Department of Health and Human Services November 3, 2020 – Federal Register Recent Federal Regulation Documents

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

Synthetic biology is a multidisciplinary field of research that involves the design, modification, and creation of biological systems and holds broad promise to advance both basic and applied research in areas ranging from materials science to molecular medicine. However, synthetic nucleic acids and associated technologies may also pose risks if misused. To reduce the risk that individuals with ill intent may exploit the application of nucleic acid synthesis technology to obtain genetic material derived from or encoding Select Agents and Toxins and, as applicable, agents on the Export Administration Regulations' (EAR's) Commerce Control List (CCL), the U.S. Government issued guidance in 2010 providing a framework for screening synthetic double-stranded DNA (dsDNA). This document, the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (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, so they are filled in compliance with U.S. regulations prohibiting the possession, use, and transfer of specific pathogens and biological toxins. The other goals of the Guidance are to encourage best practices in addressing biosecurity concerns associated with the potential misuse of these products to inflict harm or bypass existing regulatory controls and to minimize any negative impacts on the conduct of research and business operations. Rapid and continued advances in nucleic acid synthesis technologies and synthetic biology applications necessitate periodic reevaluation of associated risks and mitigation measures. We invite public comments on whether and, if so, how the Guidance should be modified to address new and emerging challenges posed by advances in this area. Please submit all comments related to this request for information (RFI) through the web form on the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA website at https:// www.phe.gov/syndna/update2020.

This document proposes the methodology and data sources necessary to determine Federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.