Notice 3 Jul 2025 healthcare, regulation, pharmaceuticals, fda, drug approvals

💊FDA Determines SYNDROS Not Withdrawn, Opens Doors for Generics

The Food and Drug Administration (FDA, Agency, or we) has determined that SYNDROS (dronabinol) solution, 5 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SYNDROS (dronabinol) solution, 5 mg/ mL, if all other legal and regulatory requirements are met.

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Rule 3 Jul 2025 environmental protection, business compliance, environmental regulations, federal agencies, environmental impact statements, nepa, department of the interior, infrastructure projects

🌱Update on NEPA Regulations and Compliance Requirements

The Department of the Interior (Department or DOI) is partially rescinding and making necessary targeted updates to its remaining regulations implementing the National Environmental Policy Act (NEPA), which were promulgated to "supplement" now-rescinded Council on Environmental Quality (CEQ) NEPA implementing regulations. Mindful that the Supreme Court recently clarified NEPA is a "purely procedural statute," DOI will henceforth maintain the remainder of its NEPA procedures--which apply only to DOI's internal processes--in a Handbook separate from the Code of Federal Regulations (CFR). This interim final rule requests comments on this action and related matters to inform DOI's decision-making.

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Rule 3 Jul 2025 regulation, aviation, incorporation by reference, business compliance, alaska, airspace, navigation (air)

✈️Class E Airspace Modification at Wrangell Airport - Business Impact

This action modifies the Class E airspace extending upward from 700 feet above the surface at Wrangell Airport, Wrangell, AK; removes redundant Class E airspace extending upward from 1,200 feet above the surface; and makes administrative updates to the airport's legal description. In sum, these actions support the safety and management of instrument flight rules (IFR) operations at the airport.

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Presidential Document 3 Jul 2025 federal regulations, executive order, international relations, peace missions

🕊️Executive Order Establishing White House Office for Special Peace Missions

Executive Order 14311 establishes a White House Office for Special Peace Missions aimed at resolving global conflicts. Headed by a Special Envoy for Peace Missions, the office will coordinate with existing departments to advance peace efforts. The order clarifies its implementation aligns with current laws and does not create enforceable rights.

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Rule 3 Jul 2025 environmental protection, regulation, foreign relations, defense, environmental impact statements, nepa, army, federal-contracting, environmental-compliance

🌍Army NEPA Regulations Rescinded

This interim final rule rescinds the Department of the Army regulations implementing the National Environmental Policy Act (NEPA), because the Council on Environmental Quality's (CEQ) NEPA regulations, which they were meant to supplement, have been rescinded, and because the DoD is promulgating Department-wide NEPA procedures that will guide the Army's NEPA process. In addition, this interim final rule requests comments on this action and related matters.

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Notice 3 Jul 2025 business compliance, financial regulations, treasury, immigration bonds, interest rates

💰Notice on Interest Rate for Immigration Bonds by Treasury

For the period beginning July 1, 2025, and ending on September 30, 2025, the U.S. Immigration and Customs Enforcement Immigration Bond interest rate is 3 per centum per annum.

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Notice 3 Jul 2025 compliance, regulation, treasury department, executive order, business law, criminal enforcement

⚖️Treasury Guidance on Criminal Enforcement Referrals for Businesses

Pursuant to the recent executive order, "Fighting Overcriminalization in Federal Regulations," this notice announces plans to address criminally liable regulatory offenses, including factors to be considered in deciding whether to refer alleged violations of criminal regulatory offenses to the Department of Justice.

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Notice 3 Jul 2025 compliance, healthcare, information collection, fda, medical devices, 510k

📋FDA Notice on Proposed Information Collection for 510(k) Reviews

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 information collection associated with the 510(k) Third-Party Review Program.

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Notice 3 Jul 2025 compliance, government, sunshine act, nuclear regulatory commission, public meetings

🏢NRC Announces Public Meeting Schedule for June 2025

The Nuclear Regulatory Commission (NRC) announces its public meetings for the week of June 30, 2025, under the Government in the Sunshine Act. The meetings will address internal management and personnel matters, and individuals requiring accommodations for participation can contact the NRC for assistance.

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Notice 3 Jul 2025 compliance, safety standards, regulation, transportation, united states, railroad, canada, air brakes

🚂Notice of Waiver Petition for Air Brake Compliance in Rail Transport

This document provides the public notice that Canadian Pacific Kansas City Limited (CPKC) and Union Pacific Railroad (UP) petitioned FRA for relief from certain regulations concerning air brake testing.

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