98-32741. Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin Sulfate Injection  

  • [Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
    [Rules and Regulations]
    [Pages 68182-68183]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-32741]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 522
    
    
    Implantation or Injectable Dosage Form New Animal Drugs; 
    Gentamicin Sulfate Injection
    
    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 a supplemental new animal drug 
    application (NADA) filed by Merial Ltd. The supplemental NADA provides 
    for use of gentamicin sulfate injection in the neck of 1 to 3-day-old 
    turkey poults for prevention of early mortality due to susceptible 
    Arizona paracolon infections.
    
    EFFECTIVE DATE: December 10, 1998.
    FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
    Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
    Standish Pl., Rockville, MD 20855, 301-827-0209.
    
    SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
    08830-3077, filed supplemental NADA 200-147 that provides for 
    subcutaneous use of Genta-Ject (gentamicin sulfate) 
    injectable solution in the neck of 1 to 3-day-old turkey poults as an 
    aid in the prevention of early mortality due to A. paracolon infections 
    susceptible to gentamicin. The supplemental NADA is approved as of 
    October 30, 1998, and the regulations are amended in 21 CFR 
    522.1044(b)(4) 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 supplemental 
    application may be seen in the Dockets Management Branch (HFA-305), 
    Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
    MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
        The agency has determined under 21 CFR 25.33(a)(1) that this action 
    is of a type that does not individually or 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 522
    
        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 522 is 
    amended as follows:
    
    PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
    
        1. The authority citation for 21 CFR part 522 continues to read as 
    follows:
    
        Authority: 21 U.S.C. 360b.
        2. Section 522.1044 is amended by revising paragraph (b)(4) to read 
    as follows:
    
    
    Sec. 522.1044  Gentamicin sulfate injection.
    
     * * * * *
        (b) * * *
        (4) See No. 050604 for use of 100 milligram-per-milliliter solution 
    in turkeys as in paragraph (d)(2) of this section and in chickens as in 
    paragraph (d)(3) of this section.
     * * * * *
    
    
    [[Page 68183]]
    
    
        Dated: December 2, 1998.
    Andrew J. Beaulieu,
    Acting Director, Office of New Animal Drug Evaluation, Center for 
    Veterinary Medicine.
    [FR Doc. 98-32741 Filed 12-9-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
12/10/1998
Published:
12/10/1998
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-32741
Dates:
December 10, 1998.
Pages:
68182-68183 (2 pages)
PDF File:
98-32741.pdf
CFR: (1)
21 CFR 522.1044