[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]


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

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.

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

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