[Federal Register Volume 60, Number 225 (Wednesday, November 22, 1995)]
[Rules and Regulations]
[Pages 57832-57833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28543]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 approval of an abbreviated new animal drug
application (ANADA) filed by Fort Dodge Laboratories. The ANADA
provides for subcutaneous or intramuscular use of a selenium/vitamin E
injection for prevention and treatment of selenium/tocopherol
deficiency syndrome in weanling calves and breeding beef cattle.
EFFECTIVE DATE: November 22, 1995.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Fort Dodge Laboratories, 800 Fifth St. NW.,
P.O. Box 518, Fort Dodge, IA 50501, filed ANADA 200-109, which provides
for subcutaneous or intramuscular use of VeleniumTM (selenium,
vitamin E) Injection for prevention and treatment of selenium/
tocopherol deficiency syndrome in weanling calves and breeding beef
cattle. The drug is limited to use by or on the order of a licensed
veterinarian.
Approval of ANADA 200-109 for Fort Dodge's selenium/vitamin E
injection is as a generic copy of Schering-Plough's Mu-Se
(selenium/vitamin E) Injection
[[Page 57833]]
in NADA 30-314. The ANADA is approved as of October 20, 1995, and the
regulations are amended in 21 CFR 522.2100(d)(2) to reflect the
approval. The basis for approval is discussed in the freedom of
information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a
summary of safety and effectiveness data and information submitted to
support approval of this application may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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).
2. Section 522.2100 is amended by revising paragraph (d)(2) to read
as follows:
Sec. 522.2100 Selenium, vitamin E injection.
* * * * *
(d) * * *
(2) Sponsors. See Nos. 000061 and 000856 in Sec. 510.600(c) of this
chapter.
* * * * *
Dated: November 13, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-28543 Filed 11-21-95; 8:45 am]
BILLING CODE 4160-01-F
