[Federal Register: December 3, 2002 (Volume 67, Number 232)]
[Rules and Regulations]
[Page 71820-71821]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de02-12]
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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
provides for use of ractopamine and tylosin single-ingredient Type A
medicated articles to make combination drug Type C medicated feeds used
for increased rate of weight gain, improved feed efficiency, increased
carcass leanness; and for the prevention of swine dysentery in
finishing swine.
DATES: This rule is effective December 3, 2002.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1600, e-mail:
candres@cvm.fda.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 PAYLEAN (9 or 45
grams per pound (g/lb) ractopamine hydrochloride) and TYLAN (10, 40, or
100 g/lb tylosin phosphate) Type A medicated articles to make
combination drug Type C medicated feeds used for increased rate of
weight gain, improved feed efficiency, and increased carcass leanness;
and for the prevention of swine dysentery in finishing swine. The
supplemental NADA is approved as of June 19, 2002, and the regulations
are amended in Sec. 558.500 (21 CFR 558.500) to reflect the approval.
The basis of approval is discussed in the freedom of information
summary.
In addition, Sec. 558.500 is being revised to reflect a current
format. The entire text of this section is being provided for the
convenience of the reader.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 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 Dockets Management Branch (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 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.
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 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.
2. Section 558.500 is revised to read as follows:
Sec. 558.500 Ractopamine.
(a) Specifications. Type A medicated articles containing 9 or 45
grams of ractopamine hydrochloride per pound.
(b) Approvals. See No. 000986 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.570 of this chapter.
(d) Special considerations.
(1) Labeling of Type B and Type C swine feeds shall bear the
following:
(i) ``Caution: Pigs fed PAYLEAN are at an increased risk for
exhibiting the downer pig syndrome (also referred to as ``slows,''
``subs,'' or ``suspects''). Pig handling methods to reduce the
incidence of downer pigs should be thoroughly evaluated prior to
initiating use of PAYLEAN.''
(ii) ``Not for use in breeding swine.''
(2) Tylosin in combinations as tylosin phosphate.
(e) Conditions of use. (1) Swine--
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Ractopamine in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
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(i) 4.5 .................. For increased rate of weight Feed continuously as 000986
gain, improved feed sole ration.
efficiency, and increased
carcass leanness in
finishing swine fed a
complete ration containing
at least 16 percent crude
protein from 150 lb (68 kg)
to 240 lb (109 kg) body
weight.
[[Page 71821]]
(ii) 4.5 Tylosin 40 Finishing swine: As in Feed continuously as 000986
paragraph (e)(1)(i) of this sole ration until
section; and for prevention market weight
of swine dysentery following the use of
(vibrionic). tylosin at 100 grams
per ton (g/t) for at
least 3 weeks.
(iii) 4.5 Tylosin 100 1. Finishing swine: As in Feed continuously as 000986
paragraph (e)(1)(i) of this sole ration for 21 000986
section; and for prevention days.
and/or control of porcine Feed continuously as
proliferative enteropathies sole ration for at
(ileitis) associated with least 3 weeks
Lawsonia intracellularis. followed by tylosin
2. Finishing swine: As in at 40 g/t until
paragraph (e)(1)(i) of this market weight.
section; and for prevention
of swine dysentery
(vibrionic).
(iv) 4.5 to 18 .................. For improved feed efficiency Feed continuously as 000986
and increased carcass sole ration.
leanness in finishing swine
fed a complete ration
containing at least 16
percent crude protein from
150 lb (68 kg) to 240 lb
(109 kg) body weight.
(v) 4.5 to 18 Tylosin 40 Finishing swine: As in Feed continuously as 000986
paragraph (e)(1)(iv) of this sole ration until
section; and for prevention market weight
of swine dysentery following the use of
(vibrionic). tylosin at 100 g/t
for at least 3 weeks.
(vi) 4.5 to 18 Tylosin 100 1. Finishing swine: As in Feed continuously as 000986
paragraph (e)(1)(iv) of this sole ration for 21 000986
section; and for prevention days.
and/or control of porcine Feed continuously as
proliferative enteropathies sole ration for at
(ileitis) associated with least 3 weeks
Lawsonia intracellularis. followed by tylosin
2. Finishing swine: As in at 40 g/t until
paragraph (e)(1)(iv) of this market weight.
section; and for prevention
of swine dysentery
(vibrionic).
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(2) [Reserved]
Dated: November 8, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 02-30637 Filed 12-2-02; 8:45 am]
BILLING CODE 4160-01-S