[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Rules and Regulations]
[Page 70776-70777]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de07-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; 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. The supplemental NADA
provides for an increased level of monensin in three-way combination
Type C medicated feeds containing ractopamine, melengestrol, and
monensin for heifers fed in confinement for slaughter.
DATES: This rule is effective December 13, 2007.
FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@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 141-234 that provides for use of OPTAFLEXX
(ractopamine hydrochloride), MGA (melengestrol acetate), and RUMENSIN
(monensin USP) Type A medicated articles to make dry and liquid three-
way combination Type C medicated feeds used for increased rate of
weight gain, improved feed efficiency, and increased carcass leanness;
for prevention and control of coccidiosis due to Eimeria bovis and E.
zuernii; and for suppression of estrus (heat) in heifers fed in
confinement for slaughter during the last 28 to 42 days on feed. The
supplemental NADA provides for an increased level of monensin. The
supplemental NADA is approved as of November 20, 2007, 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(a)(2) 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 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.
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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:
[[Page 70777]]
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
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1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
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2. In Sec. 558.500, in the table in paragraph (e)(2), revise paragraph
(e)(2)(viii) and add paragraph (e)(2)(xii) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
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Ractopamine Combination Indications
grams/ton grams/ton for use Limitations Sponsor
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* * * * * * *
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(viii) 9.8 to Monensin 10 to Heifers fed in As in 000986
24.6 40 to provide confinement paragraph
0.14 to 0.42 for (e)(2)(vi)
mg monensin/ slaughter: As of this
lb of body in paragraph section; see
weight, (e)(2)(vi) of Sec. Sec.
depending on this section; 558.342(d)
severity of for and
coccidiosis prevention 558.355(d)
challenge, up and control of this
to 480 mg/ of chapter.
head/day, coccidiosis Melengestrol
plus due to acetate as
melengestrol Eimeria bovis provided by
acetate to and E. No. 000009
provide 0.25 zuernii; and in Sec.
to 0.5 mg/ for 510.600(c)
head/day suppression of this
of estrus chapter.
(heat).
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* * * * * * *
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(xii) 9.8 to Monensin 10 to Heifers fed in As in 021641
24.6 30, plus confinement paragraph
melengestrol for (e)(2)(vi)
acetate to slaughter: As of this
provide 0.25 in paragraph section; see
to 0.5 mg/ (e)(2)(vi) of Sec. Sec.
head/day this section; 558.342(d)
for and
prevention 558.355(d)
and control of this
of chapter.
coccidiosis Melengestrol
due to acetate as
Eimeria bovis provided by
and E. No. 021641
zuernii; and in Sec.
for 510.600(c)
suppression of this
of estrus chapter.
(heat).
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Dated: December 5, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-24145 Filed 12-12-07; 8:45 am]
BILLING CODE 4160-01-S