Search Results for keywords:"public health"

The Food and Drug Administration (FDA) has released a new guidance to help reduce the risk of transmitting Mycobacterium tuberculosis (Mtb) through human cells, tissues, and cellular and tissue-based products (HCT/Ps). The guidance provides recommendations for screening donors to check for signs and risk factors of tuberculosis infection. This document was issued urgently due to recent multistate outbreaks linked to Mtb transmissions from donors and aims to enhance screening until official tests are available. Although the guidance is effective immediately, the FDA is open to receiving comments on it.

The Department of Health and Human Services (HHS) finalized a rule to modify the Vaccine Injury Table, which relates to the National Vaccine Injury Compensation Program (VICP). This new rule removes Shoulder Injury Related to Vaccine Administration (SIRVA) and vasovagal syncope from the list of injuries eligible for compensation under the VICP. Some members of the public opposed the change, expressing concerns about safety and potential impacts on liability for vaccine administrators. However, HHS argued that these injuries are often due to improper administration techniques rather than the content of the vaccines themselves, and stated that this change aims to ensure that funds are directed to injuries directly caused by vaccines.

The Centers for Disease Control and Prevention (CDC), part of the Department of Health and Human Services (HHS), has renewed the charter for the CDC/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment (CHAC). This renewal extends the committee's charter until November 25, 2026. The committee focuses on providing guidance and recommendations related to the prevention and treatment of these diseases. Jonathan Mermin, M.D., M.P.H., is the designated federal officer for this committee.

The Food and Drug Administration (FDA) has decided to deny Yong Sheng Jiao's request for a hearing and issued a final debarment order. Jiao, who pleaded guilty to felony charges related to importing a misbranded drug into the U.S., is barred for five years from providing services connected to drug application processes. The FDA determined that the seriousness of Jiao's offense warranted this punishment, despite Jiao's claims of misunderstanding and attempts to challenge the penalty's severity. The decision reflects the FDA's commitment to maintaining the safety and integrity of the drug industry in the United States.

The Food and Drug Administration (FDA) has announced the release of a report titled "Food and Drug Administration Report and Plan on Best Practices for Guidance." This report, requested by the Consolidated Appropriations Act, 2023, outlines best practices for creating, prioritizing, and using guidance documents efficiently. The FDA gathered and considered public feedback on a draft report published in December 2023, which led to this final version. The report aims to enhance transparency, improve regulatory processes, and support the development of new products for public health.

In a proclamation by President Donald J. Trump, he declared that the situation at the U.S. southern border is an "invasion" under the U.S. Constitution. As a response, he has ordered the temporary suspension of entry for certain aliens who cross the southern border, due to concerns over public health, safety, and national security. The proclamation cites the President's authority under the Immigration and Nationality Act and the Constitution to deny entry and impose restrictions on individuals who do not meet specific criteria. This action aims to address the challenges posed by the influx of illegal aliens and protect the interests of the United States.

The Environmental Protection Agency (EPA) concluded that the Piti-Cabras area in Guam did not meet the required sulfur dioxide air quality standards by the deadline of April 9, 2023. This decision is based on the analysis of available data, showing emissions were too high, and necessary emission controls were not implemented on time. As a result, Guam must now submit a revised plan to achieve air quality standards within the next five years, according to the Clean Air Act requirements. This measure ensures continued efforts to protect public health from pollution.

The U.S. International Trade Commission announced a request for public comments related to a potential violation of Section 337 involving certain collapsible and portable furniture. On February 18, 2021, an administrative law judge recommended remedies and bonds if a violation is confirmed. The Commission is specifically interested in how these remedies might affect public health, competitive conditions, the economy, and consumers in the U.S. The deadline for public submissions is March 22, 2021, and details on filing can be found on the Commission's website.

The Centers for Disease Control and Prevention (CDC) is seeking public comments on their study titled “Medication-Assisted Treatment (MAT) for Opioid Use Disorder,” which is under review by the Office of Management and Budget (OMB). This study aims to evaluate the effectiveness of different treatments for opioid use disorders, which affect about 2.4 million adults in the U.S. The CDC has extended the recruitment deadline due to lower than expected patient enrollment and requires OMB approval to continue data collection. The public can submit comments or suggestions concerning the necessity, methodology, and cost of the proposed information collection within 30 days of the notice's publication.