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, A Division of Eli Lilly & Co. The supplemental NADA provides for administering ractopamine hydrochloride Type C medicated feeds as a top dress to cattle fed in confinement for slaughter.
This rule is effective January 11, 2010.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Suzanne J. Sechen, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail: email@example.com.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 141-221 that provides for use of OPTAFLEXX 45 (ractopamine hydrochloride) Type A medicated articles to formulate Type B and Type C medicated feeds administered to cattle fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed. The supplement provides for feeding ractopamine hydrochloride Type C medicated feed as a top dress. The supplemental NADA is approved as of December 11, 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.
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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.
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 Start Printed Page 1276
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, in paragraph (e)(2), in the heading of the first table column, remove “Ractopame” and in its place add “Ractopamine”; and add paragraph (e)(2)(xi) to read as follows:End Amendment Part
(e) * * *
|Ractopamine in grams/ton||Combination in grams/ton||Indications for use||Limitations||Sponsor|
|* * * * * * *|
|(xi) Not to exceed 800; to provide 70 to 400 mg/head/day.||Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section.||Top dress in a minimum of 1.0 lb of medicated feed.||000986|
|* * * * * * *|
Dated: December 31, 2009.
Director, Center for Veterinary Medicine.
[FR Doc. 2010-208 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S