[Federal Register Volume 65, Number 200 (Monday, October 16, 2000)]
[Rules and Regulations]
[Pages 61090-61091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26403]


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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; 
Levamisole Phosphate Injection

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 an abbreviated new animal drug 
application (ANADA) filed by Agri Laboratories, Ltd. The ANADA provides 
for use of levamisole phosphate solution by subcutaneous injection for 
the treatment of various species of gastrointestinal parasites in 
cattle.

DATES: This rule is effective October 16, 2000.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St. 
Joseph, MO 64503, filed ANADA 200-271 for LEVAMISOLE PHOSPHATE 
Injectable Solution, 13.65%. The ANADA provides for use of levamisole 
phosphate solution by subcutaneous injection for the treatment of 
various species of gastrointestinal parasites in cattle. The ANADA is 
approved as a generic copy of Schering-Plough Animal Health's NADA 126-
742 for LEVASOLE Injection. ANADA 200-271 is approved as of 
September 7, 2000, and the regulations are amended in 21 CFR 522.1244 
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 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 Dockets Management Branch (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.
    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 522

    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 522 is 
amended as follows:

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

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

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


Sec. 522.1244  [Amended]

    2. Section 522.1244 Levamisole phosphate injection is amended in 
paragraph (b) by removing ``No. 000061'' and by adding in its place 
``Nos. 000061 and 057561''.


[[Page 61091]]


    Dated: October 6, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-26403 Filed 10-13-00; 8:45 am]
BILLING CODE 4160-01-F