[Federal Register Volume 68, Number 181 (Thursday, September 18, 2003)]
[Rules and Regulations]
[Pages 54658-54660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


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, improved 
feed efficiency, and increased carcass leanness in cattle fed in 
confinement for slaughter.

DATES: This rule is effective September 18, 2003.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary

[[Page 54659]]

Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
141-221 that provides for use of OPTAFLEXX 45 (ractopamine 
hydrochloride) Type A medicated article to make dry and liquid Type B 
and dry Type C medicated feeds used for increased rate of weight gain, 
improved feed efficiency, and increased carcass leanness in cattle fed 
in confinement for slaughter during the last 28 to 42 days on feed. The 
NADA is approved as of June 13, 2003, and the regulations in 21 CFR 
556.570 and 558.500 are amended to reflect the approval. The basis of 
approval is discussed in the freedom of information summary.
    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 carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA'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 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 (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning June 13, 2003 .
    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 
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. Section 556.570 is revised to read as follows:


Sec.  556.570  Ractopamine.

    (a) Acceptable Daily Intake (ADI). The ADI for total residues of 
ractopamine hydrochloride is 1.25 micrograms per kilogram of body 
weight per day.
    (b) Tolerances --(1) Cattle--(i) Liver (the target tissue). The 
tolerance for ractopamine hydrochloride (the marker residue) is 0.09 
parts per million (ppm).
    (ii) Muscle. The tolerance for ractopamine hydrochloride (the 
marker residue) is 0.03 ppm.
    (2) Swine--(i) Liver (the target tissue). The tolerance for 
ractopamine hydrochloride (the marker residue) is 0.15 ppm.
    (ii) Muscle. The tolerance for ractopamine hydrochloride (the 
marker residue) is 0.05 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. Section 558.500 is amended by adding paragraphs (d)(3) and (e)(2) to 
read as follows:


Sec.  558.500  Ractopamine.

* * * * *
    (d) * * *
    (3) Ractopamine liquid Type B cattle feeds may be manufactured from 
dry ractopamine Type A articles. The liquid Type B feeds must be 
maintained at a pH of 4.5 to 7.5. Mixing directions for liquid Type B 
feeds requiring recirculation or agitation: Recirculate immediately 
prior to use for not less than 10 minutes, moving not less than 1 
percent of the tank contents per minute from the bottom of the tank to 
the top. Recirculate daily as described even when not used.
    (e) * * *
    (2) Cattle--

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                          Combination
Ractopamine in grams/ton   in grams/        Indications for use                Limitations             Sponsor
                              ton
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(i) 8.2 to 24.6           ...........  Cattle fed in confinement for  Feed continuously as sole           000986
                                        slaughter: For increased       ration during the last 28 to
                                        rate of weight gain and        42 days on feed. Not for
                                        improved feed efficiency       animals intended for
                                        during the last 28 to 42       breeding.
                                        days on feed.
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(ii) 9.8 to 24.6          ...........  Cattle fed in confinement for  Feed continuously as sole           000986
                                        slaughter: For increased       ration during the last 28 to
                                        rate of weight gain,           42 days on feed. Not for
                                        improved feed efficiency,      animals intended for
                                        and increased carcass          breeding.
                                        leanness during the last 28
                                        to 42 days on feed.
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[[Page 54660]]

    Dated: September 9, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-23892 Filed 9-17-03; 8:45 am]
BILLING CODE 4160-01-S