New Animal Drugs for Use in Animal Feed:

Federal Register: September 3, 2010 (Volume 75, Number 171)

Rules and Regulations

Page 54019-54020

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

DOCID:fr03se10-6

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 Feed; Ractopamine

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 two supplemental new animal drug applications (NADAs) filed by Elanco Animal Health, A Division of

Eli Lilly & Co. The supplemental NADAs provide for administering a Type

C medicated feed containing ractopamine hydrochloride as a top dress on

Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter.

DATES: This rule is effective September 3, 2010.

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: suzanne.sechen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli

Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 141-225 that provides for use of OPTAFLEXX

(ractopamine hydrochloride) and RUMENSIN (monensin, USP) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter. Elanco

Animal Health also filed a supplement to NADA 141-224 that provides for use of OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin, USP), and TYLAN (tylosin phosphate) Type A medicated articles to formulate three-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter.

The supplemental NADAs provide for administering ractopamine hydrochloride Type C medicated feeds as a top dress on Type C medicated feeds containing monensin, USP, or monensin, USP, and tylosin phosphate to cattle fed in confinement for slaughter as the means by which the two-way or three-way combinations will be created. Supplemental NADA 141-224 is approved as of June 7, 2010; supplemental NADA 141-225 is approved as of June 17, 2010; and the regulations in 21 CFR 558.500 are amended to reflect the approvals.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summaries of safety and effectiveness data and information submitted to support approval of these applications 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 these actions are of a type that do 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 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)(2)(xii) and (e)(2)(xiii) to read as follows:

Sec. 558.500 Ractopamine.

* * * * *

(e) * * *

(2) * * *

Combination in

Ractopamine in grams/ton

grams/ton

Indications for use

Limitations

Sponsor

* * * * * * *

(xii) Not to exceed 800; to

Monensin 10 to

Cattle fed in

Top dress ractopamine

000986 provide 70 to 400 mg/head/day. 40 to provide

confinement for

in a minimum of 1.0 lb 0.14 to 0.42 mg slaughter: As in

of medicated feed monensin/lb of paragraph (e)(2)(i) of during the last 28 to body weight,

this section; for

42 days on feed. Not depending on

prevention and control for animals intended severity of

of coccidiosis due to for breeding. See Sec. coccidiosis

Eimeria bovis and E.

558.355(d). challenge, up

zuernii. to 480 mg/head/ day.

Page 54020

(xiii) Not to exceed 800; to

Monensin 10 to

Cattle fed in

Top dress ractopamine

000986 provide 70 to 400 mg/head/day. 40 to provide

confinement for

in a minimum of 1.0 lb 0.14 to 0.42 mg slaughter: As in

of medicated feed monensin/lb of paragraph (e)(2)(i) of during the last 28 to body weight,

this section; for

42 days on feed. Not depending on

prevention and control for animals intended severity of

of coccidiosis due to for breeding. See Sec. coccidiosis

Eimeria bovis and E.

Sec. 558.355(d) and challenge, up

zuernii; and for

558.625(c). to 480 mg/head/ reduction of incidence day, plus

of liver abscesses tylosin 8 to

caused by 10.

Fusobacterium necrophorum and

Arcanobacterium

(Actinomyces) pyogenes.

* * * * *

Dated: August 31, 2010.

Elizabeth Rettie,

Deputy Director, Office of New Animal Drug Evaluation, Center for

Veterinary Medicine.

FR Doc. 2010-22071 Filed 9-2-10; 8:45 am

BILLING CODE 4160-01-S