05-12421. New Animal Drugs; Moxidectin

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 new animal drug application (NADA) filed by Fort Dodge Animal Health. The NADA provides for use of an injectable moxidectin solution for the treatment and control of various internal and external parasites of cattle.

DATES:

This rule is effective June 23, 2005.

FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed NADA 141-220 that provides for use of CYDECTIN (moxidectin) Injectable Solution for Beef and Nonlactating Dairy Cattle for the treatment and control of various internal and external parasites. The NADA is approved as of May 20, 2005, and the regulations are amended in part 522 (21 CFR part 522) by adding § 522.1450 and in part 556 (21 CFR part 556) by revising § 556.426 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning May 20, 2005.

The agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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 522

• Animal drugs

21 CFR Part 556

• Animal drugs
• Foods

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 parts 522 and 556 are 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.

2. Section 522.1450 is added to read as follows:

§ 522.1450

Moxidectin solution.

(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) moxidectin.

(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.426 of this chapter.

(d) Conditions of use in beef and nonlactating dairy cattle.—(1) Amount. 0.2 mg/kilogram body weight (0.2 mg/2.2 pound) as a single subcutaneous injection.

(2) Indications for use. For treatment and control of gastrointestinal roundworms: Ostertagia ostertagi (adults and inhibited fourth-stage larvae), Haemonchus placei (adults), Trichostrongylus axei (adults), T. colubriformis (fourth-stage larvae), Cooperia oncophora (adults), C. punctata (adults and fourth-stage larvae), C. surnabada (adults and fourth-stage larvae), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); grubs: Hypoderma bovis and H. lineatum; mites: Psoroptes ovis (P. communis var. bovis); lice: Linognathus vituli and Solenopotes capillatus; for protection of cattle from reinfection with D. viviparus and O. radiatum for 42 days after treatment, with H. placei for 35 days after treatment, and with O. ostertagi and T. axei for 14 days after treatment.

(3) Limitations. Do not slaughter cattle within 21 days of treatment. Because a withholding time for milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal.

§ 522.1451

[Amended]

3. Section 522.1451 is amended by revising the section heading to read “Moxidectin for suspension.”

PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

4. The authority citation for 21 CFR part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

5. Section 556.426 is amended by redesignating paragraphs (b)(1)(i) through (b)(1)(iii) as paragraphs (b)(1)(ii) through (b)(1)(iv); by revising newly redesignated paragraphs (b)(1)(ii) and (b)(1)(iv); and by adding new paragraphs (b)(1)(i) and (c) to read as follows:

§ 556.426

Moxidectin.

* * * * *

(b) * * *

(1) * * *

(i) Fat (the target tissue). The tolerance for parent moxidectin (the marker residue) is 900 parts per billion (ppb).

(ii) Liver. The tolerance for parent moxidectin (the marker residue) is 200 ppb.

(iii) * * *

(iv) Milk. The tolerance for parent moxidectin (the marker residue) is 40 ppb.

* * * * *

(c) Related conditions of use. See § 522.1451 of this chapter.

Dated: June 10, 2005.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.