[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Rules and Regulations]
[Pages 21283-21284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10622]


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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

<BD>AGENCY: <RM>Food and Drug Administration, HHS.

<BD>ACTION: <RM>Final rule.

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<BD>SUMMARY: <RM>The Food and Drug Administration (FDA) is amending the 
animal drug regulations to reflect approval of a new animal drug 
application (NADA) filed by Elanco Animal Health. The 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 prevention and/or control of porcine 
proliferative enteropathies (ileitis) in swine.

<BD>DATES: <RM>This rule is effective April 30, 2001.

<BD>FOR FURTHER INFORMATION CONTACT: <RM>Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

<BD>SUPPLEMENTARY INFORMATION: <RM>Elanco Animal Health, A Division of 
Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed 
NADA 141-172 that provides for use of Paylean<IT><Register> <RM>(9 
grams per pound (g/lb) ractopamine hydrochloride) and 
Tylan<IT><Register> <RM>(10, 40, or 100 g/lb tylosin phosphate) Type A 
medicated article to make combination drug Type C medicated feeds used 
for increased rate of weight gain, improved feed efficiency, and 
increased carcass leanness, and for prevention and/or control of 
porcine proliferative enteropathies (ileitis) associated with 
<IT>Lawsonia intracellularis <RM>in swine. The NADA is approved as of 
February 20, 2001, and the regulations are amended in 21 CFR 558.500 
and 558.625 to reflect the approval. The basis of approval is discussed 
in the freedom of information summary.
    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.

[[Page 21284]]

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:

     <CS>Authority: <RM>21 U.S.C. 360b, 371.
    2. Section 558.500 is amended by revising paragraph (d)(1) to read 
as follows:


Sec. 558.500  Ractopamine.

* * * * *
    (d) <IT>Conditions of use<RM>.
     (1) <IT>Swine<RM>.

----------------------------------------------------------------------------------------------------------------
                                   Combination in grams
   Ractopamine in grams per ton           per ton          Indications for use        Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4.5..........................    ..................  For increased rate of   Feed continuously as     000986
                                                          weight gain, improved   sole ration. Feed in
                                                          feed efficiency, and    a complete ration
                                                          increased carcass       containing at least
                                                          leanness.               16 percent crude
                                                                                  protein to finishing
                                                                                  swine from 150 to
                                                                                  240 pounds body
                                                                                  weight. Not for use
                                                                                  in breeding swine.
(ii) 4.5 to 18...................    ..................  For improved feed       Feed continuously as     000986
                                                          efficiency and          sole ration. Feed in
                                                          increased carcass       a complete ration
                                                          leanness.               containing at least
                                                                                  16 percent crude
                                                                                  protein to finishing
                                                                                  swine from 150 to
                                                                                  240 pounds body
                                                                                  weight. Not for use
                                                                                  in breeding swine.
(iii) 4.5........................  Tylosin 100.........  For increased rate of   Feed continuously as     000986
                                                          weight gain, improved   sole ration for 21
                                                          feed efficiency, and    days. Feed in a
                                                          increased carcass       complete ration
                                                          leanness; and for       containing at least
                                                          prevention and/or       16 percent crude
                                                          control of porcine      protein to finishing
                                                          proliferative           swine from 150 to
                                                          enteropathies           240 pounds body
                                                          (ileitis) associated    weight. Not for use
                                                          with <IT>Lawsonia<RM>           in breeding swine.
                                                          <IT>intracellularis.<RM>
(iv) 4.5 to 18...................  Tylosin 100.........  For improved feed       Feed continuously as     000986
                                                          efficiency and          sole ration for 21
                                                          increased carcass       days. Feed in a
                                                          leanness; and for       complete ration
                                                          prevention and/or       containing at least
                                                          control of porcine      16 percent crude
                                                          proliferative           protein to finishing
                                                          enteropathies           swine from 150 to
                                                          (ileitis) associated    240 pounds body
                                                          with <IT>Lawsonia<RM>           weight. Not for use
                                                          <IT>intracellularis.<RM>        in breeding swine.
----------------------------------------------------------------------------------------------------------------

* * * * *
    3. Section 558.625 is amended by adding paragraph (f)(2)(vii) to 
read as follows:


Sec. 558.625  Tylosin.

* * * * *
    (f) * * * 
    (2) * * * 
    (vii) Ractopamine hydrochloride as in Sec. 558.500.

    Dated: April 16, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-10622 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S