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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs; Ractopamine

DATES: This rule is effective November 6, 2007.

DOCUMENT 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 an increased level of monensin in threeway combination Type C medicated feeds containing ractopamine, monensin, and tylosin for cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature.

SUMMARY: Ractopamine,

SUPPLEMENTAL INFORMATION

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 141224 that provides for use of OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin USP), and TYLAN (tylosin phosphate) Type A medicated articles to make dry and liquid threeway combination medicated feeds for cattle fed in confinement for slaughter. The supplemental NADA provides for an increased level of monensin in combination Type C medicated feeds and a revision to bacterial pathogen nomenclature. The supplemental NADA is approved as of October 12, 2007, and the regulations in 21 CFR 558.500 are amended to reflect the approval.

[[Page 62571]]

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 (HFA305), 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(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. 801808.
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 558NEW 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 Sec. 558.500, in the table in paragraph (e)(2), revise paragraphs (e)(2)(iv) and (e)(2)(ix) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
Ractopamine in
grams/ton Combination in grams/ton Indications for use Limitations Sponsor * * * * * * * (iv) 8.2 to 24.6 Monensin 10 to 40 to Cattle fed in confinement As in paragraph 000986 provide 0.14 to 0.42 mg for slaughter: As in (e)(2)(i) of this monensin/lb of body paragraph (e)(2)(i) of this section; see Sec. Sec. weight, depending on section; for prevention and 558.355(d) and severity of coccidiosis control of coccidiosis due 558.625(c) of this challenge, up to 480 mg/ to Eimeria bovis and E. chapter. head/day, plus tylosin 8 zuernii; and for reduction to 10 of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. * * * * * * * (ix) 9.8 to 24.6 Monensin 10 to 40 to Cattle fed in confinement As in paragraph 000986 provide 0.14 to 0.42 mg for slaughter: As in (e)(2)(vi) of this monensin/lb of body paragraph (e)(2)(vi) of section; see Sec. Sec. weight, depending on this section; for 558.355(d) and severity of coccidiosis prevention and control of 558.625(c) of this challenge, up to 480 mg/ coccidiosis due to Eimeria chapter. head/day, plus tylosin 8 bovis and E. zuernii; and to 10 for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. * * * * * * *

Dated: October 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E721816 Filed 11507; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Daniel A. Benz, Center for Veterinary Medicine (HFV126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018270223, email: daniel.benz@fda.hhs.gov.