U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 15, 2021

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)

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

• Today, the FDA issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.” This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency.
• On January 14, the FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement

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U.S. Department of Veterans Affairs Celebrates 75 Years of the Veterans Health Administration | site |



(Information contained in U.S. Department of Veterans Affairs press release: January 12, 2021)

Washington - - This year, the U.S. Department of Veterans Affairs (VA) commemorates 75 years of the Veterans Health Administration (VHA).

Originally established in 1946 as the Department of Medicine & Surgery to care for Veterans returning from World War II, VHA has evolved to meet the unique challenges and care needs of Veterans from every era and at every stage of their lives. “As we celebrate this historic milestone, we are presented with an opportunity to share VHA’s rich history while looking toward our next chapter as a learning organization that is committed to continuous improvement,” said VA Secretary Robert Wilkie. “It is also a fitting occasion to recognize the extraordinary efforts of VHA staff and volunteers during the ...

U.S. Food and Drug Administration Releases Artificial Intelligence/Machine Learning Action Plan | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: January 12, 2021)

Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). “The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effecti...

Walgreens Expects to Complete Administration of COVID-19 Vaccine First Doses in Skilled Nursing Facilities by January 25 | site |


Walgreens continues to accelerate access to COVID-19 vaccinations among additional vulnerable populations as part of state and local jurisdictions distribution plans


(Information contained in Walgreens press release dated: January 6, 2021)

Deerfield, Ill., January 06, 2021 - Walgreens expects to complete the administration of COVID-19 vaccine first doses in skilled nursing facilities by Monday, Jan. 25. The company is also rapidly expanding access to vaccinations among assisted living facilities and additional vulnerable populations outlined by states and local jurisdictions as part of expanded distribution plans. “Since receiving our first allotments of vaccines in late December, Walgreens has remained on track in vaccinating our most vulnerable populations, and we are steadfast in our comm...

National Highway Transportation Safety Administration Seeks Comment on Cybersecurity Best Practices for the Safety of Modern Vehicles | site |



(Information contained in National Highway Transportation Safety Administration [NHTSA] press release dated: January 8, 2021)


January 8, 2021 | Washington, DC - - The National Highway Traffic Safety Administration is seeking public comment on the draft Cybersecurity Best Practices for the Safety of Modern Vehicles (2020 Best Practices) it submitted to the Federal Register for publication today. This is an update to the existing best practices document that was published in 2016, and describes NHTSA’s nonbinding guidance to the automotive industry for improving vehicle cybersecurity for safety. “Vehicle cybersecurity has high stakes,” said NHTSA Deputy Administrator James Owens. “The safety and security of everyone on our roads depend on it. We have learned a great deal in the past...

U.S. Department of Agriculture says Trump Administration Invests $4.6 Million in High-Speed Broadband in Rural Georgia | site |


ReConnect Funding to Connect 1,326 Rural Georgia Households to High-Speed Internet e-Connectivity


(Information contained in U.S. Department of Agriculture press release: January 7, 2021)

Claxton, Ga., Jan. 7, 2021 - - The Trump Administration today announced that the United States Department of Agriculture (USDA) is investing $4.6 million to provide broadband service in unserved and underserved rural areas in Georgia. This investment is part of the $550 million Congress allocated to the second round of the ReConnect Program. “The need for rural broadband has never been more apparent than it is now – as our nation manages the coronavirus national emergency. Access to telehealth services, remote learning for school children, and remote business operations all require access to broadband,” U.S. Secret...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 5, 2021 | site |



(Information included in U.S. Food and Drug Administration [FDA] press release dated: January 5, 2021)


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

• Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.

The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:

Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA. Include

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U.S. Small Business Administration Launches Largest Expansion of Women’s Business Centers in 30 Years | site |


20 Women’s Business Centers to Open Across America Supporting Women-Owned Small Businesses


(Information contained in U.S. Small Business Administration [SBA] press release dated: January 4, 2021)

Washington - - The U.S. Small Business Administration today announced grant funding and the historic launch of 20 new Women’s Business Centers (WBC) across America to serve rural, urban and underserved communities alike. The opening of the 20 new WBCs is the largest single expansion of WBCs across America in its 30-year tenure, and these centers will be pivotal to the success of women-owned businesses as they continue to recover during this time. The WBCs will be hosted in rural and underserved markets and widen the footprint and partnership with Historically Black Colleges and Universities (HBCUs). “Over the past severa...

Federal Railroad Administration Announces Landmark Achievement with Full Implementation of Positive Train Control | site |



(Information contained in Federal Railroad Administration press release dated: December 29, 2020) Washington - - The U.S. Department of Transportation’s Federal Railroad Administration (FRA) announced today that positive train control (PTC) technology is in operation on all 57,536 required freight and passenger railroad route miles, prior to the statutory deadline of December 31, 2020, set by Congress. In addition, as required, FRA has certified that each host railroad’s PTC system complies with the technical requirements for PTC systems. Furthermore, railroads have reported that interoperability has been achieved between each applicable host and tenant railroad that operates on PTC-governed main lines. “Achieving 100 percent PTC implementation is a tremendous accomplishment and reflects the Department’s top priorities – safe...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 30, 2020 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: December 30, 2020)

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

• Today, the FDA published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.

• In a new FDA Voices entitled, 2020 at FDA: A Year of Unparalleled Contributions to Public Health, FDA Commissioner

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National Highway Traffic Safety Administration Consumer Alert: Changes to Odometer Disclosure Requirements | site |



(Information contained in National Highway Traffic Safety Administration [NHTSA] press release: December 22, 2020)

December 22, 2020 | Washington, DC - - The U.S. Department of Transportation’s National Highway Traffic Safety Administration is reminding consumers that, starting January 1, 2021, odometer disclosures will be required for every transfer of ownership for the first 20 years, beginning with Model Year 2011 vehicles. Model Year 2010 and older vehicles will continue to be subject to the previous 10-year disclosure requirements and thus are exempt from extended Federal odometer disclosure requirements. The U.S. fleet of vehicles is, on average, older than ever, and NHTSA finalized this rule late last year to address an increase in odometer fraud involving older vehicles. Model Year 2011 or newer vehicles will ...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 28, 2020 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020)

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

• On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, the FDA added the following device types in the testing supplies and equipment category: pipette tips (product codes LXG and PPM) and micro pipettes (product code JRC). The FDA also added clarifying notes and links to more resources in the “Additional Information” column, as well as adding clarity to the categories, such as grouping gloves under “Personal Protective Equipment – Gloves.” The device shortage list reflects the categories of

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National Highway Traffic Safety Administration Releases 2019 Crash Fatality Data | site |



2019 Showed Significant Improvements in Traffic Safety, Including the Lowest Percentage of Alcohol-Impaired Driving Fatalities on Record


(Information contained in National Highway Traffic Safety Administration [NHTSA] press release dated: December 18, 2020)

December 18, 2020 | Washington, DC - - The U.S. Department of Transportation’s National Highway Traffic Safety Administration today released its annual 2019 traffic fatality data from the Fatality Analysis Reporting System (FARS).

Traffic deaths decreased nationwide during 2019 as compared to 2018, and alcohol-impaired driving fatalities decreased to the lowest percentage since 1982, when NHTSA started reporting alcohol data. There were 36,096 fatalities in motor vehicle traffic crashes in 2019. This represents a decrease of 739 (down 2%) from the reported 36,835 fatalities ...

Walgreens Begins Administration of Pfizer’s COVID-19 Vaccine in Long-Term Care Facilities | site |



Walgreens Plans to Administer the Vaccine to Approximately 3 Million Residents and Staff in 35,000 Long-Term Care Facilities as Part of the Centers for Disease Control and Prevention Program


(Information contained in Walgreens press release dated: December 18, 2020)

Deerfield, Ill., December 18, 2020 - Today Walgreens began administering Pfizer’s COVID-19 vaccine to residents and staff at long-term care facilities in a monumental first in the company’s 119-year history. Pharmacists are providing the vaccinations at nursing homes and assisted living facilities in Ohio and Connecticut as part of the Centers for Disease Control and Prevention (CDC) Pharmacy Partnership for Long-term Care Program. Walgreens pharmacy team members will provide COVID-19 vaccinations in approximately 800 long-term care facilities across 12 s...

Federal Railroad Administration Publishes Final Rule for State Highway-Rail Grade Crossing Action Plans | site |


All states and the District of Columbia impacted


(Information contained in Federal Railroad Administration [FRA] press release: December 15, 2020) Washington - - The U.S. Department of Transportation’s Federal Railroad Administration (FRA) published a final rule requiring 40 states and the District of Columbia to develop and implement highway-rail grade crossing action plans to improve public safety. In addition, the rule requires 10 states that have already developed grade crossing action plans, as required by the Rail Safety Improvement Act of 2008 (RSIA) and FRA’s implementing regulation, to update their plans and submit reports describing the actions they have taken to implement them. “Grade crossing accidents and incidents are the second leading cause of rail-related deaths in the United States, but nearly every one of...