[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Rules and Regulations]
[Page 74466-74467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de06-7]
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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:
joan.gotthardt@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 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