[Federal Register Volume 63, Number 31 (Tuesday, February 17, 1998)]
[Rules and Regulations]
[Pages 7702-7703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3900]
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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; Tricaine
Methanesulfonate
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 Western Chemical, Inc. The ANADA provides
for the use of tricaine methanesulfonate in the water of fish and other
cold-blooded aquatic animals for temporary immobilization.
EFFECTIVE DATE: February 17, 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: Western Chemical, Inc., 1269 Lattimore Rd.,
Ferndale, WA 98248, is the sponsor of ANADA 200-226, which provides for
the use of tricaine methanesulfonate powder to be mixed in the water of
fish and other cold-blooded animals to be used for anesthesia and
tranquilization. Western Chemical's ANADA 200-226 is approved as a
generic copy of Argent Chemical Laboratories' NADA 42-427
Finquel. The ANADA is approved as of November 21, 1997, and
the regulations are amended in 21 CFR 529.2503(b) 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 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. to 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 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: 21 U.S.C. 360b.
Sec. 529.2503 [Amended]
2. Section 529.2503 Tricaine methanesulfonate is amended in
paragraph (b) by removing ``No.
[[Page 7703]]
051212'' and adding in its place ``Nos. 050378 and 051212''.
Dated: January 21, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-3900 Filed 2-13-98; 8:45 am]
BILLING CODE 4160-01-F
