[Federal Register Volume 60, Number 246 (Friday, December 22, 1995)] [Notices] [Pages 66553-66554] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-31153] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 95N-0403] Drug Export; SURGISCREEN0.8 Percent, Reagent Red Blood Cells AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that Ortho Diagnostic Systems, Inc., has filed an application requesting approval for the export of the human biological product SURGISCREEN 0.8 percent, Reagent Red Blood Cells to Australia, Austria, Belgium, Canada, Denmark, The Federal Republic of Germany, Finland, France, Iceland, Ireland, Italy, Japan, Luxembourg, The Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, and The United Kingdom. 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 human biological products under the Drug Export Amendments Act of 1986 should also be directed to the contact person. FOR FURTHER INFORMATION CONTACT: Cathy E. Conn, Center for Biologics Evaluation and Research (HFM-610), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-2006. 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 human biological products 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 [[Page 66554]] review of the application. To meet this requirement, the agency is providing notice that Ortho Diagnostic Systems, Inc., 1001 U.S. Highway 202, Raritan, NJ 08869-0606, has filed an application requesting approval for the export of the human biological product SURGISCREEN 0.8 percent, Reagent Red Blood Cells to Australia, Austria, Belgium, Canada, Denmark, The Federal Republic of Germany, Finland, France, Iceland, Ireland, Italy, Japan, Luxembourg, The Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, and The United Kingdom. The SURGISCREEN 0.8 percent, Reagent Red Blood Cells, is an in vitro diagnostic test kit for the detection of unexpected blood group antibodies in test methods requiring a 0.8 percent red cell suspension in a low ionic strength diluent. The application was received and filed in the Center for Biologics Evaluation and Research on November 24, 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 (insert date 10 days after date of publication in the Federal Register), 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 Biologics Evaluation and Research (21 CFR 5.44). Dated: December 4, 1995. James C. Simmons, Director, Office of Compliance, Center for Biologics Evaluation and Research. [FR Doc. 95-31153 Filed 12-21-95; 8:45 am] BILLING CODE 4160-01-F