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COVID-19 Update
September 22, 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.

Note: After today, the federal legislation section will resume when bipartisan negotiations on COVID legislation do.

Iowa Update

Currently, IDPH has reported on the state’s coronavirus dashboard, 81,007 Iowans have tested positive, up 597 from our update yesterday morning, with a total of 743,956 tested. Antigen test results are now included in the overall data and broken out separately from PCR test results in the data here. 19 additional deaths were reported since our last update, bringing the total to 1,284 deaths. Now 59,163 Iowans have recovered. The overall positivity rate is 10.9% and the total 14 day rolling average positivity rate is 8.8%. The latest on hospitalizations, including how many patients have been admitted in the last 24 hours can be found here.

School district statistics including positivity rates by county can be found here. According to guidance issued by the Iowa Department of Education, schools may petition to go to hybrid or online learning with less than 50 percent in-person instruction when the per county percentage positivity rates are above 15 percent in a county on average over the past 14 days (rolling average) AND 10% absenteeism among students is expected for in-person learning.

Currently 10 counties are above 15 percent positivity rate over the past 14 days:
Sioux 29.9%
Crawford 22.2%
Osceola 20.0%
Lyon 21.8%
Plymouth 18.8%
Sac 18.1%
Henry 17.5%
Ida 17.5%
Winnebago 15.9%
Woodbury 15.1%
 
Federal Legislation
Supplemental IV
Timeline/Process/Politics: As Supreme Court Justice Ruth Bader Ginsberg’s death on Friday injected a new burst of partisanship into Congress, the likelihood of reaching a bipartisan deal before Election Day has decreased substantially. Parties’ capacity for bipartisanship will likely be dedicated to passing a continuing resolution (CR) to keep the government open through December, rather than negotiating a COVID bill where both sides remain far apart. The CR will remain separate from any COVID-related package.
 
Policy: As negotiations remain stalled, there’s little consensus between Democrats and Republicans over what would be included in a package. Senate Republicans have pushed back at a high price tag, requiring offsets in the most recent Republican proposal. Democrats passed their bid for COVID 4 back in May with the Heroes Act, but their priorities have, for the most part, remained steady. See below for highlights and information on the various proposals.
 
Problem Solvers Caucus – Last week, the Problems Solvers Caucus released a proposal. Proposal here. Highlights below:
  • $290 billion in for Small Business support, including funding for PPP, Employee Retention Tax Credit, Main Street Lending program;
  • $120 billion in for Unemployment Insurance ($450 a week for eight-week transition, then up to $600/week but not to exceed 100 percent previous wages for five weeks, ends January 2021);
  • $500.3 billion for support for State/Local/Tribal/Territorial governments;
  • $100 billion for testing and healthcare, including provider support, testing, contact tracing
  • $316 billion for assistance for individuals/families, including stimulus checks, rental assistance/eviction moratorium, student loan forbearance, SNAP/WIC;
  • Liability protections for organizations that follow OSHA guidelines, with increased OSHA enforcement.
  • $145 billion for education: (childcare, K-12, higher ed);
  • $52 billion for other appropriations, including broadband, agriculture support, USPS, the Census;
  • $400 million in election support; AND
  • Based on COVID hospitalizations and vaccine development, there could be the below additions
    • $400 billion in Automatic Boosters (additional UI, stimulus checks), and
    • (-)$200 billion in Automatic Reducers (from PPP, state/local/tribal/territorial funding, rental support).
Senate R Skinny Bill – Earlier this month, Senate Republicans released and voted on another COVID proposal. While it did not pass the Senate, it can be seen as a marker for the priorities Republicans will focus on in negotiations. Text here. Summary here. The bill clocks in at $300 billion, after offsets. There were many similarities between the bill and the one Republicans released mid-August.  See below for the highlights.
  • Offsets from $204 billion from funding allocated to Federal Reserve programs in CARES, sets the 13(3) facilities to expire in January, rescinds $146 billion in unspent small business funding from CARES Act.
  • Liability protections for businesses and healthcare providers;
  • $300 per week in enhanced unemployment insurance through the end of the year;
  • Small Business policies including:
    • Allows small businesses to take out a second Paycheck Protection Program (PPP) loan if they have revenue loss of 35 percent or more (HEALS set the threshold at 50 percent or more);
    • Provides $257.7 billion for PPP, which includes $100 billion in unused funds;
    • Simplification of the loan process (Sen. Cramer’s Paycheck Protection Small Business Forgiveness Act);
    • Additional reporting required for businesses receiving loan forgiveness;
    • Funding for audits.
  • $10 billion for the U.S. Postal Service – the bill would convert a $10 billion loan to the USPS into a grant if the USPS falls below $8 billion in cash on hand.
  • Education policies including:
    • Funding for scholarship-granting organizations for expenses like private school tuition and home-schooling expenses; Also, provides tax credits for two years dedicated for scholarship granting organizations (School Choice Now Act);
    • Allow students to use 529 plan funds for relevant expenses for two years (Student Empowerment Act);
    • Childcare program included in HEALS (see here for HEALS education text)
  • Health policies and funding, including:
    • Pandemic preparedness program (supply chain, SNS) in HEALS (see here for HEALS education text)
  • Extends when states/local/tribal governments must spend CARES Act funding until September 30, 2021 (extended from December 31, 2020).
  • Increases tax incentives for charity from $300 above-the-line deduction (as implemented in the CARES Act) to $600 for individuals and $1,200 for those filing a joint return.
  • Appropriations title, including:
    • $105 billion for Education Stabilization Fund (66 percent for K-12 and 29 percent for higher education and 5 percent to governors to use for either higher education or K-12);
    • $16 billion for testing/contact tracing;
    • $31 billion for vaccine and treatment development and distribution (the mid-August skinny bill allocated $29 billion for these purposes);
    • $20 billion for farm assistance,
    • $500 million for fisheries, and
    • $15 billion for child care ($5 billion for Child Care Development Block Grant and $10 billion for the program authorized above “Back to Work Child Care Grants”).
The HEALS Act – Senate Republicans released an eight-bill package, known as the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act. Its provisions represent the first step in a multi-step process. The bill is around $1 trillion, with a third dedicated to appropriations, a majority of which is under the Labor-HHS subcommittee. Expect significant changes from this draft to the final bill, as text has yet to be negotiated with Democrats. The bill was released in sections by various senators. See below for text and summaries of the sections below.
  • American Workers, Families, and Employers Assistance Act (Senate Finance Committee provisions) – text here, section by section here
    • Extension of enhanced unemployment insurance. After July 31, would provide $200 a week until October, when benefits would then be capped (when combined with state contribution) at 70 percent of an individual’s lost wages.
      • Note: One Democratic (House) option was advanced in the HEROES Act (extension of the full $600 per-week expansion into Jan/March 2021), while another option gaining increasing momentum would be to tie UI extension to underlying economic metrics to eliminate the need for Congress to act to see future extensions and increases. 
    • Another round of direct payments to individuals. Those eligible make less than $75k, are not dependents, and those with a work eligible social security number (i.e. can work in the U.S. legally). An additional $500 will go to taxpayers with dependents (of any age).
    • Tax provisions, including:
      • Enhanced employee retention tax credit (from 50 percent of wages to 65 percent);
      • Adds COVID-19 unemployment recipients as a targeted group to the work opportunity tax credit (WOTC), which provides a tax credit to employers that hire individuals from certain groups;
      • PPE tax credit (refundable payroll tax credit equal to 50 percent of what an employer spends on “employee protection”);
      • Mandates that through 2024, employees performing work in multiple states will only be subject to income tax in their state of residence; and
    • Health provisions, including:
      • Part B premium freeze until 2022;
      • Extension of telemedicine reimbursement either through 2021 or the end of the public health emergency; and,
      • Extended timeline for providers to repay Medicare Accelerated and Advance payment loans.
    • Certain flexibilities and limitations on Coronavirus Relief Fund payments to state, local, and tribal governments (no additional funding for state/local/tribal governments):
      • Extends the timeline for spending the funds to 90 days after the last day of FY21,
      • Allows states to use the funding to make up lost revenues, and
      • Prohibits the use of funding for pensions/rainy-day funds.
  • Continuing Small Business Recovery and Paycheck Protection Program Act (Small Business provisions) – Press release here, text here, section by section here, one pager here
    • Extends the Paycheck Protection Program.
    • Allows businesses with fewer than 300 employees that had seen revenue decline by 50 percent or more in Q1/Q2 to receive a second PPP loan. Includes a set aside within the program for those with 10 or fewer employees and $10 billion set aside for community lenders.
    • Expands eligibility to 501(c)(6) organizations that either:
      • have fewer than 50 employees and limited lobbying activity, OR
      • are Chambers of Commerce or Destination Marketing Organizations with 300 or fewer employees.
    • Forgiveness to include other costs like PPE, safety supplies, and other expenses.
    • Streamlined forgiveness for loans under $150k.
    • Creation of working capital loan for businesses with fewer than 500 workers and have seen revenue decline by 50 percent or more (as an alternative to PPP second round).
  • Coronavirus Response Additional Supplemental Appropriations Act (Appropriations provisions) –text here, summary here
    • $118 for HHS, including:
      • $16 billion for testing (you might see this cited at $25 billion, but that includes unallocated funding from COVID 3.5),
      • $26 billion for vaccines development distribution (BARDA and CDC),
      • $25 billion for provider relief fund,
      • $15 billion for child chare (“Back to Work Child Care Grants” one pager here),
      • $15.5 billion for NIH,
      • $4.5 billion for SAMHSA,
      • $3.4 billion to CDC, and
      • $7.6 billion for Community Health Centers.
    • $105 billion for Department of Education
      • $70 billion for K-12, though two-thirds of it will be reserved for aiding schools in reopening and will be rewarded based on certain reopening requirements.
      • $29 billion for higher education, though institutions that paid endowment taxes in 2019 can only use the funding for student aid.
      • $5 billion for the Governors Emergency Education Relief Fund;
      • $1 billion for BIE.
    • $20 billion for Agriculture-FDA,
    • $29 billion for Defense,
    • $3 billion for Homeland,
    • $13 billion for THUD, and
    • $4.4 billion for SFOPS.
  • Restoring Critical Supply Chains and Intellectual Property Act (Supply Chain and Research provisions) – text here, section by section here
    • Requires certain products within the Strategic National Stockpile to be produced in the U.S. (U.S. MADE Act),
    • Creates a tax credit for 30 percent of the equipment costs for manufacturing personal protective equipment,
    • Creates a federal council focused on oversight of federal grants, national security, and the misappropriation of research and data,
    • Authorizes restrictions on certain non-citizens’ access to research, conferences, and academics,
    • Creates a semiconductor grant program and other onshoring incentives (CHIPS for America Act), and,
    • Includes provisions relating to securing the critical mineral and rare earth supply chains.  
  • SAFE TO WORK Act (Liability Relief) – Text here, section by section here
    • Creates liability for a broad range of organizations that mandate plaintiffs show defendants were grossly negligent/engaged in willful misconduct AND violated public health guidelines.
  • Safely Back to School and Back to Work Act (Health, Education, and Labor Provisions) – text here, section by section here
    • Includes onshoring manufacturing and stockpile-related provisions,
    • Requires HHS to issue guidance on how states and tribes are to request and access the Strategic National Stockpile,
    • Changes student loan repayment options to either be 10-year or income-based (one pager here),
    • Creates $15 billion childcare grant programs (one pager here), and
    • Creates scholarship program for emergency student expenses (one pager here).
       
  • Supporting America’s Restaurant Workers Act – text here
    • Business meals deduction increased to 100 percent from 50 percent.
       
  • TRUST Act – text here, section by section here, one pager here
    • Establishes various committees to address the long-term fiscal sustainability of various mandatory spending programs.
The Heroes Act – House Democrats passed the Heroes Act in May.  The bill as it stands totals around $3 trillion. See text here. Section by section here. One pager here. State and Local one pager here. NCAI’s summary on tribal provisions here. Highlights of the bill below.
  • Support for State, local, Tribal governments
    • $500 billion for State governments,
    • $375 billion for local governments,
    • $20 billion for Tribal governments,
    • $20 billion for Territories, and
    • $755 million for the District of Columbia.
  • Health providers and insurance coverage
    • $100 billion for hospitals/health care providers.
    • Special two-month open enrollment period, elimination of cost sharing for COVID-19 treatments, and full COBRA subsidies for those who lost employer-provided health care coverage.
    • Increases in FMAP and DSH payments, extends Medicare Accelerated payments and lowers the interest rate.
  • Public Health strategy and capacity-building
    • $75 billion for testing, contact tracing, monitoring capabilities (CONTACT Initiative);
    • Establishes supply chain czar to coordinate health care officials, supply chain officials, and states; and,
    • Requires expansion of manufacturing capacity of vaccines and potential vaccines.
  • Support for Small Businesses
    • Expands PPP eligibility to all 501(c) organizations, extends date to rehire to 12/31/2020,
    • Appropriates $10 billion for the Economic Injury Disaster Loan (EIDL) program.
    • Expands eligibility of Main Street Lending Program to nonprofits.
  • Support for Individuals
    • Second round of stimulus payments of $1,200 per taxpayer plus $1,200 per dependent (limited to 3).
    • $175 billion for renter/homeowner assistance for renters and homeowners to make rent, mortgage, and utility payments.
    • Suspends negative consumer credit reporting, bans consumer debt collection.
  • Paid Leave and Worker Protections
    • Eliminates certain paid leave employer exemptions (500+ employee exemption, health care provider and emergency responders, small business self-exemption), expands uses of and ability to use paid sick days and paid leave.
    • Requires OSHA to issue an emergency temporary standard (ETS) for worker safety/those at risk of exposure to COVID-19. Standard would be enforceable by OSHA.
    • $190 billion for a Heroes Fund for essential workers to be administered by Treasury. Eligible employers will be given grants from this fund to provide hazard pay to their essential workers ($13 per hour on top of regular pay, $10,000 per worker).
  • Education
    • $100 billion for ED ($90 billion for State Fiscal Stabilization Fund [K-12], $10 billion for universities/students).
    • Continues suspension of student loan payments and accrual of interest to 9/30/2021 and extends to include FFEL and Perkins loans.
    • Clarifies that emergency financial aid grants (broad definition) will not be considered as income/assets for calculation of student’s eligibility for federal financial aid.
    • Prohibits the Secretary from placing limits on what types of students may receive funds under the CARES Act’s Higher Education Emergency Relief Fund.
  • Other key provisions
    • $5 billion for broadband (E-Rate), creation of broadband subsidy for households with a member laid off/furloughed and bans providers from discontinuing service/adding late fees due to customer’s inability to pay related to COVID-19.
    • $3.6 billion for grants to states for election preparedness and security.
    • $25 billion for the U.S. Postal Service.
Details of the tax and Unemployment Insurance (UI) provisions below.
  • Narrowing of CARES Act tax provisions: The draft contains two provisions narrowing tax benefits from CARES, which would likely raise significant revenue relative to current law:
    • Net Operating Losses / NOLs (Sec. 20302): CARES allowed NOLs arising in tax years 2018, 2019, and 2020 to be carried back up to five years. The proposed provision would narrow that benefit, allowing NOLs arising in 2019 or 2020 to be carried back only to 2018 and 2019. This would prevent using a post-TCJA NOL against the pre-TCJA 35% rate, which CARES allows.
    • Limitation on non-corporate losses (Sec. 20301): reinstates the $500,000 ($250,000 for unmarried filers) active loss limitation for shareholders and owners of pass-through businesses from TCJA that CARES suspended for 2018, 2019, and 2020.
  • Elimination of the SALT Deduction Cap for 2020 and 2021 (Sec. 20161);
  • Employer retention and expenses payroll tax benefits:
    • Employee retention tax credit (Sec. 20211): The proposal enhances the CARES employee retention credit to 80% of wages (from 50%) and increases the cap from $10,000 overall to $45,000 and $15,000 quarterly. Large employer threshold generally increased from 100 employees to 1,500 employees.
    • Fixed expenses refundable payroll tax credit (Sec. 20212) for up to 50% of rent, mortgage, and utility payments, maximum of the lesser of (1) $50,000, (2) fixed expenses same quarter in 2019, (3) 25% of payroll, (4) 6.25% of gross receipts;
    • Employee benefit expense refundable payroll tax credit (Sec. 20204) for benefit payments by employers, up to $5,000 per employee, 50% credit (for COVID benefits) or 30% credit (for non-COVID benefits); and
    • Business interruption credit for self-employed businesses (Sec. 20213).
  • Modifications and enhancements to other CARES and FFCRA tax provisions:
    • Payroll tax deferral for two years from CARES would be allowed to businesses that have received loan forgiveness under SBA PPP, reversing a limitation from CARES (Sec. 20231);
    • Expenses related to SBA PPP loans would be deductible, reversing an IRS ruling (Notice 2020-32) to the contrary (Sec. 20235);
    • Phase II FFCRA Leave Mandate Credits extended through 2021 (Sec. 20221);
    • Certain CARES loan forgiveness, including EIDL and emergency financial aid, not included in income (Secs. 20232 and 20233).
  • Individual Stimulus / Cash Grant Tax Rebates Modifications
    • CARES stimulus payments enhanced in several ways, including expanding dependent definition to include those over 17 and full-time students 24 or younger (Sec. 20101); SSN requirement eliminated (Sec. 20102); past-due support payments no longer disqualifying (Sec. 20103);
    • Second round of stimulus payments of $1,200 ($2,400 joint) per taxpayer plus $1,200 per dependent (limited to 3, up from $500 per child in CARES); same income limitations as CARES; and
    • Prohibits the use of POTUS’ signature on future distributions (Sec. 20111(e), p186).
  • Additional tax relief for individuals and families largely following H.R. 3300, which W&M marked up in June of last year.  Includes:
    • Earned Income Tax Credit (EITC) expansions for 2020 for childless workers, tracking prior legislation by Chairman Neal (Sec. 20121); SSN requirement eliminated (Sec. 20122); rules on separated spouses (Sec. 20123); Elimination of investment income test (Sec. 20124);
    • Taxpayers may elect to substitute 2019 earned income for 2020 for EITC (Sec. 20126);
    • Child Tax Credit (CTC) expansions for 2020, eliminating refundability cap of credit (Sec. 20131);
    • EITC and CTC for Possessions and Puerto Rico (Secs. 20125 and 20132);
    • Child and Dependent Care Assistance Credit refundable for 2020 (sec. 20141);
    • Dependent care assistance expansions (Sec. 20142);
    • Increase in carryovers for Health FSAs and Dependent Care FSAs (Secs. 20151 and 20152);
  • Other tax provisions
    • Above-the-line deduction for educator expenses up to $500 from $250 (Sec. 20201);
    • Above-the-line deduction for first responders and supplies (Secs. 20202 and 20203);
  • Unemployment Insurance (UI) Expansions from CARES extended to 3/31/2021 (Division E, Sec. 50001).
Details of the PPP provisions outlined below:
  • Amendments to Paycheck Protection Program (Sec. 90001)
    • Extends the covered period of the PPP until 12/31/2020, expands eligibility to tribal businesses, critical access hospitals, and all 501(c) category organizations.
    • Adds news organizations to the restaurant/hospitality NAICS code employee count exemption from CARES Act.
    • Increases minimum loan maturity to 5 years.
    • 25% set aside for organizations with 10 or fewer employees.
    • 25% set aside for nonprofits, caps PPP funds at 12.5% for nonprofits with over 500 employees.
    • $10 billion set aside for community financial institutions.
    • Bars eligibility of organizations owned 20% or greater by an individual who has been convicted of financial fraud in the last 5 years.
    • $1 billion for technical assistance grants to community financial institutions.
  • Amendments to Paycheck Protection Program Loan Forgiveness (Sec. 90004)
    • Extends maximum covered period for loan forgiveness period to 24 weeks or 12/31/2020, whichever is first.
    • Clarifies that PPP funds can be used for interest on any debt obligation incurred before 2/15/2020.
    • Adds exemption to rehiring requirement for forgiveness if a business can show that it was unable to rehire employees and can demonstrate an inability to find similarly qualified employees before 12/31/2020.
  • Clarifies that PPP payments and loan forgiveness will not be considered taxable income (Sec. 90006).
  • Clarifies that expenses covered by PPP loan forgiveness would be deductible, reversing an IRS ruling (Notice 2020-32) (Sec. 20235).
  • Allows businesses that have received PPP loan forgiveness to access CARES Act payroll tax deferral, reversing a limitation from CARES (Sec. 20231).
Passed Legislation

 New Implementation Information and Guidance
  • 9/21 – HHS released updated guidance on the information recipients of the Provider Relief Fund will need to report to HHS beginning on October 1, 2020. The requirements narrowed providers ability to use the funds for certain expenses and lost revenues. Additionally, the double-dipping prohibition appears to have been extended to cover payments from insurance and amounts received from federal, state, local, or tribal governments. Guidance here.
Members of Congress in Quarantine or Treatment (new additions in bold)
Tested Positive (1)Rep. Jahana Hayes (D-CT)
Currently Self-Quarantined (2): Sen. Ron Johnson (R-WI), Sen. Shelley Moore Capito (R-WV) 
Recovered (15): 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), Rep. Tom Rice (R-SC), Rep. Morgan Griffith (R-VA), Rep. Louie Gohmert (R-TX), Rep. Raúl Grijalva (D-AZ), Rep. Rodney Davis (R-IL), Sen. Bill Cassidy (R-LA), Rep. Jenniffer Gonzalez-Colon (R-Puerto Rico at large), Rep. Dan Meuser (R-PA)
Completed Quarantine (45): 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), Rep. Randy Weber (R-TX), Rep. Kay Granger (R-TX), Rep. Mike Johnson (R-LA), Rep. Jody Hice (R-GA), Rep. Guy Reschenthaler (R-PA)
 
*Mark Meadows quarantined March 9 - 12 after coming in contact with a CPAC attendee who tested positive. On March 20, he resigned from his position in the House to become the White House Chief of Staff.

Other Federal Actions
  • On Friday, the CDC posted guidance warning that the coronavirus spreads most commonly through the air and is more contagious than had previously been suggested. The Agency specifically cautioned that choir practice, restaurants, and fitness classes or any indoor environments without good ventilation increase a person's risk of catching the virus. However, the caution was retracted over the weekend, and the page now reads that the guidance was "posted in error."
  • To help inform the COVID-19 response and help stay up to date on the latest COVID-19 research, CDC has created a series called COVID-19 Science Update. The series provides brief summaries of new COVID-19-related studies on many topics, including epidemiology, clinical treatment and management, laboratory science, and modeling. These summaries are released Tuesdays and Fridays and include an overview of key findings, methods, and implications. Read Friday's here
  • The FDA has added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The updated guidance includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol.
  • A new video entitled, Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments, explains to consumers that there are currently no FDA-approved drugs or vaccines to treat or prevent COVID-19. Products that fraudulently claim to cure, treat, diagnose, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness for such use, and they might be dangerous to you and your family.
  • The FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. The FDA will also hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on:
    • September 23, 12:15 PM
    • September 30, 12:15 PM
  • Over the weekend, HHS released updated guidance on the information recipients of the Provider Relief Fund will need to report to HHS beginning on October 1, 2020. Providers that received more than $10,000 in grants will have to report on how they spent funds on coronavirus-related expenses and lost revenue. The $10,000 reporting threshold is a significant change from the statutory requirement in the CARES Act, which required detailed reporting disclosures from any entity that had received more than $150,000 in total funds from any COVID-19 relief legislation.
  • As of yesterday, 249 tests are authorized by FDA under EUAs; these include 199 molecular tests, 46 antibody tests, and 4 antigen tests.
  • The GAO released a report today titled, "COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions." The report updates GAO's oversight of federal actions to support public health, individuals, and the economy during the COVID-19 pandemic. The report found that PPE shortages were a result of the U.S. relying heavily on in-demand foreign goods, HHS could probably collect more complete data, and the Treasury and IRS still don't know how many people haven't received their stimulus payments who are eligible to receive them. The report also includes a list of 16 recommendations. 
  • The Senate Committee on Health, Education, Labor, and Pensions (HELP) will meet on Wednesday at 10 AM to hear testimony from four of the country's top health officials about the Federal Response to COVID-19. A memo of this hearing will be available upon request. 
  • Rep. Jahana Hayes (D-CT) said that she tested positive for COVID-19 after visiting three facilities in an attempt to get a diagnosis.
Updates from the States
  • Out of the cases under investigation detected by U.S. surveillance, there are 6,786,352 total cases and 199,024 deaths The CDC data closes out the day before reporting, but some sources are reporting that the U.S. has surpassed 200,000 deaths. 
  • More than 4,500 students, teachers and staff at Texas schools have tested positive for the coronavirus since the school year began, according to the Dallas Morning News.
  • A third of states are still seeing rates of new cases that are at least 75 percent of their peak levels.
  • Virginia health officials on Friday reported the state’s first coronavirus-related death of a child since the start of the pandemic.
  • Maryland Gov. Larry Hogan (R) eased restrictions on indoor dining to coincide with a new statewide restaurant week promotion that his administration created. As of today, restaurants can serve patrons at 75 percent capacity — up from 50 percent — in jurisdictions where local leaders agree it is safe for larger crowds indoors.
  • Colorado Gov. Jared Polis (D) amended and extended the Safer at Home EO, which includes the last call order. The last call order will now take effect based on what level a county is in according to the COVID-19 dial.
  • Illinois Gov. JB Pritzker (D) announced that Region 7, which includes the greater Will and Kankakee County areas, returned to Phase 4 of the Restore Illinois Plan.
  • Oregon Gov. Kate Brown (D) announced that Umatilla and Morrow Counties have succeeded in reducing the spread of COVID-19 sufficiently enough to be removed from the County Watch List. She also announced that Morrow County's application to move to Phase 2 of reopening has been approved, effective immediately.
  • Hawaii’s Department of Health released benchmarks, including COVID-19 case counts, that will help determine when schools should open or close.
  • Louisiana Gov. John Bel Edwards (D) announced the state will move to quickly implement new guidance from the federal government easing restrictions on visits to nursing homes.
  • New Mexico’s Energy, Minerals and Natural Resources Department’s State Parks Division announces the reopening of overnight camping in most State Parks beginning October 1.
  • California’s Division of Occupational Safety and Health will move forward with emergency statewide standards to address what worker advocates have been calling “an occupational health emergency.” A seven-member board voted unanimously to begin creating standards that would require employers to take stricter precautions against COVID-19.
  • Guam Gov. Lou Leon Guerrero signed an EO regarding the utilization of quarantine and isolation to combat the spread of COVID-19.
  • The Illinois Department of Public Health reported that 24 counties in Illinois are considered to be at a warning level for COVID-19. A county enters a warning level when two or more COVID-19 risk indicators that measure the amount of COVID-19 increase.
  • On the first day of school in N.Y.C. yesterday, most students started virtually, but up to 90,000 began learning in person.
  • Useful state data:
    • Johns Hopkins University’s COVID-19 U.S. map is 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 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.
International Affairs
  • Here are the most recent editions of the WHO's Weekly Epidemiological Update and Operational Update.
  • Around the world, at least 73 countries are seeing surges in newly detected cases.
  • The WHO and partners said countries comprising more than 60 percent of the world’s population have signed up to its international initiative to buy coronavirus vaccines, but said they still need billions of dollars to pay for the shots.
  • New Zealand Prime Minister Jacinda Ardern announced plans to lift coronavirus-related restrictions for most of the country, saying the nation’s mystery outbreak that began in August appears to be largely under control.
  • Britain’s chief medical officers have raised the nation’s official COVID-19 alert level, meaning the virus is in general circulation and transmission rates are high.
  • Communities located on the U.S.-Canada border, which have reported no cases of COVID-19, are pushing for end to restrictions on cross-border travel for their community.
  • Hundreds of protesters gathered over the weekend in Madrid to demonstrate against the new lockdown measures. Isabel Díaz Ayuso, the president of the Madrid region, announced on Friday that 850,000 people would be placed in partial lockdown beginning today in order to stop an emerging second wave of COVID-19.
  • President of Turkey Recep Tayyip Erdogan said the U.N. failed in its response to the coronavirus pandemic.
  • Iraq will bar entry to religious pilgrims due to COVID-19 according to its government health committee. The announcement comes just weeks ahead of a Shi'ite Muslim pilgrimage which is the largest annual religious gathering in the world.
  • Top government scientists in the U.K. warned that Britain could face 50,000 coronavirus cases a day by mid-October based on to its current trajectory.
  • Infections in France reached a new record-high this weekend with over 13,000 new cases in 24 hours. As a result of outbreaks, Italy added Paris and other parts of France to its COVID-19 blacklist.
  • Northern Ireland will apply restrictions imposed in some areas 10 days ago to the whole region in order to slow the spread of COVID-19 and is open to considering collective action across the U.K, First Minister Arlene Foster said yesterday.
  • The Taj Mahal, one of India’s most famous landmarks, reopened yesterday after being closed for more than six months as part of efforts to curb the spread of the virus. India has the second-highest coronavirus caseload behind the U.S.
  • Global Cases: 31,352,177     Total Deaths: 965,529
Lifestyle, Science, and Economy
  • The National Medical Association (NMA), which was founded in 1895 when Black doctors were being excluded from other professional medical societies, is forming a task force to screen federal decisions about coronavirus vaccines and treatments. Although experiencing disproportionately high rates of COVID-19 cases and deaths, minorities are historically underrepresented in clinical trials. The purpose of the NMA panel is to more closely evaluate vaccine trial results, particularly the effects on non-white trial participants, before fully promoting a vaccine as safe.  
  • After facing increased pressure to be transparent with their vaccine trials, AstraZeneca published its vaccine trial blueprint. Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, compared the three major trials happening now.
  • Scientists estimate that 60 to 70 percent of the population might need to gain immunity, whether by vaccine or previous infection, to COVID-19 before herd immunity is reached.
  • Despite the CDC recent 180 on airborne transmission of coronavirus, most scientists agree that the virus spreads through aerosols, or micro-particles in respiratory droplets that linger in the air, and say that air filtration systems, like those with HEPA filters, can help reduce the concentration of aerosols in a space as long as the systems are properly sized and the filters are regularly replaced.
  • The coronavirus pandemic has triggered or exacerbated economic crises around the world, adding pressure on families to send their children to work, as many schools remain closed. A report by the International Labour Organization found the pandemic’s economic and social impact “will hit children particularly hard.”
  • Apple CEO Tim Cook said that 85 to 90 percent of Apple workers have been doing their jobs from home since March and that the company likely will not return to in-person operations until “sometime next year.”
  • Since mid-March, tofu shortages have been reported from Seattle to Washington, with manufacturers struggling to keep up with demand even as grocery stores rationed sales to customers. Nielsen data shows tofu sales were 40 percent higher in the first half of 2020 compared with last year, likely due to COVID-19 lockdowns. Pulmuone Brands — owner of Nasoya, the nation’s No. 1 tofu brand — had to ship an additional 1 million packs from South Korea, the world’s biggest consumer of tofu, to the U.S. this summer while its American plants caught up with demand.
  • 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. The New York Times has a very helpful vaccine tracker as well, which you can view here
  • BIO’s COVID-19 pipeline tracker for vaccines, treatments and antivirals can be found here.
  • The Johns Hopkins Center for Health Security has an extensive list of commercial and lab-developed tests. 
  • The NIH Office of Portfolio Analysis’s (OPA) expert-curated portfolio of COVID-19 publications and preprints 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.
Helpful Articles/Media
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.


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