[Federal Register Volume 70, Number 70 (Wednesday, April 13, 2005)]
[Rules and Regulations]
[Page 19261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Dichlorophene and Toluene 
Capsules

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 that reflect approval of a new animal drug application 
(NADA) for dichlorophene and toluene capsules used in dogs and cats for 
removal of certain intestinal parasites. In a notice published 
elsewhere in this issue of the Federal Register, FDA is withdrawing 
approval of the NADA.

DATES:  This rule is effective April 25, 2005.

FOR FURTHER INFORMATION CONTACT:  Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-7818; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Natchez Animal Supply Co., 201 John R. 
Junkin Dr., Natchez, MS 39120, has requested that FDA withdraw approval 
of NADA 121-557 for THR Worm (dichlorophene and toluene) Capsules used 
in dogs and cats for removal of certain intestinal parasites. This 
action is requested because the product is no longer manufactured or 
marketed. The animal drug regulations are amended to reflect the 
withdrawal of approval.
    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.  520.580  [Amended]

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2. Section 520.580 is amended in paragraph (b)(1) by removing 
``049968,''.

    Dated: March 31, 2005.
Catherine P. Beck,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-7337 Filed 4-12-05; 8:45 am]
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