[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Rules and Regulations]
[Pages 29985-29986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13828]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 an abbreviated new animal drug 
application (ANADA) filed by Sanofi Animal Health, Inc. The ANADA 
provides for use of gentamicin sultate injection in day-old chickens 
for the prevention of early mortality caused by Escherichia coli, 
Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to 
gentamicin sulfate.

EFFECTIVE DATE: June 7, 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: Sanofi Animal Health, Inc., 7101 College 
Blvd., Overland Park, KS 66210, has filed ANADA 200-147, which provides 
for use of gentamicin sulfate injection in day-old chickens for the 
prevention of early mortality caused by E. coli, S. typhimurium, and P. 
aeruginosa susceptible to gentamicin sulfate.
    Sanofi Animal Health, Inc.'s, ANADA 200-147 for gentamicin sulfate 
injection (100 milligrams of gentamicin per milliliter (mg/mL) 
solution) is approved as a generic copy of Schering-Plough Animal 
Health's NADA 101-862 for Garasol (50 and 100 mg of gentamicin/mL 
solution) injection. The ANADA is approved as of April 10, 1995, and 
the regulations are amended in Sec. 522.1044 (21 CFR 522.1044) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In addition, the regulation failed to reflect that Schering-
Plough's NADA 101-862 was approved for use of 100 mg of gentamicin/mL 
as well as 50 mg of gentamicin/mL injection. At this time, 
Sec. 522.1044 is amended to indicate that both concentrations of the 
drug are approved for use in day-old chickens.
    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 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

     2. Section 522.1044 is amended by revising paragraphs (a) and 
(b)(1) and by adding new paragraph (b)(4) to read as follows:


Sec. 522.1044  Gentamicin sulfate injection.

    (a) Specifications. Each milliliter of sterile aqueous solution 
contains gentamicin sulfate equivalent to either 5, 50, or 100 
milligrams of gentamicin.
    (b) Sponsors. (1) See No. 000061 in Sec. 510.600(c) of this chapter 
for use of 5 milligrams-per-milliliter solution in swine as in 
paragraph (d)(4) of this section, for use of 50 milligrams-per-solution 
in dogs, cats, and chickens as in paragraph (d)(1) and (d)(3) of this 
section, for use of 100 milligrams-per- [[Page 29986]] milliliter 
solution in chickens as in paragraph (d)(3) of this section.
* * * * *
    (4) See No. 050604 for use of 100 milligrams-per-milliliter 
solution in chickens as in paragraph (d)(3) of this section.
* * * * *

    Dated: May 22, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-13828 Filed 6-6-95; 8:45 am]
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