[Federal Register Volume 71, Number 7 (Wednesday, January 11, 2006)]
[Rules and Regulations]
[Page 1689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-229]



[[Page 1689]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Hyaluronate Sodium Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Bayer HealthCare LLC. The supplemental NADA 
provides for veterinary prescription use of a hyaluronate sodium 
solution, formulated with a benzyl alcohol preservative, for 
intravenous administration to horses for the treatment of 
osteoarthritis.

DATES: This rule is effective January 11, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health 
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement 
to NADA 140-883 that provides for veterinary prescription use of LEGEND 
Multi-dose (hyaluronate sodium) Injectable Solution. The supplemental 
NADA provides for use of this hyaluronate sodium solution, formulated 
with a benzyl alcohol preservative, from a multi-dose vial for 
intravenous administration to horses for the treatment of carpal or 
fetlock osteoarthritis. The supplemental NADA is approved as of 
December 15, 2005, and the regulations are amended in 21 CFR 522.1145 
to reflect the approval and a current format. 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.
    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 Subject in 21 CFR Part 522

    Animal drugs.

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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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. Section 522.1145 is amended by revising paragraph (e) to read as 
follows:


Sec.  522.1145  Hyaluronate sodium injection.

* * * * *
    (e)(1) Specifications. Each milliliter of solution contains:
    (i) 10 milligrams (mg) hyaluronate sodium; or
    (ii) 10 mg hyaluronate sodium with benzyl alcohol as a 
preservative.
    (2) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (3) Conditions of use in horses--(i) Amount. 20 mg of the product 
described in paragraph (e)(1)(i) of this section by intra-articular 
injection into the carpus or fetlock; or 40 mg of the product described 
in paragraph (e)(1)(i) or (e)(1)(ii) of this section by slow 
intravenous injection into the jugular vein. Treatment may be repeated 
at weekly intervals for a total of three treatments.
    (ii) Indications for use. For treatment of carpal or fetlock joint 
dysfunction due to noninfectious synovitis associated with equine 
osteoarthritis.
    (iii) 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 4, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-229 Filed 1-10-06; 8:45 am]
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