97-4515. Oral Dosage Form New Animal Drugs; Sulfadimethoxine Oral Solution  

  • [Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)]
    [Rules and Regulations]
    [Pages 8370-8371]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-4515]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    21 CFR Part 520
    
    
    Oral Dosage Form New Animal Drugs; Sulfadimethoxine Oral Solution
    
    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 an abbreviated new animal drug 
    application (ANADA) filed by Fermenta Animal Health. The ANADA provides 
    for use of sulfadimethoxine oral solution to prepare medicated drinking 
    water for animals to treat bacterial infections sensitive to 
    sulfadimethoxine.
    
    EFFECTIVE DATE: February 25, 1997.
    
    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: Fermenta Animal Health Co., 10150 North 
    Executive Hills Blvd., Kansas City, MO 64153, filed ANADA 200-165, 
    which provides for use of sulfadimethoxine 12.5 percent oral solution 
    to prepare medicated drinking water for broiler and replacement 
    chickens, meat-producing turkeys, and dairy calves, dairy heifers, and 
    beef cattle for the treatment of bacterial diseases susceptible to 
    sulfadimethoxine.
        Fermenta Animal Health's ANADA 200-165 for sulfadimethoxine oral 
    solution 12.5 percent is approved as a generic copy of Hoffmann-
    LaRoche's Albon/Agribon (sulfadimethoxine) 12.5 percent solution in 
    NADA 31-205. The ANADA is approved as of December 4,
    
    [[Page 8371]]
    
    1996, and the regulations are amended by revising 21 CFR 520.2220a(b) 
    to reflect the approval. The basis of approval is discussed in the 
    freedom of information summary.
        In accordance with the freedom of information provisions of 21 CFR 
    part 20 and 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
    between 9 a.m. and 4 p.m., Monday through Friday.
        FDA has determined under 21 CFR 25.24(d)(1)(i) that this action is 
    of a type that does not individually of 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 520
    
        Animal drugs.
        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 520 is 
    amended as follows:
    
    PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
    
        1. The authority citation for 21 CFR part 520 continues to read as 
    follows:
    
        Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
    (21 U.S.C. 360b).
    
    Sec. 520.2220a  [Amended]
    
        2. Section 520.2220a Sulfadimethoxine oral solution and soluble 
    powder is amended in paragraph (b) by removing ``000069 and 057561'' 
    and adding in its place ``000069, 054273, and 057561''.
    
        Dated: February 3, 1997.
    Stephen F. Sundlof,
    Director, Center for Veterinary Medicine.
    [FR Doc. 97-4515 Filed 2-24-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
2/25/1997
Published:
02/25/1997
Department:
Health and Human Services Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
97-4515
Dates:
February 25, 1997.
Pages:
8370-8371 (2 pages)
PDF File:
97-4515.pdf
CFR: (1)
21 CFR 520.2220a