💰FDA Final Guidance on Medical Device User Fees for Small Businesses
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Medical Device User Fee Small Business Qualification and Determination Guidance." This guidance updates the previous version of the guidance, titled "Medical Device User Fee Small Business Qualification and Certification Guidance", issued on August 1, 2018. The guidance includes updates which describe how FDA plans to determine if a small business is experiencing "financial hardship" which makes them eligible for a waiver of their registration fee. The guidance details what information FDA intends to review and consider in making this determination.
Learn More🐬Incidental Take Authorization for Kingston Ferry Terminal Project
In accordance with regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to Washington Department of Transportation (WSDOT) for authorization to take marine mammals incidental to harass marine mammals during construction activities associated with a Kingston Ferry Terminal project in Kingston, WA.
Learn More📡FCC Revises Spectrum Sharing Rules for Satellite Systems
In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget has approved new information collection requirements under OMB Control Number 3060-0678, as adopted in the Commission's Report and Order, FCC 23-29, and revised in the Commission's Second Report and Order, FCC 24- 117.
Learn More📊CFTC Notice on End-User Notification of Non-Cleared Swaps
The Commodity Futures Trading Commission ("CFTC" or "Commission") is announcing an opportunity for public comment on the proposed renewal of a collection of certain information by the agency. Under the Paperwork Reduction Act ("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. This notice solicits comments on the renewal of the reporting requirement that is embedded in the final rule adopting the end-user exception to the Commission's swap clearing requirement.
Learn More🎓VA Proposes Changes to Overpayment Recovery Regulations for Education
The Department of Veterans Affairs (VA) proposes to amend the Veteran Readiness and Employment and Education regulations to implement section 1019 of the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 (Isakson Roe Act), which was effective January 5, 2021. These proposed amendments would update regulations governing the waiver or recovery of overpayments to address the assignment of financial responsibility for benefits paid directly to an educational institution on behalf of the student.
Learn More⚖️NAGPRA Inventory Completion Notice - Kansas State Historical Society
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Kansas State Historical Society (KSHS) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Learn More✈️New Airworthiness Directive for Piaggio Aviation Airplanes Issued
The FAA is superseding Airworthiness Directive (AD) 2023-25- 03, which applied to certain Piaggio Aviation S.p.A. (Piaggio) Model P- 180 airplanes. AD 2023-25-03 required a one-time detailed inspection of the horizontal stabilizer (HS) central box for corrosion; an assessment of the corrosion level; and depending on the determination, repetitive detailed inspections of the HS central box for corrosion and the internal composite structure for surface cracks, distortion, and damage; and repair or replacement of the HS assembly. Repair or replacement of the HS assembly was terminating action for the repetitive inspections. Since the FAA issued AD 2023-25-03, it was determined that AD 2023-25-03 imposed an unintended restriction that is not in the mandatory continuing airworthiness information (MCAI). This AD retains certain actions of AD-2023-25-03 and removes the unintended restriction. The FAA is issuing this AD to address the unsafe condition on these products.
Learn More💰FY 2026 Medical Device User Fees
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2026, which apply from October 1, 2025, through September 30, 2026, and provides information on how the fees for FY 2026 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Learn More🚬FDA Advisory Committee Meeting on Tobacco Products - Upcoming Notice
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC, the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Learn More📜Notice of Inventory Completion
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Wisconsin Oshkosh (UWO) has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
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