[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Rules and Regulations]
[Pages 71820-71821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30637]


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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.

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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: 
[email protected].

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 am]
BILLING CODE 4160-01-S