[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Rules and Regulations]
[Pages 22888-22889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10913]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529


Certain Other Dosage Form New Animal Drugs; Gentamicin Sulfate

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 Med-Pharmex, Inc. The ANADA provides for 
the use of gentamicin sulfate solution in the dipping treatment of 
turkey hatching eggs as an aid in the reduction or elimination of 
certain organisms.

EFFECTIVE DATE: April 28, 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: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767, has filed ANADA 200-191, which provides for use of 
Gentasol (gentamicin sulfate solution) in the dipping treatment of 
turkey hatching eggs as an aid in the reduction or elimination of the 
following organisms from turkey hatching eggs: Arizona hinshawii 
(paracolon), Salmonella st. paul, and Mycoplasma meleagridis.
    The ANADA is approved as a generic copy of Schering Plough's NADA 
92-523, Garasol Solution (gentamicin sulfate veterinary). 
ANADA 200-191 is approved as of March 24, 1997, and the regulations are 
amended in 21 CFR 529.1044b to reflect the approval. The basis for 
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.
    The agency has determined under 21 CFR 25.24(d)(1)(i) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore,

[[Page 22889]]

neither an environmental assessment nor an environmental impact 
statement is required.

List of Subjects in 21 CFR Part 529

    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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 529 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 529.1044b  [Amended]

    2. Section 529.1044b Gentamicin sulfate solution is amended in 
paragraph (b) by removing ``No. 000061'' and adding in its place ``Nos. 
000061 and 051259''.

    Dated: April 8, 1997.
Michael J. Blackwell,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 97-10913 Filed 4-25-97; 8:45 am]
BILLING CODE 4160-01-F