New Animal Drugs for Use in Animal Feeds: Ractopamine; Monensin

Federal Register: February 5, 2010 (Volume 75, Number 24)

Rules and Regulations

Page 5887-5888

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr05fe10-5

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 558

Docket No. FDA-2010-N-0002

New Animal Drugs for Use in Animal Feeds; Ractopamine; Monensin

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 an original new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli

Lilly & Co. The NADA provides for use of single-ingredient Type A medicated articles containing ractopamine hydrochloride and monensin to formulate two-way combination Type C medicated feeds for finishing hen and tom turkeys.

DATES: This rule is effective February 5, 2010.

FOR FURTHER INFORMATION CONTACT: Linda M. Wilmot, Center for Veterinary

Medicine (HFV-120), Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 240-276-8101, e-mail: linda.wilmot@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli

Lilly

Page 5888

& Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 141- 301 for use of TOPMAX (ractopamine hydrochloride) and COBAN (monensin,

USP) single-ingredient Type A medicated articles to formulate two-way combination Type C medicated feeds for finishing hen and tom turkeys.

The 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.

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. 0

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

Authority: 21 U.S.C. 360b, 371. 0 2. In Sec. 558.500, add paragraphs (e)(3)(iii) and (e)(3)(iv) to read as follows:

Sec. 558.500 Ractopamine.

* * * * *

(e) * * *

(3) * * *

Ractopamine in

Combination in grams/ton

grams/ton

Indications for use

Limitations

Sponsor

* * * * * * *

(iii) 4.6 to 11.8

Monensin 54 to 90

Finishing hen turkeys: As in Feed continuously as sole

000986

(5 to 13 ppm)

paragraph (e)(3)(i) of this ration during the last 7 section; and for the

to 14 days prior to prevention of coccidiosis

slaughter. See Sec. in growing turkeys caused

558.355(d). by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.

(iv) 4.6 to 11.8 (5 Monensin 54 to 90

Finishing tom turkeys: As in Feed continuously as sole

000986 to 13 ppm)

paragraph (e)(3)(ii) of

ration during the last 14 this section; and for the

days prior to slaughter. prevention of coccidiosis

Feeding ractopamine to tom in growing turkeys caused

turkeys during periods of by Eimeria adenoeides, E.

excessive heat can result meleagrimitis and E.

in increased mortality. gallopavonis.

See Sec. 558.355(d).

Dated: February 1, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

FR Doc. 2010-2427 Filed 2-4-10; 8:45 am

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