[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Rules and Regulations]
[Page 8547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3802]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Tylosin and 
Virginiamycin

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 remove those portions reflecting approval of four 
new animal drug applications (NADA's) held by Premiere Agri 
Technologies, Inc. The NADA's provide for use of Type A medicated 
articles and Type B medicated feeds containing tylosin and Type B 
medicated feeds containing virginiamycin. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADA's.

EFFECTIVE DATE: February 27, 1995.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1722.

SUPPLEMENTARY INFORMATION: In a notice published elsewhere in this 
issue of the Federal Register, FDA is withdrawing approval of the 
following NADA's:

------------------------------------------------------------------------
                                                     Sponsor name and   
        NADA No.                Drug name                 address       
------------------------------------------------------------------------
45-690.................  Tylosin Type B           Premiere Agri         
                          medicated feeds and      Technologies, Inc.,  
                          Type A medicated         P.O. Box 2508, Fort  
                          article.                 Wayne, IN 46801-2508 
                                                   (former sponsor      
                                                   Henwood Feed         
                                                   Additives)           
97-289.................  Tylosin Type B           Do. (Former sponsor   
                          medicated feeds and      Feed Specialties Co.,
                          Type A medicated         Inc.)                
                          article.                                      
133-361................  Virginiamycin Type B     Do. (Former sponsor   
                          medicated feed.          Feed Specialties Co.,
                                                   Inc.)                
133-839................  Virginiamycin Type B     Do. (Former sponsor   
                          medicated feed.          Mac-Page, Inc.)      
------------------------------------------------------------------------

    The sponsor requested withdrawal of approval of the NADA's. This 
final rule removes 21 CFR 558.625(b)(11) and (b)(15) and amends 21 CFR 
558.635(b)(2) to reflect the withdrawal of approval of these NADA's.

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).


Sec. 558.625  [Amended]

    2. Section 558.625 Tylosin is amended by removing and reserving 
paragraphs (b)(11) and (b)(15).
     3. Section 558.635 Virginiamycin is amended by revising paragraph 
(b)(2) to read as follows:


Sec. 558.635  Virginiamycin

 * * * * *
     (b) * * *
     (2) 2.2 percent activity (10 grams per pound) to 011490, 016968, 
and 017790 in Sec. 510.600(c) of this chapter for use as in paragraphs 
(f)(1)(iv) and (f)(1)(v) of this section.
 * * * * *

    Dated: January 6, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-3802 Filed 2-14-95; 8:45 am]
BILLING CODE 4160-01-F