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

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 [Federal Register: July 12, 2006 (Volume 71, Number 133)]
[Rules and Regulations]
[Page 39204]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy06-3]

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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 Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc. The supplemental NADA provides for a revised food safety 
warning on labeling for hyaluronate sodium injectable solution.

DATES: This rule is effective July 12, 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.hhs.gov.

SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of 
Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed a supplement 
to NADA 112-048 for HYLARTIN (sodium hyaluronate) Injection, approved 
for veterinary prescription use by intra-articular injection for the 
treatment of joint dysfunction in horses due to noninfectious synovitis 
associated with equine osteoarthritis. The supplemental NADA provides 
for a revised food safety warning on the labeling. The application is 
approved as of May 30, 2006, 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.
    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 522

    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 522 is 
amended as follows:

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

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

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

Sec.  522.1145  [Amended]

? 2. In Sec.  522.1145, in the heading remove the word ``injection''; and 
in paragraph (a)(3)(iii) remove the sentence ``Not for use in horses 
intended for food.'' and add in its place ``Do not use in horses 
intended for human consumption''.

    Dated: June 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10879 Filed 7-11-06; 8:45 am]
BILLING CODE 4160-01-S

 
 

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