[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Rules and Regulations]
[Pages 54019-54020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22071]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2010-N-0002]
New Animal Drugs for Use in Animal Feed; 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 two supplemental new animal
drug applications (NADAs) filed by Elanco Animal Health, A Division of
Eli Lilly & Co. The supplemental NADAs provide for administering a Type
C medicated feed containing ractopamine hydrochloride as a top dress on
Type C medicated feeds containing monensin, USP, or monensin, USP, and
tylosin phosphate to cattle fed in confinement for slaughter.
DATES: This rule is effective September 3, 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:
[email protected].
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 141-225 that provides for use of OPTAFLEXX
(ractopamine hydrochloride) and RUMENSIN (monensin, USP) Type A
medicated articles to formulate two-way combination drug Type C
medicated feeds for cattle fed in confinement for slaughter. Elanco
Animal Health also filed a supplement to NADA 141-224 that provides for
use of OPTAFLEXX (ractopamine hydrochloride), RUMENSIN (monensin, USP),
and TYLAN (tylosin phosphate) Type A medicated articles to formulate
three-way combination drug Type C medicated feeds for cattle fed in
confinement for slaughter.
The supplemental NADAs provide for administering ractopamine
hydrochloride Type C medicated feeds as a top dress on Type C medicated
feeds containing monensin, USP, or monensin, USP, and tylosin phosphate
to cattle fed in confinement for slaughter as the means by which the
two-way or three-way combinations will be created. Supplemental NADA
141-224 is approved as of June 7, 2010; supplemental NADA 141-225 is
approved as of June 17, 2010; and the regulations in 21 CFR 558.500 are
amended to reflect the approvals.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summaries of safety and
effectiveness data and information submitted to support approval of
these applications 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 these actions are
of a type that do 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
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, add paragraphs (e)(2)(xii) and (e)(2)(xiii) to
read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
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Combination in
Ractopamine in grams/ton grams/ton Indications for use Limitations Sponsor
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* * * * * * *
(xii) Not to exceed 800; to Monensin 10 to Cattle fed in Top dress ractopamine 000986
provide 70 to 400 mg/head/day. 40 to provide confinement for in a minimum of 1.0 lb
0.14 to 0.42 mg slaughter: As in of medicated feed
monensin/lb of paragraph (e)(2)(i) of during the last 28 to
body weight, this section; for 42 days on feed. Not
depending on prevention and control for animals intended
severity of of coccidiosis due to for breeding. See Sec.
coccidiosis Eimeria bovis and E. 558.355(d).
challenge, up zuernii.
to 480 mg/head/
day.
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[[Page 54020]]
(xiii) Not to exceed 800; to Monensin 10 to Cattle fed in Top dress ractopamine 000986
provide 70 to 400 mg/head/day. 40 to provide confinement for in a minimum of 1.0 lb
0.14 to 0.42 mg slaughter: As in of medicated feed
monensin/lb of paragraph (e)(2)(i) of during the last 28 to
body weight, this section; for 42 days on feed. Not
depending on prevention and control for animals intended
severity of of coccidiosis due to for breeding. See Sec.
coccidiosis Eimeria bovis and E. Sec. 558.355(d) and
challenge, up zuernii; and for 558.625(c).
to 480 mg/head/ reduction of incidence
day, plus of liver abscesses
tylosin 8 to caused by
10. Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces)
pyogenes.
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* * * * *
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22071 Filed 9-2-10; 8:45 am]
BILLING CODE 4160-01-S