[Federal Register: July 31, 2007 (Volume 72, Number 146)]
[Rules and Regulations]
[Page 41618-41619]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy07-6]
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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 and Tylosin
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
revises the indications for use of two-way combination Type B and Type
C medicated swine feeds formulated with ractopamine hydrochloride and
tylosin phosphate.
DATES: This rule is effective July 31, 2007.
FOR FURTHER INFORMATION CONTACT: Harlan J. Howard, Center for
Veterinary Medicine (HFV-120), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0231, e-mail:
harlan.howard@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 141-172 that provides for use of two-way combination
Type B and Type C medicated swine feeds formulated with PAYLEAN
(ractopamine hydrochloride) and TYLAN (tylosin phosphate) single-
[[Page 41619]]
ingredient Type A medicated articles. The supplement provides for
revised indications for use of Type C medicated feeds used for
increased rate of weight gain, improved feed efficiency, and increased
carcass leanness; and for control of swine dysentery associated with
Brachyspira hyodysenteriae and porcine proliferative enteropathies
(ileitis) associated with Lawsonia intracellularis in finishing swine,
weighing not less than 150 pounds (lbs), fed a complete ration
containing at least 16 percent crude protein for the last 45 to 90 lbs
of gain prior to slaughter. The supplemental NADA is approved as of
June 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.
FDA 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 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. In Sec. 558.500, revise the table in paragraphs (e)(1)(ii) and
(e)(1)(iii) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(1) * * *
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Ractopamine Combination
grams/ton grams/ton Indications for use Limitations Sponsor
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* * * * * * *
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(ii) 4.5 to Tylosin 40 Finishing swine: As Feed 000986
9 in paragraph continuous
(e)(1)(i) of this ly as sole
section; and for ration
control of swine until
dysentery market
associated with weight
Brachyspira following
hyodysenteriae and the use of
porcine tylosin at
proliferative 100 grams
enteropathies per ton (g/
(ileitis) ton) for
associated with at least 3
Lawsonia weeks.
intracellularis.
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(iii) 4.5 Tylosin 100 1. Finishing swine: Feed 000986
to 9 As in paragraph continuous
(e)(1)(i) of this ly as sole
section; and for ration for
control of porcine 21 days.
proliferative Feed
enteropathies continuous
(ileitis) ly as sole
associated with ration for
Lawsonia at least 3
intracellularis. weeks
2. Finishing swine: followed
As in paragraph by tylosin
(e)(1)(i) of this at 40 g/
section; and for ton until
control of swine market
dysentery weight.
associated with
Brachyspira
hyodysenteriae.
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Dated: July 12, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-14699 Filed 7-30-07; 8:45 am]
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