[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Rules and Regulations]
[Pages 22887-22888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10914]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for a new abbreviated
animal drug application (ANADA) from Phoenix Pharmaceutical, Inc., to
Phoenix Scientific, Inc.
EFFECTIVE DATE: April 28, 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 200-042 (ketamine hydrochloride injection)
to Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box
6457, St. Joseph, MO 64506-0457. Accordingly, the agency is amending
the regulations in 21 CFR 522.1222a 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:
[[Page 22888]]
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.1222a [Amended]
2. Section 522.1222a Ketamine hydrochloride injection is amended in
paragraph (c) by removing the number ``057319'' and adding in its place
``059130''.
Dated: March 31, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-10914 Filed 4-25-97; 8:45 am]
BILLING CODE 4160-01-F
