🏥Proposed Information Collection Activities for Medicaid and CHIP
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low-burden, and uncontroversial collections," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More📋CMS Notice on Information Collection and Compliance for Businesses
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More🦠FDA Classifies Antimicrobial Susceptibility Testing Device as Class II
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cellular analysis system for multiplexed antimicrobial susceptibility testing into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cellular analysis system for multiplexed antimicrobial susceptibility testing's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More⚖️Patient Safety Organization Delistings
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Michigan Surgical Quality Collaborative, PSO number P0143, of its status as a PSO, and has delisted the PSO accordingly. AHRQ delisted the Proximie PSO, PSO number P0244, due to its failure to correct a deficiency.
Learn More⚖️DEA Revocation of Registration for James F. Brown, D.P.M.
The Department of Justice's Drug Enforcement Administration issued a Decision and Order revoking James F. Brown’s DEA registration due to material falsification on his application and lack of authority in California. The case highlights the critical importance of accurate disclosures in licensing and compliance within the healthcare sector.
Learn More👶Grant Opportunity for Infant Death Prevention Program Funding
HRSA will provide additional award funds to the one recipient of the SUID Prevention Program with period of performance ending in fiscal year 2025 to extend the current period of performance by 12 months to continue the activities of the program related to reducing infant deaths.
Learn More💊FDA Requests Comments for Rare Disease Innovation Workshop Series
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following request for comments for a future public workshop series entitled "Rare disease Innovation, Science, and Exploration (RISE) Workshop." The purpose of the public workshops will be to focus on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions. The workshops will primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the Agency.
Learn More📋Opportunity to Comment on CMS Information Collection Activities
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More🏥CDC Notice on National Healthcare Safety Network Data Collection
The Centers for Disease Control and Prevention (CDC) is seeking public comments on an information collection request for the National Healthcare Safety Network. This includes data from healthcare facilities aimed at improving patient safety and reducing healthcare-associated infections. The notice outlines a 30-day comment period and details the data collection processes involved.
Learn More📊CDC Notice
The CDC announces a 30-day public comment period for the National Program of Cancer Registries Program Evaluation Instrument (NPCR-PEI) under the Paperwork Reduction Act. The NPCR-PEI aims to monitor cancer registry operations and improve data quality for cancer control and prevention initiatives throughout the U.S.
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