[Federal Register Volume 60, Number 107 (Monday, June 5, 1995)]
[Rules and Regulations]
[Pages 29481-29482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13636]



=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Lasalocid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Hoffmann-La Roche, Inc. The supplemental 
NADA provides for the use of 20 percent of lasalocid Type A medicated 
article in making Type C medicated feed used for chukar partridges as a 
coccidiostat.

EFFECTIVE DATE: June 5, 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 
a Type A medicated article HFV238 containing 20 percent (90.7 grams per 
pound (g/lb)) of lasalocid sodium activity in making 68- to 113-g per 
ton (g/t) Type C medicated feed for broiler or fryer chickens. The firm 
has filed a supplemental NADA that expands the use of the article to 
make a 113-g/t Type C medicated feed for chukar partridges for the 
prevention of coccidiosis caused by Eimeria legionensis. Approval is 
based in part on data and information in Public Master File (PMF) 5429 
established under the Interregional Research Project No. 4 (IR-4), 
Northeastern Region, New York State College of Veterinary Medicine, 
Cornell University, Ithaca, NY 14853-6401.
    The supplemental NADA is approved as of April 19, 1995, and the 
regulations are amended in Sec. 558.311 (21 CFR 558.311) to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    Additionally, in a final rule published in the Federal Register of 
August 6, 1990 (55 FR 31827), that amended the regulations in 
Sec. 558.311(e)(1), the agency failed to also revise Sec. 558.311(b)(6) 
to remove reference to entry (xiii) in the table in paragraph (e)(1). 
This document corrects that error.
    In accordance with the freedom of information provisions of part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., 
Monday through Friday.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
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 558.311 is amended in paragraph (b)(6) by removing 
``(e)(1)(xiii),'' by adding new paragraph (b)(7), and in the table in 
paragraph (e)(1) by adding new entry ``(xiii)'' to read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (b) * * *
    (7) 20 percent activity to No. 000004 for use in chukar partridges 
as in paragraph (e)(1)(xiii) of this section.
* * * * *
    (e)(1) * * *

                                                                        
[[Page 29482]]
                                                                                                                
----------------------------------------------------------------------------------------------------------------
    Lasalocid sodium                                                                                            
 activity in grams per    Combination in grams     Indications for use            Limitations          Sponsor  
          ton                   per ton                                                                         
----------------------------------------------------------------------------------------------------------------
  *                    *                    *                    *                    *                    *    
                                                             *                                                  
(xiii) 113 (0.0125       .....................  Chukar partridges; for     Feed continuously as           000004
 pct).                    ..............         prevention of              sole ration up to 8                 
                                                 coccidiosis caused by      weeks of age.                       
                                                 Eimeria legionensis.                                           
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: May 24, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13636 Filed 6-2-95; 8:45 am]
BILLING CODE 4160-01-F