74 FR 106 pg. 26782 - Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor; Diclofenac; Ivermectin Otic Suspension
Type: RULEVolume: 74Number: 106Page: 26782
Docket number: [Docket No. FDA-2009-N-0665]
FR document: [FR Doc. E9-13015 Filed 6-3-09; 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 Part 524
[Docket No. FDA-2009-N-0665]
Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor; Diclofenac; Ivermectin Otic Suspension
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for diclofenac sodium cream and ivermectin otic suspension from IDEXX Pharmaceuticals, Inc., to Boehringer Ingelheim Vetmedica, Inc.
DATES:
This rule is effective June 4, 2009.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8307, e-mail: david.newkirk@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141-186 for SURPASS (diclofenac sodium) topical cream and NADA 141-174 for ACAREXX (ivermectin) otic suspension to Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002. Accordingly, the regulations are amended in 21 CFR 524.590 and 524.1195 to reflect the change of sponsorship.
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.
List of Subjects in 21 CFR Part 524
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 524 is amended as follows:
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
§ 524.590 [Amended]
2. In paragraph (b) of § 524.590, remove "065274" and in its place add "000010".
§ 524.1195 [Amended]
3. In paragraph (b) of § 524.1195, remove "065274" and in its place add "000010".
Dated: May 27, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-13015 Filed 6-3-09; 8:45 am]
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