[Federal Register Volume 67, Number 140 (Monday, July 22, 2002)]
[Rules and Regulations]
[Pages 47691-47692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18365]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 for their 
ractopamine hydrochloride Type A medicated article. The supplemental 
NADAs provide for use of a 45-gram-per-pound (g/lb) strength Type A 
medicated article to make Type B and Type C medicated feeds for 
finishing swine, for amending the assay limits for Type B and Type C 
medicated feeds containing ractopamine, and for the addition of 
cautionary statements to labeling.

DATES: This rule is effective July 22, 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 two 
supplemental applications to NADA 140-863 for PAYLEAN (ractopamine 
hydrochloride), a Type A medicated article used to make Type B and Type 
C medicated feeds for finishing swine. The first supplemental NADA 
provides for use of a 45-g/lb strength of PAYLEAN and for amending the 
assay limits for Type B and Type C medicated feeds containing 
ractopamine. The second supplemental NADA provides for addition of 
cautionary statements to labeling. The supplemental NADAs are approved 
as of February 27 and June 1, 2001, respectively, and the regulations 
are amended in Secs. 558.4 and 558.500 (21 CFR 558.4 and 558.500) to 
reflect the approval.
    In addition, Sec. 558.500 is being revised to correct the wording 
of the indications for the use of ractopamine alone or in combination 
with tylosin.
    Approval of the first supplemental NADA did not require review of 
safety or effectiveness data; therefore, a freedom of information 
summary is not required.
    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 submitted to support approval of the second supplemental 
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)(1) 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

[[Page 47692]]

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.


Sec. 558.4  [Amended]

    2. Section 558.4 Requirement of a medicated feed mill license is 
amended in paragraph (d) in the ``Category I'' table in the entry for 
``Ractopamine'' in the ``Assay limits percent\1\ type B/C\2\'' column 
by removing ``80-110'' and adding in its place ``80-110/75-125''.
    3. Section 558.500 is amended in paragraph (a) by removing ``9'' 
and adding in its place ``9 or 45'' and by revising the table in 
paragraph (d)(1) to read as follows:


Sec. 558.500  Ractopamine.

* * * * *
    (d) *  *  *
    (1) *  *  *

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                           Combination
 Ractopamine grams/ton      grams/ton          Indications for use             Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 4.5                                   For increased rate of weight  Feed continuously as sole  000986
                                           gain, improved feed           ration. Pigs fed PAYLEAN
                                           efficiency, and increased     are at an increased risk
                                           carcass leanness in           for exhibiting the
                                           finishing swine fed a         downer pig syndrome
                                           complete ration containing    (also referred to as
                                           at least 16 percent crude     ``slows,'' ``subs,'' or
                                           protein from 150 pounds       ``suspects''). Pig
                                           (lb) (68 kilograms (kg)) to   handling methods to
                                           240 lb (109 kg) body          reduce the incidence of
                                           weight.                       downer pigs should be
                                                                         thoroughly evaluated
                                                                         prior to initiating use
                                                                         of PAYLEAN. Not for use
                                                                         in breeding swine.
(ii) 4.5                Tylosin           Finishing swine: As in        Feed continuously as sole  000986
                        100                paragraph (d)(1)(i) of this   ration for 21 days. Not
                                           section; and for prevention   for use in breeding
                                           and/or control of porcine     swine.
                                           proliferative enteropathies
                                           (ileitis) associated with
                                           Lawsonia intracellularis.
(iii) 4.5 to 18                           For improved feed efficiency  Feed continuously as sole  000986
                                           and increased carcass         ration. Pigs fed PAYLEAN
                                           leanness in finishing swine   are at an increased risk
                                           fed a complete ration         for exhibiting the
                                           containing at least 16        downer pig syndrome
                                           percent crude protein from    (also referred to as
                                           150 lb (68 kg) to 240 lb      ``slows,'' ``subs,'' or
                                           (109 kg) body weight.         ``suspects''). Pig
                                                                         handling methods to
                                                                         reduce the incidence of
                                                                         downer pigs should be
                                                                         thoroughly evaluated
                                                                         prior to initiating use
                                                                         of PAYLEAN. Not for use
                                                                         in breeding swine.
(iv) 4.5 to 18          Tylosin           Finishing swine: As in        Feed continuously as sole  000986
                        100                paragraph (d)(1)(iii) of      ration for 21 days. Not
                                           this section; and for         for use in breeding
                                           prevention and/or control     swine.
                                           of porcine proliferative
                                           enteropathies (ileitis)
                                           associated with L.
                                           intracellularis.
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    (2) [Reserved]

    Dated: July 9, 2002.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 02-18365 Filed 7-19-02; 8:45 am]
BILLING CODE 4160-01-S