[Federal Register Volume 72, Number 146 (Tuesday, July 31, 2007)]
[Rules and Regulations]
[Pages 41618-41619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14699]


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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 
revises the indications for use of two-way combination Type B and Type 
C medicated swine feeds formulated with ractopamine hydrochloride and 
tylosin phosphate.

DATES: This rule is effective July 31, 2007.

FOR FURTHER INFORMATION CONTACT: Harlan J. Howard, Center for 
Veterinary Medicine (HFV-120), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0231, 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 two-way combination 
Type B and Type C medicated swine feeds formulated with PAYLEAN 
(ractopamine hydrochloride) and TYLAN (tylosin phosphate) single-

[[Page 41619]]

ingredient Type A medicated articles. The supplement provides for 
revised indications for use of Type C medicated feeds used for 
increased rate of weight gain, improved feed efficiency, and increased 
carcass leanness; and for control of swine dysentery associated with 
Brachyspira hyodysenteriae and porcine proliferative enteropathies 
(ileitis) associated with Lawsonia intracellularis in finishing swine, 
weighing not less than 150 pounds (lbs), fed a complete ration 
containing at least 16 percent crude protein for the last 45 to 90 lbs 
of gain prior to slaughter. The supplemental NADA is approved as of 
June 20, 2007, and the regulations in 21 CFR 558.500 are amended to 
reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 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)(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.

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. In Sec.  558.500, revise the table in paragraphs (e)(1)(ii) and 
(e)(1)(iii) to read as follows:


Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (1) * * *

------------------------------------------------------------------------
Ractopamine  Combination
 grams/ton    grams/ton    Indications for use  Limitations    Sponsor
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                              * * * * * * *
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(ii) 4.5 to  Tylosin 40   Finishing swine: As   Feed              000986
 9                         in paragraph          continuous
                           (e)(1)(i) of this     ly as sole
                           section; and for      ration
                           control of swine      until
                           dysentery             market
                           associated with       weight
                           Brachyspira           following
                           hyodysenteriae and    the use of
                           porcine               tylosin at
                           proliferative         100 grams
                           enteropathies         per ton (g/
                           (ileitis)             ton) for
                           associated with       at least 3
                           Lawsonia              weeks.
                           intracellularis.
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(iii) 4.5    Tylosin 100  1. Finishing swine:   Feed              000986
 to 9                      As in paragraph       continuous
                           (e)(1)(i) of this     ly as sole
                           section; and for      ration for
                           control of porcine    21 days.
                           proliferative        Feed
                           enteropathies         continuous
                           (ileitis)             ly as sole
                           associated with       ration for
                           Lawsonia              at least 3
                           intracellularis.      weeks
                          2. Finishing swine:    followed
                           As in paragraph       by tylosin
                           (e)(1)(i) of this     at 40 g/
                           section; and for      ton until
                           control of swine      market
                           dysentery             weight.
                           associated with
                           Brachyspira
                           hyodysenteriae.
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                              * * * * * * *
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    Dated: July 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-14699 Filed 7-30-07; 8:45 am]
BILLING CODE 4160-01-S