[Federal Register Volume 64, Number 99 (Monday, May 24, 1999)]
[Rules and Regulations]
[Page 27916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12963]


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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; 
Selenium, Vitamin E Injection

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 previously approved supplemental new 
animal drug application (NADA) held by Schering-Plough Animal Health 
Corp. and to remove certain information no longer required in the 
regulations. The approval concerns use of selenium, vitamin E 
injection.

EFFECTIVE DATE: May 24, 1999.
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: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 1982, Union, NJ 07083-1982, provided information 
to support prior approval of supplemental NADA 30-315 for selenium, 
vitamin E injection. The supplement for use of 2 percent benzyl alcohol 
instead of 1:10,000 thimerosal had been approved by letter of August 
10, 1981. FDA reviewed the information and concurred that the change in 
ingredient was approved. FDA also reviewed the information requirements 
of the animal drug regulations and determined that specification of 
ingredients other than active ingredients is not needed. Therefore, 21 
CFR 522.2100 is amended to remove statement of ingredients other than 
active ingredients.

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. 522.2100  [Amended]

    2. Section 522.2100 Selenium, vitamin E injection is amended in 
paragraph (a)(1) by removing ``, 250 milligrams polyoxyethylated 
vegetable oil, and 2.0 percent benzyl alcohol, and water for 
injection''; in paragraph (b)(1) by removing ``, 100 milligrams of 
polyoxyethylated vegetable oil,
 1:10,000 thimerosal, and water for injection''; and in paragraphs 
(c)(1), (d)(1), and (e)(1) by removing ``, 250 milligrams polysorbate 
80, 2 percent benzyl alcohol, water for injection q.s''.

    Dated: May 11, 1999.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-12963 Filed 5-21-99; 8:45 am]
BILLING CODE 4160-01-F