Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Hess & Clark, Inc., to Phoenix Scientific, Inc.
This rule is effective October 12, 2004.Start Further Info
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511, has informed FDA that it has transferred ownership of , and all rights and interest in, the following three approved NADAs, to Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503:
|NADA Number||Trade Name|
|6-391||S.Q. (sulfaquinoxaline) 40% Medicated Feed|
|6-677||S.Q. (sulfaquinoxaline) 20% Solution|
Accordingly, the agency is amending the regulations in 21 CFR 520.2325a and 558.586 to reflect the transfer of ownership and a current format.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.Start List of Subjects
List of SubjectsEnd List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Section 520.2325a is amended in paragraph (a)(1) by removing “050749” and by adding in its place “059130”.End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
3. The authority citation forEnd Amendment Part Start Amendment Part
4. Section 558.586 is amended by revising the section heading; by removing paragraphs (c) and (d); by redesignating paragraphs (e) and (f) as paragraphs (c) and (d); and by revising paragraph (a) and adding paragraph (b) to read as follows:End Amendment Part
(a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.
(b) Approvals. See No. 059130 in § 510.600(c) of this chapter.
Dated: September 27, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 04-22760 Filed 10-8-04; 8:45 am]
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