[Federal Register Volume 65, Number 144 (Wednesday, July 26, 2000)]
[Rules and Regulations]
[Page 45876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18827]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Ivermectin Sustained-Release 
Bolus

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 Merial Ltd. The supplemental NADA provides 
for changes to labeling of ivermectin sustained-release bolus for 
cattle.

DATES: This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578.

SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Iselin, NJ 
08830-3077, filed a supplement to NADA 140-988 that provides for use of 
Ivomec (ivermectin) SR bolus for cattle. The supplement 
provides for reducing the predicted duration of effectiveness in 
labeling from approximately 135 days to approximately 130 days, based 
on bolus stability data. The supplement is approved as of June 21, 
2000, and the regulations in 21 CFR 520.1197 are amended 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 part 20 
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 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 25.24(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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec. 520.1197  [Amended]

    2. Section 520.1197 Ivermectin sustained-release bolus is amended 
in paragraph (d)(2) by removing the parenthetical phrase 
``(approximately 135 days)'' and by adding in its place `` 
(approximately 130 days)''.

    Dated: July 18, 2000.
Claire M. Lathers,
Director, New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 00-18827 Filed 7-25-00; 8:45 am]
BILLING CODE 4160-01-F