Four Major Health Care Organizations release Updated Guidance on Maintaining Essential Surgery during the Ongoing Pandemic

American Hospital Association says, As COVID-19 Cases surge again, four Major Health Care Organizations release Updated Guidance on Maintaining Essential Surgery during the Ongoing Pandemic | site |



(Information contained in American Hospital Association press release: November 24, 2020)


As COVID-19 cases surge again, four major health care organizations release updated guidance on maintaining essential surgery during the ongoing pandemic


Joint roadmap addresses the dual need to meet health care demands for patients hospitalized with COVID-19, along with patients who need essential surgical services; calls for centralized coordinated governmental action to deploy necessary supplies


CHICAGO (November 24, 2020): Hospitals in many regions across the United States are now reporting near or at bed and ICU capacity due to the resurgence of the Coronavirus Disease 2019 (COVID-19), which is presenting new...

U.S. Securities and Exchange Commission Issues Statement on European Central Counterparties Seeking to Register or Request Exemptions From the SEC | site |


(Information contained in U.S. Securities and Exchange Commission [SEC] press release: November 23, 2020) Washington D.C., Nov. 23, 2020 - - The Securities and Exchange Commission today issued a Policy Statement and Guidance focused on central counterparties (CCPs) authorized under the European Markets Infrastructure Regulation (EMIR) that may seek to access and operate in the U.S. securities markets. The Statement provides transparency into the Commission’s processes and highlights efficient ways that CCPs based in the European Union (EU) can register as a clearing agency or request exemptions from certain requirements under the Securities Exchange Act of 1934. The SEC has a longstanding and collaborative relationship with its European counterparts with respect to supervision and enforcement of regulate...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 24, 2020 | site |




(Information contained in U.S. Food and Drug Administration [FDA] press release: November 24, 2020)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA today published Face Masks, Including Surgical Masks, and Respirators for COVID-19, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators. The topics covered in this new page include:
  • The basics on face masks, surgical masks, and respirators
  • Using face masks, surgical masks, and respirators
  • Shortages of face masks, surgical masks, and respirators during COVID-19
  • The Emergency Use Authorizations for face masks, surgical masks, and respirators
  • Manufacturing and importing face masks, surgical masks, and respirators during

...

U.S. Reinforces Commitment to Secure, Stable, Democratic, and Self-Reliant Afghanistan at 2020 Conference | site |



(Information contained in U.S. Department of State Office of the Spokesperson press release fact sheet: November 24, 2020)


The United States participated in the 2020 Afghanistan Conference on November 23-24, the sixth quadrennial gathering to coordinate international development support for Afghanistan. The conference was hosted virtually by the Government of the Islamic Republic of Afghanistan, the Government of Finland, and the United Nations Assistance Mission in Afghanistan. At the conference, the United States emphasized its commitment to a secure, stable, democratic, and self-reliant Afghanistan that is at peace with itself and its neighbors, and underscored the following:

• The United States has announced the availability of up to approximately $600 million in civilian assistance for Afghanistan for calendar year

...

U.S. Internal Revenue Service says Get Ready for Taxes: Steps to take Now to make Tax Filing easier in 2021 | site |


(Information contained in U.S. Internal Revenue Service [IRS] press release: November 24, 2020)

Washington – The Internal Revenue Service today encouraged taxpayers to take necessary actions this fall to help file federal tax returns timely and accurately in 2021.

This is the second in a series of reminders to help taxpayers get ready for the upcoming tax filing season. A special page, updated and available on IRS.gov, outlines steps taxpayers can take now to make tax filing easier in 2021. 2020 has been a busy year, with a lot of changes. To make sure taxpayers don't miss out on tax benefits or make mistakes, they can take a few simple steps now to make filing their taxes easier in 2021. An important first step to getting taxes ready is to gather all tax records. Having records organized makes preparing a tax return easier. It...

U.S. Department of Housing and Urban Development launches Recovery Housing Program to aid Americans recovering from Substance Abuse | site |


The pilot program would provide housing and stability to those who are currently in recovery from substance abuse disorder


(Information contained in U.S. Department of Housing and Urban Development press release: November 24, 2020)

Washington - U.S. Department of Housing and Urban Development (HUD) Secretary Ben Carson announced the publication of the Notice for HUD’s pilot Recovery Housing Program (RHP). The program was authorized by the SUPPORT Act to provide stable, temporary housing to individuals in recovery from a substance use disorder. RHP is funding 25 grantees, 24 states and the District of Columbia, whose age-adjusted rate of drug overdose deaths was above the national overdose mortality rate. “As a Nation, we need to remove the stigma associated with substance-use disorder, m...

Statement from U.S. Department of Health and Human Services Chief of Staff Brian Harrison on Efforts to Increase Transparency at HHS | site |


(Information contained in U.S. Department of Health and Human Services press release: November 24, 2020)

Today, the Department of Health and Human Services (HHS) through a Notice published in the Federal Register announced a policy to enhance transparency at HHS by requiring that all assumptions, working papers, models, and other information used as part of any impact analysis associated with a rule or demonstration project are shared at the time the results of that analysis are publicly disclosed. HHS Chief of Staff Brian Harrison issued the following statement:

“We are providing needed transparency by requiring the Department to show its math so the American people can know and challenge the methods government uses to calculate effects of regulations it imposes on them.”

Frequently...

Statement from U.S. Department of Health and Human Services Chief of Staff Brian Harrison on Efforts to Increase Transparency at HHS | site |


(Information contained in U.S. Department of Health and Human Services press release: November 24, 2020)

Today, the Department of Health and Human Services (HHS) through a Notice published in the Federal Register announced a policy to enhance transparency at HHS by requiring that all assumptions, working papers, models, and other information used as part of any impact analysis associated with a rule or demonstration project are shared at the time the results of that analysis are publicly disclosed. HHS Chief of Staff Brian Harrison issued the following statement:

“We are providing needed transparency by requiring the Department to show its math so the American people can know and challenge the methods government uses to calculate effects of regulations it imposes on them.”

Frequently...

National Institutes of Health says Commonly used Antibiotic shows Promise for Combating Zika Infections | site |


NIH preclinical study suggests FDA-approved tetracycline-based antibiotics may slow infection and reduce neurological problems.


(Information contained in National Institutes of Health [NIH] press release: November 24, 2020)

In 2015, hundreds of children were born with brain deformities resulting from a global outbreak of Zika virus infections. Recently, National Institutes of Health researchers used a variety of advanced drug screening techniques to test out more than 10,000 compounds in search of a cure. To their surprise, they found that the widely used antibiotic methacycline was effective at preventing brain infections and reducing neurological problems associated with the virus in mice. In addition, they found that drugs originally designed to combat Alzheimer’s disease and inflammation may also help fight infections. �...

National Institutes of Health says Commonly used Antibiotic shows Promise for Combating Zika Infections | site |


NIH preclinical study suggests FDA-approved tetracycline-based antibiotics may slow infection and reduce neurological problems.


(Information contained in National Institutes of Health [NIH] press release: November 24, 2020)

In 2015, hundreds of children were born with brain deformities resulting from a global outbreak of Zika virus infections. Recently, National Institutes of Health researchers used a variety of advanced drug screening techniques to test out more than 10,000 compounds in search of a cure. To their surprise, they found that the widely used antibiotic methacycline was effective at preventing brain infections and reducing neurological problems associated with the virus in mice. In addition, they found that drugs originally designed to combat Alzheimer’s disease and inflammation may also help fight infections. �...

The Treasury Department and IRS issue Final Regulations regarding Like-kind Exchanges of Real Property | site |


(Information contained in U.S. Internal Revenue Service [IRS] press release: November 23, 2020)

WASHINGTON – Today the Treasury Department and Internal Revenue Service issued final regulations relating to section 1031 like-kind exchanges. These final regulations address the definition of real property under section 1031 and also provide a rule addressing the receipt of personal property that is incidental to real property received in a like-kind exchange. The 2017 Tax Cuts and Jobs Act (TCJA) limited like-kind exchange treatment to exchanges of real property. As of January 1, 2018, exchanges of personal or intangible property such as vehicles, artwork, collectibles, patents, and other intellectual property generally do not qualify for nonrecognition of gain as like-kind exchanges. Also, like-kind exchange treatment applies only to exchange...

U.S. Veterans Affairs Program helping more Veterans connect with Bank, Credit Union Account choices | site |




(Information contained in U.S. Department of Veterans Affairs press release: November 20, 2020)

Washington - - The U.S. Department of Veterans Affairs (VA) announced today at least 25,000 more Veterans are now receiving monetary benefits through federally-insured banks and credit unions — mitigating their risk of fraud occurrence.

Prior to the inception of the Veterans Benefits Banking Program (VBBP), established in December 2019, Veterans who did not have bank accounts were only able to receive monetary benefits through pre-paid debit cards or paper checks. “At any given time, there are approximately 250,000 Veterans who do not have bank accounts, and as a result of the Veterans Benefits Administration working diligently to contact Veterans directly by mail and telephone calls to explain the benefits of switchin...

U.S. Food and Drug Administration Approves First Drug to Treat Rare Metabolic Disorder | site |


Approval is for primary hyperoxaluria type 1, which causes recurrent kidney stones and loss of kidney function


(Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020) Today, the U.S. Food and Drug Administration approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. This approval is a cumulation of the work of experts and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative. “The approval of Oxlumo represents a great triumph of community involvement to address a rare disease. It is a result of input from patients, treating physicians, experts and sponsors at a patient-focused drug development meeting and through other collaborative efforts,” said Norman Stockbridge, M.D., Ph.D., director of the ...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: November 23, 2020 | site |


(Information contained in U.S. Food and Drug Administration [FDA] press release: November 23, 2020)

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

• On Nov. 20, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to safe and effective medical products to help address critical needs of the American

...

Federal Railroad Administration Publishes Railroads’ Third Quarter 2020 Positive Train Control Implementation Status Updates | site |


PTC systems governing operations on 99.6% of all 57,537 PTC-mandated route miles


(Information contained in Federal Railroad Administration [FRA] press release: November 18, 2020) WASHINGTON - The U.S. Department of Transportation’s Federal Railroad Administration (FRA) today released a quarterly status update on railroads’ self-reported progress, as of September 30, 2020, toward fully implementing positive train control (PTC) systems by December 31, 2020, as required by Congress. All railroads subject to the statutory mandate are currently operating PTC systems in revenue service or in advanced field testing, known as revenue service demonstration (RSD). As of September 30, PTC technology remains to be activated on approximately 223 required route miles, based on railroads’ Third Quarter 2020 PTC Progres...

Johns Hopkins Medicine Joins Top US Hospitals To Encourage Everyone to #Maskup | site |


Growing numbers of COVID-19 cases and deaths are troubling; face masks can slow the trend


(Information contained in a Johns Hopkins Medicine news release: November 19, 2020)

Johns Hopkins Medicine, together with 100 of the nation’s top health care systems, representing thousands of hospitals in communities across the U.S., have come together with an urgent plea for all Americans — mask up, because wearing a face mask is one of the best ways to slow the surging COVID-19 pandemic. With cases of COVID-19 rising across the nation, it’s more vital than ever for us to join this public health campaign to spread the word about the importance of mask-wearing, among other public health measures such as physical distancing and proper hand-washing. More than 11.5 million Americans have tested positive for the virus, leading to nearly 250,000 deaths. The nex...

U.S. Department of State issues Statement addressing Treaty on Open Skies | site |


(Information contained in U.S. Department of State press release: November 22, 2020)


Statement attributed to Cale Brown, Deputy Spokesperson, U.S. Department of State:

On May 22, 2020, the United States exercised its right pursuant to paragraph 2 of Article XV of the Treaty on Open Skies by providing notice to the Treaty Depositaries and to all States Parties of its decision to withdraw from the Treaty, effective six months from the notification date. Six months having elapsed, the U.S. withdrawal took effect on November 22, 2020, and the United States is no longer a State Party to the Treaty on Open Skies....

National Institute of Standards and Technology Sensor Experts Invent Supercool Mini-Thermometer | site |



(Information contained in National Institute of Standards and Technology [NIST] press release: November 17, 2020)

Researchers at the National Institute of Standards and Technology (NIST) have invented a miniature thermometer with big potential applications, such as monitoring the temperature of processor chips in superconductor-based quantum computers, which must stay cold to work properly.

NIST’s superconducting thermometer measures temperatures below 1 kelvin (minus 272.15 C or minus 457.87 F), down to 50 ...

Organisation for Economic Co-operation and Development Working Group on Bribery Issues Report Commending United States for Maintaining Leading Role in the Fight Against Transnational Corruption | site |


(Information contained in U.S. Department of Commerce press release: November 18, 2020) The Working Group on Bribery of the Organisation for Economic Co-operation and Development (OECD Working Group) issued its Phase 4 Report of the United States, announced the U.S. Departments of Justice, Commerce, State, and the Securities and Exchange Commission (SEC). The Phase 4 Report is part of the OECD Working Group’s peer monitoring process and focuses primarily on the United States’ enforcement of its foreign bribery statute, the Foreign Corrupt Practices Act (FCPA), and was issued following a year-long review that included a series of interviews with government, private sector, academic, and civil society experts. In releasing the report, the 44-country OECD Wor...

HHS and DOD Award $11.6 Million Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests | site |


(Information contained in U.S. Department of Health and Human Services press release: November 23, 2020) The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) have jointly awarded an $11.6 million contract to Puritan Medical Products Company, LLC, to expand domestic production capacity of Cue Sample Wands, the nasal swabs used exclusively with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, Inc. The test generates results in about 20 minutes at the point-of-care (POC). Awarded November 19, the new contract will allow Puritan Medical to expedite upgrades at its Maine facility and increase production capability of Cue’s nasal swabs to 3 million per month by March 2021. These efforts support the federal government’s procurement of 6 millio...

American Medical Association CEO says "COVID-19 is a Painful Validation of Our Long-term Vision for Health Care" | site |





(Information contained in American Medical Association [AMA] press release: November 13, 2020)

AMA CEO James L. Madara, MD In his address to the House of Delegates at the American Medical Association (AMA) November Special Meeting, AMA CEO James L. Madara, MD, highlights how the AMA has supported physicians during the pandemic and how COVID-19 is a painful validation of the organization’s long-term strategic vision for health care.

...

American Hospital Association Statement On U.S. Department of Health and Human Services Final Rules Removing Barriers To Coordinated Care | site |




(Information contained in American Hospital Association [AHA] press release: November 20, 2020)

AHA Statement On HHS Final Rules Removing Barriers To Coordinated Care

Tom Nickels
Executive Vice President
American Hospital Association

November 20, 2020

The actions taken today by the Department of Health and Human Services will significantly benefit patients by allowing their health care providers to work together to improve their care. The AHA greatly appreciates the leadership of Deputy Secretary Hargan in finalizing this rule and listening to the concerns of hospitals and health systems. The AHA has long called for the ability to coordinate care among providers to provide comprehensive patient care. Outd...

American Hospital Association Statement on Most Favored Nation Model Interim Final Rule | site |


(Information contained in American Hospital Association [AHA] press release: November 20, 2020)

AHA Statement on Most Favored Nation Model Interim Final Rule

Tom Nickels
Executive Vice President
American Hospital Association

November 20, 2020

America’s hospitals and health systems have very deep concerns about the substance and legality of today’s Most Favored Nation Model interim final rule. Instead of holding drug companies accountable for drug prices, it slashes reimbursement to hospitals for drugs. In addition to the continued concerns we have expressed about the impact this model has on the 340B drug pricing program, we strongly question whether attempting to institute such a sweeping and controversial policy in an interim final rule is legally permissible. B...

Decades of National Institutes of Health Research help lead to first FDA-approved Treatment for Progeria | site |


(Information included in a National Institutes of Health [NIH] news release media advisory: November 23, 2020)

The U.S. Food and Drug Administration has approved the first treatment for progeria, a rare and fatal pediatric disease, characterized by dramatic, rapid aging beginning in childhood. The treatment was made possible thanks in part to work at the National Institutes of Health over nearly two decades to identify and understand the function of the mutant gene and the protein it encodes (called progerin), with the goal of identifying new therapeutic drugs for the disorder. Progeria, also known as Hutchinson-Gilford progeria syndrome, is a rare, multisystemic disease that causes premature aging and premature death in children. Progeria is caused by a genetic mutation in the LMNA (“lamin A”) gene, which helps maintain the normal ...

U.S. Internal Revenue Service announces Procurement Research Partnership to improve Contracting Processes | site |


(Information contained in U.S. Internal Revenue Service [IRS] press release: November 23, 2020) WASHINGTON — The Internal Revenue Service's Office of the Chief Procurement Officer today announced a research partnership with Data and Analytic Solutions, a small business located in Fairfax, Virginia. The partnership also includes a group of academic researchers with a goal to use data science to improve IRS procurement operations. The effort will bring together a multi-disciplinary team comprised of procurement practitioners as well as university professors and students with procurement and machine learning experience. Machine learning is a form of artificial intelligence that allows computers to become more accurate at predicting outcomes without being explicitly programmed. "As with many agencies, we have a wealth of data available to us to u...

Federal Emergency Management Agency Announces $140 Million for Emergency Food and Shelter Program | site |


(Information included in Federal Emergency Management Agency [FEMA] press release: November 23, 2020) WASHINGTON -- FEMA has announced that $140 million will be available to communities across the county to assist with feeding and sheltering. Congress made $125 million available for Fiscal Year 2020, and this year, the Emergency Food and Shelter Program (EFSP) National Board is including an additional $15 million from funds that have not been used from prior grant years. FEMA awarded the $125 million to the National Board, which is now allocating the funds, combined with the additional $15 million, to qualifying jurisdictions (counties and cities). EFSP funds assist local organizations dedicated to feeding, sheltering, and providing critical resources to people with economic emergencies, including our nation's hungry and homeless populations. These fun...

Federal Emergency Management Agency Announces $140 Million for Emergency Food and Shelter Program | site |


(Information included in Federal Emergency Management Agency [FEMA] press release: November 23, 2020) WASHINGTON -- FEMA has announced that $140 million will be available to communities across the county to assist with feeding and sheltering. Congress made $125 million available for Fiscal Year 2020, and this year, the Emergency Food and Shelter Program (EFSP) National Board is including an additional $15 million from funds that have not been used from prior grant years. FEMA awarded the $125 million to the National Board, which is now allocating the funds, combined with the additional $15 million, to qualifying jurisdictions (counties and cities). EFSP funds assist local organizations dedicated to feeding, sheltering, and providing critical resources to people with economic emergencies, including our nation's hungry and homeless populations. These fun...

U.S. Environmental Protection Agency Continues Action to Address Ethylene Oxide | site |


(Information contained in U.S. Environmental Protection Agency press release: November 19, 2020) WASHINGTON (November 19, 2020) — As the U.S. Environmental Protection Agency (EPA) pursues its mission to protect human health and the environment, addressing ethylene oxide (EtO) continues to be a major priority across the agency. Today, as part of this cross-agency effort, EPA took the next step in its review of the pesticide registration for EtO by releasing a draft risk assessment for public comment. Based on EPA’s thorough review of the body of available information about EtO’s toxicity, the agency believes that additional steps are needed to mitigate the risks associated with the use of EtO. EtO is used to sterilize certain medical equipment and spices. “EtO is used on half of all sterilized medical devices in the United States annually and, in some cases, it is th...

U.S. Environmental Protection Agency Continues Action to Address Ethylene Oxide | site |


(Information contained in U.S. Environmental Protection Agency press release: November 19, 2020) WASHINGTON (November 19, 2020) — As the U.S. Environmental Protection Agency (EPA) pursues its mission to protect human health and the environment, addressing ethylene oxide (EtO) continues to be a major priority across the agency. Today, as part of this cross-agency effort, EPA took the next step in its review of the pesticide registration for EtO by releasing a draft risk assessment for public comment. Based on EPA’s thorough review of the body of available information about EtO’s toxicity, the agency believes that additional steps are needed to mitigate the risks associated with the use of EtO. EtO is used to sterilize certain medical equipment and spices. “EtO is used on half of all sterilized medical devices in the United States annually and, in some cases, it is th...

U.S. Consumer Product Safety Commission says ´Tis the Season to Be Safe: Top Tips for Your Family During COVID-19 | site |



CPSC releases latest data for injuries and deaths related to toys, holiday decorating and cooking; announces 2020 toy recalls


(Information contained in U.S. Consumer Product Safety Commission (CPSC) press release: November 19, 2020)

WASHINGTON, D.C. – The holidays normally are a time to get together in person with friends and family. However, the pandemic may mean virtual celebrations this year. Regardless of how you celebrate, it’s important to protect yourself from possible dangers associated with holiday trees, candles, and cooking fires, as well as unsafe toys.

To keep the season safe, here’s what you need to know:


TOYS

Data:

• Choking on small parts and riding toy injuries: CPSC reports that in 2019, there were an estimated 162,700 toy-related, emergency

...

U.S. Department of Agriculture Shares Easy At-Home Advice for Handling Food Safely this Thanksgiving | site |


(Information contained in U.S. Department of Agriculture press release: November 23, 2020) (Washington, D.C., November 23, 2020) – This week, Americans will enjoy a delicious meal on Thanksgiving Day with family and friends – either in person or virtually. Taking the necessary steps toward safe food handling and sanitation will help protect you and your loved ones this year. To make sure your Thanksgiving meal is prepared safely, the U.S. Department of Agriculture (USDA) is offering food safety advice to reduce foodborne illness, including on Thanksgiving Day. “Our data shows that consumers can reduce their likelihood of foodborne illness by focusing on good hand hygiene and other food safety practices,” said Dr. Mindy Brashears, USDA’s Under Secretary for Food Safety. “As home chefs nationwide prepare their Thanksgiving meals, proper handwashi...

U.S. Department of Agriculture Shares Easy At-Home Advice for Handling Food Safely this Thanksgiving | site |


(Information contained in U.S. Department of Agriculture press release: November 23, 2020) (Washington, D.C., November 23, 2020) – This week, Americans will enjoy a delicious meal on Thanksgiving Day with family and friends – either in person or virtually. Taking the necessary steps toward safe food handling and sanitation will help protect you and your loved ones this year. To make sure your Thanksgiving meal is prepared safely, the U.S. Department of Agriculture (USDA) is offering food safety advice to reduce foodborne illness, including on Thanksgiving Day. “Our data shows that consumers can reduce their likelihood of foodborne illness by focusing on good hand hygiene and other food safety practices,” said Dr. Mindy Brashears, USDA’s Under Secretary for Food Safety. “As home chefs nationwide prepare their Thanksgiving meals, proper handwashi...

U.S. Department of Transportation Seeks Public Comment on Automated Driving System Safety Principles | site |



Publishes an advance notice of proposed rulemaking on ADS safety framework


(Information contained in U.S. Department of Transportation National Highway Traffic Safety Administration press release: November 19, 2020)

November 19, 2020 | Washington, DC - - The U.S. Department of Transportation’s National Highway Traffic Safety Administration (NHTSA) is seeking public comment on the potential development of a framework of principles to govern the safe behavior of automated driving systems (ADS) in the future. The advance notice of proposed rulemaking (ANPRM) was submitted to the Federal Register on November 19 and is available online here. “This rulemaking will help address legitimate public concerns about safety, security and privacy without hampering innovation in the development of automated driving systems,”...

U.S. Food and Drug Administration Expands Approval of Influenza Treatment to Post-Exposure Prevention | site |


(Information contained in U.S. Food and Drug Administration press release: November 23, 2020)

Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra ...

U.S. Department of Health and Human Services Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19 | site |


(Information contained in U.S. Department of Health and Human Services press release: November 23, 2020)

The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.

In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health...

U.S. Department of Health and Human Services Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19 | site |


(Information contained in U.S. Department of Health and Human Services press release: November 23, 2020)

The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.

In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


(Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


(Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di...

Centers for Disease Control and Prevention issues revised COVID-19 Travel Health Notice Levels and Testing for International Travelers| site |


(Information contained in Centers for Disease Control and Prevention (CDC) press release: November 22, 2020)

On Saturday, November 21, CDC revised the Travel Health Notice system for COVID-19 and released new recommendations for testing before and after international air travel to help the public make informed decisions for safer, healthier, and more responsible travel during the COVID-19 pandemic.

CDC’s Travel Health Notices inform travelers and clinicians about current health issues in destinations around the world. For most diseases, the Travel Health Notices have 3 levels. This new 4-level travel health notice system is specific to COVID-19 and details the level of COVID-19 in international destinations and U.S. territories. The COVID-19 Travel Health Notices now indicate low, moderate, high, and...

Centers for Disease Control and Prevention issues revised COVID-19 Travel Health Notice Levels and Testing for International Travelers| site |


(Information contained in Centers for Disease Control and Prevention (CDC) press release: November 22, 2020)

On Saturday, November 21, CDC revised the Travel Health Notice system for COVID-19 and released new recommendations for testing before and after international air travel to help the public make informed decisions for safer, healthier, and more responsible travel during the COVID-19 pandemic.

CDC’s Travel Health Notices inform travelers and clinicians about current health issues in destinations around the world. For most diseases, the Travel Health Notices have 3 levels. This new 4-level travel health notice system is specific to COVID-19 and details the level of COVID-19 in international destinations and U.S. territories. The COVID-19 Travel Health Notices now indicate low, moderate, high, and...

U.S. Department of Housing and Urban Development announces over $80 Million in Targeted Funding for Coronavirus Relief | site |


Mainstream Vouchers aid non-elderly populations with disabilities in response to, and recovery from, COVID-19


(Information contained in U.S. Department of Housing and Urban Development press release: November 17, 2020)

Washington - - The U.S. Department of Housing and Urban Development (HUD) today made $86.85 million available to public housing agencies (PHAs) in the form of Mainstream funding vouchers to assist non-elderly populations impacted by Coronavirus. Mainstream Vouchers are administered using the same rules as other housing choice vouchers but targeted to serve a special population to ensure residents of low income housing, including those with unique circumstances, receive necessary funding to protect their health and safety against COVID-19. “Recently, we have learned a great deal about Coron...

U.S. Department of Health and Human Services makes Stark Law and Anti-Kickback Statute Reforms to support Coordinated, Value-Based Care | site |



(Information contained in U.S. Department of Health and Human Services press release: November 20, 2020) Today, the Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system into one that pays for value and promotes the delivery of coordinated care. The rules provide greater flexibility for healthcare providers to participate in value-based arrangements and to provide coordinated care for patients. The final rules also ease unnecessary compliance burden for healthcare providers and other stakeholders across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse. The HHS Office of Inspector General (OIG) issued the final rule “Revi...

Statement by U.S. Secretary of State Michael R. Pompeo concerning Marking of Country of Origin | site |



(Information contained in U.S. Department of State press release: November 19, 2020)

Statement by U.S. Secretary of State Michael R. Pompeo: Today, the Department of State is initiating new guidelines to ensure that country of origin markings for Israeli and Palestinian goods are consistent with our reality-based foreign policy approach.  In accordance with this announcement, all producers within areas where Israel exercises the relevant authorities – most notably Area C under the Oslo Accords - will be required to mark goods as “Israel”, “Product of Israel”, or “Made in Israel” when exporting to the United States.  This approach recognizes that Area C producers operate within the economic and administrative framework of Israel and their goods should be treated accordingly...

Federal Communications Commission Modernizes 5.9 GHz Band for WI-FI and Auto Safety | site |


New Plan Makes Additional Spectrum Available Immediately for Improved Indoor Wi-Fi Connectivity While Authorizing Market-Driven Transportation Safety Services


(Information contained in Federal Communications Commission [FCC] press release: released November 20, 2020) WASHINGTON, November 18, 2020—The Federal Communications Commission today adopted new rules for the 5.9 GHz band (5.850-5.925 GHz) to make new spectrum available for unlicensed uses, such as Wi-Fi, and improve automotive safety. Specifically, the new band plan designates the lower 45 megahertz (5.850-5.895 GHz) for unlicensed uses and the upper 30 megahertz (5.895-5.925 GHz) for enhanced automobile safety using Cellular Vehicle-to-Everything (C-V2X) technology. Increasing the amount of spectrum available for unlicensed operations is critical for meeting our nation’s connectivity needs...

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate | site |


(Information contained in U.S. Food and Drug Administration [FDA] press release: November 20, 2020)

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and...

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate | site |


(Information contained in U.S. Food and Drug Administration [FDA] press release: November 20, 2020)

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and...

Agencies provide Temporary Relief to Community Banking Organizations | site |



(Information contained in Board of Governors of the Federal Reserve System press release: November 20, 2020)


Board of Governors of the Federal Reserve System

Federal Deposit Insurance Corporation

Office of the Comptroller of the Currency The federal bank regulatory agencies on Friday announced an interim final rule that provides temporary relief for certain community banking organizations related to certain regulations and reporting requirements as a result, in large part, of their growth in size from the coronavirus response. Community banking organizations are subject to different rules and requirements based on their risk profile and asset size. Due to participating in federal coronavirus response programs—such as the Paycheck Protection Program—and other lending that supports the U.S. economy, many community banking organizations h...

Statement from U.S. Department of Health and Human Services Chief of Staff Brian Harrison on Unapproved Drugs Initiative | site |


(Information contained in U.S. Department of Health and Human Services press release: November 20, 2020)


Statement from HHS Chief of Staff Brian Harrison on Unapproved Drugs Initiative

Today, the Department of Health and Human Services (HHS) through a Notice published in the Federal Register announced the withdrawal of guidance documents issued as part of the Unapproved Drugs Initiative. HHS Chief of Staff Brian Harrison issued the following statement:

“We are committed to putting American patients first by ending government programs like the Unapproved Drugs Initiative that, while well-intentioned, have distorted markets and produced the unintended consequences of price spikes and drug shortages.” – HHS Chief of Staff Brian Harrison

Read the Frequently Asked Questions Regarding...

IRS says Register by Nov. 21 to get an Economic Impact Payment; same Deadline for Federal Beneficiaries to get missed $500 per Child Payments | site |



(Information contained in U.S. Internal Revenue Service [IRS] press release: November 19, 2020)

WASHINGTON — The Internal Revenue Service today reminded people who don't normally file tax returns that they have until November 21 at 3 p.m. Eastern time to register for an Economic Impact Payment. They also may be eligible to get to a $1,200 payment for their spouse and $500 for each qualifying child.

The extended November 21 deadline also gives more time to federal beneficiaries who already received an EIP but didn't register to receive supplemental $500 payments for qualifying children. Those eligible to provide this information include people with qualifying children who receive Social Security retirement, survivor or disability benefits, Supplemental Security Income (SSI), Railroad...

IRS says Register by Nov. 21 to get an Economic Impact Payment; same Deadline for Federal Beneficiaries to get missed $500 per Child Payments | site |



(Information contained in U.S. Internal Revenue Service [IRS] press release: November 19, 2020)

WASHINGTON — The Internal Revenue Service today reminded people who don't normally file tax returns that they have until November 21 at 3 p.m. Eastern time to register for an Economic Impact Payment. They also may be eligible to get to a $1,200 payment for their spouse and $500 for each qualifying child.

The extended November 21 deadline also gives more time to federal beneficiaries who already received an EIP but didn't register to receive supplemental $500 payments for qualifying children. Those eligible to provide this information include people with qualifying children who receive Social Security retirement, survivor or disability benefits, Supplemental Security Income (SSI), Railroad...