[Federal Register Volume 73, Number 244 (Thursday, December 18, 2008)]
[Rules and Regulations]
[Pages 76946-76947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29861]



[[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: 
[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 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