Copy
View this email in your browser
COVID-19 Update
May 28, 2020

IowaBio wants to provide our members useful information during the COVID-19 pandemic. This newsletter compiles information on state, federal and industry action to combat the virus and its impacts.

If your company is helping respond to COVID-19, IowaBio wants to know about it. Please, send any information about what your biotechnology company or organization is doing to help, to Jessica Hyland at Jessica@iowabio.org.

If IowaBio can assist you in getting information out, connecting with public officials, or support your company in another way, please do not hesitate to reach out.

Past IowaBio COVID-19 Update newsletters are now available at www.iowabio.org/COVID19 and can be found under the Industry News tab on the IowaBio website.

Iowa Update

Governor Reynolds will hold a press conference today from the State Emergency Operations Center (SEOC) in Johnston, IA at 11:00 a.m. to provide an update to the state of Iowa on COVID-19. That press conference will be livestreamed and posted in full on Governor Reynolds’ Facebook Page.

Currently, IDPH has reported on the state’s coronavirus dashboard, 18,498 Iowans have tested positive, up 311 from our update yesterday morning, with a total of 142,316 Iowans tested.  19 more deaths were reported since our update yesterday, bringing the total to 500 deaths.  Now 10,137 Iowans have recovered. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here.

Yesterday at her press conference, Governor Reynolds discussed the importance of testing and contact tracing. A strike team is in Brummer County doing surveillance testing of up to 1,000 employees of long term care facilities in the area. Nearly 15,000 Iowans have been tested at a Test Iowa site, she said. She said data will help understand and track virus activity as well as respond to contain the virus. 139,000 or 1 in 23 Iowans have been tested, which amounts to 4.4 percent of Iowa’s population. The CDC has asked Iowa to put together a test plan to plan to test 2 percent of the State’s population each month.

Four new Test Iowa sites are opening in Sioux Center, Marshalltown, Council Bluffs and a unique test Iowa site in West Burlington partnering with Great River Health. The Governor fielded a question about serology testing and if it’s possible to do large scale serology testing. Sarah Reisetter, Deputy Director of IDPH, said they are evaluating testing options now to make additional testing methods available. They are hoping a finger prick test will be available to allow serology testing, without using a phlebotomist to draw blood.

Here is a quick reminder of what is reopening in Iowa when:

Establishments
  • May 28th through June 17th
    • Restaurants & Bars are limited to 50% capacity and must cap tables at 10 people
      • Self Service is still prohibited
    • Fitness Centers can remain open and are limited to 50% capacity
    • Malls can remain open and are limited to 50% capacity
  • June 1 through June 17th
    • Outdoor Performance Venues can open at 50% capacity
    • Casinos can open at 50% capacity
    • Amusement venues (bingo, bowling, pool halls, arcades) can open at 50% capacity
    • Outdoor playgrounds can open on June 1st
  • Senior citizen centers and Adult daycare facilities shall remain closed through June 17th
Mass Gatherings
  • June 1st through June 17th
    • A social, community, recreational, leisure, or sporting gathering (including festivals, conventions and fundraisers) can be held if it’s at 50% capacity in an indoor venue.
    • Non-school Sporting and recreational events are allowed so long as the organizer implements reasonable measures.
    • Spiritual & religious gatherings are not subject to capacity restrictions
    • Farmer’s Markets are limited to selling farm products and food. Children’s activities and common seating is prohibited
    • Auctions are allowed at a 50% normal operating capacity
Federal Legislation
Supplemental IV – The Heroes Act (HR 6800)
Timeline/Process/Politics: Not much has changed since last Friday – Republicans continue to assert that they will wait a few more weeks before taking up another coronavirus supplemental. With Paycheck Protection Program (PPP) loans starting to expire in early June, there will likely be increasing pressure for a version of some fixes to the program (as discussed below). If a standalone bill doesn’t pass (the House is voting on one tomorrow), it could be a driver of a “3.75” package. Other drivers could include rising unemployment, reelection pressure from vulnerable Republicans (including the President), or the PPP running out of funding.
 
Policy: The Heroes Act passed the House on May 15, but Leader McConnell has indicated that the Senate will not consider the bill as a base for negotiations. The bill nonetheless outlines Democratic priorities (to a certain extent). Heroes Act text (as of 5/12/2020) here. Section by section here. One pager here. State and Local one pager here. NCAI’s summary on tribal provisions here. Manager’s amendment here. House Rules Committee report here.
 
Legislation to Watch
Tomorrow the House will vote on the Paycheck Protection Flexibility Act, which has been modified by the Small Business Committee to address both Democratic and Republican concerns. It’s unclear if those changes will be enough to pass the Senate. After an unsuccessful hotline of a similarly focused bill in the Senate last week, there were rumors that the Senate could pass the House bill (after House passage) in one of its pro forma sessions later this week. That outcome is unlikely, as the Senate bill still has significant differences than the House bill. It is unclear which bill will move through both chambers or whether a conference will be necessary.

Highlights of the House bill (H.R. 7010) below. Updated text here.
  • Allow loan forgiveness for expenses beyond the 8-week covered period.  
  • Removes the limitation that restrict non-payroll expenses (rent, utilities) to 25% of the loan. 
  • Eliminate limitations that restrict loan terms to 2 years. 
  • Allow businesses that take PPP loans to be eligible for payroll tax deferment.  
  • Extend the rehiring deadline to align with the enhanced Unemployment Insurance to offset its effects. 
  • Clarify safe harbor language, specifically that an “inability to return to the same level of business activity,” refers to compliance with HHS, CDC, OSHA standards or any other worker/customer safety requirement related to COVID-19.
  • Allows borrowers to defer payments until SBA has made forgiveness determination.
Highlights of the Senate bill below. Text here. One pager here.
  • Extends the deadline to apply for a PPP from 6/30/2020, to 12/31/2020;
  • Allows borrowers a full 16 weeks to use funds, extending it from 8 weeks;
  • Expand use of funds to include PPP and investments in safety for reopening;
  • Clarifies the lender hold harmless provision.
Passed Legislation
New Implementation Information and Guidance
  • 5/27 – Treasury extended the deadline for tribes to submit data from 5/26 to 5/29 at 12pm EST.
  • 5/16 – SBA released updated information on PPP and EIDL loans from both CARES and COVID 3.5 rounds of lending. PPP Data here. EIDL Loan data here. EIDL Advance data here.
  • 5/22 – HHS announced it will distribute $4.9 billion to skilled nursing facilities (SNF). Each SNF will receive a fixed distribution of $50,000, plus a distribution of $2,500 per bed. Press release here.
  • 5/22 – HHS announced it will distribute $500 million to IHS and tribal hospitals, clinics, and urban health centers. Press release here.
    • IHS/tribal hospitals will receive a base of $2.81 million and three percent of their total operating expenses.
    • IHS/tribal clinics and programs will receive a base of $187,000 and five percent of the following: their estimated service population multiplied by the average cost per user.
    • IHS urban programs will receive a base of $181,000 and six percent of the following: their estimated service population multiplied by the average cost per user.
Previously Reported Implementation Information and Guidance
Small Business Loans & Treasury Main Street Lending
  • 5/20 – In reviewing the PPP loan forgiveness application, our team has found some information that may prove useful to organizations receiving PPP loans. Information below:
    • In determining the forgiveness amount, the SBA will forgive the LESSER of three things:
      • The total of the following:
        • Payroll costs incurred or paid during the Covered Period or Alternative Payroll Covered Period PLUS
        • Amount of mortgage interest payments paid during Covered Period on real or personal property on an obligation incurred prior to 2/15/20 PLUS
        • Amount of business rent or lease payments for real or personal property paid during covered period pursuant to agreements in place prior to 2/15/20 PLUS
        • Amount of business utility payments paid during the covered period for business utilities for which service began before 2/15/20 MINUS
        • Any salary/hourly wage reduction amount required (this calculation is spelled out in the application) MULTIPLIED BY
        • FTE Reduction quotient (this calculation is spelled out in the application).
      • The PPP loan amount.
      • Total Payroll costs divided by 0.75.
    • The covered period begins on the date the loan proceeds are disbursed to the borrower.
    • In some portion of the loan forgiveness calculation, the application requires the borrower to use the Covered Period. In other portions of the loan forgiveness calculation, certain borrowers can choose the Covered Period of the Alternative Payroll Covered Period. Those borrowers with a biweekly (or more frequent) payroll schedule can elect to calculate eligible payroll costs using the 8-week period that begins on the first day of their first pay period following the PPP loan disbursement date. Those borrowers who choose the Alternative Payroll Covered Period for payroll calculation MUST apply the Alternative Payroll Covered Period whenever there is a reference to that or Covered Period – i.e., they must apply it consistently throughout the loan forgiveness calculation.
  • 5/15 – Treasury released the loan forgiveness application for businesses that have received loans under the Paycheck Protection Program. Application here.
  • 5/11 – SBA released updated PPP statistics, including recent state by state information here.
  • 5/8 – SBA’s Inspector General released a report on the implementation of the Paycheck Protection Program. The report found the Administration’s administration of the program did not align with the law in four ways: prioritization of underserved/rural markets, loan proceeds eligibility for forgiveness, guidance on loan deferment, and registration of loans. Report here.
  • 5/7 -- The Washington Post reported that the SBA has imposed a new loan limit on the department’s Economic Injury Disaster Loans (EIDL), moving the loan limit from $2 million to $150,000. The department also announced that it would only be accepting applications from agricultural businesses onward.
  • 5/6 – Treasury released an updated FAQ for the Paycheck Protection Program. FAQ here.
  • 5/3 – Treasury and SBA released a data set for the most recent tranche of P3 funds. Data here.
  • 4/30 – The IRS issued guidance that most expenses funded by forgiven Paycheck Protection Program (PPP) loans are non-deductible for federal income tax purposes.
  • 4/30 – The Federal Reserve released the term sheets and other information relating to its expansion of scope and eligibility of the Main Street Lending Program. Term sheets and other information here. Other information on other facilities and programs here.
  • 4/29 – SBA announced that from 4:00-11:49pm on 4/29, SBA systems would only accept loans from lending institutions with asset sizes less than $1 billion dollars. The move was aimed at ensuring access to the PPP loan program for smaller lenders and their customers.
  • 4/28 – SBA announced it would no longer accept PPP loan applications submitted by robotic processing systems.
  • Treasury released an interim final rule for the Paycheck Protection Program on how lenders will calculate loan amounts for employers with seasonal employees. Rule here.
  • 4/24 – SBA issued a procedural guidance on participation sales here.
  • 4/24 – SBA released an interim final rule on requirements for Promissory Notes, Authorizations, Affiliation, and Eligibility. Interim Final Rule here. Additional eligibility criteria and requirements for certain loans here.
  • 4/24 – Data on Economic Injury Disaster Loans here, EIDL Advance here.
  • 4/23 – The Treasury Department asked all publicly traded companies that received funds under the program to return the funds within two weeks.
  • The Treasury Department released an interim final rule on the small business provisions in the bill. See here for a memo Cornerstone put together on the interim final rule.
  • Treasury FAQs on the Paycheck Protection Program
    • Top-line overview of the program here
    • Lender information here, Borrower information here, borrower application here
State, Local, and Tribal Government Funding
  • 5/20 – Tribes have begun to receive instructions for responding to Treasury’s second data request last night. An email from Treasury should have gone to whomever at the Tribe submitted Treasury’s first data request. The portal closes at 11:59 p.m. Alaskan time on Tuesday, May 26.
  • 5/15 – In a court document filed Friday, Treasury indicated that it will open a portal this week for tribes to submit information outlined in last week’s data request. Tribes will have five business days to submit the data (expected submission deadline is May 26). Treasury expects to process the data and determine allocations within a week of the submission deadline (by June 4). Treasury will disburse payments one business day after Treasury has finished computing amounts. In a call today, Treasury indicated that they will hold back funding for Alaskan Native Corporations (ANCs). Treasury also explained that the data request for employees should include both government employees and tribal-entity employees, while the expenditure data should only include government expenditures.
  • 5/14 – Treasury issued a data request to disburse the second round of funding for tribes in the Coronavirus Relief Fund. The data request includes information on employees and expenditures. Portal will likely open sometime next week. More information here.
  • 5/12 – Treasury released its list of payments to states and qualifying localities for the Coronavirus Relief Fund. List here.
  • 5/8 – Treasury still has a remaining $3.2 billion to distribute among tribes and plans plans to submit a new data request soon, with a portal open soon after. The next round of funding will be based on employment and expenditure data of Tribes and tribally-owned entities.
  • 5/5 – Treasury released distribution details regarding the tribal portion of the Coronavirus Release Fund. The first 60% of the fund will be distributed to tribes based on population used in the Indian Housing Block Grant (IHBG) and will include a floor of $100,000. The remaining 40% will be distributed based on the number of individuals employed by the Tribe, including employees of tribally owned entities. Treasury still needs to collect and verify employment data before distributing the second round of funding. Amounts for ANCs will not be distributed, as litigation is still pending. Press release here. Details here.
    • More than a dozen tribes have sued the Treasury Department over its guidance identifying Alaska Native Corporations (ANCs) as eligible entities for the fund. Last Wednesday, Secretary Mnuchin said that the department would not be releasing funding until Tuesday, April 28 – two days after the deadline outlined in the CARES Act. The court on Monday preliminarily enjoined Treasury from disbursing funds to ANCs.
  • 5/5 – Treasury released an updated FAQ regarding distribution of CARES Act state/local funds. FAQ here.
  • 4/27 – USDA announced that Kansas and Virginia have been approved to operate Pandemic Electronic Benefit Transfer (EBT), authorized by the Families First Coronavirus Response Act (FFCRA), which provides assistance to families of children eligible for free or reduced-price meals dealing with school closures.
  • 4/22 – Treasury issued guidance on the state/local/tribal governments fund here. The guidance further defines what expenses qualify as “necessary expenditures” and provides examples as well as examples of ineligible expenses.
  • 4/13 – Treasury launched its web portal for payments to state, local, and tribal governments. Treasury announced that eligible government entities must provide required information by Friday, April 17 to receive payment within the 30-day window allowed under CARES and those that miss that deadline may not receive funding. Submission page here. Some highlights from the announcement below:
    • Funds are only allowed to be used for expenses which
      • Are necessary expenses during the coronavirus emergency,
      • Were not accounted in the most recent budget (as of March 27, 2020), and
      • Were incurred between 3/1/2020 – 12/30/2020.
    • Eligible local governments are those below the state level (county, municipality etc.) with a population higher than 500,000. See here for data sources and the distribution methodology.  See here for a list of eligible local government units.
    • Amounts paid to governments will be based on population and the amounts allocated to states will be reduced by the total amount provided to local governments in the state. 
Oversight
  • 5/18 – The Congressional Oversight Commission (COC) issued its first report. The Commission was created by the CARES Act to conduct oversight of the Treasury Department and the Federal Reserve’s implementation of Division A , Title IV , Subtitle A of the CARES Act, which provided $500 billion for Treasury and the Federal Reserve for loans and loan guarantees to the airline industry, businesses critical to national security, and medium-sized businesses through lending facilities. Report here. Cover letter here.
  • 5/7 – The remaining members of the House Select Committee on Coronavirus Crisis were named. Minority Whip Scalise’s priorities for the committee here. Full Committee membership below:
    • Chair Jim Clyburn (D-SC) – Chair
    • Maxine Waters (D-CA)
    • Carolyn Maloney (D-NY)
    • Nydia Velázquez (D-NY)
    • Bill Foster (D-IL)
    • Jamie Raskin (D-MD)
    • Andy Kim (D-NJ)
    • Steve Scalise (R-LA) – Ranking Member
    • Rep. Jim Jordan (R-OH)
    • Rep Blaine Luetkemeyer (R-MO)
    • Rep. Jackie Walorski (R-IN)
    • Rep. Mark Green (R-TN)
  • 4/29 – Speaker Pelosi announced the Democratic members of the House Select Committee on the Coronavirus Crisis, to be chaired by Majority Whip Jim Clyburn.
Public Health Systems, Education, and Healthcare
  • 5/21 – There is still $100 billion remaining to be disbursed to health providers. The next batch of funding will likely focus on Medicaid providers who have not received any funding to date (many of which may be pediatric and dental practices) and potentially high Medicaid DSH hospitals. Subsequent tranches may focus on safety net (serve high number of uninsured) hospitals.
  • 5/20 – HHS announced that the Health Resources and Services Administration (HRSA) has provided $225 million to Rural Health Clinics (RHCs) for COVID-19 testing. The funding came from COVID 3.5 (formally titled “Paycheck Protection Program and Health Care Enhancement Act”). Press release here.
  • 5/18 – The Department of Housing and Urban Development (HUD) announced nearly $77 million in a fourth wave of CARES Act funding, supporting up to 8,300 additional vouchers. Provided through HUD's Section 811 Mainstream Housing Choice Voucher Program, this wave of relief funds will provide affordable housing to non-elderly people living with disabilities. Press release here.
  • 5/13 – HRSA announced the winners of $15 million in telehealth grants that were authorized through the CARES Act. Press release here. Awards here.
  • 5/1 – As part of the $100 billion dedicated to hospitals and health providers in CARES, HHS is distributing funding to “hotspot” hospitals and providers. HHS will be distributing $12 billion to 395 hospitals who provided inpatient care for 100 or more COVID-19 patients through April 10, 2020. $2 billion of the funding will be distributed based on low-income/uninsured data (Medicare and Medicaid disproportionate share and uncompensated care payments).
  • 4/27 – Outline of the Provider Relief Fund with additions from COVID 3.5 here.
  • 4/27 – Education Sec. Betsy DeVos announced that more than $300 million in discretionary grant funds will be available for states to use to create adaptable, innovative learning opportunities for K-12 and postsecondary learners in response to COVID-19. The grants will be funded through the Education Stabilization Fund (ESF), authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
  • 4/26 – CMS announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program (AAP) and suspending its Advance Payment Program to Part B suppliers effective immediately. Press release here.
    • The announcement came as a surprise to Democrats, who were actively negotiating with the department officials on modifying the program.
  • 4/23 – As part of negotiations on 3.5, the Administration made commitments on how the next $60 billion in the health relief fund will be distributed. HHS has committed that it will send out an additional $60 billion dollars in the coming weeks, much of it coming within the next 10 days.
  • 4/23 – As part of negotiations on 3.5, the Administration made commitments on changes to Medicare advance payment policies. The administration committed that, by the end of this week, Secretary Mnuchin and Chief of Staff Meadows will release a letter stating that they will:
    • Use their administrative authority to reduce the interest rate down from what is currently 10.25 percent to a rate that is more in line with a traditional federal interest rate.
    • Use their administrative authority to extend the repayment period beyond 12 months.
    • Work with Congress and support legislation in Corona 4 that will place the liability for these payments in Treasury’s General Revenue fund, rather than the Medicare Hospital Insurance and Supplemental Medical Insurance Trust Funds. The expansion of these programs must not adversely affect Medicare’s solvency or result in premium increases for seniors.
  • 4/22 – CARES Act Provider Relief Fund overview here. State by state breakdown of first payment here.
  • 4/9 – Secretary DeVos indicated that she would be moving to "immediately distribute" the $6 billion in CARES for emergency financial aid grants to college students. The grants can be used by college students for technology, course materials, food, housing, and healthcare. DeVos distributed the funding to colleges, which are meant to then distribute the aid among students. See here for the specific allocations for each college.
Individual and Business Tax Relief
  • IRS guidance on deferral of payroll taxes here
  • House Ways and Means factsheet on Economic Impact Rebate portal here
  • IRS’s FAQ page on individual economic relief here
  • Treasury Guidance on Employee Retention Tax Credit here
  • Treasury FAQ on Employee Retention Tax Credit here (updated 4/29)
Economic Stabilization
  • 4/30 – Transportation Secretary Elaine Chao announced the FAA will begin awarding the AIP and other discretionary grants funding through the CARES Act. Press release here. Complete list of grants here. Map of airports receiving funding here.
  • 4/10 – Treasury Q&A on Loans to Air Carriers and Eligible Businesses and National Security Businesses here. Loan application here.
  • 3/30 – The Treasury Department released guidance on payroll support to airline industry employees, and on loans to the airline industry and businesses critical to national security. Guidance for payroll support here. Guidance on procedures and minimum requirements for loans here. Treasury press release here.
Supplemental 3.5 – Interim Emergency Coronavirus Relief, formally titled “Paycheck Protection Program and Health Care Enhancement Act” (HR 266)
The President signed the bill into law on April 24. Text here. Section by section here. Summary of hospital and testing provisions here. DPCC one pager here. Senate Democrats summary of health provisions. Overview of commitments regarding health funding and Medicare advance payments the Administration made as part of negotiations.
 
Supplemental III – Coronavirus Aid, Relief, and Economic Security (CARES) Act
After a unanimous vote by the Senate, the House passed the bill on March 27 and the President signed the bill into law shortly after. Final text here. Democratic summary here. Republican section by section here.
 
Supplemental II – Families First Coronavirus Response Act (HR 6201)
The Senate passed the House bill on March 18 and the President signed the bill into law that evening. Bill text here. Factsheet here. Bill section by section here. A summary of paid leave provisions, incorporating changes made by technical correction, is here.
 
Supplemental I – Coronavirus Supplemental
Signed by the President March 6. Text here, summary here.
 
Congress
Hearings/Floor Activity: The House is in session for votes yesterday and today. For what bills will be prioritized for floor time, House Leadership aims to pair COVID-19-related bills with non-COVID-related must-pass legislation (NDAA, appropriations etc.). Look for COVID-19-related bills to be led by Democratic front liners and be bipartisan, as Speaker Pelosi will be looking to give them wins going into November. The Senate is out until next week.
 
Appropriations: HAC is still a couple of weeks away from formulating a real markup schedule. If that’s the case, we’re not likely to see markups commence until mid-to-late June at best. It will take some time to develop and implement committee guidance and procedures for the new remote latitude afforded through the House Rules change. The plan remains to move through COVID Phase 4 before turning to FY21. We still expect a rapid-fire markup process. The hope is that all 12 subcommittees can go through subcommittee markups over the course of a week – whenever the markups begin – with most of the full committee markups in the following week. HAC-D will likely go in the middle of the pack, largely due to the fact they still need to work on the classified annex which hasn’t been addressed yet as staff cannot work in classified spaces.
 
The FY21 Senate Appropriations schedule has slipped indefinitely, and the staff are no longer saying bills will be marked up prior to July 4th recess. Chairman Shelby has publicly said that the Homeland Security and the MilCon-VA spending bills are unlikely to move forward due to political disagreements over funding for the border wall. The Defense bill is unlikely to go through the formal markup process and may post a Chairman’s recommendation and explanatory statement online as was done in FY18. Last week, Leader McConnell and Chairman Shelby announced that they had reached an agreement to exempt VA health programs from the budget caps by designating it as emergency spending. This would save $11-$12 billion on the non-defense discretionary side and increase the odds of producing bipartisan bills. Another plan would be to agree to a budget cap adjustment similar to the Overseas Contingency Operations (OCO). If appropriators cannot reach an agreement, domestic subcommittees will be significantly hurt as it will go toward non-defense discretionary spending. There is still no agreement on subcommittee allocations for the 12 spending bills.
 
NDAA: HASC and SASC are finalizing their bills. SASC is looking to markup NDAA 2021 June 8-10, with the goal to have a bill to floor before the 4th of July recess. HASC markup is unlikely to occur on June 10-12 as previously reported – HASC is continuing to work through the logistics of the markup. Markup dates now have slipped to July 1-2, which will impact passing HASC bill on the floor prior to July 4 recess.
 
Remote voting/virtual protocols: This week is the first week the House will allow proxy voting and remote hearings and markups. House Republicans sued House officials in attempt to block remote voting. The Senate has not moved forward with any proxy voting or remote procedures.
 
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (0):
Currently Self-Quarantined (0):
Recovered (7): Sen. Rand Paul (R-KY), Rep. Joe Cunningham (D-SC), Rep. Ben McAdams (D-UT), Rep. Mario Diaz-Balart (R-FL), Rep. Mike Kelly (R-PA), Rep. Nydia Velazquez (D-NY), Rep. Neal Dunn (R-FL)
Completed Quarantine (38): Sen. Ted Cruz (R-TX), Rep. Mark Meadows (R-NC), Sen. Lindsay Graham (R-SC), Rep. Don Beyer (D-VA), Rep. Sharice Davids (D-KS), Rep. Doug Collins (R-GA), Rep. Paul Gosar (R-AZ), Sen. Cory Gardner (R-CO), Sen. Rick Scott (R-FL), Rep. Matt Gaetz (R-FL), Rep. Jason Crow (D-CO), Rep. Julia Brownley (D-CA), Rep. Ben Ray Luján (D-NM), Rep. Gwen Moore (D-WI), Rep. Stephanie Murphy (D-FL), Rep. John Yarmuth (D-KY), Rep. Adam Schiff (D-CA), Rep. Vincente Gonzalez (D-TX), Rep. Drew Ferguson (R-GA), Rep. David Schweikert (R-AZ), Rep. Anthony Brindisi (D-NY), Rep. David Price (D-NC), Rep. Ann Wagner (R-MO), Rep. Kathleen Rice (D-NY), Rep. Matt Cartwright (D-PA), Rep. Tom Cole (R-OK), Rep. Steve Scalise (R-LA), Rep. Frederica Wilson (D-FL), Rep. Andy Kim (D-NJ), Rep. Kendra Horn (D-OK), Sen. Mike Lee (R-UT), Sen. Mitt Romney (R-UT), Rep. Katie Porter (D-CA), Rep. Seth Moulton (D-MA), Rep. Lizzie Fletcher (D-TX), Rep. Josh Gottheimer (D-NJ), Rep. Ayanna Pressley (D-MA), Rep. Mikie Sherrill (D-NJ), Sen. Lamar Alexander (R-TN)

Other Federal Actions
  • 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 Tuesday 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:
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 graduation ceremonies beginning on July 6th.
  • New Mexico Gov. Michelle Lujan Grisham (D) announced the state’s emergency public health order will be amended to permit limited outdoor dine-in services for most of the state beginning today. Dine-in services inside restaurants and bars remain temporarily closed.
  • Mississippi Gov. Tate Reeves (R) announced that his Safer-at-Home Order will be replaced on June 1st with a Safe Return Order.  Under the new order, all businesses can open, including movie theaters and ballparks, but they must follow the strict health guidelines in place. Indoor gatherings of no more than 50 people and outdoor gatherings of up to 100 people will be allowed in areas where social distancing is possible. Otherwise, no more than 20 people may gather indoors and no more than 50 may gather outside. The Safe Return Order will be in effect until June 15th. 
  • Useful state data:
    • The NYT is tracking which states are reopening and which are still shut down.
    • These charts show cumulative coronavirus cases and deaths for metropolitan areas over time.
    • Use Johns Hopkins University’s COVID-19 U.S. map as a resource for media, policymakers, and communities to view a collection of critical public health data in one online destination and better understand and track the COVID-19 pandemic in populations both large and small across the country.
    • NASHP has developed a COVID-19 State Action Center which serves as a state-level policy dashboard. Governing is also keeping a running tally of coronavirus news and impacts at the intersection of the health and economic crises in the states and localities.
    • This site from the Kaiser Family Foundation provides state-level information on cases/deaths, social distancing measures, health policy actions, and more.
    • This resource from Bloomberg Law is a database of State Quarantine and Public Health Laws related to the COVID-19 response.
    • This series of maps shows how states are responding to COVID-19, and this tracker, created and maintained by MultiState Associates, has an up-to-date list of executive orders and various travel restrictions.
    • Finally, this site offers COVID-19 projections assuming full social distancing and can be broken down by state.
International Affairs
  • New Zealand now has zero COVID-19 hospital patients. There are still a couple dozen active cases in the country, but those patients are not being treated in a hospital.
  • Both chambers of the French Parliament voted in favor of the "StopCovid" app today, despite the contact tracing app being criticized by opposition parties for its infringements on individual freedoms. French digital rights association La Quadrature du Net said that between 60 and 80 percent of the population would need to use the app for it to help mitigate COVID-19.
  • According to Spain's top COVID-19 health ministry official, mortality rates in Spain were 55 percent higher than usual between March 10th and May 10th of this year. Not all of those additional deaths can be linked directly to COVID-19, but many of them are likely due to people not wanting to go to hospitals or get medical assistance during the peak of the pandemic. 
  • El Salvador's president Nayib Bukele says he's taking hydroxychloroquine as a treatment to prevent COVID-19 despite the drug's efficacy being repeatedly questioned for this use. 
  • In fact, the French Health Ministry revoked its authorization for the drug to be given to those with COVID-19, saying that the scientific data available currently does not provide sufficient “evidence of a benefit” to support its use. 
  • England announced plans to launch a "test and trace" system to track COVID-19 with a goal of replacing national lockdown restrictions. The contact tracing program will ask anyone with COVID-19 symptoms to isolate immediately, get a coronavirus test, and speak with the U.K.'s National Health Service (NHS) on a voluntary basis. Those who test positive will be contacted by the NHS within 24 hours. 
  • Dubai’s Crown Prince Sheikh Hamdan Mohammed bin Rashid Al Maktoum has directed all government workers in Dubai to return to work by June 14th. 
  • Moscow's Mayor, Sergey Sobyanin, announced that the city will begin to gradually ease some lockdown restrictions starting June 1st. Sobyanin said the Russian capital would allow the reopening of stores selling non-food items, and would allow some services to resume operation, including laundries, dry cleaners, and repair shops.
  • The head of the United Nations World Tourism Organization said today that global tourism is expected to plummet by 70 percent compared to last year. The Organization expects more international flights to resume in September if COVID-19 seems to be more under control. 
  • Global Cases:  5,716,570       Total Deaths:  356,213
Lifestyle, Science, and Economy
  • U.S. stocks surged today on optimism that economic activity is gathering steam and authorities may offer more stimulus to bolster the recovery. The S&P 500 closed out above 3000 for the first time in nearly three months.
  • A recent poll of nearly 2,000 voters from May showed that, across political parties, people largely believe COVID-19 testing should be required for employees and students returning to their places of work and study. Democrats who participated in the poll were about 20 percent more likely than their republican counterparts to say they backed mandatory testing. 
  • A scientific brief has been published by WHO investigating any association between smoking and an increased risk for COVID-19. At the time of this review, the available evidence suggests that in hospitalized COVID-19 patients, smoking is associated with increased severity of disease and death.
  • After the English Premier League conducted more than 1,000 individual COVID-19 tests over the last two days, four players and staff from three clubs were found to have tested positive for the virus.
  • Winegrowers in France have announced they will be thanking some of the country's front line healthcare workers by giving away 5,000 free bottles of champagne.
  • Similar to recent data showing that women in the U.S. were more likely to have lost employment than men, a new report in the U.K. shows that mothers in the country are more likely than fathers to have quit, lost their job, or to have been furloughed since the start of the country's lockdown. 
  • Amazon’s Kindle and Echo engineer teams are pivoting to work on the company’s COVID-19 testing project.
  • Ancestry and 23andMe have started researching the genetic factors affecting COVID-19, after conducting a nationwide survey of customers to cross-reference with their DNA.
  • The WHO keeps a running list of COVID-19 vaccine candidates, which you can view here. STAT News also has a resource tracking COVID-19 drugs and vaccines
  • WHO has published a population-based age-stratified seroepidemiological investigation protocol for COVID-19 virus infection. This protocol was designed to investigate the extent of infection, as determined by positive blood tests in the general population, in any country in which COVID19 virus infection has been reported.
  • Continue to look at the NIH Office of Portfolio Analysis’s (OPA) expert-curated portfolio of COVID-19 publications and preprints. The portfolio includes peer-reviewed articles from PubMed and preprints from medRxiv, bioRxiv, ChemRxiv, and arXiv. It is updated daily with the latest available data and enables users to explore and analyze the rapidly growing set of advances in COVID-19 research.
  • Forbes is keeping a running list of all major international airline COVID-19-related change and cancellation policies.
  • RetailDive tracks store reopenings in the U.S. 
Helpful Articles/Media
Please contact me directly with any questions and I would be happy to assist.

Sincerely,
Jessica

Jessica Hyland, J.D.
Executive Director
Iowa Biotechnology Association
Cell: (515) 822-1315
Office: (515) 327-9156
Fax: (515) 327-1407
jessica@iowabio.org
www.iowabio.org
Copyright © 2020 Iowa Biotech Association, All rights reserved.


Want to change how you receive these emails?
You can update your preferences or unsubscribe from this list.

Email Marketing Powered by Mailchimp