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  • NIH expands Clinical Trials to Test Convalescent Plasma against COVID-19

    NIH expands Clinical Trials to Test Convalescent Plasma against COVID-19

    National Institutes of Health expands Clinical Trials to Test Convalescent Plasma against COVID-19 | site |


    Rigorous studies to build on earlier efforts to test the experimental treatment


    (September 22, 2020) - - Today the National Institutes of Health published the following information: Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19. Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and
    ...
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  • NIH Funds Community Engagement Research Efforts in Areas Hardest Hit by COVID-19

    NIH Funds Community Engagement Research Efforts in Areas Hardest Hit by COVID-19

    National Institutes of Health Funds Community Engagement Research Efforts in Areas Hardest Hit by COVID-19 | site |




    (September 16, 2020) - - Today, September 16, 2020, the U.S. Department of Health and Human Services (HHS) published the following information:

    The National Institutes of Health today announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center.


    The CEAL research teams will focus on COVID-19 awareness and education research, especially among African Americans,
    ...
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  • U.S. Department of Labor Awards 11.2 Million Dollars in Worker Safety and Health Training Grants

    U.S. Department of Labor Awards $11.2 Million in Worker Safety and Health Training Grants | site |



    (September 18, 2020) - - Today, September 18, 2020, the U.S. Department of Labor published the following information: WASHINGTON, DC – The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has awarded approximately $11.2 million in Susan Harwood federal safety and health training grants to 90 nonprofit organizations nationwide. The grants will provide education and training programs to help workers and employers recognize serious workplace hazards, including the coronavirus, implement injury prevention measures and understand their rights and responsibilities under the Occupational Safety and Health Act of 1970. Under President Trump’s Qualified Opportunity Zones Executive Order, OSHA awarded 80 grants to conduct occupational safety and health training in urban and economically distressed areas. The 2020 Harwood grant awards al
    ...
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  • U.S. Department of Health and Human Services Awards 15 Million Dollars to Combat the COVID-19 Pandemic in Rural Tribal Communities

    U.S. Department of Health and Human Services Awards $15 Million to Combat the COVID-19 Pandemic in Rural Tribal Communities| site |



    (May 28, 2020) - - The U.S. Department of Health and Human Services (HHS) published (today) the following information: Today, the U.S. Department of Health and Human Services (HHS) through the Health Resources and Services Administration (HRSA) awarded $15 million to 52 Tribes, Tribal organizations, urban Indian health organizations, and other health services providers to Tribes across 20 states to prepare, prevent, and respond to COVID-19 in rural tribal communities. “President Trump stands with Tribal nations across the country as they grapple with COVID-19 in rural communities,” said HHS Secretary Alex Azar. “Today’s funding gives Tribes critical support to build up their capacity for fighting COVID-19, boost testing capabilities, increase purchases of PPE, and hire and pay the personnel they need.” These awards ...
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  • U.S. Department of Health and Human Services Announces 45-Day Compliance Deadline Extension for Providers

    U.S. Department of Health and Human Services Announces 45-Day Compliance Deadline Extension for Providers| site |



    (May 22, 2020) - - The U.S. Department of Health and Human Services (HHS) published (today) the following information: Today, the U.S. Department of Health and Human Services (HHS) is announcing a 45 day deadline extension for providers who are receiving payments from the Provider Relief Fund to accept the Terms and Conditions for Provider Relief Fund payments. This announcement means providers have now been granted 90 days from the date they received a payment to accept HHS Terms and Conditions or return the funds. HHS, alongside other federal agencies, has been working day and night to support local communities and has taken action to help our healthcare system respond quickly and effectively to this pandemic. The department has kept an open line of communication with our heroic frontline providers and is being responsive to their request for ad...
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  • U.S. Health and Human Services accepts Donations of Medicine to Strategic National Stockpile as Possible Treatments for COVID-19 Patients

    U.S. Health and Human Services accepts Donations of Medicine to Strategic National Stockpile as Possible Treatments for COVID-19 Patients | site |




    FDA issues emergency use authorization for donated hydroxychloroquine sulfate, chloroquine phosphate


    (March 29, 2020) - - Today (March 29, 2020), the U.S. Department of Health and Human Services published the following information:

    The U.S. Department of Health and Human Services (HHS) today accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market. “President Trump is ta
    ...
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  • U.S. Department of Health and Human Services Announces Grants to Provide Meals for Older Adults

    U.S. Department of Health and Human Services Announces Grants to Provide Meals for Older Adults | site |




    (March 24, 2020) - - The U.S. Department of Health of Human Services (HHS) published (today) the following information:

    Today, the Department of Health and Human Services (HHS) is announcing $250 million in grants from the Administration for Community Living (ACL) to help communities provide meals for older adults. The Families First Coronavirus Response Act, signed into law by President Trump on March 18, 2020, provided the additional funding for the nutrition services programs authorized by the Older Americans Act (OAA) of 1965. These programs provide meals to more than 2.4 million older adults each year, both through home delivery and in places like community centers. The need for these services, particularly home-delivered and packaged meals, has increased as community measures to slow transmission of COVID-19 have closed meal sites ...
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  • Office for Civil Rights Issues Guidance to Help Ensure First Responders and Others Receive Protected Health Information

    Office for Civil Rights Issues Guidance to Help Ensure First Responders and Others Receive Protected Health Information about Individuals Exposed to COVID-19 | site |




    (March 24, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information: Today, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) issued guidance on how covered entities may disclose protected health information (PHI) about an individual who has been infected with or exposed to COVID-19 to law enforcement, paramedics, other first responders, and public health authorities in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The guidance explains the circumstances under which a covered entity may disclose PHI such as the name or other identifying information about individuals, without their HIPAA authorization, and provides examples including:...
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  • U.S. Department of Health and Human Services Awards 100 Million Dollars to Health Centers for COVID-19 Response

    U.S. Department of Health and Human Services Awards $100 Million to Health Centers for COVID-19 Response | site |




    (March 24, 2020) - - The U.S. Department of Health and Human Services (HHS) published (today) the following information: Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded $100 million to 1,381 health centers across the country with funding provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. HRSA-funded health centers may use the awards to address screening and testing needs, acquire medical supplies and boost telehealth capacity in response to the Coronavirus Disease 2019 (COVID-19) pandemic. On Friday, March 6, 2020, President Trump signed into law the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, which provides $8.3 billion in emergency funding for federal agencies to respond to the COVID...
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  • National Institutes of Health Shifts non-mission-critical Laboratory Operations to Minimal Maintenance Phase

    National Institutes of Health Shifts non-mission-critical Laboratory Operations to Minimal Maintenance Phase | site |




    (March 20, 2020) - - Today (March 20, 2020), the National Institutes of Health (NIH) published the following information: To further reduce the risk of transmission of COVID-19 and enhance the safety of staff, the National Institutes of Health is shifting all non-mission-critical laboratory operations to a maintenance phase. Beginning on Monday, March 23, only mission-critical functions within NIH research laboratories will be supported. Mission-critical functions include the following: care of research participants in NIH clinical protocols that are non-elective, research directly on COVID-19, urgent public health research recommended by NIH scientific leadership, work involving significant research investments that could be lost if not continued, and protection of life, property and resources, including the care of research animals. Th...
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  • Health and Human Services and Department of Defense Coordinate International Airlift of COVID-19 Supplies

    Health and Human Services and Department of Defense Coordinate International Airlift of COVID-19 Supplies | site |



    (March 20, 2020) - - Today (March 20, 2020), the U.S. Department of Health and Human Services (HHS) published the following information: On Thursday, the Department of Health and Human Services (HHS) and the Department of Defense (DOD) coordinated an emergency international airlift of 500,000 swabs and sample kits used in the COVID-19 testing process in an effort to increase diagnostic testing for Americans. Copan Diagnostics, Inc., located in Italy, recently informed U.S. government officials they were unable to ship their swabs and sample kits to distributors in the United States due to border closures and flight cancellations in Europe. Recognizing that the company is one of the major suppliers for the U.S. market for sample kits, and the risk this posed to creating a shortage of these critical supplies, the U.S. government took swift action. Sev...
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  • Coronavirus COVID-19 Update - - - FDA provides Update on Patient Access to certain REMS Drugs during COVID-19 Public Health Emergency

    Coronavirus COVID-19 Update - - - FDA provides Update on Patient Access to certain REMS Drugs during COVID-19 Public Health Emergency | site |




    (March 22, 2020) - - The U.S. Food and Drug Administration (FDA) published today (March 22, 2020) the following information:

    Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

    “The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Under these circumstances, undergoing
    ...
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  • Coronavirus COVID-19 Update - - - FDA provides Guidance on Production of Alcohol-based Hand Sanitizer to help Boost Supply, Protect Public Health

    Coronavirus COVID-19 Update - - - FDA provides Guidance on Production of Alcohol-based Hand Sanitizer to help Boost Supply, Protect Public Health | site |




    (March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

    “We are aware of significant supply disruptions for alcohol-based hand sanitizers. Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply,” said FDA Commissioner
    ...
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  • Health and Human Services Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19

    U.S. Department of Health and Human Services Funds Phase 2/3 Clinical Trial for Potential Treatment for COVID-19 | site |



    (March 21, 2020) - - Today (March 21, 2020), the U.S. Department of Health and Human Services (HHS) published the following information:

    An antibody medicine being evaluated to treat severe cases of coronavirus disease 2019 (COVID-19) will receive additional support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) under an existing partnership with Regeneron Pharmaceuticals of Tarrytown, New York.

    The Biomedical Advanced Research and Development Authority (BARDA) within ASPR will provide support for a U.S. Phase 2/3 clinical trial to evaluate Kevzara as a potential treatment for severely ill COVID-19 patients. Currently, Kevzara is approved by the U.S. Food and Drug Administration for the treatment of rheumatoid arthritis. Kevzara was developed
    ...
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  • National Institutes of Health Clinical Trial of Investigational Vaccine for COVID-19 begins

    National Institutes of Health Clinical Trial of Investigational Vaccine for COVID-19 begins| site |


    Study enrolling Seattle-based healthy adult volunteers.


    (March 16, 2020) - - Today (March 16, 2020), the National Institutes of Health (NIH) published the following information:

    A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today. The study is evaluating different doses of the experimental vaccine for
    ...
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  • Staff Reporter 1
    NIH expands Clinical Trials to Test Convalescent Plasma against COVID-19
    by Staff Reporter 1
    National Institutes of Health expands Clinical Trials to Test Convalescent Plasma against COVID-19 | site |


    Rigorous studies to build on earlier efforts to test the experimental treatment


    (September 22, 2020) - - Today the National Institutes of Health published the following information: Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19. Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and
    ...
    09-22-2020, 07:17 PM
  • Staff Reporter 1
    NIH Funds Community Engagement Research Efforts in Areas Hardest Hit by COVID-19
    by Staff Reporter 1
    National Institutes of Health Funds Community Engagement Research Efforts in Areas Hardest Hit by COVID-19 | site |




    (September 16, 2020) - - Today, September 16, 2020, the U.S. Department of Health and Human Services (HHS) published the following information:

    The National Institutes of Health today announced a $12 million award for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. The award to RTI International, a non-profit research institution, will support teams in 11 states established as part of the NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities. These teams have received initial funding to immediately create CEAL programs, and RTI will serve as the Technical and Administrative Support and Coordination (TASC) center.


    The CEAL research teams will focus on COVID-19 awareness and education research, especially among African Americans,
    ...
    09-21-2020, 11:41 PM
  • Staff Reporter 1
    U.S. Department of Labor Awards 11.2 Million Dollars in Worker Safety and Health Training Grants
    by Staff Reporter 1
    U.S. Department of Labor Awards $11.2 Million in Worker Safety and Health Training Grants | site |



    (September 18, 2020) - - Today, September 18, 2020, the U.S. Department of Labor published the following information: WASHINGTON, DC – The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has awarded approximately $11.2 million in Susan Harwood federal safety and health training grants to 90 nonprofit organizations nationwide. The grants will provide education and training programs to help workers and employers recognize serious workplace hazards, including the coronavirus, implement injury prevention measures and understand their rights and responsibilities under the Occupational Safety and Health Act of 1970. Under President Trump’s Qualified Opportunity Zones Executive Order, OSHA awarded 80 grants to conduct occupational safety and health training in urban and economically distressed areas. The 2020 Harwood grant awards al
    ...
    09-21-2020, 01:55 PM
  • Staff Reporter 1
    U.S. Department of Health and Human Services Awards 15 Million Dollars to Combat the COVID-19 Pandemic in Rural Tribal Communities
    by Staff Reporter 1
    U.S. Department of Health and Human Services Awards $15 Million to Combat the COVID-19 Pandemic in Rural Tribal Communities| site |



    (May 28, 2020) - - The U.S. Department of Health and Human Services (HHS) published (today) the following information: Today, the U.S. Department of Health and Human Services (HHS) through the Health Resources and Services Administration (HRSA) awarded $15 million to 52 Tribes, Tribal organizations, urban Indian health organizations, and other health services providers to Tribes across 20 states to prepare, prevent, and respond to COVID-19 in rural tribal communities. “President Trump stands with Tribal nations across the country as they grapple with COVID-19 in rural communities,” said HHS Secretary Alex Azar. “Today’s funding gives Tribes critical support to build up their capacity for fighting COVID-19, boost testing capabilities, increase purchases of PPE, and hire and pay the personnel they need.” These awards ...
    05-29-2020, 04:24 AM
  • Staff Reporter 1
    U.S. Department of Health and Human Services Announces 45-Day Compliance Deadline Extension for Providers
    by Staff Reporter 1
    U.S. Department of Health and Human Services Announces 45-Day Compliance Deadline Extension for Providers| site |



    (May 22, 2020) - - The U.S. Department of Health and Human Services (HHS) published (today) the following information: Today, the U.S. Department of Health and Human Services (HHS) is announcing a 45 day deadline extension for providers who are receiving payments from the Provider Relief Fund to accept the Terms and Conditions for Provider Relief Fund payments. This announcement means providers have now been granted 90 days from the date they received a payment to accept HHS Terms and Conditions or return the funds. HHS, alongside other federal agencies, has been working day and night to support local communities and has taken action to help our healthcare system respond quickly and effectively to this pandemic. The department has kept an open line of communication with our heroic frontline providers and is being responsive to their request for ad...
    05-23-2020, 07:33 AM

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