[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
