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###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 520

# AGENCY:

 Food   and   Drug   Administration, HHS.

# ACTION:

 Final rule.

# SUMMARY:

 The  Food  and  Drug  Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Merial Ltd.  The NADA provides for veterinary prescription  use  of firocoxib oral paste  in  horses  for  the  control  of  pain  and  inflammation associated with osteoarthritis.

# DATES:

 This   rule   is   effective   February 3, 2006.

# FOR FURTHER INFORMATION CONTACT:

                         Melanie R. Berson, Center for Veterinary Medicine (HFV-110),  Food and Drug  Administration,  7500  Standish  Pl.,  Rockville, MD 20855, 301-827-7540,               e-mail:                         *melanie.berson@fda.gov*.                    

# SUPPLEMENTARY   INFORMATION:

Merial   Ltd., 3239  Satellite  Blvd.,  Bldg.  500, Duluth, GA 30096-4640, filed  NADA  141-253  for veterinary  prescription  use  of EQUIOXX  (firocoxib) oral paste  for  the  control  of  pain  and inflammation  associated with osteoarthritis in horses.  The NADA is approved as  of  December  30,  2005,  and  21 CFR part 520 is amended  by  adding  new  § 520.930  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 21  CFR 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  Division  of  Dockets Management  (HFA-305),  Food  and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(ii) of  the Federal Food, Drug, and Cosmetic  Act  (21  U.S.C.  360b(c)(2)(F)(ii)),   this   approval qualifies for 3 years of marketing exclusivity beginning December 30, 2005.

The  agency has determined under 21 CFR 25.33(d)(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.

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 520

      - 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 520 is amended as follows:

# PART    520—ORAL    DOSAGE   FORM   NEW   ANIMAL DRUGS

1.  The authority citation for 21 CFR part 520 continues to read as follows:

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

2.  Revise the section heading of § 520.928 to read as follows: 

§ 520.928 

3.  Add § 520.930 to read as follows: 

§ 520.930 

                        (a)                         *Specifications*.   Each  milligram  (mg) of paste contains 0.82 mg firocoxib.                    

                        (b)                         *Sponsors*.     See    No.   050604   in § 510.600(c) of this chapter.                    

                        (c)                         *Conditions  of use in horses*                        —(1)                         *Amount*.  0.1 mg per kilogram (0.045 mg per pound) body weight daily for up to 14 days.                    

                        (2)                         *Indications for  use*.   For  the  control of pain and inflammation associated with osteoarthritis.                    

                        (3)                         *Limitations*.  Do not use in horses  intended for human consumption. Federal law restricts this drug to  use by or on the order of a licensed veterinarian.                    

Dated: January 18, 2006.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 06-993 Filed 2-2-06; 8:45 am]

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