[Federal Register Volume 63, Number 27 (Tuesday, February 10, 1998)]
[Rules and Regulations]
[Pages 6643-6644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3294]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 529


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for two abbreviated new 
animal drug applications (ANADA's) from Phoenix Pharmaceutical, Inc., 
to Phoenix Scientific, Inc.

EFFECTIVE DATE: February 10, 1998.
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 200-068 (Oxytetracycline hydrochoride 
injection) and ANADA 200-137 (Gentamicin sulfate intrauterine solution) 
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 522.1662a and 529.1044a to reflect the change of 
sponsor.

List of Subjects in 21 CFR Parts 522 and 529

    Animal drugs.

[[Page 6644]]

    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 parts 522 and 
529 are 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. 522.1662a  [Amended]

    2. Section 522.1662a Oxytetracycline hydrochoride injection is 
amended in paragraph (h)(2) by removing ``057319'' and adding in its 
place ``059130''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 529 continues to read as 
follows:

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


Sec. 529.1044a  [Amended]

    4. Section 529.1044a Gentamicin sulfate intrauterine solution is 
amended in paragraph (b) by removing ``057319'' and adding in its place 
``059130''.

    Dated: January 28, 1998.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-3294 Filed 2-9-98; 8:45 am]
BILLING CODE 4160-01-F