Document ID: FDA-2009-N-0665-0074
Agency: fda
Document Type: Notice
Title: New Animal Drugs for Use in Animal Feeds; Ractopamine; Tylosin
Posted Date: 2009-12-17T05:00Z

[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Rules and Regulations]               
[Page 66914-66915]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de09-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

 
New Animal Drugs for Use in Animal Feeds; Ractopamine; Tylosin

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 a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health. The supplemental NADA 
provides for use of two-way combination Type B and C medicated swine 
feeds formulated with ractopamine hydrochloride and tylosin phosphate 
following use of tylosin tartrate medicated drinking water consistent 
with the sequential use approved for single-ingredient tylosin 
medicated swine feed.

DATES:  This rule is effective December 17, 2009.

FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary 
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, a Div. of Eli Lilly & 
Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement 
to NADA 141-172 for use of two-way combination Type B and C medicated 
swine feeds formulated with PAYLEAN (ractopamine hydrochloride) and 
TYLAN (tylosin phosphate) single-ingredient Type A medicated articles. 
The supplement provides use of two-way combination Type B and C 
medicated swine feeds formulated with ractopamine hydrochloride and 
tylosin phosphate following use of tylosin tartrate medicated drinking 
water consistent with the sequential use approved for single-ingredient 
tylosin medicated swine feed (73 FR 76946, December 18, 2008). The 
supplemental NADA is approved as of October 23, 2009, 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.
    In addition, FDA has noticed that the tylosin levels for single-
ingredient Type C medicated swine feed are not clearly described in 21 
CFR 558.625. At this time, those regulations are being revised to 
clarify this use of levels. This action is being taken to improve the 
accuracy of the regulations.
    FDA has determined under 21 CFR 25.33 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); and add paragraph (e)(1)(iv) to read as follows:

Sec.  558.500  Ractopamine.

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

----------------------------------------------------------------------------------------------------------------
   Ractopamine in       Combination in
     grams/ton            grams/ton            Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(ii) 4.5 to 9        Tylosin              Finishing swine: As in        Feed 100 grams per tons (g/       000986
                     40 or 100             paragraph (e)(1)(i) of this   ton) continuously as sole
                                           section; and for control of   ration for at least 3
                                           swine dysentery associated    weeks followed by 40 g/ton
                                           with Brachyspira              until market weight.
                                           hyodysenteriae and porcine
                                           proliferative enteropathies
                                           (PPE, ileitis) associated
                                           with Lawsonia
                                           intracellularis.
----------------------------------------------------------------------------------------------------------------
(iii) 4.5 to 9       Tylosin              Finishing swine: As in        Feed continuously as sole         000986
                     100                   paragraph (e)(1)(i) of this   ration for 21 days.
                                           section; and for control of
                                           porcine proliferative
                                           enteropathies (PPE,
                                           ileitis) associated with L.
                                           intracellularis.
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[[Page 66915]]

(iv) 4.5 to 9        Tylosin              Finishing swine: As in        Feed continuously as sole         000986
                     40 to 100             paragraph (e)(1)(i) of this   ration for 2 to 6 weeks,
                                           section; for treatment and    immediately after
                                           control of swine dysentery    treatment with tylosin
                                           associated with B.            tartrate in drinking water
                                           hyodysenteriae and for        as in Sec.
                                           control of porcine            520.2640(d)(3) of this
                                           proliferative enteropathies   chapter.
                                           (PPE, ileitis) associated
                                           with L. intracellularis.
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec.  558.625  [Amended]

0
3. In Sec.  558.625, in paragraph (f)(1)(vi)(b), remove ``Tylosin, 40-
100 grams.'' and in its place add ``Tylosin, 40 or 100 grams.''; and 
remove paragraph (f)(1)(vi)(d)(vi).

    Dated: December 11, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29998 Filed 12-16-09; 8:45 am]

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