Document ID: FDA-2009-N-0665-0025
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs; Change of Sponsor; Diclofenac; Ivermectin Otic Suspension - Final Rule
Posted Date: 2009-06-04T04:00Z

[Federal Register: June 4, 2009 (Volume 74, Number 106)]
[Rules and Regulations]               
[Page 26782]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04jn09-7]                         

=======================================================================
-----------------------------------------------------------------------

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.

0
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

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

Sec.  524.590  [Amended]

0
2. In paragraph (b) of Sec.  524.590, remove ``065274'' and in its 
place add ``000010''.

Sec.  524.1195  [Amended]

0
3. In paragraph (b) of Sec.  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]

BILLING CODE 4160-01-S