[Federal Register Volume 71, Number 134 (Thursday, July 13, 2006)]
[Rules and Regulations]
[Pages 39547-39548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Furosemide

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 Intervet Inc. The supplemental NADA 
provides for the revision of a food safety warning on labeling of 
furosemide injectable solution for use in horses.

DATES: This rule is effective July 13, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, filed a supplement to NADA 34-478 for SALIX 
(furosemide) Injection 5%. The supplemental NADA provides for the 
revision of a food safety warning on labeling of furosemide injectable 
solution for use in horses. The supplemental application is approved as 
of June 20, 2006, and the regulations are amended in 21 CFR 522.1010 to 
reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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 in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner

[[Page 39548]]

of Food and Drugs and redelegated to the Center for Veterinary 
Medicine, 21 CFR part 522 is amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. In Sec.  522.1010, revise paragraph (b)(3); and add paragraphs 
(b)(4) and (d)(2)(iii) to read as follows:


Sec.  522.1010  Furosemide.

* * * * *
    (b) * * *
    (3) No. 059130 as described in paragraph (a)(2) for use as in 
paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section.
    (4) No. 057926 as described in paragraph (a)(2) for use as in 
paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section.
* * * * *
    (d) * * *
    (2) * * *
    (iii) Amount. 250 to 500 mg/animal once or twice daily, 
intramuscularly or intravenously.
    (A) Indications for use. For the treatment of edema (pulmonary 
congestion, ascites) associated with cardiac insufficiency, and acute 
noninflammatory tissue edema.
    (B) Limitations. Do not use in horses intended for human 
consumption.
* * * * *

    Dated: June 30, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-10974 Filed 7-12-06; 8:45 am]
BILLING CODE 4160-01-S