Animal drugs, feeds, and related products: Ractopamine and tylosin,

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Federal Register: December 3, 2002 (Volume 67, Number 232)Rules and RegulationsPage 71820-71821From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr03de02-12

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal Feeds; Ractopamine and Tylosin

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 a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for use of ractopamine and tylosin single-ingredient Type A medicated articles to make combination drug Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, increased carcass leanness; and for the prevention of swine dysentery in finishing swine.

DATES: This rule is effective December 3, 2002.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-1600, e-mail: candres@cvm.fda.gov.

SUPPLEMENTARY 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 PAYLEAN (9 or 45 grams per pound (g/lb) ractopamine hydrochloride) and TYLAN (10, 40, or 100 g/lb tylosin phosphate) Type A medicated articles to make combination drug Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and for the prevention of swine dysentery in finishing swine. The supplemental NADA is approved as of June 19, 2002, and the regulations are amended in Sec. 558.500 (21 CFR 558.500) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, Sec. 558.500 is being revised to reflect a current format. The entire text of this section is being provided for the convenience of the reader.

In accordance with the freedom of information provisions of 21 CFR part 20 and 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 Dockets Management Branch (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(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.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under 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.

2. Section 558.500 is revised to read as follows:

Sec. 558.500 Ractopamine.

  (a) Specifications. Type A medicated articles containing 9 or 45 grams of ractopamine hydrochloride per pound.

  (b) Approvals. See No. 000986 in Sec. 510.600(c) of this chapter.

  (c) Related tolerances. See Sec. 556.570 of this chapter.

  (d) Special considerations.

  (1) Labeling of Type B and Type C swine feeds shall bear the following:

  (i) ``Caution: Pigs fed PAYLEAN are at an increased risk for exhibiting the downer pig syndrome (also referred to as ``slows,'' ``subs,'' or ``suspects''). Pig handling methods to reduce the incidence of downer pigs should be thoroughly evaluated prior to initiating use of PAYLEAN.''

  (ii) ``Not for use in breeding swine.''

  (2) Tylosin in combinations as tylosin phosphate.

  (e) Conditions of use. (1) Swine--

Ractopamine in Combination in grams/ton

grams/ton

Indications for use

Limitations

Sponsor

  (i) 4.5

.................. For increased rate of weight Feed continuously as

000986 gain, improved feed

sole ration. efficiency, and increased carcass leanness in finishing swine fed a complete ration containing at least 16 percent crude protein from 150 lb (68 kg) to 240 lb (109 kg) body weight.

[Page 71821]

  (ii) 4.5

Tylosin 40

Finishing swine: As in

Feed continuously as

000986 paragraph (e)(1)(i) of this sole ration until section; and for prevention market weight of swine dysentery

following the use of (vibrionic).

tylosin at 100 grams per ton (g/t) for at least 3 weeks. (iii) 4.5

Tylosin 100

1. Finishing swine: As in Feed continuously as

000986 paragraph (e)(1)(i) of this sole ration for 21

000986 section; and for prevention days. and/or control of porcine Feed continuously as proliferative enteropathies sole ration for at (ileitis) associated with least 3 weeks Lawsonia intracellularis. followed by tylosin 2. Finishing swine: As in at 40 g/t until paragraph (e)(1)(i) of this market weight. section; and for prevention of swine dysentery (vibrionic). (iv) 4.5 to 18 .................. For improved feed efficiency Feed continuously as

000986 and increased carcass

sole ration. leanness in finishing swine fed a complete ration containing at least 16 percent crude protein from 150 lb (68 kg) to 240 lb (109 kg) body weight. (v) 4.5 to 18 Tylosin 40

Finishing swine: As in

Feed continuously as

000986 paragraph (e)(1)(iv) of this sole ration until section; and for prevention market weight of swine dysentery

following the use of (vibrionic).

tylosin at 100 g/t for at least 3 weeks. (vi) 4.5 to 18 Tylosin 100

1. Finishing swine: As in Feed continuously as

000986 paragraph (e)(1)(iv) of this sole ration for 21

000986 section; and for prevention days. and/or control of porcine Feed continuously as proliferative enteropathies sole ration for at (ileitis) associated with least 3 weeks Lawsonia intracellularis. followed by tylosin 2. Finishing swine: As in at 40 g/t until paragraph (e)(1)(iv) of this market weight. section; and for prevention of swine dysentery (vibrionic).

  (2) [Reserved]

Dated: November 8, 2002. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

FR Doc. 02-30637 Filed 12-2-02; 8:45 amBILLING CODE 4160-01-S

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