NADA 96-298, which currently provides for the use of 
several concentrations of lasalocid sodium-containing Type A medicated 
articles in making Type C medicated cattle feeds (68 to 113 grams of 
activity per ton) for the control of coccidiosis caused by Eimeria 
bovis and E. zuernii. The firm has filed a supplemental NADA that 
expands this use of the drug to nonveal calves using milk replacer 
powder.
    Additionally, FDA concurred with another supplemental NADA which 
was filed to modify the feeding directions for lasalocid medicated feed 
when used to 

[[Page 54194]]
control coccidiosis in cattle. The supplemental NADA modifies the 
feeding directions in the table in Sec. 558.311(e)(1) by changing 
``feed continuously'' to ``hand feed''.
    The supplemental NADA's are approved as of August 7, 1995, and the 
regulations are amended in Sec. 558.311 (21 CFR 558.311) to reflect the 
approvals.
    Under 21 CFR 514.106(b)(2), these are Category II changes. Approval 
of these changes is not expected to have any adverse effect on the 
safety or effectiveness of this new animal drug. Accordingly, these 
approvals did not require a reevaluation of the safety and 
effectiveness data in the parent application.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals for food-
producing animals do not qualify for marketing exclusivity because the 
supplemental applications do not contain new clinical or field 
investigations (other than bioequivalence or residue studies) and new 
human food safety studies (other than bioequivalence or residue 
studies) essential to the approvals and conducted or sponsored by the 
applicant.

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 558.311 is amended in paragraph (b)(3) by removing 
``(xiii)'' and adding in its place ``(xv)'' and in the table in 
paragraph (e)(1), in the ``Limitations'' column, in the entry for 
``(xii)'' by removing ``feed continuously'' and adding in its place 
``hand feed'', and by adding new entry ``(xv)'' to read as follows:


Sec. 558.311  Lasalocid.

* * * * *
    (e)(1) * * *

                                                                                                                
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  Lasalocid sodium activity in     Combination in                                                               
         grams per ton              grams per ton      Indications for use         Limitations         Sponsor  
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
(xv)........................     ..................  Replacement calves;     In milk replacer             000004
                                  ............        for control of          powder; hand feed at              
                                                      coccidiosis caused by   a rate of 1 mg of                 
                                                      E. bovis and E.         lasalocid per 2.2 lb              
                                                      zuernii.                body weight per day;              
                                                                              include on labeling               
                                                                              warning: ``A                      
                                                                              withdrawal period has             
                                                                              not been established              
                                                                              for lasalocid in pre-             
                                                                              ruminating calves. Do             
                                                                              not use in calves to              
                                                                              be processed for                  
                                                                              veal.''.                          
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* * * * *

    Dated: October 5, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 95-25972 Filed 10-19-95; 8:45 am]
BILLING CODE 4160-01-F