E9-18337. New Animal Drugs; Nitrofurazone Ointment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for use of nitrofurazone ointment on horses for prevention or treatment of superficial bacterial infections.

DATES:

This rule is effective August 3, 2009.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200-425 for use of Nitrofurazone Soluble Dressing in horses for prevention or treatment of superficial bacterial infections of wounds, burns, and cutaneous ulcers. First Priority, Inc.'s Nitrofurazone Soluble Dressing is approved as a generic copy of FURA-ZONE (nitrofurazone) ointment, sponsored by Squire Laboratories, Inc., under NADA 132-427. In addition, First Priority, Inc., has informed FDA of a change of address. The ANADA is approved as of July 13, 2009, and §§ 510.600 and 524.1580b (21 CFR 510.600 and 524.1580b) are amended to reflect the approval.

In addition, FDA has found that the pioneer sponsor's drug labeler code (DLC) was inadvertently omitted from § 524.1580b during format changes in 2005 (70 FR 50181; August 26, 2005). At this time, § 524.1580b is amended to include Squire Laboratories, Inc.'s DLC. Section 524.1580b is also amended to reflect current food safety warnings.

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.

FDA has determined under 21 CFR 25.33(a)(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

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 524

• 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 parts 510 and 524 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

§ 510.600

[Amended]

2. In § 510.600, in the table in paragraph (c)(1), in the entry for “First Priority, Inc.” and in the table in paragraph (c)(2), in the entry for ”058829”, remove “1585 Todd Farm Dr.” and in its place add “1590 Todd Farm Dr.”.

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 524 continues to read as follows:

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

4. In § 524.1580b, add paragraph (b)(3) and revise paragraph (d)(3) to read as follows:

§ 524.1580b

Nitrofurazone ointment.

* * * * *

(b) * * *

(3) See Nos. 017153 and 058829 for use on horses.

* * * * *

(d) * * *

(3) Limitations. For use only on dogs, cats, and horses. Do not use in horses intended for human consumption. Federal law prohibits the use of this product in food-producing animals. In case of deep or puncture wounds or serious burns, use only as recommended by veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian.

Dated: July 28, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.