Notice 31 Jul 2025 regulatory compliance, healthcare, hhs, hipaa, nppes, provider data

🏥Changes to NPPES Data Collection Practices Impacting Providers

This notice provides information on changes to a data element collected by the National Plan and Provider Enumeration System (NPPES) when a provider applies for a National Provider Identifier (NPI), which changes are made pursuant to provisions of the January 20, 2025, Executive Order, 14168 (90 FR 8615). This notice also provides an explanation of the nature and rationale for the changes, and their effect on public-facing data available in NPPES downloadable files and the query-only database on the internet.

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Notice 31 Jul 2025 compliance, healthcare, cms, information collection, regulation, medicare

🏥Agency Information Collection Notice - CMS Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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Notice 30 Jul 2025 healthcare, regulation, business impact, fda, user fees, biosimilars

💵FDA Announces Biosimilar User Fee Rates for FY 2026

The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year.

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Notice 30 Jul 2025 compliance, healthcare, regulation, data collection, transplant centers

🏥Agency Information Collection for Stem Cell Therapeutic Outcomes Database

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 30 Jul 2025 healthcare, regulations, medicare, financial incentives, alternative payment models, clinicians

💰Medicare APM Incentive Payment Advisory for Clinicians

This advisory is to alert certain clinicians who are qualifying Alternative Payment Model (APM) participants (QPs) and have earned an APM incentive payment that CMS does not have the current information needed to disburse the payment. This advisory provides information to QPs on how to update their Medicare billing information so that CMS can disburse APM incentive payments.

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Notice 30 Jul 2025 healthcare, regulations, advisory committee, fda, arthritis

🏥FDA Terminates Arthritis Advisory Committee Notice

The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Agency's Arthritis Advisory Committee (Committee) by the Commissioner of Food and Drugs (Commissioner). The Commissioner has determined that it is not necessary to continue to maintain this Committee.

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Notice 30 Jul 2025 healthcare, business compliance, fda, fees, outsourcing facilities

💰FDA Announces FY 2026 Outsourcing Facility Fee Rates

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2026 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2026 rates for the small business establishment fee ($6,829), the non-small business establishment fee ($20,726), and the reinspection fee ($20,486) for outsourcing facilities; provides information on how the fees for FY 2026 were determined; and describes the payment procedures outsourcing facilities should follow.

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Notice 30 Jul 2025 healthcare, information collection, regulation, health resources, federal programs

📋HRSA Proposed Information Collection for Nurse Corps and NHSC

In compliance with the Paperwork Reduction Act of 1995 requirement for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

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Notice 29 Jul 2025 compliance, healthcare, regulations, fda, medical devices

📋FDA Medical Device Reporting Requirements and Compliance Overview

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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Notice 29 Jul 2025 regulatory compliance, healthcare, business operations, fda, export requirements

📦FDA Review of Export Notification and Recordkeeping Requirements

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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