[Federal Register Volume 62, Number 135 (Tuesday, July 15, 1997)]
[Rules and Regulations]
[Page 37713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-18461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation of Injectable Dosage 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 abbreviated new 
animal drug application (ANADA) from Phoenix Pharmaceutical, Inc., to 
Phoenix Scientific, Inc.

EFFECTIVE DATE: July 15, 1997.
FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: Phoenix Pharmaceutical, Inc., 4621 Easton 
Rd., P.O. Box 6457 Farleigh Station, St. Joseph, MO 64506-0457, has 
informed FDA that it has transferred ownership of, and all rights and 
interests in, approved ANADA 200-108 (dexamethasone injection) to 
Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, 
St. Joseph, MO 64506-0457. Accordingly, FDA is amending the regulations 
in 21 CFR 522.540 to reflect the change of sponsor.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).


Sec. 522.540  [Amended]

    2. Section 522.540 Dexamethasone injection is amended in paragraph 
(a)(2) by removing ``057319'' and adding in its place ``059130''.

    Dated: June 27, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-18461 Filed 7-14-97; 8:45 am]
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