FDA Seeks Comments on Export Certificate Requirements

The Food and Drug Administration seeks comments by Jan. 26, 2018, on export certificate requirements for FDA-regulated products, it said. FDA has developed four different types of certificates it issues for exports of food, animal feed, pharmaceuticals, biologics and devices that are either legally marketed in the U.S. or not legally marketed but acceptable to the importing country: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product and (4) Non-Clinical Research Use Only Certificates. Comments should address whether the information collections are necessary, whether FDA’s estimates of the burden of the information collections are accurate, ways to enhance the information collected and ways to minimize the burden of the information collections, FDA said.