[Federal Register Volume 70, Number 161 (Monday, August 22, 2005)]
[Rules and Regulations]
[Page 48868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16499]


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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; Flunixin

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 abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for veterinary prescription use of flunixin 
meglumine solution by intravenous injection in lactating dairy cattle 
for control of fever associated with bovine respiratory disease and 
endotoxemia, and for control of inflammation in endotoxemia.

DATES: This rule is effective August 22, 2005.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplemental ANADA 200 124 
that provides for veterinary prescription use of Flunixin Meglumine 
Injection intravenously in lactating dairy cattle for control of fever 
associated with bovine respiratory disease and endotoxemia, and for 
control of inflammation in endotoxemia. The supplemental ANADA is 
approved as of July 18, 2005, and the regulations are amended in 21 CFR 
522.970 to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    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.
    FDA 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 Subject in 21 CFR Part 522

    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 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. Section 522.970 is amended by revising paragraph (e)(2)(iii) to read 
as follows:


Sec.  522.970  Flunixin.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Do not slaughter for food use within 4 days of 
last treatment. A withdrawal period has not been established for use in 
preruminating calves. Do not use in calves to be processed for veal. 
For Nos. 000061 and 059130: Do not use in dry dairy cows. Milk that has 
been taken during treatment and for 36 hours after the last treatment 
must not be used for food. For Nos. 055529 and 057561: Not for use in 
lactating or dry dairy cows.

    Dated: August 10, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05-16499 Filed 8-19-05; 8:45 am]
BILLING CODE 4160-01-S