[Federal Register Volume 74, Number 241 (Thursday, December 17, 2009)]
[Rules and Regulations]
[Pages 66914-66915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29998]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Ractopamine; Tylosin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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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 two-way combination Type B and C medicated swine
feeds formulated with ractopamine hydrochloride and tylosin phosphate
following use of tylosin tartrate medicated drinking water consistent
with the sequential use approved for single-ingredient tylosin
medicated swine feed.
DATES: This rule is effective December 17, 2009.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: Elanco Animal Health, a Div. of Eli Lilly &
Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement
to NADA 141-172 for use of two-way combination Type B and C medicated
swine feeds formulated with PAYLEAN (ractopamine hydrochloride) and
TYLAN (tylosin phosphate) single-ingredient Type A medicated articles.
The supplement provides use of two-way combination Type B and C
medicated swine feeds formulated with ractopamine hydrochloride and
tylosin phosphate following use of tylosin tartrate medicated drinking
water consistent with the sequential use approved for single-ingredient
tylosin medicated swine feed (73 FR 76946, December 18, 2008). The
supplemental NADA is approved as of October 23, 2009, 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.
In addition, FDA has noticed that the tylosin levels for single-
ingredient Type C medicated swine feed are not clearly described in 21
CFR 558.625. At this time, those regulations are being revised to
clarify this use of levels. This action is being taken to improve the
accuracy of the regulations.
FDA has determined under 21 CFR 25.33 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
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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, revise the table in paragraphs (e)(1)(ii) and
(e)(1)(iii); and add paragraph (e)(1)(iv) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(1) * * *
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Ractopamine in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
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* * * * * * *
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(ii) 4.5 to 9 Tylosin Finishing swine: As in Feed 100 grams per tons (g/ 000986
40 or 100 paragraph (e)(1)(i) of this ton) continuously as sole
section; and for control of ration for at least 3
swine dysentery associated weeks followed by 40 g/ton
with Brachyspira until market weight.
hyodysenteriae and porcine
proliferative enteropathies
(PPE, ileitis) associated
with Lawsonia
intracellularis.
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(iii) 4.5 to 9 Tylosin Finishing swine: As in Feed continuously as sole 000986
100 paragraph (e)(1)(i) of this ration for 21 days.
section; and for control of
porcine proliferative
enteropathies (PPE,
ileitis) associated with L.
intracellularis.
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[[Page 66915]]
(iv) 4.5 to 9 Tylosin Finishing swine: As in Feed continuously as sole 000986
40 to 100 paragraph (e)(1)(i) of this ration for 2 to 6 weeks,
section; for treatment and immediately after
control of swine dysentery treatment with tylosin
associated with B. tartrate in drinking water
hyodysenteriae and for as in Sec.
control of porcine 520.2640(d)(3) of this
proliferative enteropathies chapter.
(PPE, ileitis) associated
with L. intracellularis.
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* * * * *
Sec. 558.625 [Amended]
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3. In Sec. 558.625, in paragraph (f)(1)(vi)(b), remove ``Tylosin, 40-
100 grams.'' and in its place add ``Tylosin, 40 or 100 grams.''; and
remove paragraph (f)(1)(vi)(d)(vi).
Dated: December 11, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-29998 Filed 12-16-09; 8:45 am]
BILLING CODE 4160-01-S