[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Rules and Regulations]
[Pages 20732-20733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 526


Intramammary Dosage Form New Animal Drugs; Cephapirin Sodium for 
Intramammary Infusion

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. The supplemental 
NADA provides for amending the milk discard statement to state the milk 
discard time only (i.e., to remove reference to the number of 
milkings).

DATES: This rule is effective April 18, 2000.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7569.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Home Products Corp., 800 Fifth Street NW., P.O. Box 518, Fort 
Dodge, IA 50501, filed supplemental NADA 97-222 that provides for a 96-
hour milk-discard time (i.e., removal of the parenthetical reference to 
an 8-milking milk discard time) for use of CEFA-LAK<Register> and 
TODAY<Register> (cephapirin sodium) intramammary infusion products for 
treatment of lactating cows for bovine mastitis. The supplemental NADA 
is approved as of February 4, 2000, and the regulations are amended in 
21 CFR 526.365(d)(3) to reflect the approval.
    Approval of this supplemental NADA conforms to the requirements of 
21 CFR 510.105. Approval does not require review of the safety or 
effectiveness data required for approval of the NADA. Therefore, a 
freedom of information summary is not required.
    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 526

    Animal drugs.

    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 526 is 
amended as follows:

PART 526--INTRAMAMMARY DOSAGE FORMS

    1. The authority citation for 21 CFR part 526 continues to read as 
follows:

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


[[Page 20733]]




Sec. 526.365  [Amended]

    2. Section 526.365 Cephapirin sodium for intramammary infusion is 
amended in paragraph (d)(3) by removing ``(8 milkings)''.

    Dated: March 17, 2000.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 00-9572 Filed 4-17-00; 8:45 am]
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