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The Food and Drug Administration (FDA) has announced the release of draft guidance titled "Developing Drugs for Optical Imaging." This guidance aims to provide advice to drug sponsors on designing clinical trials to develop and approve optical imaging drugs used with imaging devices during surgeries. Optical imaging drugs help surgeons identify tumors and differentiate them from normal tissue, enhancing surgical safety and effectiveness. Public comments on the draft can be submitted until April 8, 2025, although feedback is welcomed anytime.

The Agricultural Marketing Service (AMS) of the Department of Agriculture is implementing a new rule to establish standardized formulas for calculating user fees for services provided by the Federal Grain Inspection Service (FGIS). The changes aim to help FGIS charge fees that cover the costs of these services and maintain a reserve fund for operations, as required by law. The rule also includes some corrections and updates to existing regulations without imposing new requirements. These new fee regulations will ensure greater transparency and predictability for businesses using FGIS services.

The U.S. Nuclear Regulatory Commission (NRC) is updating its regulations to increase the maximum fines it can impose for violations. These changes are required by a federal law that adjusts penalties for inflation. For violations of the Atomic Energy Act, the penalty will increase from $362,814 to $372,240 per violation, per day. Additionally, for false claims under the Program Fraud Civil Remedies Act, the penalty will increase from $13,946 to $14,308. These new penalties take effect on January 15, 2025.

The Rural Business-Cooperative Service of the USDA released a correction to a previous notice about the Rural Energy for America Program. The original notice contained mistakes regarding the points given for the size of the funding request and for applicants who hadn’t received grants or loan commitments in the past two years. The corrections specify that applicants who haven’t recently received funding can earn 5 extra points. Additionally, smaller grant requests can qualify for 10 extra points, with a total maximum score possible of 100 points for those applications.

The U.S. Nuclear Regulatory Commission (NRC) has updated its rules to adjust the maximum fines it can charge for violations. This is required by a law called the Federal Civil Penalties Inflation Adjustment Act, which makes sure penalties keep pace with inflation. Now, fines for breaking the Atomic Energy Act will increase from $303,471 to $307,058 per violation, per day. Additionally, fines related to fraudulent claims under the Program Fraud Civil Remedies Act will rise from $11,665 to $11,803 per false claim or statement.

The Federal Energy Regulatory Commission (FERC) has issued a final rule to update its regulations by incorporating the latest standards (Version 004) for business practices and communication protocols for public utilities. These standards, developed by the North American Energy Standards Board (NAESB), aim to enhance consistency in utility operations and bolster cybersecurity. FERC requires utilities to make compliance filings by June 27, 2025, and to implement cybersecurity standards by February 27, 2026, with the remaining standards by August 27, 2026. The rule ensures public utilities adhere to updated practices that support reliable and secure energy systems.

The Food and Drug Administration (FDA) is seeking public comments on a concept paper regarding the use of medically important antimicrobial drugs in animal feed. The paper suggests a framework for how drug sponsors can define the duration of use for these drugs in food-producing animals, aiming to prevent antimicrobial resistance and promote public health. The FDA is particularly interested in input on the timelines and processes proposed in the paper and hopes to use the feedback to create draft guidance. Comments can be submitted electronically or in writing by April 12, 2021.

The Food and Drug Administration (FDA) has issued a correction notice regarding a previously published document in the Federal Register on January 7, 2025. The original document announced the availability of final guidance for industry titled "Action Levels for Lead in Processed Food Intended for Babies and Young Children" but contained an error in the Background section. The correction clarifies that the parenthetical citation should refer to "88 FR 4797" instead of the incorrect information. This correction ensures accuracy in the FDA's guidance documentation.

The U.S. Nuclear Regulatory Commission (NRC) has issued a new version, Revision 4, of Regulatory Guide (RG) 1.32 and introduced a new guide, RG 1.238, concerning the standards for power systems in nuclear power plants. RG 1.32 details how to design, operate, and test electric power systems in nuclear plants, while RG 1.238 focuses on protecting specific types of power systems and equipment. These guides provide methods approved by the NRC for meeting regulations, and they incorporate updated standards from the Institute of Electrical and Electronics Engineers (IEEE). The issuance of these guides does not enforce any new regulatory requirements on licensees.

The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have issued a notice about two requests for proposals that were initially published on September 24, 2020. These proposals involve the reimportation of insulin and the personal importation of prescription drugs. The notice updates these proposals to include revised versions in the Federal Register. Responses to the proposals can be submitted via email and will be reviewed on a rolling basis.