E9-29998. New Animal Drugs for Use in Animal Feeds; Ractopamine; Tylosin

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 a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for use of two-way combination Type B and C medicated swine feeds formulated with ractopamine hydrochloride and tylosin phosphate following use of tylosin tartrate medicated drinking water consistent with the sequential use approved for single-ingredient tylosin medicated swine feed.

DATES:

This rule is effective December 17, 2009.

FOR FURTHER INFORMATION CONTACT:

Timothy Schell, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8116, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, a Div. of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 141-172 for use of two-way combination Type B and C medicated swine feeds formulated with PAYLEAN (ractopamine hydrochloride) and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles. The supplement provides use of two-way combination Type B and C medicated swine feeds formulated with ractopamine hydrochloride and tylosin phosphate following use of tylosin tartrate medicated drinking water consistent with the sequential use approved for single-ingredient tylosin medicated swine feed (73 FR 76946, December 18, 2008). The supplemental NADA is approved as of October 23, 2009, 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.

In addition, FDA has noticed that the tylosin levels for single-ingredient Type C medicated swine feed are not clearly described in 21 CFR 558.625. At this time, those regulations are being revised to clarify this use of levels. This action is being taken to improve the accuracy of the regulations.

FDA 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 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); and add paragraph (e)(1)(iv) to read as follows:

§ 558.500

Ractopamine.

(e) * * *

(1) * * *

Ractopamine in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
(ii) 4.5 to 9	Tylosin 40 or 100	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 (PPE, ileitis) associated with Lawsonia intracellularis.	Feed 100 grams per tons (g/ton) continuously as sole ration for at least 3 weeks followed by 40 g/ton until market weight.	000986
(iii) 4.5 to 9	Tylosin 100	Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.	Feed continuously as sole ration for 21 days.	000986
(iv) 4.5 to 9	Tylosin 40 to 100	Finishing swine: As in paragraph (e)(1)(i) of this section; for treatment and control of swine dysentery associated with B. hyodysenteriae and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.	Feed continuously as sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water as in § 520.2640(d)(3) of this chapter.	000986

§ 558.625

[Amended]

3. In § 558.625, in paragraph (f)(1)(vi)( b), remove “Tylosin, 40-100 grams.” and in its place add “Tylosin, 40 or 100 grams.”; and remove paragraph (f)(1)(vi)(d)(vi).

Dated: December 11, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.