In the latest World Health Organization daily situation report, as of March 11, 2020, the WHO reported 118,326 COVID-19 cases confirmed and 4,292 deaths worldwide, and the U.S. Centers for Disease Control and Prevention (CDC) reported 938 cases and 29 deaths in the United States. The same day, WHO characterized COVID-19 as the first global pandemic sparked by a coronavirus. Additionally, the Secretary of the U.S. Department of Health and Human Services (HHS), issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to provide liability immunity for entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of covered medical countermeasures (MCMs). Prioritized pathways are now available to expedite review of new, responsive technology proposals for MCMs from diagnostics to therapeutics.
Continue Reading Expanding the Coronavirus Disease 2019 (COVID-19) Response through Diagnostic Development
System for Award Management
U.S. Government Seeks Industry Solutions in Novel Coronavirus Response
As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States. The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than 2,000 to 3,000 new cases each day.
Due to the lack of approved therapeutics, vaccines, and diagnostics for this threat, developing new products and testing products already approved for other uses is a high priority for the U.S. interagency response effort—the Medical Countermeasure (MCM) Task Force. The Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), is leading this Task Force in partnership with U.S. Department of Defense, Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health.
BARDA is currently looking at the effectiveness of existing countermeasures for similar viruses, as well as potential new responsive technologies, including vaccines, diagnostics, therapeutics, and medical supplies. BARDA is serving as the sole point of entry for product and technology submissions to ensure there is an expedited process for receipt and review of proposed solutions for 2019-nCoV. In this capacity, BARDA has released two opportunities to submit potential solutions for the 2019-nCoV response discussed below: (1) the EZ-BAA for 2019-nCoV diagnostics and (2) market research packages for any and all potential products and supplies. Covington encourages those with technology that could be potentially useful to respond.Continue Reading U.S. Government Seeks Industry Solutions in Novel Coronavirus Response
Still Just A Rat In A CAGE: Recent GAO Decisions Underscore the Need for Precision in Identifying Corporate Entities During the Procurement Process
Many government contractors are part of corporate families consisting of multiple corporate entities. One entity may be named as the official contracting party, but use the resources of affiliates, parents, or subsidiaries during performance. The distinction between those members of the corporate family may not seem important in terms of day-to-day operations — in fact, the synergy and seamlessness between the corporate entities may be a selling point. Two recent GAO decisions make clear, however, that when it comes to bidding on government work, it is important to precisely identify which corporate entity is going to do what and which corporate entity has which resources.
In BDO USA, LLP and Intermarkets Global USA, LLC, GAO’s decisions turned on a perceived misidentification of corporate entities at some point in the procurement process. In BDO, the problem occurred during bid submission. In Intermarkets, the problem occurred when the protest was filed.Continue Reading Still Just A Rat In A CAGE: Recent GAO Decisions Underscore the Need for Precision in Identifying Corporate Entities During the Procurement Process
Fraudulent SAM Accounts Lead to More Complicated SAM Registration Requirements
GSA recently announced it is supporting an Inspector General investigation into alleged, third-party fraudulent activity in the System for Award Management (“SAM”). The GSA announcement suggests that fraudulent SAM accounts may have been used to divert certain federal payments to unauthorized bank accounts. The announcement does not elaborate on the scope of potentially impacted entities or the amount of misdirected payments at issue. GSA has advised impacted entities to validate their SAM registration and confirm their financial information. Although GSA has indicated it has or will reach out to impacted entities, contractors would be well advised to confirm independently the accuracy of their current SAM registration.
Continue Reading Fraudulent SAM Accounts Lead to More Complicated SAM Registration Requirements