2010-11282. Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin

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 Sparhawk Laboratories, Inc. The ANADA provides for use of an ivermectin injectable solution in cattle and swine for treatment and control of various internal and external parasites.

DATES:

This rule is effective May 12, 2010.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215, filed ANADA 200-429 for the use of Ivermectin Injection in cattle and swine for treatment and control of various internal and external parasites. Sparhawk Laboratories, Inc.'s, Ivermectin Injection is approved as a generic copy of Merial Ltd.'s IVOMEC Injection for Cattle and Swine, approved under NADA 128-409. The ANADA is approved as of March 26, 2010, and the regulations in 21 CFR 522.1192 are amended to reflect the approval.

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.

The agency 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 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.

2. In § 522.1192, revise paragraphs (b)(1), (b)(2), and (e)(2)(ii) to read as follows:

§ 522.1192.

Ivermectin

(b)* * *

(1) No. 050604 for use of the product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section; the product described in paragraph (a)(2) of this section as in paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) of this section; and the product described in paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this section.

(2) Nos. 055529, 058005, and 059130 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2), (e)(3), (e)(4), and (e)(5) of this section.

(e) * * *

(2) * * *

(ii) Indications for use. For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis). For control of infections and to protect from reinfection with D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; H. placei and C. oncophora for 14 days after treatment.

Dated: May 7, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.