[Federal Register Volume 71, Number 224 (Tuesday, November 21, 2006)]
[Rules and Regulations]
[Pages 67300-67301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19615]
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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 two supplemental new animal
drug applications (NADAs) filed by Elanco Animal Health. The first
supplemental NADA revises the concentrations of ractopamine
hydrochloride in single-ingredient Type B and C medicated swine feeds
used for increased rate of weight gain, improved feed efficiency, and
increased carcass leanness. The other supplemental NADA revises the
concentrations of ractopamine hydrochloride used with tylosin phosphate
in two-way Type C medicated swine feeds to conform with approved
single-ingredient ractopamine use.
DATES: This rule is effective November 21, 2006.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-120), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855; tel: 301-827-7561; 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 140-863 that provides for use of PAYLEAN
(ractopamine hydrochloride) Type A medicated articles in Type B and C
medicated feeds used for increased rate of weight gain, improved feed
efficiency, and increased carcass leanness in finishing swine. The
supplement revises the concentrations of ractopamine hydrochloride fed
to finishing swine, weighing not less than 150 pounds, fed a complete
ration containing at least 16 percent crude protein for the last 45 to
90 pounds of gain prior to slaughter. This supplemental NADA was
approved on April 25, 2006. Under section 512(c)(2)(F)(iii) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years
of marketing exclusivity beginning April 25, 2006.
Elanco Animal Health also filed a supplement to NADA 141-172 that
provides for use of two-way combination Type C medicated swine feeds
formulated with PAYLEAN (ractopamine hydrochloride) and TYLAN (tylosin
phosphate) single-ingredient Type A medicated articles. The supplement
revises the concentrations of ractopamine hydrochloride in Type C
medicated feeds used for increased rate of weight gain, improved feed
efficiency, and increased carcass leanness; and for prevention and/or
control of porcine proliferative enteropathies (ileitis) associated
with Lawsonia intracellularis and for prevention of swine dysentery
(vibrionic) in finishing swine, weighing
[[Page 67301]]
not less than 150 pounds, fed a complete ration containing at least 16
percent crude protein for the last 45 to 90 pounds of gain prior to
slaughter. This supplemental NADA is approved as of October 20, 2006,
and the regulations in 21 CFR 558.500 are amended to reflect both
approvals. The basis of these approvals is discussed in the freedom of
information summaries.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), 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.
FDA has determined under 21 CFR 25.33(a)(1) 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
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. Amend Sec. 558.500 as follows:
a. Revise paragraph (d)(1)(i);
b. Add paragraph (d)(1)(iii);
c. In the table in paragraph (e)(1), revise paragraph (e)(1)(i);
d. In the table in paragraph (e)(1), in paragraphs (e)(1)(ii) and
(e)(1)(iii), in the ``Ractopamine in grams/ton'' column, remove ``4.5''
and add in its place ``4.5 to 9''; and
e. In the table in paragraph (e)(1), remove paragraphs (e)(1)(iv),
(e)(1)(v), and (e)(1)(vi).
The revisions, addition, and removals read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(d) * * *
(1) * * *
(i) Ractopamine may increase the number of injured and/or fatigued
pigs during marketing.
* * * * *
(iii) No increased benefit has been shown when ractopamine
concentrations in the diet are greater than 4.5 g/ton.
* * * * *
(e) * * *
(1) * * *
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Ractopamine in grams/ Combination grams/
ton ton Indications for use Limitations Sponsor
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(i) 4.5 to 9 ................. For increased rate of weight Feed continuously as 000986
gain, improved feed sole ration.
efficiency, and increased
carcass leanness in finishing
swine, weighing not less than
150 lbs, fed a complete
ration containing at least
16% crude protein for the
last 45 to 90 lbs of gain
prior to slaughter.
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* * * * *
Dated: November 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E6-19615 Filed 11-20-06; 8:45 am]
BILLING CODE 4160-01-S