Document ID: FDA-2009-N-0665-0080
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium - Final Rule
Posted Date: 2010-01-11T05:00Z

[Federal Register: January 11, 2010 (Volume 75, Number 6)]
[Rules and Regulations]               
[Page 1274]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja10-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Hyaluronate Sodium

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 Anika Therapeutics, Inc. The supplemental 
NADA provides for a revised human food safety warning for use of 
hyaluronate sodium injectable solution in horses.

DATES:  This rule is effective January 11, 2010.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Anika Therapeutics, Inc., 236 W. Cummings 
Park, Woburn, MA 01801, filed a supplement to NADA 122-578 that 
provides for the veterinary prescription use of HYVISC (hyaluronate 
sodium) Sterile Injection in horses. The supplemental NADA provides for 
a revised human food safety warning on product labeling. The 
supplemental NADA is approved as of December 11, 2009, and the 
regulations are amended in 21 CFR 522.1145 to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    FDA has determined under 21 CFR 25.33 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 522

    Animal drugs.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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

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

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

Sec.  522.1145   [Amended]

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2. In paragraph (f)(3)(iii) of Sec.  522.1145, remove the third 
sentence and in its place add ``Do not use in horses intended for human 
consumption.''

    Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-207 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S