Document ID: FDA-2008-N-0039-0082
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Ractopamine
Posted Date: 2008-12-01T05:00Z

[Federal Register: December 1, 2008 (Volume 73, Number 231)]
[Rules and Regulations]               
[Page 72714-72715]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de08-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

[Docket No. FDA-2008-N-0039]

 
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 new animal drug application 
(NADA) filed by Elanco Animal Health. The NADA provides for use of 
ractopamine hydrochloride Type A medicated articles to make Type B and 
Type C medicated feeds used for increased rate of weight gain and 
improved feed efficiency in finishing turkeys.

DATES: This rule is effective December 1, 2008.

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 Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
141-290 that provides for use of TOPMAX 9 (ractopamine hydrochloride) 
Type A medicated article to make Type B and Type C medicated feeds used 
for increased rate of weight gain and improved feed efficiency in 
finishing turkeys. The NADA is approved as of November 12, 2008, and 
the regulations in 21 CFR 556.570 and 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

[[Page 72715]]

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 carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Division 
of Dockets Management (see address in the previous paragraph) between 9 
a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(ii)), this 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.

List of Subjects

21 CFR Part 556

    Animal drugs, Foods.

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 parts 556 and 
558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
2. In Sec.  556.570, add paragraph (b)(3) to read as follows:

Sec.  556.570  Ractopamine.

* * * * *
    (b) * * *
    (3) Turkeys--(i) Liver (the target tissue). The tolerance for 
ractopamine (the marker residue) is 0.45 ppm.
    (ii) Muscle. The tolerance for ractopamine (the marker residue) is 
0.1 ppm.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

0
4. In Sec.  558.500:
0
a. Revise paragraph (d)(1);
0
b. Redesignate paragraphs (d)(2) and (d)(3) as paragraphs (d)(4) and 
(d)(5);
0
c. Add new paragraphs (d)(2) and (d)(3);
0
d. In paragraph (e)(2)(i), in the ``Limitations'' column, remove ``Not 
for animals intended for breeding.''; and
0
e. Add paragraph (e)(3).
    The revisions and additions read as follows:

Sec.  558.500  Ractopamine.

* * * * *
    (d) * * *
    (1) Labeling of Type B and Type C feeds shall bear the following: 
``Not for animals intended for breeding.''
    (2) Labeling of Type B and Type C swine feeds shall bear the 
following:
    (i) ``No increased benefit has been shown when ractopamine 
concentrations in the diet are greater than 4.5 g/ton.''
    (ii) ``Ractopamine may increase the number of injured and/or 
fatigued pigs during marketing.''
    (3) Labeling of Type B and Type C tom turkey feeds shall bear the 
following: ``No increased benefit has been shown when ractopamine 
concentrations in the diet are greater than 4.6 g/ton.''
* * * * *
    (e) * * *
    (3) Turkeys--

------------------------------------------------------------------------
                Combination
 Ractopamine    in  grams/     Indications     Limitations     Sponsor
in  grams/ton       ton          for use
------------------------------------------------------------------------
(i) 4.6 to     ............  Finishing hen   Feed                 000986
 11.8 (5 to                   turkeys: For    continuously
 13 ppm)                      increased       as sole
                              rate of         ration during
                              weight gain     the last 7 to
                              and improved    14 days prior
                              feed            to slaughter.
                              efficiency
                              when fed for
                              the last 7 to
                              14 days prior
                              to slaughter.
------------------------------------------------------------------------
(ii) 4.6 to    ............  Finishing tom   Feed                 000986
 11.8 (5 to                   turkeys: For    continuously
 13 ppm)                      increased       as sole
                              rate of         ration during
                              weight gain     the last 14
                              and improved    days prior to
                              feed            slaughter.
                              efficiency      Feeding
                              when fed for    ractopamine
                              the last 14     to tom
                              days prior to   turkeys
                              slaughter.      during
                                              periods of
                                              excessive
                                              heat can
                                              result in
                                              increased
                                              mortality.
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    Dated: November 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-28384 Filed 11-28-08; 8:45 am]

BILLING CODE 4160-01-S