[Federal Register Volume 71, Number 224 (Tuesday, November 21, 2006)]
[Rules and Regulations]
[Pages 67300-67301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19615]


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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.

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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. The first 
supplemental NADA revises the concentrations of ractopamine 
hydrochloride in single-ingredient Type B and C medicated swine feeds 
used for increased rate of weight gain, improved feed efficiency, and 
increased carcass leanness. The other supplemental NADA revises the 
concentrations of ractopamine hydrochloride used with tylosin phosphate 
in two-way Type C medicated swine feeds to conform with approved 
single-ingredient ractopamine use.

DATES: This rule is effective November 21, 2006.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-120), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855; tel: 301-827-7561; 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 140-863 that provides for use of PAYLEAN 
(ractopamine hydrochloride) Type A medicated articles in Type B and C 
medicated feeds used for increased rate of weight gain, improved feed 
efficiency, and increased carcass leanness in finishing swine. The 
supplement revises the concentrations of ractopamine hydrochloride fed 
to finishing swine, weighing not less than 150 pounds, fed a complete 
ration containing at least 16 percent crude protein for the last 45 to 
90 pounds of gain prior to slaughter. This supplemental NADA was 
approved on April 25, 2006. Under section 512(c)(2)(F)(iii) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years 
of marketing exclusivity beginning April 25, 2006.
    Elanco Animal Health also filed a supplement to NADA 141-172 that 
provides for use of two-way combination Type C medicated swine feeds 
formulated with PAYLEAN (ractopamine hydrochloride) and TYLAN (tylosin 
phosphate) single-ingredient Type A medicated articles. The supplement 
revises the concentrations of ractopamine hydrochloride in 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 Lawsonia intracellularis and for prevention of swine dysentery 
(vibrionic) in finishing swine, weighing

[[Page 67301]]

not less than 150 pounds, fed a complete ration containing at least 16 
percent crude protein for the last 45 to 90 pounds of gain prior to 
slaughter. This supplemental NADA is approved as of October 20, 2006, 
and the regulations in 21 CFR 558.500 are amended to reflect both 
approvals. The basis of these approvals is discussed in the freedom of 
information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), 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.
    FDA has determined under 21 CFR 25.33(a)(1) 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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. Amend Sec.  558.500 as follows:
    a. Revise paragraph (d)(1)(i);
    b. Add paragraph (d)(1)(iii);
    c. In the table in paragraph (e)(1), revise paragraph (e)(1)(i);
    d. In the table in paragraph (e)(1), in paragraphs (e)(1)(ii) and 
(e)(1)(iii), in the ``Ractopamine in grams/ton'' column, remove ``4.5'' 
and add in its place ``4.5 to 9''; and
    e. In the table in paragraph (e)(1), remove paragraphs (e)(1)(iv), 
(e)(1)(v), and (e)(1)(vi).
    The revisions, addition, and removals read as follows:


Sec.  558.500  Ractopamine.

* * * * *
    (d) * * *
    (1) * * *
    (i) Ractopamine may increase the number of injured and/or fatigued 
pigs during marketing.
* * * * *
    (iii) No increased benefit has been shown when ractopamine 
concentrations in the diet are greater than 4.5 g/ton.
* * * * *
    (e) * * *
    (1) * * *

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Ractopamine in grams/ Combination grams/
         ton                 ton               Indications for use            Limitations           Sponsor
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(i) 4.5 to 9          .................  For increased rate of weight    Feed continuously as             000986
                                          gain, improved feed             sole ration.
                                          efficiency, and increased
                                          carcass leanness in finishing
                                          swine, weighing not less than
                                          150 lbs, fed a complete
                                          ration containing at least
                                          16% crude protein for the
                                          last 45 to 90 lbs of gain
                                          prior to slaughter.
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                                    * *   * * *                           * *                                  *
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* * * * *

    Dated: November 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-19615 Filed 11-20-06; 8:45 am]
BILLING CODE 4160-01-S