Document ID: FDA-2011-N-0003-0033
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Tylosin
Posted Date: 2011-09-23T04:00Z

[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Rules and Regulations]
[Pages 59023-59024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24461]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form 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 an original abbreviated new 
animal drug application (ANADA) filed by Cross Vetpharm Group, Ltd. The 
ANADA provides for use of tylosin tartrate soluble powder in chickens, 
turkeys, swine, and honey bees.

DATES: This rule is effective September 23, 2011.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group, Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-455 for use of TYLOMED-WS 
(tylosin tartrate), a water soluble powder, in chickens, turkeys, 
swine, and honey bees. The abbreviated application is approved as of 
July 5, 2011, and the regulations are amended in 21 CFR 520.2640 to 
reflect the approval and to make minor revisions that will improve 
accuracy of the regulations.
    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.
    The Agency 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.

[[Page 59024]]

List of Subjects in 21 CFR Part 520

    Animal drugs.

    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 520 is 
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, add paragraph (b)(3); and revise paragraphs (a), 
(b)(1), (b)(2), (d)(2)(ii), (d)(3)(ii)(A), (d)(3)(ii)(B), and 
(d)(3)(iii) to read as follows:

Sec.  520.2640  Tylosin.

    (a) Specifications. Each container of soluble powder contains 
tylosin tartrate equivalent to either 100 or 256 grams tylosin base.
    (b) * * *
    (1) No. 000986 for use of a 100-gram jar as in paragraph (d) of 
this section.
    (2) No. 016592 for use of a 100-gram jar or pouch as in paragraphs 
(d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of 
this section.
    (3) No. 061623 for use of a 100- or 256-gram jar or pouch as in 
paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and 
(d)(4) of this section.
* * * * *
    (d) * * *
    (2) * * *
    (ii) Indications for use. For maintaining weight gain and feed 
efficiency in the presence of infectious sinusitis associated with 
Mycoplasma gallisepticum sensitive to tylosin.
* * * * *
    (3) * * *
    (ii) * * *
    (A) For the treatment and control of swine dysentery associated 
with Brachyspira hyodysenteriae when followed immediately by tylosin 
phosphate medicated feed; and for the control of porcine proliferative 
enteropathies (PPE, ileitis) associated with Lawsonia intracellularis 
when followed immediately by tylosin phosphate medicated feed.
    (B) For the treatment and control of swine dysentery associated 
with Brachyspira hyodysenteriae.
    (iii) Limitations. Prepare a fresh solution daily. Do not 
administer within 48 hours of slaughter. As indicated in paragraph 
(d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated 
feed as in Sec.  558.625(f)(1)(vi)(c) of this chapter.
* * * * *

    Dated: September 20, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-24461 Filed 9-22-11; 8:45 am]
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