2010-207. Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium

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 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: [e-mail].

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

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

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

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

§ 522.1145

[Amended]

2. In paragraph (f)(3)(iii) of § 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.