HHS has published a notice announcing the release of a guidance document, “Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA.” The guidance sets forth recommended baseline standards for the gene and genome synthesis industry and other providers of synthetic dsDNA products regarding the screening of orders to address biosecurity concerns associated with the potential misuse of these products. The framework includes customer screening and sequence screening, follow-up screening as necessary, and consultation with U.S. Government contacts, as needed. While following the guidance is voluntary, many specific recommendations outline obligations under existing regulations. According to HHS, the “overriding responsibilities” of synthetic dsDNA providers in this context are: (1) knowing to whom they are distributing a product, and (2) knowing if the product that they are synthesizing and distributing contains, in part or in whole, a “sequence of concern."