[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Rules and Regulations]
[Pages 41587-41588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Furazolidone 
Aerosol Powder

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 a supplemental new animal drug 
application (NADA) filed by Fort Dodge Animal Health, a Division of 
American Cyanamid Co. The supplemental NADA provides for removal of 
that portion of the approval reflecting topical cattle use of 
furazolidone aerosol powder.

DATES: This regulation is effective July 6, 2000.

FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6642.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, a 1Division of 
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501, is the 
sponsor of NADA 32-319 for Furox (furazolidone) aerosol powder for use 
in dogs, horses, ponies, and cattle. The sponsor filed a supplemental 
NADA requesting removal of topical ocular use of the product in cattle. 
The supplemental NADA is approved as of November 29, 1999, and the 
regulations are amended in 21 CFR

[[Page 41588]]

524.1005(b)(1), (c)(2)(iii), and (c)(3) to reflect the approval.
    The regulations in Sec. 524.1005(b)(1) (21 CFR 524.1005(b)(1)) 
indicate that Pfizer, Inc., is sponsor of NADA 32-319 for use of a 10 
percent furazolidone aerosol powder in dogs, horses, and cattle. The 
NADA had been acquired by Fort Dodge Animal Health, a Division of 
American Cyanamid Co. At this time, the regulation is amended in 
Sec. 524.1005(b) to reflect the sponsor change.
    Approval of this supplemental NADA provides for removal of a cattle 
use. It does not affect the safety or effectiveness data in the 
application. Therefore, a freedom of information summary is not 
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 congressional review requirements in 5 
U.S.C. 801-808.

List of Subjects in 21 CFR Part 524

    Animal drugs.

    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 part 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

    2. Section 524.1005 is amended by revising paragraphs (b)(1) and 
(c)(3) and by removing and reserving paragraph (c)(2)(iii) to read as 
follows:


Sec. 524.1005  Furazolidone aerosol powder.

* * * * *
    (b) * * *
    (1) See No. 053501 in Sec. 510.600(c) of this chapter for use as in 
paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and (c)(3) of this section.
* * * * *
    (c) * * *
    (2) * * *
    (iii) [Reserved]
    (3) Limitations. For topical application in horses, ponies, and 
dogs: Clean affected area thoroughly, apply drug once or twice daily, 
and repeat treatment as required. Use only as recommended by a 
veterinarian in treatment of puncture wounds, wounds requiring surgical 
debridement or suturing, those of a chronic nature involving proud 
flesh, generalized and chronic infections of the skin, and those skin 
conditions associated with intense itching. If redness, irritation, or 
swelling persists or increases, discontinue use and consult a 
veterinarian. Not for use in horses intended for food.

    Dated: June 15, 2000.
Andrew J. Beaulieu,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 00-16977 Filed 7-5-00; 8:45 am]
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