Document ID: FDA-2009-N-0665-0081
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Ractopamine - Final Rule
Posted Date: 2010-01-11T05:00Z

[Federal Register: January 11, 2010 (Volume 75, Number 6)]
[Rules and Regulations]               
[Page 1275-1276]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja10-6]                         

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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; 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 a supplemental new animal drug 
application (NADA) filed by Elanco Animal Health, A Division of Eli 
Lilly & Co. The supplemental NADA provides for administering 
ractopamine hydrochloride Type C medicated feeds as a top dress to 
cattle fed in confinement for slaughter.

DATES:  This rule is effective January 11, 2010.

FOR FURTHER INFORMATION CONTACT:  Suzanne J. Sechen, Center for 
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8105, e-mail: 
suzanne.sechen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 141-221 that provides for use of OPTAFLEXX 45 
(ractopamine hydrochloride) Type A medicated articles to formulate Type 
B and Type C medicated feeds administered to cattle fed in confinement 
for slaughter for increased rate of weight gain and improved feed 
efficiency during the last 28 to 42 days on feed. The supplement 
provides for feeding ractopamine hydrochloride Type C medicated feed as 
a top dress. The supplemental NADA is approved as of December 11, 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.
    The agency 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3 years of marketing exclusivity beginning on the date of 
approval.
    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 1276]]

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, in paragraph (e)(2), in the heading of the first 
table column, remove ``Ractopame'' and in its place add 
``Ractopamine''; and add paragraph (e)(2)(xi) to read as follows:

Sec.  558.500   Ractopamine.

* * * * *
    (e) * * *
    (2) Cattle--

------------------------------------------------------------------------
Ractopamine in   Combination    Indications
   grams/ton     in grams/ton     for use      Limitations     Sponsor
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                              * * * * * * *
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(xi) Not to     .............  Cattle fed in  Top dress in        000986
 exceed 800;                    confinement    a minimum of
 to provide 70                  for            1.0 lb of
 to 400 mg/                     slaughter:     medicated
 head/day.                      As in          feed.
                                paragraph
                                (e)(2)(i) of
                                this
                                section.
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                              * * * * * * *
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* * * * *

    Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-208 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S