69 FR 196 pg. 60547 - New Animal Drugs; Change of Sponsor; Sulfaquinoxaline
Type: RULEVolume: 69Number: 196Page: 60547
FR document: [FR Doc. 04-22760 Filed 10-8-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520 and 558
New Animal Drugs; Change of Sponsor; Sulfaquinoxaline
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) isamending the animal drug regulations to reflect a change of sponsor for anapproved new animal drug application (NADA) from Hess Clark, Inc., toPhoenix Scientific, Inc.
DATES:
This rule is effective October 12, 2004.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk,Center for Veterinary Medicine (HFV-100), Food and DrugAdministration, 7500 Standish Pl., Rockville, MD 20855,301-827-6967, e-mail: david.newkirk@fda.gov .
SUPPLEMENTARY INFORMATION:
Hess Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511, hasinformed FDA that it has transferred ownership of , and all rights andinterest 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 |
| 7-087 | Sulfaquinoxaline Solubilized |
Accordingly, the agency is amending the regulations in 21 CFR 520.2325aand 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 5U.S.C. 801-808.
List of Subjects
21 CFR Part 520
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,Drug, and Cosmetic Act and under authority delegated to the Commissioner ofFood and Drugs and redelegated to the Center for Veterinary Medicine, 21CFR parts 520 and 558 are amended as follows:
PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read asfollows:
Authority:
21 U.S.C. 360b.
§ 520.2325a [Amended]
2. Section 520.2325a is amended in paragraph (a)(1) by removing"050749" and by adding in its place"059130".
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMALFEEDS
3. The authority citation for 21 CFR part 558 continues to read asfollows:
Authority:
21 U.S.C. 360b, 371.
4. Section 558.586 is amended by revising the section heading; byremoving paragraphs (c) and (d); by redesignating paragraphs (e) and (f) asparagraphs (c) and (d); and by revising paragraph (a) and adding paragraph (b) to read asfollows:
§ 558.586 Sulfaquinoxaline.
(a) Specifications . Type A medicated articles containing40 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 forVeterinary Medicine.
[FR Doc. 04-22760 Filed 10-8-04; 8:45 am]
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