Export Certificates; FDA Export Reform and Enhancement Act of 1996; Certification Fees for Drugs, Animal Drugs, and Devices

Streszczenie

The Food and Drug Administration (FDA) is announcing the fees for issuing export certificates. The FDA Export Reform and Enhancement Act of 1996 provides that any person who exports a drug, animal drug, or device may request FDA to certify in writing that the exported drug, animal drug, or device meets certain specified requirements. It further provides that FDA shall issue such a certification within 20 days of the receipt of a request for such certification, and that FDA may charge up to $175 for each certification that is issued within the 20 days. This notice describes the fee schedule for export certifications, the costs that form the basis for those fees, and the billing and collection processes. The agency requests comments on the fee schedule and its effects on small business.