The proposed Revised Guidance is a draft submitted for public review and comment for 60 days. Stakeholder comments will be considered by an interagency working group (IWG), led by the Office of the Assistant Secretary for Preparedness and Response. The IWG will develop a Final Revised Guidance and issue it for publication in the Federal Register in late 2022 or early 2023.
Publication of the Final Revised Guidance will not establish new regulations. Adherence is voluntary, as no federal laws require compliance with this Guidance, and no HHS or other federal agency currently requires compliance with the Guidance as a condition for research funding. The proposed Revised Guidance provides recommendations on baseline standards for providers of synthetic oligonucleotides, customers and users of these products, and for manufacturers of benchtop oligonucleotide synthesizers. These recommendations are intended to enhance communication between providers and customers to streamline the sequence and customer screening processes, to ensure that all entities are aware of best practices they should adopt to mitigate the risks associated with oligonucleotides encoding sequences of concern, encourage the responsible screening of customers and users, and to encourage the establishment of best practices in the manufacturing of benchtop oligonucleotide synthesis equipment. Some specific recommendations serve to remind entities of their obligations under existing regulations, but no new regulations are imposed.