Food and Drug Administration, HHS.
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.
This rule is effective July 31, 2007.Start Further Info
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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-Start Printed Page 41619ingredient 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.Start List of Subjects
List of Subjects in 21 CFR Part 558End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part Start Amendment Part
2. In § 558.500, revise the table in paragraphs (e)(1)(ii) and (e)(1)(iii) to read as follows:End Amendment Part
(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.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-14699 Filed 7-30-07; 8:45 am]
BILLING CODE 4160-01-S