/~ 11 { J« \...._ -::z 'f. U.S. FOOD& DRUG ADMINISTRATION Christine H. Monahan AMERICAN OVERSIGHT 1030 15th Street NW, B255 Washington, DC 20005 September 2, 2020 Re: FDA FOIA requests 2020-1977, 2020-2523, 2020-4765/20-cv-01063 Dear Requester, This is a partial response to the Freedom of Information Act (FOIA) requests. Please find enclosed 26 pages of record responsive to your request from the Office of the Commissioner. I have determined to withhold portions of the enclosed pages pursuant to Exemption (b)(6) of the Freedom of Information Act. Sincerely, Meredith J. Schlaifer -S Digitally signed by Meredith J. Schlaifer -S Date: 2020.09.02 09:22:58 -04'00' Meredith J. Schlaifer, M.S., J.D. FOIA Officer, Office of the Commissioner Division of Freedom of Information U.S. Food and Drug Administration U.S. Food and Drug Administration 5630 Fishers Lane, Room 1035 Rockville, MD 20857 www.fda.gov ERSIGHT Sent: To: Miller, Katie R. EOP/OVP @ovp.eop.gov] 5/29/2020 1:44:26 PM Hahn, Stephen [/o=Exchangelabs/ou=Exc hange Admin istrative Group Subject: reporter contact From: Stephen .Hahl Sarah Owermoh le AM {I AN PVERSIGHT FDA-OC-000001 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000001 From: Sent : 4/15/2020 6:19:27 PM Miller, Katie R. EOP/OVP To: Hahn, Stephen [/o=Excha ngelabs/ou=Exchange Admin istrative Group @ovp .eop .gov] Stephen .Hahl Fwd: Thurs at 11 am ET: FDA Commissioner Dr. Stephen Hahn, Steve Ballmer with Wash Post Live Attachments : invite.ics; ATT00O0l.htm Subject: Sent from my iPhone Begin forwarded message: From: The Washington Post Live Date: April 15, 2020 at 4:41:32 PM EDT To: "Miller, Katie R. EOP/OVP" ovp.eop.gov> Subject: Thurs at 11 am ET: FDA Commissioner Dr. Stephen Hahn, Steve Ballmer with Wash Post Live AM {I AN PVERSIGHT FDA-OC-000002 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000002 SIGN UP FOR A LIVESTREAM REMINDER Thursday, April 16th Streaming will begin at 11 :00 a.m. ET This event will be streamed on The Washington Post Live's Facebook, Tw itter and YouTube pages , as well as The Washington Post homepage. To sign up for email notificationsfor upcoming WashingtonPost Live virtual events, click here. Presented by AM RI AN PVERSIGHT FDA-OC-000003 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000003 This email contains news or other information about an event from Washington Post Live. the live journalism division of The Washington Post. If you no longer wish to receive these emails related to Washington Post Live events , please click the unsubscribe link below. The Washington Post I 1301 K Street r-NV, Washing ton D.C ., 20071 Unsubscribe AM {I AN PVERSIGHT FDA-OC-000004 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000004 From: To: Subject: Date: Caliguiri, Laura Kimberly, Brad; Lynch, Sarah; Capobianco, Abigail FW: What You Need To Know President Trump’s Coronavirus Response Efforts Tuesday, March 31, 2020 8:53:05 PM     From: Mitchell, Austin A. EOP/WHO (b) (6) @who.eop.gov> Sent: Tuesday, March 31, 2020 8:51 PM Subject: What You Need To Know President Trump’s Coronavirus Response Efforts   What You Need To Know President Trump’s Coronavirus Response Efforts ________________________________ President Trump and his Administration are working every day to protect the health and wellbeing of Americans and respond to the coronavirus. WHOLE-OF-GOVERNMENT APPROACH • The President signed the CARES Act, providing unprecedented and immediate relief to American families, workers, and businesses. • President Trump declared a national emergency, inviting States, territories, and tribes to access over $42 billion in existing funding.  • President Trump signed initial legislation securing $8.3 billion for coronavirus response.  • President Trump signed the Families First Coronavirus Response Act, ensuring that American families and businesses impacted by the virus receive the strong support they need. • To leverage the resources of the entire government, the President created a White House Coronavirus Task Force to coordinate response. • The Vice President named Dr. Deborah Birx to serve as the White House Coronavirus Response Coordinator. • At the request of President Trump, FEMA is leading federal operations on behalf of the White House Coronavirus Task Force.  • FEMA’s National Response Coordination Center has been activated to its highest level in support of coronavirus response.  • The President held a teleconference with other G20 leaders to coordinate VERSIGHT FDA-OC-000005 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000005 coronavirus response. • President Trump signed an executive order giving the DoD and DHS the authority to activate the ready reserve components of the armed forces to assist with coronavirus response. SUPPORTING STATE AND LOCAL EFFORTS • President Trump issued a letter informing our nation’s governors that the Administration is developing new guidelines for state and local policy makers. • Through the CARES Act, we more than doubled the funds available through the President’s Emergency and Disaster Declarations to help State, local, and tribal leaders effectively respond. • The President has approved major disaster declarations for heavily impacted states. • The Administration is covering costs of deploying National Guard units to assist with response efforts in hard hit states, while ensuring governors remain in command. • The President has held multiple teleconferences with our nation’s governors to coordinate response efforts and offer his full support. TRAVEL RESTRICTIONS • In January, President Trump reacted quickly to implement travel restrictions on travel from China, buying us valuable time to respond to the virus. • The President has announced further travel restrictions on global hotspots, including Europe, the United Kingdom and Ireland, and Iran. • American citizens returning from travel-restricted countries are being routed to specific airports, where they can be screened and isolated as needed.  • The United States reached mutual agreements with Mexico and Canada to restrict non-essential travel across our northern and southern borders. • The Administration announced it will expeditiously return aliens who cross between ports of entry or are otherwise not allowed to enter the country, as the facilities in which these aliens would be held cannot support quarantine for the time needed to assess potential cases. • The Administration raised travel warnings to their highest level for other hot spot locations, like Japan and South Korea. • The President has expanded airport screenings to identify travelers showing symptoms and instituted mandatory quarantines. • The State Department issued a global level 4 travel advisory, urging Americans to avoid all international travel due to the coronavirus outbreak worldwide.   VERSIGHT FDA-OC-000006 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000006 • The State Department has worked to safely repatriate thousands of Americans from around the world. EXPANDING TESTING ACCESS • The FDA has issued emergency approval for multiple new commercial coronavirus tests, including some that deliver results to healthcare providers within minutes. • The President secured legislation that will ensure Americans are able to be tested for free. • The Administration is working with state and local partners and the private sector to open up drive-through testing sites. • The Administration worked with Apple to launch an app and website to help Americans determine if they should seek care for coronavirus, and provide them guidance on next steps. • HHS is providing funding to help accelerate the development of rapid diagnostic tests for the coronavirus. • The FDA cut red tape to expand testing availability.   • Admiral Brett Giroir – the Assistant Secretary for Health and head of the Public Health Service – has been appointed to coordinate coronavirus testing efforts. • The FDA is empowering states to authorize tests developed and used by laboratories in their states.   • • The Department of Defense has set up 15 coronavirus testing sites worldwide. • DoD and HHS worked to airlift hundreds of thousands of swabs and sample test kits from Italy to the United States. The President signed legislation requiring more reporting from state and private labs to ensure our public health officials have the data they need to respond to this outbreak.  HELPING FAMILIES AND WORKING AMERICANS • President Trump signed historic legislation to provide direct payments to Americans, significantly expand unemployment benefits, and more. • The Administration negotiated legislation which will provide tax credits for eligible businesses that give paid leave to Americans affected by the virus. • The Department of Labor issued guidance to help inform Americans about the paid family and medical leave available to them. • The Administration took action to provide more flexibility in unemployment insurance programs for workers impacted by the coronavirus. VERSIGHT FDA-OC-000007 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000007 • • The Treasury Department moved tax day from April 15 to July 15.  • USDA announced new flexibilities to allow meal service during school closures.    • USDA announced a new collaboration with the private sector to deliver nearly 1,000,000 meals a week to students in rural schools closed due to the coronavirus.    • USDA launched a partnership with Panera Bread and the Children’s Hunger Alliance to provide meals to children across Ohio, with more states to come. • HHS has announced $250 million in grants to help communities provide meals for seniors. • The Administration is halting foreclosures and evictions for families with FHAinsured mortgages. • The Department of Labor announced up to $100 million in dislocated worker grants in response to the coronavirus national health emergency. • The White House worked with the private sector to launch a central website where families, students, and educators can access online education technologies.    • President Trump signed legislation to provide continuity in educational benefits for veterans and their families who attend schools that have had to switch to online learning. • The Department of Education has given broad approval to colleges and universities to allow them to more easily move their classes online.  • The Department of Education set interest rates on all federally-held student loans to 0% for at least 60 days.   • The Department of Education announced borrowers will have the option to suspend their payments on federally-held student loans for at least two months. • The Department of Education is providing waivers for federal testing requirements to states that have had to close schools.  President Trump signed legislation providing funding and flexibility for emergency nutritional aid for senior citizens, women, children, and low-income families. SUPPORTING IMPACTED BUSINESSES • President Trump signed legislation providing almost $350 billion in loans for small businesses and much needed payroll tax relief. • The President secured legislation giving the Treasury and Federal Reserve $500 VERSIGHT FDA-OC-000008 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000008 billion to provide liquidity and purchase business, municipal, and State debt. • Thanks to legislation signed by President Trump, the Federal Reserve can leverage more than $4 trillion in funds if needed during this crisis. • The Small Business Administration has announced disaster loans which provide impacted businesses with up to $2 million.      • SBA relaxed criteria for disaster assistance loans – expanding small businesses’ access to economic assistance. • The President directed the Energy Department to purchase large quantities of crude oil for the strategic reserve.  • President Trump has held calls and meetings with business leaders from the pharmaceutical industry, airlines, health insurers, grocery stores, retail stores, banks, and more. • The Treasury Department approved the establishment of the Money Market Mutual Fund Liquidity Facility to provide liquidity to the financial system. • The Export-Import Bank announced four new temporary relief programs to provide maximum financing flexibility and inject liquidity into the market. INFORMING THE PUBLIC • The Administration launched a website – coronavirus.gov – to keep the public informed about the outbreak.   • The President announced he is extending CDC guidelines for 30 days to slow the spread of the virus. • The President launched a partnership with the Ad Council, media networks, and digital platforms to communicate public services announcements about the coronavirus. • The President announced guidelines for Americans to follow and do their part to stem the spread of the virus. • The Task Force is holding nearly daily press conferences to provide the American people with the latest information. • The Task Force recommended mitigation strategies to heavily impacted communities, like those in New York, Washington, and California. • CMS announced guidance to protect vulnerable elderly Americans and limit medically unnecessary visits to nursing homes.  • President Trump’s PREVENTS initiative started a new public awareness campaign to promote emotional wellbeing for veterans during the coronavirus pandemic. VERSIGHT FDA-OC-000009 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000009 SUPPORTING PATIENTS AND HEALTHCARE PROVIDERS • The President worked with Congress to secure $100 billion for out healthcare providers. • In January, the Administration declared the coronavirus to be a public health emergency. • The President donated his fourth-quarter 2019 salary to the Department of Health and Human Services for coronavirus response efforts.  • The Army Corps of Engineers and FEMA are helping to build temporary hospitals and medical facilities in hard hit areas.  • The Vice President penned a letter to hospital administrators asking hospitals to report testing data to HHS to help inform policies. • The President took action to give HHS authority to waive rules and regulations so that healthcare providers have maximum flexibility to respond to this outbreak. • CMS issued sweeping regulatory changes to increase hospital capacity, rapidly expand the healthcare workforce, and cut paperwork so doctors can put patients first. • HHS is providing funding to help healthcare systems across the country quickly prepare for a surge in coronavirus patients. • CMS is giving flexibility to Medicare Advantage and Part D plans to waive costsharing for coronavirus tests and treatment. • The President announced that Humana and Cigna will waive co-pays, coinsurance, and deductibles for coronavirus treatments. • CMS created new billing codes for coronavirus tests to promote better tracking of the public health response. • The White House Office of Science and Technology Policy coordinated with the NIH, the tech industry, and non-profits to release a machine readable collection of 29,000 coronavirus-related research articles, which will help scientists discover insights to virus’ genetics, incubation, treatment, symptoms, and prevention. • The White House launched a new public-private consortium to help provide coronavirus research projects access to powerful supercomputer resources. • The Administration announced that health plans with health savings accounts will be able to cover coronavirus testing and treatment without co-payments. • CMS dramatically expanded telehealth for Medicare beneficiaries, ensuring more patients can access their doctors remotely while avoiding exposure.  VERSIGHT FDA-OC-000010 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000010 • HHS lifted HIPAA penalties to enable healthcare providers to expand telehealth access for patients.  • The FDA took action to allow expanded use of devices to monitor patients’ vital signs remotely, reducing hospital visits and minimizing risks of exposure. • The VA established 19 emergency operations centers across the country and put in place visitation restrictions to limit patients’ exposure. • Thanks to a waiver from the Office of Personnel Management, the VA is working to rehire retired medical personnel during the coronavirus outbreak.  • CMS and the VA are working to limit nonessential, elective medical procedures to free up healthcare resources.   • The Department of Defense issued guidance to delay elective medical procedures at military facilities in order to preserve healthcare resources.  • • The Navy deployed two medical ships to help support impacted areas. The President announced Carnival Cruise Lines will be making ships available for hospitals to use for non-coronavirus patients.  STRENGTHENING ESSENTIAL MEDICAL SUPPLIES • The Administration mobilized a Supply Chain Stabilization Task Force led by Rear Admiral John Polowczyk. • FEMA is working to distribute ventilators and other critical supplies to hard hit states. • FEMA launched Project Airbridge to help quickly airlift critical supplies across the country. • The President invoked the Defense Production Act, providing a number of authorities that can be used as needed. • The President took action under the Defense Production Act to compel General Motors to accept, perform, and prioritize Federal contracts for ventilators.   • President Trump signed an executive order providing HHS and DHS with the full authorities available under the Defense Production Act to respond to this outbreak. • The President urged the private sector to bolster response efforts, leading companies across the country to produce more critical supplies like masks, ventilators, and hand sanitizer. • The President signed a memorandum directing his Administration to make general-use face masks available to healthcare workers. • HHS announced it will be purchasing 500 million N95 respirators for the VERSIGHT FDA-OC-000011 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000011 Strategic National Stockpile. • The Department of Defense announced it will be providing 5 million respirator masks and 2,000 specialized ventilators to assist.   • The Department of Defense is procuring 8,000 ventilators worth an estimated $84.4 million • The President signed legislation removing restrictions that prevented manufacturers from selling industrial masks – which can readily protect healthcare workers – directly to hospitals.  • The FDA gave emergency approval to a new system to sterilize N95 masks, helping hospitals get the most use out of their masks.  • The President signed an executive order to prevent hoarding and price-gouging of critical medical supplies. • The Department of Justice has taken action to combat coronavirus related fraud. DEVELOPING VACCINES AND THERAPEUTICS • The Administration is working to help accelerate the development of therapeutics and a vaccine to combat the coronavirus. • The FDA is evaluating existing drugs that could serve as potential therapeutics for coronavirus patients. • The FDA approved emergency use of convalescent plasma treatments for seriously ill coronavirus patients.  • HHS accepted 30 million doses of hydroxychloroquine sulfate donated by pharmaceutical companies. • The Trump Administration is actively working with drug manufacturers to monitor any potential drug supply chain issues. • The Administration is expanding research and consulting with experts to better understand the transmission of coronavirus.  • The National Institutes of Health has announced the beginning of a clinical trial for a coronavirus vaccine candidate.      ###   VERSIGHT FDA-OC-000012 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000012 From: To: Subject: Date: Caliguiri, Laura Lynch, Sarah; Capobianco, Abigail; Kimberly, Brad FW: What You Need To Know President Trump’s Coronavirus Response Efforts Tuesday, March 24, 2020 8:36:17 PM     From: Mitchell, Austin A. EOP/WHO (b) (6) @who.eop.gov> Sent: Tuesday, March 24, 2020 8:35 PM Subject: What You Need To Know President Trump’s Coronavirus Response Efforts   What You Need To Know President Trump’s Coronavirus Response Efforts ________________________________ President Trump and his Administration are working every day to protect the health and wellbeing of Americans and respond to the coronavirus. WHOLE-OF-GOVERNMENT APPROACH • President Trump declared a national emergency, inviting States, territories, and tribes to access over $42 billion in existing funding.  • President Trump signed legislation securing $8.3 billion for coronavirus response.  • President Trump signed the Families First Coronavirus Response Act, ensuring that American families and businesses impacted by the virus receive the strong support they need. • To leverage the resources of the entire government, the President created a White House Coronavirus Task Force to coordinate response. • The Vice President named Dr. Deborah Birx to serve as the White House Coronavirus Response Coordinator. • At the request of President Trump, FEMA is leading federal operations on behalf of the White House Coronavirus Task Force.  • FEMA’s National Response Coordination Center has been activated to its highest level in support of coronavirus response.  SUPPORTING STATE AND LOCAL EFFORTS • The President has approved major disaster declarations for impacted states like New York, Washington, and California. VERSIGHT FDA-OC-000013 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000013 • The Administration is covering costs of deploying National Guard units to assist with response efforts in hard hit states, while ensuring governors remain in command. • The President has held multiple teleconferences with our nation’s governors to coordinate response efforts and offer his full support. TRAVEL RESTRICTIONS • In January, President Trump reacted quickly to implement travel restrictions on travel from China, buying us valuable time to respond to the virus. • The President has announced further travel restrictions on global hotspots, including Europe, the United Kingdom and Ireland, and Iran. • American citizens returning from travel-restricted countries are being routed to specific airports, where they can be screened and isolated as needed.  • The United States reached mutual agreements with Mexico and Canada to restrict non-essential travel across our northern and southern borders. • The Administration announced it will expeditiously return aliens who cross between ports of entry or are otherwise not allowed to enter the country, as the facilities in which these aliens would be held cannot support quarantine for the time needed to assess potential cases. • The Administration raised travel warnings to their highest level for other hot spot locations, like Japan and South Korea. • The President has expanded airport screenings to identify travelers showing symptoms and instituted mandatory quarantines. • The State Department issued a global level 4 travel advisory, urging Americans to avoid all international travel due to the coronavirus outbreak worldwide.   • The State Department has worked to safely repatriate 9,000 Americans from 28 countries around the world. EXPANDING TESTING ACCESS • The FDA has issued emergency approval for multiple new commercial coronavirus tests to significantly expand testing across the country. • The President secured legislation that will ensure Americans are able to be tested for free. • The Administration is working with state and local partners and the private sector to open up drive-through testing sites. • The Administration is working with the private sector to develop a website that Americans can utilize to determine whether they need a test and, if so, where to VERSIGHT FDA-OC-000014 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000014 get it. • HHS is providing funding to help accelerate the development of rapid diagnostic tests for the coronavirus. • • The FDA cut red tape to expand testing availability.   • The FDA is empowering states to authorize tests developed and used by laboratories in their states.   • • The Department of Defense has set up 15 coronavirus testing sites worldwide. • DoD and HHS worked to airlift hundreds of thousands of swabs and sample test kits from Italy to the United States. Admiral Brett Giroir – the Assistant Secretary for Health and head of the Public Health Service – has been appointed to coordinate coronavirus testing efforts. The President signed legislation requiring more reporting from state and private labs to ensure our public health officials have the data they need to respond to this outbreak.  SUPPORTING IMPACTED BUSINESSES • The Small Business Administration has announced disaster loans which provide impacted businesses with up to $2 million.      • SBA relaxed criteria for disaster assistance loans – expanding small businesses’ access to economic assistance. • The President directed the Energy Department to purchase large quantities of crude oil for the strategic reserve.  • President Trump has held calls and meetings with business leaders from the pharmaceutical industry, airlines, health insurers, grocery stores, retail stores, banks, and more. • The Treasury Department approved the establishment of the Money Market Mutual Fund Liquidity Facility to provide liquidity to the financial system. HELPING FAMILIES AND WORKING AMERICANS • The Administration negotiated legislation which will provide tax credits for eligible businesses that give paid leave to Americans affected by the virus. • The Administration took action to provide more flexibility in unemployment insurance programs for workers impacted by the coronavirus. • The Treasury Department moved tax day from April 15 to July 15.  • President Trump signed legislation providing funding and flexibility for emergency nutritional aid for senior citizens, women, children, and low-income families. VERSIGHT FDA-OC-000015 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000015 • USDA announced new flexibilities to allow meal service during school closures.    • USDA announced a new collaboration with the private sector to deliver nearly 1,000,000 meals a week to students in rural schools closed due to the coronavirus.  • HHS has announced $250 million in grants to help communities provide meals for seniors. • The Administration is halting foreclosures and evictions for families with FHAinsured mortgages. • The Department of Labor announced up to $100 million in dislocated worker grants in response to the coronavirus national health emergency. • The White House worked with the private sector to launch a central website where families, students, and educators can access online education technologies.    • President Trump signed legislation to provide continuity in educational benefits for veterans and their families who attend schools that have had to switch to online learning. • The Department of Education has given broad approval to colleges and universities to allow them to more easily move their classes online.  • The Department of Education set interest rates on all federally-held student loans to 0% for at least 60 days.   • The Department of Education announced borrowers will have the option to suspend their payments on federally-held student loans for at least two months. • The Department of Education is providing waivers for federal testing requirements to states that have had to close schools. INFORMING THE PUBLIC • The Administration launched a website – coronavirus.gov – to keep the public informed about the outbreak.   • The President launched a partnership with the Ad Council, media networks, and digital platforms to communicate public services announcements about the coronavirus. • The President announced guidelines for Americans to follow and do their part to stem the spread of the virus. • The Task Force is holding nearly daily press conferences to provide the American people with the latest information. VERSIGHT FDA-OC-000016 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000016 • The Task Force has recommended mitigation strategies to heavily impacted communities, like those in New York, Washington, and California. • CMS announced guidance to protect vulnerable elderly Americans and limit medically unnecessary visits to nursing homes. SUPPORTING PATIENTS AND HEALTHCARE PROVIDERS • In January, the Administration declared the coronavirus to be a public health emergency. • The President donated his fourth-quarter 2019 salary to the Department of Health and Human Services for coronavirus response efforts. • The President took action to give HHS authority to waive rules and regulations so that healthcare providers have maximum flexibility to respond to this outbreak. • HHS is providing funding to help healthcare systems across the country quickly prepare for a surge in coronavirus patients. • CMS is giving flexibility to Medicare Advantage and Part D plans to waive costsharing for coronavirus tests and treatment. • CMS created new billing codes for coronavirus tests to promote better tracking of the public health response. • The White House Office of Science and Technology Policy coordinated with the NIH, the tech industry, and non-profits to release a machine readable collection of 29,000 coronavirus-related research articles, which will help scientists discover insights to virus’ genetics, incubation, treatment, symptoms, and prevention. • The White House launched a new public-private consortium to help provide coronavirus research projects access to powerful supercomputer resources. • The Administration announced that health plans with health savings accounts will be able to cover coronavirus testing and treatment without co-payments. • CMS dramatically expanded telehealth for Medicare beneficiaries, ensuring more patients can access their doctors remotely while avoiding exposure.  • HHS lifted HIPAA penalties to enable healthcare providers to expand telehealth access for patients.  • The FDA took action to allow expanded use of devices to monitor patients’ vital signs remotely, reducing hospital visits and minimizing risks of exposure. • The VA established 19 emergency operations centers across the country and put in place visitation restrictions to limit patients’ exposure. VERSIGHT FDA-OC-000017 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000017 Thanks to a waiver from the Office of Personnel Management, the VA is working to rehire retired medical personnel during the coronavirus outbreak.  • CMS and the VA are working to limit nonessential, elective medical procedures to free up healthcare resources.   • The Department of Defense issued guidance to delay elective medical procedures at military facilities in order to preserve healthcare resources.  • • The Navy will be deploying two medical ships to help support impacted areas. The President announced Carnival Cruise Lines will be making ships available for hospitals to use for non-coronavirus patients. STRENGTHENING ESSENTIAL MEDICAL SUPPLIES • • The President announced he is invoking the Defense Production Act. • The President signed a memorandum directing his Administration to make general-use face masks available to healthcare workers. • HHS announced it will be purchasing 500 million N95 respirators for the Strategic National Stockpile. • The Department of Defense announced it will be providing 5 million respirator masks and 2,000 specialized ventilators to assist.   • The President signed legislation removing restrictions that prevented manufacturers from selling industrial masks – which can readily protect healthcare workers – directly to hospitals. • The President signed an executive order to prevent hoarding and price-gouging of critical medical supplies. • The Department of Justice has taken action to combat coronavirus related fraud. The President has urged companies to bolster response efforts, leading companies across the country to step up and produce more critical supplies like face masks and hand sanitizer. DEVELOPING VACCINES AND THERAPEUTICS • The Administration is working to help accelerate the development of therapeutics and a vaccine to combat the coronavirus. • The FDA is evaluating existing drugs that could serve as potential therapeutics for coronavirus patients. • The Trump Administration is actively working with drug manufacturers to monitor any potential drug supply chain issues. • The Administration is expanding research and consulting with experts to better understand the transmission of coronavirus.  VERSIGHT FDA-OC-000018 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000018 • The National Institutes of Health has announced the beginning of a clinical trial for a coronavirus vaccine candidate.    ###   VERSIGHT FDA-OC-000019 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000019 From: To: Subject: Date: Caliguiri, Laura Lynch, Sarah; Kimberly, Brad; Capobianco, Abigail FW: What You Need To Know President Trump’s Coronavirus Response Efforts Thursday, March 26, 2020 8:08:24 PM     From: Mitchell, Austin A. EOP/WHO (b) (6) @who.eop.gov> Sent: Thursday, March 26, 2020 7:56 PM Subject: What You Need To Know President Trump’s Coronavirus Response Efforts   What You Need To Know President Trump’s Coronavirus Response Efforts ________________________________ President Trump and his Administration are working every day to protect the health and wellbeing of Americans and respond to the coronavirus. WHOLE-OF-GOVERNMENT APPROACH • President Trump declared a national emergency, inviting States, territories, and tribes to access over $42 billion in existing funding.  • President Trump signed legislation securing $8.3 billion for coronavirus response.  • President Trump signed the Families First Coronavirus Response Act, ensuring that American families and businesses impacted by the virus receive the strong support they need. • To leverage the resources of the entire government, the President created a White House Coronavirus Task Force to coordinate response. • The Vice President named Dr. Deborah Birx to serve as the White House Coronavirus Response Coordinator. • At the request of President Trump, FEMA is leading federal operations on behalf of the White House Coronavirus Task Force.  • FEMA’s National Response Coordination Center has been activated to its highest level in support of coronavirus response.  • The President held a teleconference with other G20 leaders to coordinate coronavirus response. SUPPORTING STATE AND LOCAL EFFORTS VERSIGHT FDA-OC-000020 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000020 • President Trump issued a letter informing our nation’s governors that the Administration is developing new guidelines for state and local policy makers. • The President has approved major disaster declarations for heavily impacted states. • The Administration is covering costs of deploying National Guard units to assist with response efforts in hard hit states, while ensuring governors remain in command. • The President has held multiple teleconferences with our nation’s governors to coordinate response efforts and offer his full support. TRAVEL RESTRICTIONS • In January, President Trump reacted quickly to implement travel restrictions on travel from China, buying us valuable time to respond to the virus. • The President has announced further travel restrictions on global hotspots, including Europe, the United Kingdom and Ireland, and Iran. • American citizens returning from travel-restricted countries are being routed to specific airports, where they can be screened and isolated as needed.  • The United States reached mutual agreements with Mexico and Canada to restrict non-essential travel across our northern and southern borders. • The Administration announced it will expeditiously return aliens who cross between ports of entry or are otherwise not allowed to enter the country, as the facilities in which these aliens would be held cannot support quarantine for the time needed to assess potential cases. • The Administration raised travel warnings to their highest level for other hot spot locations, like Japan and South Korea. • The President has expanded airport screenings to identify travelers showing symptoms and instituted mandatory quarantines. • The State Department issued a global level 4 travel advisory, urging Americans to avoid all international travel due to the coronavirus outbreak worldwide.   • The State Department has worked to safely repatriate 9,000 Americans from 28 countries around the world. EXPANDING TESTING ACCESS • The FDA has issued emergency approval for multiple new commercial coronavirus tests to significantly expand testing across the country. • The President secured legislation that will ensure Americans are able to be tested for free. VERSIGHT FDA-OC-000021 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000021 • The Administration is working with state and local partners and the private sector to open up drive-through testing sites. • The Administration is working with the private sector to develop a website that Americans can utilize to determine whether they need a test and, if so, where to get it. • HHS is providing funding to help accelerate the development of rapid diagnostic tests for the coronavirus. • • The FDA cut red tape to expand testing availability.   • The FDA is empowering states to authorize tests developed and used by laboratories in their states.   • • The Department of Defense has set up 15 coronavirus testing sites worldwide. • DoD and HHS worked to airlift hundreds of thousands of swabs and sample test kits from Italy to the United States. Admiral Brett Giroir – the Assistant Secretary for Health and head of the Public Health Service – has been appointed to coordinate coronavirus testing efforts. The President signed legislation requiring more reporting from state and private labs to ensure our public health officials have the data they need to respond to this outbreak.  HELPING FAMILIES AND WORKING AMERICANS • The Administration negotiated legislation which will provide tax credits for eligible businesses that give paid leave to Americans affected by the virus. • The Department of Labor issued guidance to help inform Americans about the paid family and medical leave available to them. • The Administration took action to provide more flexibility in unemployment insurance programs for workers impacted by the coronavirus. • • The Treasury Department moved tax day from April 15 to July 15.  • USDA announced new flexibilities to allow meal service during school closures.    • USDA announced a new collaboration with the private sector to deliver nearly 1,000,000 meals a week to students in rural schools closed due to the coronavirus.  • HHS has announced $250 million in grants to help communities provide meals President Trump signed legislation providing funding and flexibility for emergency nutritional aid for senior citizens, women, children, and low-income families. VERSIGHT FDA-OC-000022 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000022 for seniors. • The Administration is halting foreclosures and evictions for families with FHAinsured mortgages. • The Department of Labor announced up to $100 million in dislocated worker grants in response to the coronavirus national health emergency. • The White House worked with the private sector to launch a central website where families, students, and educators can access online education technologies.    • President Trump signed legislation to provide continuity in educational benefits for veterans and their families who attend schools that have had to switch to online learning. • The Department of Education has given broad approval to colleges and universities to allow them to more easily move their classes online.  • The Department of Education set interest rates on all federally-held student loans to 0% for at least 60 days.   • The Department of Education announced borrowers will have the option to suspend their payments on federally-held student loans for at least two months. • The Department of Education is providing waivers for federal testing requirements to states that have had to close schools. SUPPORTING IMPACTED BUSINESSES • The Small Business Administration has announced disaster loans which provide impacted businesses with up to $2 million.      • SBA relaxed criteria for disaster assistance loans – expanding small businesses’ access to economic assistance. • The President directed the Energy Department to purchase large quantities of crude oil for the strategic reserve.  • President Trump has held calls and meetings with business leaders from the pharmaceutical industry, airlines, health insurers, grocery stores, retail stores, banks, and more. • The Treasury Department approved the establishment of the Money Market Mutual Fund Liquidity Facility to provide liquidity to the financial system. • The Export-Import Bank announced four new temporary relief programs to provide maximum financing flexibility and inject liquidity into the market. INFORMING THE PUBLIC • The Administration launched a website – coronavirus.gov – to keep the public VERSIGHT FDA-OC-000023 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000023 informed about the outbreak.   • The President launched a partnership with the Ad Council, media networks, and digital platforms to communicate public services announcements about the coronavirus. • The President announced guidelines for Americans to follow and do their part to stem the spread of the virus. • The Task Force is holding nearly daily press conferences to provide the American people with the latest information. • The Task Force has recommended mitigation strategies to heavily impacted communities, like those in New York, Washington, and California. • CMS announced guidance to protect vulnerable elderly Americans and limit medically unnecessary visits to nursing homes. SUPPORTING PATIENTS AND HEALTHCARE PROVIDERS • In January, the Administration declared the coronavirus to be a public health emergency. • The President donated his fourth-quarter 2019 salary to the Department of Health and Human Services for coronavirus response efforts. • The President took action to give HHS authority to waive rules and regulations so that healthcare providers have maximum flexibility to respond to this outbreak. • HHS is providing funding to help healthcare systems across the country quickly prepare for a surge in coronavirus patients. • CMS is giving flexibility to Medicare Advantage and Part D plans to waive costsharing for coronavirus tests and treatment. • CMS created new billing codes for coronavirus tests to promote better tracking of the public health response. • The White House Office of Science and Technology Policy coordinated with the NIH, the tech industry, and non-profits to release a machine readable collection of 29,000 coronavirus-related research articles, which will help scientists discover insights to virus’ genetics, incubation, treatment, symptoms, and prevention. • The White House launched a new public-private consortium to help provide coronavirus research projects access to powerful supercomputer resources. • The Administration announced that health plans with health savings accounts will be able to cover coronavirus testing and treatment without co-payments. VERSIGHT FDA-OC-000024 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000024 CMS dramatically expanded telehealth for Medicare beneficiaries, ensuring more patients can access their doctors remotely while avoiding exposure.  • HHS lifted HIPAA penalties to enable healthcare providers to expand telehealth access for patients.  • The FDA took action to allow expanded use of devices to monitor patients’ vital signs remotely, reducing hospital visits and minimizing risks of exposure. • The VA established 19 emergency operations centers across the country and put in place visitation restrictions to limit patients’ exposure. • Thanks to a waiver from the Office of Personnel Management, the VA is working to rehire retired medical personnel during the coronavirus outbreak.  • CMS and the VA are working to limit nonessential, elective medical procedures to free up healthcare resources.   • The Department of Defense issued guidance to delay elective medical procedures at military facilities in order to preserve healthcare resources.  • • The Navy will be deploying two medical ships to help support impacted areas. • The Army Corps of Engineers is helping to build temporary hospitals and medical facilities in states like New York and Washington. The President announced Carnival Cruise Lines will be making ships available for hospitals to use for non-coronavirus patients.  STRENGTHENING ESSENTIAL MEDICAL SUPPLIES • The Administration mobilized a Supply Chain Stabilization Task Force led by Rear Admiral John Polowczyk. • FEMA is working to distribute ventilators and other critical supplies to hard hit states like New York. • The President invoked the Defense Production Act, providing a number of authorities that can be used if needed. • The President urged the private sector to bolster response efforts, leading companies across the country to produce more critical supplies like masks, ventilators, and hand sanitizer. • The President signed a memorandum directing his Administration to make general-use face masks available to healthcare workers. • HHS announced it will be purchasing 500 million N95 respirators for the Strategic National Stockpile. • The Department of Defense announced it will be providing 5 million respirator masks and 2,000 specialized ventilators to assist.   VERSIGHT FDA-OC-000025 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000025 • The President signed legislation removing restrictions that prevented manufacturers from selling industrial masks – which can readily protect healthcare workers – directly to hospitals. • The President signed an executive order to prevent hoarding and price-gouging of critical medical supplies. • The Department of Justice has taken action to combat coronavirus related fraud. DEVELOPING VACCINES AND THERAPEUTICS • The Administration is working to help accelerate the development of therapeutics and a vaccine to combat the coronavirus. • The FDA is evaluating existing drugs that could serve as potential therapeutics for coronavirus patients. • The Trump Administration is actively working with drug manufacturers to monitor any potential drug supply chain issues. • The Administration is expanding research and consulting with experts to better understand the transmission of coronavirus.  • The National Institutes of Health has announced the beginning of a clinical trial for a coronavirus vaccine candidate.  ###   VERSIGHT FDA-OC-000026 MULTI-HHS-FDA-20-0400, 20-0415, 20-0498-A-000026