[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
