New Animal Drugs for Use in Animal Feeds: Ractopamine; Tylosin
Federal Register: December 17, 2009 (Volume 74, Number 241)
Rules and Regulations
Page 66914-66915
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr17de09-2
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.
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: timothy.schell@fda.hhs.gov.
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 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); and add paragraph (e)(1)(iv) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(1) * * *
Ractopamine in
Combination in grams/ton
grams/ton
Indications for use
Limitations
Sponsor
* * * * * * *
(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.
(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.
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.
* * * * *
Sec. 558.625 [Amended] 0 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
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