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RCMHUB360

Actualizaciones de salud para prácticas en EE. UU.

Nuevas reglas, propuestas y avisos de CMS y HHS, tomados del Federal Register oficial. Los títulos aparecen en inglés porque así se publican. Abra cualquier elemento para leer la fuente original.

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47 actualizaciones · Obtenido el 03/11/2026 del Federal Register

Aviso · 03/11/2026

Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to he…

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Aviso · 03/11/2026

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: Faculty Loan Repayment Program, OMB No. 0906-0082-Revision

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 pu…

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Aviso · 03/11/2026

Agency Information Collection Activities: Proposed Collection; 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), federa…

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Aviso · 03/11/2026

Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus." The guidance document prov…

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Aviso · 02/11/2026

Prospective Grant of Exclusive Patent License: Catheter-Based Intramyocardial Ablation for Treating Ventricular Arrhythmia in a Human

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to AntaraCore, Systems, Inc., locat…

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Aviso · 02/11/2026

Agency Information Collection Activities: Proposed Collection; 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), federa…

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Aviso · 02/11/2026

Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies

The Department of Health and Human Services (HHS) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal…

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Aviso · 02/11/2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

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Aviso · 02/11/2026

Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)

The Centers for Medicare & Medicaid Services (CMS) is requesting that an information collection request revision for the Review Choice Demonstration or Home Health Services (CMS-10599/0938- 1311) processed under the eme…

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Aviso · 02/11/2026

Proposed Information Collection Activity; Federal Fiscal Year (FFY) 2027 Child Care and Development Fund (CCDF) Quality Progress Report

The Administration for Children and Families (ACF) is requesting a 3-year reinstatement with changes to information collection: Child Care and Development Fund (CCDF) Quality Progress Report (QPR)--(Office of Management…

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Aviso · 30/10/2026

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program-Transformation: Optimization and Best Practices in the Evolving Health Care Landscape, OMB No. 0906-XXXX-New

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), …

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Aviso · 30/10/2026

Notice of Amended Order Requirement for Attestation by All Persons Arriving in the United States From Any Foreign Country Via Transportation by Aircraft and Controlled Free Pratique for Airlines and Other Aircraft Operators Confirming That Such Persons Have Not Been in the Democratic Republic of the Congo in the Past 21 Days

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of an Amended Order under Sections 361, 365, 368, and 369 of the Public Heal…

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Aviso · 30/10/2026

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drug…

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Aviso · 30/10/2026

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting

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Aviso · 30/10/2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

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Aviso · 30/10/2026

Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

The Secretary of the Department of Health and Human Services (HHS) is announcing the availability of an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." This documen…

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Aviso · 30/10/2026

Solicitation of Nominations for Appointment to the Advisory Committee on Immunization Practices

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisor…

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Aviso · 30/10/2026

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, titled Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-…

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Aviso · 29/10/2026

Office of the Director, National Institutes of Health; Notice of Meeting

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Aviso · 29/10/2026

Office of the Director, National Institutes of Health; Notice of Meeting

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Aviso · 29/10/2026

Office of the Director, National Institutes of Health; Notice of Meeting

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Aviso · 29/10/2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

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Aviso · 29/10/2026

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

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Aviso · 29/10/2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

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Aviso · 29/10/2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

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Aviso · 29/10/2026

Agency Information Collection Activities: Submission for OMB Review; 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), federa…

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Aviso · 29/10/2026

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

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Aviso · 29/10/2026

Agency Information Collection Request. 60-Day Public Comment Request

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services (HHS), the Assistant Secretary for Planning and Evaluation (ASPE) is i…

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Aviso · 29/10/2026

Privacy Act of 1974; Matching Program

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), is providing notice of a computer matching…

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Aviso · 28/10/2026

Agency Information Collection Activities: Proposed Collection; Comment Request

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 extension without change of the currently approved infor…

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Aviso · 28/10/2026

National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

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Aviso · 28/10/2026

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

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Aviso · 28/10/2026

Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management." T…

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Aviso · 28/10/2026

Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this …

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Aviso · 28/10/2026

Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs

The Food and Drug Administration (FDA, Agency, or we) 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), Fed…

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Aviso · 28/10/2026

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification

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 o…

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Aviso · 28/10/2026

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys

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 …

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Aviso · 28/10/2026

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; EMCITATE (Tiratricol)

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authoriz…

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Aviso · 28/10/2026

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ATEBRIOZ (Zilurgisertib)

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authoriz…

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