Notice 29 Sep 2025 patent extension, fda, regulatory compliance, healthcare, medical devices

🏥FDA Notice on Patent Extension for DIAMONDBACK 360 Device

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE 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 medical device.

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Proposed Rule 29 Sep 2025 disability benefits, veterans, veterans affairs, regulatory compliance, healthcare

💼VA Proposes Rule on Pain Evidence for Disability Evaluations

The Department of Veterans Affairs (VA) proposes to revise 38 CFR 4.118, diagnostic code (DC) 7804 ("Scar(s), unstable or painful"), by adding a note clarifying that VA still requires objective evidence of pain when rating a scar as painful. The inclusion of this note would align with current policy and ensure consistent application of the rating criteria.

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Notice 29 Sep 2025 patent extension, pharmaceuticals, fda, regulatory compliance, healthcare, drug approval

💊FDA Announces Regulatory Review Period for MIPLYFFA Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MIPLYFFA 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 drug product.

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Rule 29 Sep 2025 administrative practice and procedure, caregiving, claims, veterans, health care, travel and transportation expenses, regulatory compliance, financial assistance, public assistance programs, health professions, healthcare, mental health programs, health facilities

🏥Extension of PCAFC for Legacy Participants and Applicants

The Department of Veterans Affairs (VA) adopts as final, with changes, an interim final rule that amended VA's regulations governing the Program of Comprehensive Assistance for Family Caregivers (PCAFC) and extended the transition period for legacy participants, legacy applicants, and their Family Caregivers (the legacy cohort) through September 30, 2025. This final rule will further extend the transition period for the legacy cohort through September 30, 2028.

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Notice 29 Sep 2025 dod, information collection, survey, regulation, healthcare, military

📄Department of Defense Information Collection Notice on Healthcare Survey

The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

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Notice 29 Sep 2025 preparedness, public health, cooperative agreement, financial assistance, healthcare, infectious disease

🏥Cooperative Agreement for Special Pathogen Preparedness Funded by ASPR

ASPR intends to provide a five-year single-source Cooperative Agreement (CoAg) to the National Emerging Special Pathogens Training and Education Center (NETEC). The CoAg will enable NETEC to continue to lead special pathogen preparedness and response for currently active or emergent High Consequence Infectious Disease (HCID) threats. The total proposed cost of the single-source CoAg is $7,730,000 for Fiscal Year (FY) 2025. Supporting collaboration between the U.S. Public Health Service and public and private community health programs and agencies to respond to health emergencies is an authority provided to HHS under section 311(c) of the Public Health Service Act.

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Notice 29 Sep 2025 information-collection, affordable-care-act, cms, regulation, healthcare

📋CMS Requests Emergency Extension for Information Collection Activities

The Centers for Medicare & Medicaid Services (CMS) submitted an emergency extension request for the information collection titled “Medicaid Program; Eligibility Changes under the Affordable Care Act of 2010.” This extension aims to ensure the collection remains active amidst the Paperwork Reduction Act compliance and to prevent public harm during the approval process.

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Notice 29 Sep 2025 funding, regulation, healthcare, compliance, education

🏥Regulatory Notice on CHGME Payment Program Submission Requirements

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

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Notice 26 Sep 2025 public meeting, veterans affairs, healthcare, advisory committee, rural health

🏥Notice of Veterans Rural Health Advisory Committee Meeting

The Department of Veterans Affairs announces a meeting of the Veterans Rural Health Advisory Committee, focusing on rural health care for veterans. The agenda includes updates from leadership, discussions on health care access, and a public comment period for stakeholders. This session aims to improve VA health services delivery for veterans in rural areas, allowing for public engagement and expert insights.

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Notice 26 Sep 2025 vaccine, liability, compensation, public health, healthcare, regulation

💉Overview of the National Vaccine Injury Compensation Program

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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