Notice 21 May 2025 financial reporting, compliance, regulation, healthcare, cms

📊CMS Notice on Information Collection Activities and Compliance

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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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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Proposed Rule 21 May 2025 compliance, regulation, healthcare, hospice, payment, medicare

🏥Medicare FY 2026 Hospice Wage Index and Payment Rate Update

The Department of Health and Human Services proposes updates to the Medicare Program, specifically concerning the FY 2026 Hospice Wage Index and Payment Rate. This document includes corrections and outlines the necessary requirements for hospice quality reporting, impacting reimbursement procedures for hospice services.

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Notice 21 May 2025 compliance, regulation, healthcare, information collection, cms

📋CMS Information Collection Activities

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 20 May 2025 fluorouracil, chemotherapy, regulatory compliance, healthcare, dihydropyrimidine dehydrogenase, fda

💉FDA Notice on DPD Deficiency and Fluoropyrimidine Drugs

The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit public comment for information on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluorouracil and capecitabine (both fluoropyrimidine chemotherapy drugs). The purposes of the docket establishment are to foster Agency transparency and to solicit input on the currently available information on DPD deficiency and the use of fluorouracil and capecitabine.

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Notice 20 May 2025 drug enforcement, controlled substances, research, import regulations, healthcare, compliance

⚗️Usona Institute Seeks Registration to Import Controlled Substances

Usona Institute. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

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Notice 19 May 2025 federal regulations, public comment, healthcare, shortage designations, hrsa

🏥Public Comment Request on Shortage Designation Management System

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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 19 May 2025 regulatory compliance, healthcare, data collection, infection prevention, ahrq

🏥Proposed Information Collection on Infection Prevention in Healthcare

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project (new): "The AHRQ Safety Program for Healthcare Associated Infection Prevention." This proposed information collection was previously published in the Federal Register on November 20, 2024 and allowed 60 days for public comment. AHRQ received comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

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Notice 19 May 2025 healthcare, research, data collection, nih, drug abuse

🧠NIH Brain Development Cohorts Data Use Certification Review Notice

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

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Notice 19 May 2025 regulatory compliance, public meeting, drug manufacturing, fda, healthcare, generic drugs, user fees

💊FDA Announces Public Meeting on Generic Drug User Fee Reauthorization

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (i.e., the GDUFA III Commitment Letter) (https://www.fda.gov/industry/ generic-drug-user-fee-amendments/gdufa-iii-reauthorization); provide a period of 30 days after the public meeting to obtain written comments from the public; and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.

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Notice 19 May 2025 healthcare, business, irs, compliance, regulation

📄IRS Seeks Comments on Health Plan Notification Requirements

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments regarding the burden associated with the requirement of informing each participant (in the individual market, primary subscriber) of the terms of the plan or coverage and their right to designate a primary care provider.

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