February 7, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is classifying the human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the HIV drug resistance genotyping assay using NGS technology's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

The Department of Veterans Affairs (VA) is providing public notice of inflationary adjustments to the maximum civil monetary penalties assessed or enforced by VA, as implemented by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, for calendar year 2020. VA may impose civil monetary penalties for false loan guaranty certifications. Also, VA may impose civil monetary penalties for fraudulent claims or written statements made in connection with VA programs generally. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, sets forth a formula that increases the maximum statutory amounts for civil monetary penalties and directs VA to give public notice of the new maximum amounts by regulation. Accordingly, VA is providing notice of the calendar year 2020 inflationary adjustments that increase maximum civil monetary penalties from $22,927 to $23,331 for false loan guaranty certifications and from $11,463 to $11,665 for fraudulent claims or written statements made in connection with VA programs generally.

The Federal Energy Regulatory Commission (Commission) approves Reliability Standard CIP-012-1 (Cyber SecurityCommunications between Control Centers). The North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization, submitted Reliability Standard CIP-012-1 for Commission approval in response to a Commission directive. In addition, the Commission directs NERC to develop modifications to the CIP Reliability Standards to require protections regarding the availability of communication links and data communicated between bulk electric system Control Centers.

This action implements the New England Fishery Management Council's Industry-Funded Monitoring Omnibus Amendment. This amendment allows the New England Council flexibility to increase monitoring in certain fishery management plans to assess the amount and type of catch and reduce uncertainty around catch estimates. This amendment establishes a process to standardize future industry-funded monitoring programs in New England fishery management plans and establishes industry-funded monitoring in the Atlantic herring fishery. This action helps ensure consistency in industry-funded monitoring programs across fisheries and increases monitoring in the Atlantic herring fishery.