E7-14699. New Animal Drugs For Use in Animal Feeds; Ractopamine and Tylosin

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 Elanco Animal Health. The supplemental NADA revises the indications for use of two-way combination Type B and Type C medicated swine feeds formulated with ractopamine hydrochloride and tylosin phosphate.

DATES:

This rule is effective July 31, 2007.

FOR FURTHER INFORMATION CONTACT:

Harlan J. Howard, Center for Veterinary Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0231, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, a Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 141-172 that provides for use of two-way combination Type B and Type C medicated swine feeds formulated with PAYLEAN (ractopamine hydrochloride) and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles. The supplement provides for revised indications for use of Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and for control of swine dysentery associated with Brachyspira hyodysenteriae and porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis in finishing swine, weighing not less than 150 pounds (lbs), fed a complete ration containing at least 16 percent crude protein for the last 45 to 90 lbs of gain prior to slaughter. The supplemental NADA is approved as of June 20, 2007, and the regulations in 21 CFR 558.500 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.

FDA has determined under 21 CFR 25.33(a)(2) 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 558

• Animal drugs
• Animal feeds

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

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

2. In § 558.500, revise the table in paragraphs (e)(1)(ii) and (e)(1)(iii) to read as follows:

§ 558.500

Ractopamine.

* * * * *

(e) * * *

(1) * * *

Ractopamine grams/ton	Combination grams/ton	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
(ii) 4.5 to 9	Tylosin 40	Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of swine dysentery associated with Brachyspira hyodysenteriae and porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis.	Feed continuously as sole ration until market weight following the use of tylosin at 100 grams per ton (g/ton) for at least 3 weeks.	000986
(iii) 4.5 to 9	Tylosin 100	1. Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. 2. Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of swine dysentery associated with Brachyspira hyodysenteriae.	Feed continuously as sole ration for 21 days. Feed continuously as sole ration for at least 3 weeks followed by tylosin at 40 g/ton until market weight.	000986
*         *         *         *         *         *         *

* * * * *

Dated: July 12, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.