Press Releases

Beginning today, the Governor has issued a "Stay Home, Stay Safe" order. This means all businesses that are considered "non-essential" are being told to close, and residents are being told to stay at home. Recently, the Department of Homeland Security identified "essential critical infrastructure and services." If you have questions as to whether your business falls into one of these categories, be sure to read the full memo here.

Now is the time for all Americans to come together to ensure the best possible outcomes in these trying times. I've spent the last few weeks talking with hundreds of First District constituents. I see the economic pain this crisis is causing across the District and I'm working every day to ensure legislation coming out of Washington directly helps our small businesses and our workers - not politicians’ pet projects. While lives and livelihoods are at stake, this is no time to score political points - it's time to unite and do what is right by our nation's workers.

I'm grateful for the opportunity to fight for you in Washington. My staff and I remain available throughout this time if there is any way we can assist you - so please don't hesitate to reach out!

Respectfully,

Jack Bergman
---------------------------------------------------------------------------------------------------------------------------------

CDC Guidance for Implementing Home Care of People Not Requiring Hospitalization for Coronavirus Disease 2019 (COVID-19)

This interim guidance is for staff at local and state health departments, infection prevention and control professionals, and healthcare personnel who are coordinating the home care and isolation of people with confirmed or suspected COVID-19 infection, including persons under investigation (see Criteria to Guide Evaluation of Persons Under Investigation (PUI) for COVID-19). This includes patients evaluated in an outpatient setting who do not require hospitalization (i.e., patients who are medically stable and can receive care at home) or patients who are discharged home following a hospitalization with confirmed COVID-19 infection.

Read more here.
---------------------------------------------------------------------------------------------------------------------------------
Information from the FDA

COVID-19 Diagnostic Tests:  For questions about development of COVID-19 diagnostic tests, there are several important resources for you:

• 24/7 Hotline for Diagnostics:  If a developer, lab, manufacturer or health care provider has questions about testing or is experiencing spot shortages of testing, personal protective equipment, or other supplies, they should call the FDA toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies for collecting patient samples for COVID-19 testing, including swabs, media needed for transport, and  conservation of the samples – among other things. Please note, however, that FDA does not control the production volume or distribution of medical devices.

• Frequently Asked Questions about COVID-19 Diagnostic Tests:  In response to questions from labs, manufacturers, health care providers, and others, FDA has generated FAQs and posted them on our website for all who are involved in test development for COVID-19s. FDA updates these FAQs on a rolling basis, often daily as issues arise. Your constituents can access these FAQs at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2. 

• Emergency Use Authorization (EUA) for COVID-19 Diagnostic Tests:  If you need additional information for completing the EUA template, would like to know how to submit Pre-EUA/EUA submissions to FDA, or wish to consider an alternative specimen type, you may contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov. Please note that FDA is unable to provide information on the status of any individual submissions (this is generally confidential commercial information) and FDA would encourage congressional offices to reach out to specific developers for the status of any pending product submissions.

Personal Protective Equipment:  If a constituent or health care provider has questions or is experiencing spot shortages of personal protective equipment or other supplies, they should call our toll-free line at 1-888-463-6332 (1-888-INFO-FDA), then choose option (*). The line is available 24 hours a day to help address difficulties obtaining supplies. Please note, however, that FDA does not control the production volume or distribution of medical devices.

Vaccines and other biological product candidates:  Biological product sponsors, including vaccine developers, wishing to develop vaccines can email industry.biologics@fda.hhs.gov or call 1-800-835-4709 for further information.

Therapeutics and other drug product candidates:  Sponsors wishing to develop therapeutics are encouraged to submit information and questions via the Pre-IND Consultation program. See https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-therapeutics-general-information-interested-stakeholders or call 301-796-1500 for additional information on this program.

Clinical Trials:  Sponsors who have questions regarding the conduct of clinical trials impacted by COVID-19 should contact clinicaltrialconduct-COVID19@fda.hhs.gov

Drug Shortages:  If a constituent healthcare provider has questions or concerns about a drug shortage, related or unrelated to COVID-19, they should contact CDER’s Division of Drug Information (DDI) at 855-543-3784, 301-796-3400, or druginfo@fda.hhs.gov. Also, FDA's Drug Shortage web page has information related to current shortages. 

Food:  If a constituent in the food industry has a question for FDA, they may find information on common questions about food safety and COVID-19 here.  If they need to contact FDA’s Center for Food Safety and Applied Nutrition about a COVID-19 related question, they may do so by submitting a question here.

Animal Drugs and Animal Food:  If a constituent has questions or concerns related to COVID-19 and its impact on products regulated by FDA’s Center for Veterinary Medicine, they may contact AskCVM@fda.hhs.gov, and their inquiry will be routed to the appropriate subject matter expert for response. A list of known animal drug shortages is kept by FDA’s Center for Veterinary Medicine.

Inspections: If your state has questions regarding the postponement of inspections under an agreement or contract with the FDA, they should contact OPFeedback@fda.hhs.gov or reach out to their specific project manager. In the meantime, we encourage states currently under contract to please submit their invoices to ensure payment for work completed.  We will process their invoices as quickly as possible.

You may find FDA’s COVID-19 FAQ  useful in addressing questions related to vaccines, biologics, human tissue products, drugs, medical devices and tests, and food products. We also have specific COVID-19 FAQs for Emergency Use Authorizations, Diagnostic Testing, Food Safety for Industry, Healthcare Professionals, and other specific audiences. 
---------------------------------------------------------------------------------------------------------------------------------

Governor Whitmer Signs “Stay Home, Stay Safe” Executive Order 

Governor directs all non-critical businesses to temporarily close, all Michiganders to stay home or six feet away from others during COVID-19 crisis.

Governor Gretchen Whitmer signed the “Stay Home, Stay Safe” Executive Order (EO 2020-21), directing all Michigan businesses and operations to temporarily suspend in-person operations that are not necessary to sustain or protect life. The order also directs Michiganders to stay in their homes unless they’re a part of that critical infrastructure workforce, engaged in an outdoor activity, or performing tasks necessary to the health and safety of themselves or their family, like going to the hospital or grocery store.  

Effective at 12:01 am on March 24, 2020, for at least the next three weeks, individuals may only leave their home or place of residence under very limited circumstances, and they must adhere to social distancing measures recommended by the Centers for Disease Control and Prevention when they do so, including remaining at least six feet from people from outside the individual’s household to the extent feasible under the circumstances.

Read the Executive Order here.
---------------------------------------------------------------------------------------------------------------------------------
Information from the House Transportation and Infrastructure Committee

See the full list here!

Federal Motor Carrier Safety Administration (FMCSA): 

• On March 13, 2020, FMCSA issued an emergency declaration to provide hours-of-service regulatory relief for those transporting relief items (medical supplies and equipment, masks, gloves, sanitizer, soap, food, housing and quarantine facility supplies, emergency service personnel). Drivers must still receive off duty breaks. 

FMCSA requires a minimum of 10 hours off duty if transporting freight and 8 hours if transporting passengers. 

• More Information here.

Federal Transit Administration (FTA): 

• FTA is making more resources available to for mass transit authorities by increasing program eligibility and the federal share for expenses related to the COVID-19 response. Now, capital and operating activities undertaken in response to COVID-19 are eligible for reimbursement under the Urbanized Area Formula Program and Formula Grants for Rural Areas Program. FTA also is expanding program eligibility by providing new authority for large transit authorities to use Urbanized Area Formula Program funds to cover operating expenses related to COVID-19. For example, large transit authorities can now purchase personal protective equipment (facemasks, gloves, sanitizer), which are treated as an operating expense, with these funds. Now, for recipients in states in which the Governor has declared such an emergency, FTA will permit Urbanized Area Formula Program or Formula Grants for Rural Areas Program funding to be used for COVID-19-related public transportation capital or operating expenses at an 80 percent federal share, regardless of whether operating expenses generally are an eligible expense for a recipient. Normally, the federal share for operating expenses is capped at 50 percent.

More information here.
---------------------------------------------------------------------------------------------------------------------------------

74 Actions Taken by the White House to Battle Coronavirus

WHOLE-OF-GOVERNMENT RESPONSE

• President Trump declared a national emergency, inviting States, territories, and tribes to access over $42 billion in existing funding.
• Trump signed legislation securing $8.3 billion for coronavirus response.
• 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.
• Vice President Pence named Dr. Deborah Birx to serve as the White House Coronavirus Response Coordinator.
• The president has held multiple teleconferences with our nation’s governors to coordinate response efforts and offer his full support.
• The president has approved major disaster declarations for impacted states like New York, Washington, and California.

TRAVEL RESTRICTIONS

• In January, 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.

EXPANDING TESTING ACCESSIBILITY

• The FDA issued emergency approval for 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 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.
• 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.
• 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.
• DoD and HHS worked to airlift hundreds of thousands of swabs and sample test kits from Italy to the United States.

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.
• 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.
• Trump signed legislation providing funding and flexibility for emergency nutritional aid for senior citizens, women, children, and low-income families.
• 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.
• The administration is halting foreclosures and evictions for families with FHA-insured 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.
• Trump signed legislation to provide continuity in educational benefits for veterans and their families who attend schools that have had to switch from in-person to online learning due to the coronavirus.
• 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.
• 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.
• CMS is giving flexibility to Medicare Advantage and Part D plans to waive cost-sharing 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 nonprofits 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 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 VA established 19 emergency operations centers across the country and put in place visitation restrictions to limit patients’ exposure.
• CMS and the VA are working to limit nonessential, elective medical procedures to free up 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.

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 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.