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

The Food and Drug Administration (FDA) is requesting public comments on the National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. The FDA aims to gather input to develop a draft plan, which will be discussed in a public meeting scheduled for spring 2025. They are seeking feedback on how data from NARMS is used, what additional information might be valuable, and suggestions for monitoring antimicrobial resistance within the One Health framework. Comments can be submitted electronically or in writing until March 26, 2025.

The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) is seeking public comments on a proposed plan to collect data from Sexual Risk Avoidance Education (SRAE) programs. This will help evaluate innovative strategies and improve outcomes for youth involved in these programs. The collection allows ACF to quickly gather and use data to enhance program effectiveness and understand the needs of the diverse youth populations they serve. The request also seeks comments on the necessity, accuracy, and burden of the information collection, as well as suggestions for minimizing the burden through technology.

The Health Resources and Services Administration (HRSA) announced public meetings for the National Advisory Council on the National Health Service Corps (NACNHSC) in 2025. These meetings will be held in March, June, and November, and may take place in-person, via teleconference, or video conference. The Council will provide guidance on health service policies, with opportunities for public comments. Detailed information and updates on meeting formats will be available on the NACNHSC website.

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) announced the release of final guidance titled "E11A Pediatric Extrapolation," prepared with the International Council for Harmonisation. This guidance aims to streamline pediatric drug development, focusing on strategies like safety extrapolation and statistical methodologies to ensure safe, effective medicines for children. It replaces a draft guidance from August 2022 and includes updates to study designs and modeling approaches. The public can comment on this guidance, which is accessible through FDA's regulations website.

The Centers for Medicare & Medicaid Services (CMS) is inviting the public to comment on its plan to collect information, as required by the Paperwork Reduction Act of 1995. This notice outlines the proposed collection of a new Data Management Plan Self-Attestation Questionnaire, which is intended to ensure compliance with privacy and security standards for CMS data. The agency seeks feedback on the necessity, accuracy, and potential burden of this data collection effort. Comments are due by March 22, 2021, and can be submitted online or by accessing related documents through CMS's website.

The Eunice Kennedy Shriver National Institute of Child Health & Human Development has announced a closed meeting of the Developmental Biology Subcommittee. This meeting will take place on February 26, 2021, from 11:00 a.m. to 7:00 p.m. and will be a virtual event held at the National Institutes of Health. It will focus on reviewing and evaluating grant applications, which include confidential information like trade secrets and personal information.

The National Institute of Environmental Health Sciences will hold several closed meetings in April 2025 to review and evaluate grant applications and contract proposals. These meetings will be conducted virtually and are closed to the public to protect confidential information and personal privacy. Details for each meeting, including dates, times, and contact information for the Scientific Review Officers, are provided. This action is pursuant to the Federal Advisory Committee Act.

The Centers for Medicare & Medicaid Services (CMS) is inviting public comments on its proposal to collect information, as required by the Paperwork Reduction Act of 1995. This process involves publishing a notice in the Federal Register and seeking feedback on various aspects, such as the estimate of the burden on the public and ways to improve the information collection process. Two types of information collections are highlighted: (1) the extension of the Quality Improvement Organization (QIO) Assumption of Responsibilities, which involves peer review activities, and (2) the reinstatement and modification of the Medicare Enrollment Application for Clinics/Group Practices and Other Suppliers. Public comments are due by February 14, 2025, and further details can be found on the CMS PRA website.

The Food and Drug Administration (FDA) has released a draft guidance for the industry titled "Considerations for Complying With 21 CFR 211.110." This draft guidance aims to help manufacturers ensure the uniformity and integrity of drug products by complying with specific regulations. It also provides insight into how advanced manufacturing techniques, like 3D printing and continuous manufacturing, can be incorporated into manufacturing processes. The FDA encourages industry representatives who are interested in using innovative control strategies to contact them for further guidance.