01-30037. Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Pour-On

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 an abbreviated new animal drug application (ANADA) filed by Virbac AH, Inc. The ANADA provides for topical use of ivermectin on cattle for treatment and control of various species of external and internal parasites.

DATES:

This rule is effective December 5, 2001.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137, filed ANADA 200-318 for VIRBAMEC (ivermectin) Pour-On. The ANADA provides for topical use of 0.5 percent ivermectin solution on cattle for the treatment and control of various species of gastrointestinal nematodes, lungworms, grubs, horn flies, lice, and mites. Virbac's VIRBAMEC Pour-On is approved as a generic copy of Merial Ltd.'s IVOMEC Pour-On for Cattle, approved under NADA 140-841. The ANADA 200-318 is approved as of September 21, 2001, and the regulations in 21 CFR 524.1193 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, Virbac AH, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (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(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.

2. Section 510.600 is amended in the table in paragraph (c)(1) by alphabetically adding an entry for “Virbac AH, Inc.” and in the table in paragraph (c)(2) by numerically adding an entry for “051311” to read as follows:

§ 510.600

Names, addresses, and drug labeler codes of sponsors of approved applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*         *         *         *         *         *         *
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137	051311
*         *         *         *         *         *         *

(2) * * *

Drug labeler code	Firm name and address
*         *         *         *         *         *         *
051311	Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137
*         *         *         *         *         *         *

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.

§ 524.1193

[Amended]

4. Section 524.1193 Ivermectin pour-on is amended in paragraph (b) by adding “051311,” after “051259,” and in paragraph (e)(2) by removing “Damalina” and by adding in its place “Damalinia”.

Dated: November 9, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.