[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Rules and Regulations]
[Pages 74466-74467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21021]


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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; 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, A Division of Eli 
Lilly & Co. The supplemental NADA provides for an alternate feeding 
regimen for tylosin phosphate in Type C medicated swine feeds used for 
the control of swine proliferative enteropathies.

DATES: This rule is effective December 12, 2006.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, 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 12-491 that provides for use of TYLAN (tylosin 
phosphate) Type A medicated articles. The supplement provides for an 
alternate feeding regimen for the control of swine proliferative 
enteropathies (ileitis) associated with Lawsonia intracellularis. In 
addition, Elanco Animal Health revised the names of other enteric 
pathogens of swine to reflect changes in the scientific nomenclature 
for these bacteria. The supplemental NADA is approved as of November 7, 
2006, and the regulations in 21 CFR 558.625 are amended to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning November 7, 2006.
    FDA has determined under 21 CFR 25.33(a)(1) 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 
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.  558.625, revise paragraphs (f)(1)(i)(b), (f)(1)(vi)(b)(1), 
(f)(1)(vi)(c)(1), and (f)(1)(vi)(e)(1) to read as follows:


Sec.  558.625  Tylosin.

* * * * *
    (f) * * *
    (1) * * *
    (i) * * *
    (b) Indications for use. For reduction of incidence of liver 
abscesses caused by Fusobacterium necrophorum and Arcanobacterium 
(Actinomyces) pyogenes.
* * * * *
    (vi) * * *

[[Page 74467]]

    (b) * * *
    (1) Indications for use. For control of swine dysentery associated 
with Brachyspira hyodysenteriae, and for control of porcine 
proliferative enteropathies (ileitis) associated with Lawsonia 
intracellularis.
* * * * *
    (c) * * *
    (1) Indications for use. For treatment and control of swine 
dysentery associated with B. hyodysenteriae.
* * * * *
    (e) * * *
    (1) Indications for use. For control of porcine proliferative 
enteropathies (ileitis) associated with L. intracellularis.

    Dated: November 29, 2006.
David R. Newkirk,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. E6-21021 Filed 12-11-06; 8:45 am]
BILLING CODE 4160-01-S