📊Proposed Data Collection by CDC
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN) Respiratory Data. This data collection is designed to standardize the data elements collected across the country regarding the impact of respiratory viruses on healthcare facilities.
Learn More📦FDA Proposed Info Collection for Medical Device Exports
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements for firms that intend to export certain unapproved medical devices.
Learn More⚖️FDA Proposes Information Collection on Medical Device Accessories
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with medical device accessory classification requests.
Learn More💊FDA's Patent Extension Review for ROLVEDON and Its Business Impact
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROLVEDON and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More🦠CDC Proposed Information Collection on Antimicrobial Resistance Network
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Global Action in Healthcare Network Antimicrobial Resistance Module (GAIHN-AR). This project supports planning and management of antimicrobial resistance prevention, detection, and response activities associated with the GAIHN-AR network.
Learn More🩺Nominations Open for Physician-Focused Payment Model Committee
The Medicare Access and CHIP Reauthorization Act of 2015 established the Physician-Focused Payment Model Technical Advisory Committee to provide comments and recommendations to the Secretary of Health and Human Services on physician payment models and gave the Comptroller General responsibility for appointing its members. The Government Accountability Office (GAO) is now accepting nominations of individuals for this committee.
Learn More💼Upcoming NIH Meetings on Grant Applications for Small Businesses
The Department of Health and Human Services announces closed meetings of the Center for Scientific Review to evaluate grant applications in various fields. These panels will focus on small business initiatives related to clinical care, cancer treatments, immuno-oncology, and more. Meetings are set to occur virtually at the National Institutes of Health in Bethesda, MD.
Learn More🌡️FDA Exempts Class II Clinical Electronic Thermometers from Regulations
The Food and Drug Administration (FDA, we, or the Agency) is publishing an order setting forth the Agency's final determination to exempt certain class II clinical electronic thermometers from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for such class II clinical electronic thermometers. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulations. FDA is amending the classification language within the Code of Federal Regulations for certain class II clinical electronic thermometers to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Learn More🏥FDA Pediatric Advisory Committee Meeting Notice for Public Comments
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to FDA on pediatric regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
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.
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