[Federal Register Volume 70, Number 142 (Tuesday, July 26, 2005)]
[Rules and Regulations]
[Pages 43045-43046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14696]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Tiamulin Liquid Concentrate

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 abbreviated new animal drug 
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA 
provides for use of tiamulin concentrate solution to prepare medicated 
drinking water for the treatment of swine dysentery and swine 
pneumonia.

DATES: This rule is effective July 26, 2005.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed ANADA 200-360 that provides 
for use of Tiamulin Liquid Concentrate to prepare medicated drinking 
water for the treatment of swine dysentery and swine pneumonia. Phoenix 
Scientific, Inc.'s Tiamulin Liquid Concentrate is approved as a generic 
copy of Boehringer Ingelheim Vetmedica, Inc.'s DENAGARD (tiamulin) 
Liquid Concentrate approved under NADA 140-916. The ANADA is approved 
as of June 24, 2005, and the regulations are amended in Sec.  520.2456 
(21 CFR 520.2456) to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    The regulations are also amended in Sec.  520.2456 to reflect a 
more recent genus name for the causative pathogen for swine dysentery. 
This action is being taken to improve the accuracy of the regulations.
    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.

[[Page 43046]]

    The agency 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 520

    Animal drugs.

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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

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  520.2456  [Amended]

0
2. Section 520.2456 is amended in paragraph (b) by removing ``Sponsor. 
See 000010'' and by adding in its place ``Sponsors. See Nos. 000010 and 
059130'', and in paragraph (d)(2) by removing ``Treponema'' and by 
adding in its place ``Brachyspira''.

    Dated: July 11, 2005.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-14696 Filed 7-25-05; 8:45 am]
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