[Federal Register: December 18, 2008 (Volume 73, Number 244)]
[Rules and Regulations]
[Page 76946-76947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de08-12]
[[Page 76946]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0039]
21 CFR Parts 520 and 558
New Animal Drugs; 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 two supplemental new animal
drug applications (NADAs) filed by Elanco Animal Health. The
supplemental NADAs provide for use of tylosin tartrate soluble powder
in drinking water of swine followed by tylosin phosphate in medicated
swine feed for the treatment and control of swine dysentery and the
control of porcine proliferative enteropathies.
DATES: This rule is effective December 18, 2008.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail:
cindy.burnsteel@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 for use of TYLAN (tylosin phosphate) Type A
medicated article. The supplement provides for use of tylosin tartrate
in medicated drinking water for swine for 3 to 10 days followed by
administration of tylosin phosphate in medicated swine feed for 2 to 6
weeks for the control of porcine proliferative enteropathies (PPE,
ileitis) associated with Lawsonia intracellularis.
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 supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
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.
Elanco Animal Health also filed a supplement to NADA 13 076 for use
of TYLAN (tylosin tartrate) Soluble. The supplement provides for use of
tylosin tartrate in medicated drinking water for swine for 3 to 10 days
followed by administration of tylosin phosphate in medicated swine feed
for 2 to 6 weeks for the treatment and control of swine dysentery
associated with Brachyspira hyodysenteriae and for the control of
porcine proliferative enteropathies (PPE, ileitis) associated with
Lawsonia intracellularis.
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 supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval. This period of marketing exclusivity applies only to the
claim for the control of porcine proliferative enteropathies (PPE,
ileitis) associated with Lawsonia intracellularis.
The supplemental NADAs are approved as of November 13, 2008, and
the regulations in 21 CFR 520.2640 and 558.625 are amended to reflect
the approval.
The agency has determined under 21 CFR 25.33(a)(1) that these
actions are of a type that do 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
21 CFR Part 520
Animal drugs.
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 parts 520 and
558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.2640, remove paragraph (c); redesignate paragraphs (d)
and (e) as paragraphs (c) and (d); and revise paragraphs (a) and newly
redesignated paragraphs (d)(1), (d)(2), and (d)(3) to read as follows:
Sec. 520.2640 Tylosin.
(a) Specifications. Each jar contains tylosin tartrate equivalent
to 100 grams tylosin base.
* * * * *
(d) * * *
(1) Chickens--(i) Amount. 2 grams per gallon for 1 to 5 days as the
sole source of drinking water. Treated chickens should consume enough
medicated drinking water to provide 50 milligrams (mg) tylosin per
pound of body weight per day.
(ii) Indications for use. As an aid in the treatment of chronic
respiratory disease (CRD) associated with Mycoplasma gallisepticum
sensitive to tylosin in broiler and replacement chickens. For the
control of chronic respiratory disease (CRD) associated with M.
gallisepticum sensitive to tylosin at time of vaccination or other
stress in chickens. For the control of chronic respiratory disease
(CRD) associated with Mycoplasma synoviae sensitive to tylosin in
broiler chickens.
(iii) Limitations. Prepare a fresh solution every 3 days. Do not
use in layers producing eggs for human consumption. Do not administer
within 24 hours of slaughter.
(2) Turkeys--(i) Amount. 2 grams per gallon for 2 to 5 days as the
sole source of drinking water. Treated turkeys should consume enough
medicated drinking water to provide 60 mg tylosin per pound of body
weight per day.
(ii) Indications for use. For maintaining weight gains and feed
efficiency in the presence of infectious sinusitis associated with
Mycoplasma gallisepticum sensitive to tylosin.
(iii) Limitations. Prepare a fresh solution every 3 days. Do not
use in layers producing eggs for human consumption. Do not administer
within 5 days of slaughter.
(3) Swine--(i) Amount. 250 mg per gallon as the only source of
drinking water for 3 to 10 days, depending on the severity of the
condition being treated.
(ii) Indications for use. For the control and treatment of swine
dysentery associated with Brachyspira hyodysenteriae and for the
control of porcine proliferative enteropathies (PPE, ileitis)
associated with Lawsonia intracellularis.
(iii) Limitations. Prepare a fresh solution daily. Do not
administer within 48 hours of slaughter. Follow with tylosin phosphate
medicated feed as in Sec. 558.625(f)(1)(vi)(c) of this chapter.
* * * * *
[[Page 76947]]
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In Sec. 558.625, revise paragraphs (a), (f)(1)(vi)(c)(1),
(f)(1)(vi)(c)(2), and (f)(1)(vi)(e)(1) to read as follows:
Sec. 558.625 Tylosin.
(a) Specifications. Type A medicated articles containing tylosin
phosphate.
* * * * *
(f) * * *
(1) * * *
(vi) * * *
(c) * * *
(1) Indications for use. For the treatment and control of swine
dysentery associated with Brachyspira hyodysenteriae and for the
control of porcine proliferative enteropathies (PPE, ileitis)
associated with Lawsonia intracellularis.
(2) Limitations. Administer as tylosin phosphate in feed for 2 to 6
weeks, immediately after treatment with tylosin tartrate in drinking
water as in Sec. 520.2640(d)(3) of this chapter.
* * * * *
(e) * * *
(1) Indications for use. For the control of porcine proliferative
enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
* * * * *
Dated: December 10, 2008.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E8-29861 Filed 12-17-08; 8:45 am]
BILLING CODE 4160-01-S