COVID-19 Compilation – May 27, 2020 Courtesy of Cornerstone Government Affairs Common Acronyms Centers for Disease Control and Prevention (CDC), World Health Organization (WHO), National Institutes of Health (NIH), Personal Protective Equipment (PPE), Department of Health and Human Services (HHS), Department of Defense (DOD), Department of Homeland Security (DHS), United States Department of Agriculture (USDA), Central Command (CENTCOM), Department of Housing and Urban Development (HUD), Centers for Medicare and Medicaid Services (CMS), Transportation Security Administration (TSA), Department of Veterans Affairs (VA), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) Washington, D.C. • The FDA issued a guidance entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.” The guidance provides a mechanism for FDA-regulated establishments (human food facilities and farms) to voluntarily notify the agency of temporary closures and significant reductions in operations and to request assistance from FDA on issues that might affect continuity of their operations during the pandemic. • The FDA issued a guidance document entitled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications” to provide answers to frequently asked questions. The agency is providing answers concerning certain aspects of sponsor requests for formal meetings with industry, user fee applications goals and timelines, and prioritization of drug and biological application reviews. • The FDA issued a letter to health care providers to remind reprocessing staff in health care facilities to use the correct sterilization cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. These sterilization systems help increase the availability of respirators by allowing decontaminated compatible respirators to be reused so health care workers on the front lines can be better protected when providing care to patients with COVID-19. • The FDA took a new step to support the agency’s evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance. Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA) and the FDA-supplied reference panel provides developers access to this material. The FDA’s reference panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-EUA process. • The FDA is hosting a virtual Town Hall on June 3rd at 12:15 PM for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for COVID- 19. • In response to the COVID-19 public health emergency, state and local governments, hospitals, and others are developing alternate care sites to expand capacity and provide needed care to patients. CMS published a fact sheet that provides state and local governments developing alternate care sites (ACSs) with information on how to seek payments through Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP) for acute inpatient and outpatient care furnished at the site. The Federal Healthcare Resiliency Task Force issued a toolkit to help state and local governments develop an ACS. • The CDC published more new COVID-19 documents to its dashboard today. Some highlights are: funeral guidance, updated considerations for restaurants and bars, a revised map of travel recommendations by country, and financial resources. • Education Sec. Betsy DeVos acknowledged yesterday that tribal schools have not received their COVID-19 relief funds yet because the Bureau of Indian Education programs, the Education department, and the Interior department have not agreed on terms to distribute the money. • Sens. Maggie Hassan (D-NH), Cory Booker (D-NJ), Tim Scott (R-SC), and Kelly Loeffler (R-GA) wrote a letter to Education Sec. Betsy DeVos stating that the Department should provide more instructions to colleges handling financial aid appeals because of the pandemic, and that the Department should ask about loss of family income from the pandemic in the application for federal student aid. • Energy and Commerce Chairman Frank Pallone (D-NJ) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) sent a letter to FDA Commissioner Stephen Hahn today on the agency’s efforts to maintain food safety and address food supply disruptions in the U.S. during the COVID-19 pandemic. • A handful of COVID-19 hearings are slated to take place in the next few days: o Thursday (5/28) 10 AM Committee on Appropriations, VA Subcommittee, "VA Response to COVID- 19" (rescheduled and in-person) o Thursday (5/28) 10:15 AM Education and Labor, "Examining the Federal Government’s Actions to Protect Workers from COVID-19" o Friday (5/29) 1 PM Transportation and Infrastructure, "The Status of the U.S. Maritime Supply Chain During the COVID-19 Pandemic" • No significant changes here. Republicans and Democrats still remain divided over a few key issues including liability protections (both for employers and colleges), unemployment insurance, and funding for state and local governments, which will need to be addressed before the Senate will consider further COVID-19 legislation. For an in-depth briefing on the legislative landscape, please refer to the COVID-19 Legislative Update, which is published on Mondays, Wednesdays, and Fridays. If you do not receive the Legislative Update and would like to subscribe, email [email protected] Updates from the States • Out of the cases under investigation detected by U.S. surveillance, there are 1,678,843 total cases and 99,031 deaths The CDC data closes out the day before reporting. It is now being reported that the U.S. has surpassed 100,000 deaths. • California is the most recent state to have recorded 100,000 cases. • Gov. Greg Abbott (R) issued a proclamation that will enable water parks across Texas to reopen at limited capacity under Phase 2 of reopening on May 29th. • Gov. Steve Sisolak (D) announced that Nevada is ready to move into Phase 2 of the reopening plan on May 29th including the reopening of casinos on June 4th. Additional businesses including personal services and gyms may open under new restrictions. • D.C. Mayor Muriel Bowser (D) announced today that she is signing an order to lift the district’s stay-at-home order beginning Friday after 14 days of decreased community spread. D.C. will enter Phase 1 of reopening with restaurants, barbershops and salons, and parks and recreational areas opening at limited capacity. • Gov. Gina Raimondo (D) announced that Rhode Island is on course to enter the second phase of its reopening plan on June 1st. While a focus on “keeping your group size small and consistent” will remain, the transition will allow virtually all sectors of the economy to resume activity in some form. • Maine Gov. Janet Mills (D) has announced another revision to her plan to reopen the state's economy as they approach stage 2 of the plan, which begins on June 1st. Gov. Mills now says restaurants in Androscoggin, Cumberland, and York counties are restricted to outdoor service, take-out, and delivery only, as opposed to being able to fully reopen to dine-in customers as the plan originally called for. • Gov. Laura Kelly (D) signed a new state disaster declaration to ensure that Kansas can effectively respond to the current emergency situation, which includes an unprecedented economic emergency and the imminent threat of new outbreaks of COVID-19, specifically regarding food supply. • Virginia Gov. Ralph Northam (D) announced that Northern Virginia is on track to join the rest of the state on Friday in phase one of the reopening process. Gov. Northam also signed an amended EO extending Virginia’s state of emergency declaration and directed the Department of Labor and Industry to develop emergency temporary standards to prevent workplace exposure to COVID-19. • Gov. Ned Lamont (D) released his Reopen Connecticut report, which contains recommendations from the Reopen Connecticut Advisory Group – the panel of local health, business, workforce, and education experts. • Washington Gov. Jay Inslee (D) issued guidance further clarifying outdoor recreation requirements in Phase 1 and Phase 2. • California Gov. Gavin Newsom (D) announced that barbershops and salons can now begin to reopen under Phase 3 of the state’s reopening plan. • Gov. Phil Murphy (D) announced that professional sports teams which train or play in New Jersey are now authorized to practice and engage in games or matches if their leagues resume competition. He also announced that the New Jersey Department of Education and the Office of the Secretary of Higher Education will issue updated guidance allowing school districts and colleges/universities to hold modified in- person