Search Results for keywords:"Public Health Emergency"

The Food and Drug Administration (FDA) has issued five Emergency Use Authorizations (EUAs) for drugs and biological products during the COVID-19 pandemic. These authorizations, allowed under the Federal Food, Drug, and Cosmetic Act, aim to help address public health emergencies by making medical products available when there are no adequate alternatives. The products authorized include those requested by Baxter Healthcare, the U.S. Department of Health and Human Services, Eli Lilly and Company, and Regeneron Pharmaceuticals. The FDA ensures that these authorizations are based on scientific evidence indicating that the benefits of using these products outweigh the risks.

The Department of the Treasury has proposed a new system of records titled "Health Screening and Contact Tracing Records" to track individuals who have been infected with or exposed to communicable diseases while at Treasury facilities or events. This system, established under the Privacy Act of 1974, aims to protect the health of Treasury personnel and visitors by collecting necessary information for health screening and contact tracing. Treasury will use these records to comply with health and safety regulations, respond to public health emergencies, and reduce the transmission of infectious diseases. Personal information, including health data, may be shared with relevant authorities for public health purposes while maintaining privacy safeguards.

The Department of Health and Human Services (HHS) has announced that it will not enforce penalties on health care providers for not following certain HIPAA rules when using online scheduling applications for COVID-19 vaccinations. This leniency is because of the urgent need to schedule many vaccination appointments during the pandemic. These online tools, called Web-Based Scheduling Applications (WBSAs), are used in good faith to protect privacy, but HHS encourages implementing safety measures like encryption and data protection. This policy only applies during the COVID-19 public health emergency and is specific to scheduling vaccinations, not other medical activities.

The Department of Health and Human Services has issued a notice clarifying that businesses that started producing hand sanitizers during the COVID-19 pandemic are not required to pay certain facility fees under the Food, Drug, and Cosmetic Act. These businesses, many of which normally produce alcoholic beverages, were allowed to make hand sanitizers due to a temporary policy by the FDA to address shortages. The Department emphasizes that imposing such fees would be inconsistent with the intent of the CARES Act and clarifies that these businesses are not considered drug manufacturing facilities under the law, unless they also engage in producing other over-the-counter drugs.

The Federal Transit Administration (FTA) is seeking public comments on their proposed information collection related to the Transit COVID-19 Response Program. This request is in compliance with the Paperwork Reduction Act of 1995 and aims to renew the existing framework for a three-year period to enable swift data collection during future public health emergencies. Although the formal COVID-19 emergency has ended, the FTA wants to continue gathering data to assess its impact on transit systems. Comments can be submitted until January 29, 2025, to the Office of Management and Budget (OMB), which will decide on the approval of this information collection.

The Centers for Medicare & Medicaid Services (CMS) is requesting emergency approval for a change to the CAHPS for MIPS survey, which will add a question about telehealth services used during the COVID-19 Public Health Emergency. This change aims to collect self-reported data from patients on their telehealth experiences to support the quality and performance assessments of healthcare providers. The new survey item will be used for informational purposes and not affect quality scoring or payments. Public comments on this proposed change are invited until April 9, 2021.