Search Results for agency_names:"Health and Human Services Department"

The Food and Drug Administration (FDA) has released revised final guidances to minimize the risk of spreading disease agents like sepsis and Mycobacterium tuberculosis through human cells, tissues, and related products. The guidances originally advised establishments to implement recommendations within four weeks, but now suggest a longer timeframe until May 4, 2025, to allow for further review and consideration of public comments. These changes follow a presidential directive for regulatory review, prioritizing public health while seeking further input. The FDA emphasizes that these updates are being implemented immediately, even as they remain open to additional public comments.

The Food and Drug Administration (FDA) has announced the availability of a final guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance details FDA's temporary rules for licensed pharmacists and physicians who are compounding drugs using bulk substances, while the agency works on creating a list of approved substances. The updated guidance finalizes the draft that was issued in December 2023 and replaces the previous 2017 guidance, ending the categorization of substances into different groups and outlining conditions under which the FDA will not take action against compounding that does not meet full compliance, while the list is still being developed. This guidance is issued as part of FDA's regulatory framework, but it does not establish any binding rights or obligations.

The Department of Health and Human Services (HHS) has released a notice which informs federal agencies about the laboratories and facilities certified to conduct drug testing using urine and oral fluid as per the Mandatory Guidelines for Federal Workplace Drug Testing Programs. As of now, there are no labs certified for oral fluid testing, but several are certified for urine testing, including those in Canada, which are overseen by the standards of the Department of Transportation (DOT). The list includes details about each certified laboratory and highlights a facility that is withdrawing from the certification program.

The Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee on Dose Reconstruction Review (SDRR) is updating information about their upcoming meeting. The meeting, organized by the National Institute for Occupational Safety and Health (NIOSH), will occur on February 25, 2021, and focus on quality management and assurance activities related to dose reconstruction cases. These cases involve various sites, including the Rocky Flats Plant, Hanford, and the Los Alamos National Laboratory, among others. Agenda items are subject to change depending on priorities.

The Centers for Disease Control and Prevention (CDC) is seeking public comments on an ongoing information collection project called Performance Monitoring of CDC's Core State Injury Prevention Program (SIPP). This initiative aims to improve injury prevention programs and demonstrate their effectiveness in reducing injury-related illnesses and deaths. Under the Paperwork Reduction Act, the CDC must gather public input before continuing the collection of this information, which helps track progress and effectiveness across different states. Comments must be submitted by February 3, 2025, and CDC requests approval for an estimated 286 hours of annual respondent burden time.

The Food and Drug Administration (FDA) has released draft guidance for the industry on using Artificial Intelligence (AI) to aid in regulatory decisions for drugs and biological products. This guidance explains how AI can be used to produce credible information or data regarding the safety, effectiveness, or quality of these products. It emphasizes a risk-based assessment framework for AI models and encourages early consultation with the FDA to ensure compliance and credibility. The guidance and its proposed recommendations are open for public comment until April 7, 2025, allowing stakeholders to contribute their views on the outlined framework and engagement options with the FDA.

The Department of Health and Human Services has issued an amendment to the Public Readiness and Emergency Preparedness (PREP) Act to expand the categories of healthcare professionals who can prescribe, dispense, and administer COVID-19 vaccines. This includes physicians, advanced practice nurses, registered nurses, and practical nurses who held an active license within the last five years. The amendment aims to increase the number of available COVID-19 vaccinators nationwide by granting liability immunity and preempting any state laws that might otherwise restrict these professionals from participating in vaccination efforts. This change is effective as of February 2, 2021, and lasts through October 1, 2024.

The Centers for Medicare & Medicaid Services (CMS) issued a correcting amendment to fix technical errors in two previous Medicare rules. These rules deal with appeal rights for changes in patient status and the procedures for appealing Medicare claims or prescription drug coverage determinations. The corrections involve changes to paragraph numbering and minor wording adjustments, ensuring the rules align with the intended policies. This amendment is effective immediately without a delay, as the corrections are non-substantive and will not impact public actions.

The National Institute of Allergy and Infectious Diseases is holding two closed meetings to review and evaluate contract proposals. These meetings will focus on reagents for immunologic analysis of non-mammalian and underrepresented mammalian models as part of the Small Business Innovation Research (SBIR) program. The first meeting for Phase I will occur on January 28, 2021, from 10:00 a.m. to 6:00 p.m., and the second meeting for Phase II will take place on January 29, 2021, from 10:00 a.m. to 2:00 p.m. Both meetings will be held virtually and closed to the public to protect confidential trade secrets and personal privacy.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development announced closed meetings for specific committees. These meetings are not open to the public because they will discuss confidential information, including trade secrets and private personal details related to grant applications. The Reproduction, Andrology, and Gynecology Subcommittee will meet on February 18, 2021, while the Pediatrics Subcommittee will meet on March 11, 2021. Both meetings will be conducted via video at the institute's Bethesda, Maryland location, and their purpose is to review and evaluate grant applications.