[Federal Register Volume 66, Number 215 (Tuesday, November 6, 2001)]
[Rules and Regulations]
[Page 56035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27812]


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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; Change 
of Sponsor

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 a change of sponsor for an approved new 
animal drug application (NADA) from Elanco Animal Health, A Division of 
Eli Lilly & Co., to Ivy Laboratories, Div. of Ivy Animal Health, Inc.

DATES: This rule is effective November 6, 2001.

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: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, has 
informed FDA that it has transferred to Ivy Laboratories, Div. of Ivy 
Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, ownership 
of, and all rights and interests in NADA 118-123 for COMPUDOSE 200 
(estradiol) and COMPUDOSE 400 implants for cattle. Accordingly, the 
agency is amending the regulations in 21 CFR 522.840 to reflect the 
transfer of ownership.
    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. 522.840  [Amended]

    2. Section 522.840 Estradiol is amended in paragraph (b) by 
removing ``000986'' and by adding in its place ``No. 021641''.

    Dated: October 26, 2001.
Claire M. Lathers,
Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 01-27812 Filed 11-5-01; 8:45 am]
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