[Federal Register Volume 61, Number 13 (Friday, January 19, 1996)]
[Notices]
[Pages 1388-1389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-469]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0407]


Animal Drug Export; Denagard (Tiamulin) Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Fermenta Animal Health Co. has filed an application requesting approval 
for the export of the animal drug Denagard (tiamulin) 
injection for swine to Canada.

ADDRESSES: Relevant information on this application may be directed to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, and to the contact 
person identified below. Any future inquiries concerning the export of 
food animal drugs under the Drug Export Amendments Act of 1986 should 
also be directed to the contact person.

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: The drug export provisions in section 802 of 
the Federal Food, Drug, and Cosmetic Act 

[[Page 1389]]
(the act) (21 U.S.C. 382) provide that FDA may approve applications for 
the export of drugs that are not currently approved in the United 
States. Section 802(b)(3)(B) of the act sets forth the requirements 
that must be met in an application for approval. Section 802(b)(3)(C) 
of the act requires that the agency review the application within 30 
days of its filing to determine whether the requirements of section 
802(b)(3)(B) have been satisfied. Section 802(b)(3)(A) of the act 
requires that the agency publish a notice in the Federal Register 
within 10 days of the filing of an application for export to facilitate 
public participation in its review of the application. To meet this 
requirement, the agency is providing notice that Fermenta Animal Health 
Co., 10150 North Executive Hills Blvd., Kansas City, MO 64190, has 
filed application number 4557 requesting approval for the export of the 
animal drug Denagard (tiamulin 10 percent) injection for 
swine to Canada. The product is intended for intramuscular use in swine 
for the treatment of swine dysentery associated with Treponema 
hyodysenteriae. The application was received and filed in the Center 
for Veterinary Medicine on December 6, 1995, which shall be considered 
the filing date for purposes of the act.-
    Interested persons may submit relevant information on the 
application to the Dockets Management Branch (address above) in two 
copies (except that individuals may submit single copies) and 
identified with the docket number found in brackets in the heading of 
this document. These submissions may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.
    The agency encourages any person who submits relevant information 
on the application to do so by January 29, 1996, and to provide an 
additional copy of the submission directly to the contact person 
identified above, to facilitate consideration of the information during 
the 30-day review period.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (sec. 802 (21 U.S.C. 382)) and under authority delegated to the 
Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the 
Center for Veterinary Medicine (21 CFR 5.44).

    Dated: December 20, 1995.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-469 Filed 1-18-96; 8:45 am]
BILLING CODE 4160-01-F