[Federal Register Volume 60, Number 28 (Friday, February 10, 1995)] [Notices] [Pages 7976-7977] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-3443] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 95N-0032] Drug Export; VisipaqueTM (Iodixanol) Injection 270 Milligrams Iodixanol/Milliliter (mg I/mL) and 320 mg I/mL Supplied in 50 mL Vial, 100 mL, 150 mL, and 200 mL Bottle AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that Nycomed, Inc., has filed an application requesting approval for the export of the human drug VisipaqueTM (iodixanol) Injection 270 milligrams iodixanol/milliliter (mg I/mL) and 320 mg I/mL supplied in 50 mL vial, 100 mL, 150 mL, and 200 mL bottle to Canada. ADDRESSES: Relevant information on this application may be directed to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and to the contact person identified below. Any future inquiries concerning the export of human drugs under the Drug Export Amendments Act of 1986 should also be directed to the contact person. FOR FURTHER INFORMATION CONTACT: James E. Hamilton, Center for Drug [[Page 7977]] Evaluation and Research (HFD-310), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2073. SUPPLEMENTARY INFORMATION: The drug export provisions in section 802 of the Federal Food, Drug, and Cosmetic Act (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 Nycomed, Inc., 1250 South Collegeville Rd., P.O. Box 5000, Collegeville, PA 19426-0900, has filed an application requesting approval for the export of the human drug VisipaqueTM (iodixanol) Injection 270 mg I/mL and 320 mg I/mL supplied in 50 mL vial, 100 mL, 150 mL, and 200 mL bottle to Canada. The product is used in angiocardiography (left ventriculography, aortic root injections, and selective coronary arteriography) and can be used in the diagnosis of coronary artery disease as well as evaluation of the function of the chambers of the heart and heart valves. The application was received and filed in the Center for Drug Evaluation and Research on December 28, 1994, 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 February 21, 1995, 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 Drug Evaluation and Research (21 CFR 5.44). Dated: January 31, 1995. Kathy P. Mirracco, Acting Director, Office of Compliance, Center for Drug Evaluation and Research. [FR Doc. 95-3443 Filed 2-9-95; 8:45 am] BILLING CODE 4160-01-F