Health and Human Services Department
432 Federal Register documents from Health and Human Services Department, last 60 days.
Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request; Organ Procurement and Transplantation Network Board of Directors and Committee Member Applications and Forms
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork ...
Agency Forms Undergoing Paperwork Reduction Act Review
Agency Forms Undergoing Paperwork Reduction Act Review
Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026; Correction
This document corrects a typographical error in the proposed rule that appeared in the October 20, 2026 Federal Register titled "Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026".
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program
This rule finalizes and codifies the Medicare Drug Price Negotiation Program ("Negotiation Program") and establishes certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program ("Part D Program") as required by the Inflation Reduction Act of 2022. This final rule also finalizes ...
Meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting. It is open to the public, limited only by the space available and the number of audio ...
Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies
This final rule sets forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this final rule discusses the behavior adjustments and finalizes a temporary behavior adjustment. It also finalizes the recalibrated case-mix weights and ...
Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
This final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the ...
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots
This final rule with comment period revises the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experience with these systems. We also describe the changes to the amounts and factors used to ...
Announcement of the Intent To Award a Single-Source Cooperative Agreement to the Welcoming Initiative for Newcomers in San Diego, California
The ACF, ORR announces the intent to award a single-source cooperative agreement in the amount of up to $3,500,000 to the Welcoming Initiative for Newcomers (WIN) in San Diego, California, for the next phase of the State Capacity and Readiness Initiative. Building on the nationwide baseline assessment and related ...
Food Additive Petitions; Change of Address
The Food and Drug Administration (FDA or the Agency) is amending the regulations for food additive petitions (FAPs) to update addresses and simplify notification procedures. These technical amendments are being made to improve the accuracy of the Agency's regulations and are non-substantive.
Center for Scientific Review; Notice of Closed Meetings
Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion
The Food and Drug Administration (FDA) is classifying the external mechanical stimulator for the relief of congestion into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the external mechanical ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Expedited Office of Management and Budget Review and Public Comment: Unaccompanied Alien Children Sponsor Application Packet
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services, requests expedited review, from the Office of Management and Budget (OMB), of an information collection from ORR and invites public comments on the proposed collection. This information ...
Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
The Food and Drug Administration (FDA) is classifying the digital cervical cytology slide imaging system with artificial intelligence algorithm into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification ...
Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment
The Food and Drug Administration (FDA) is classifying the prognostic assessment software of mild cognitive impairment into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the prognostic ...
Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use
The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the wearable vibration device for ...
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Center for Scientific Review; Notice of Closed Meetings
Proposed Information Collection Activity; Information Comparison With Insurance Data
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting Office of Management and Budget (OMB) approval of the Information Comparison with Insurance Data (OMB #0970-0342, expiration January 31, 2027) for an additional 3 years. OCSE revised the Insurance Match ...
Submission for Office of Management and Budget Review; Sexual Risk Avoidance Education National Evaluation Impact Study of Co-Regulation Facilitation Strategies in Sexual Risk Avoidance Education Programs
The Office of Planning, Research and Evaluation (OPRE) and the Family and Youth Services Bureau (FYSB) in the Administration for Children and Families (ACF) are proposing to collect data for the new Sexual Risk Avoidance Education (SRAE) National Evaluation Impact Study of Co-Regulation Facilitation Strategies in SRAE ...
Center for Scientific Review; Notice of Closed Meetings
Office of the Director, Notice of Charter Renewal
Center for Scientific Review; Amended Notice of Meeting
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
On November 2, 2026, CMS published a notice in the Federal Register that sought comment on a collection of information concerning CMS-10599 (OMB control number 0938-1311) and titled "Pre-Claim Review Demonstration For Home Health Services." The notice contained incorrect information regarding the subject information ...
Submission for Office of Management and Budget Review; Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting a 3-year extension of the Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits. No changes are proposed to the ...
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 help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the ...
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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage
This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and provide additional operational flexibility for OPOs to achieve high performance resulting in the successful procurement, distribution, and transplantation of more life-saving ...
Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance
The Department of Health and Human Services (HHS or Department) issues this rule to revise the regulation implementing section 504 of the Rehabilitation Act of 1973 (section 504) as it applies to recipients of HHS funding (entitled "Nondiscrimination on the Basis of Disability in Programs or Activities Receiving ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
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 provides blood establishments that collect blood and blood components, including Source Plasma, with ...
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., located in Dover, Delaware, to practice the inventions embodied in the patent applications listed in the ...
Agency Forms Undergoing Paperwork Reduction Act Review
Agency Forms Undergoing Paperwork Reduction Act Review
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
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 Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently ...
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
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 emergency clearance process associated with the implementing regulations of the Paperwork Reduction Act ...
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 and Budget #0970-0517, expiration December 31, 2024).
Infant Formula Nutrient Requirements
The Food and Drug Administration (FDA or we) proposes to amend the regulations on nutrient specifications and labeling for infant formula as part of its phased, comprehensive review of infant formula nutrients. This action, if finalized, would amend the minimum and/or maximum levels of four required nutrients, change ...
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), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, ...
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 Health Service Act, and associated implementing regulations, prohibiting the boarding of any person who ...
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 Drugs and Biological Products." This revised draft guidance revises and replaces the draft guidance ...
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury (AKI) Dialysis Payment, and ESRD Quality Incentive Program
This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also includes updates to the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates the ...
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 document describes the Secretary of HHS's enforcement policy regarding the use of certain peptide bulk drug ...
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 Advisory Committee on Immunization Practices (ACIP). The ACIP consists of up to 19 experts that ...
Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea
The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the over-the-counter device ...
Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures
The Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the spinal imaging system for ...
Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease
The Food and Drug Administration (FDA) is classifying the radiology software for referral of findings related to fibrotic lung disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the ...
Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer
The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language ...
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-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of ...
Reducing Bureaucracy and Burden for Block Grants
ACF proposes to amend its block grant regulations to modernize requirements, reduce administrative burden on States and Tribal grantees, and improve the clarity and efficiency of program administration. The current regulations include outdated provisions and procedural requirements that no longer reflect statutory ...
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG)
The Department of Health and Human Services ("HHS" or "Department") is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), published in the Federal Register on October 12, 2023).
Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG)
The Department of Health and Human Services ("HHS" or "Department") is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) published on October 12, 2023.
Office of the Director, National Institutes of Health; Notice of Meeting
Office of the Director, National Institutes of Health; Notice of Meeting
Office of the Director, National Institutes of Health; Notice of Meeting
Reducing Bureaucracy and Burden for Child Support Enforcement Programs
This final rule amends the Child Support regulations that were unnecessary or obsolete in the following sections: State Plan Approval and Grant Procedures, State Plan Requirements, Standards for Program Operations, Federal Financial Participation, Program Performance Measures, Standards, Financial Incentives, and ...
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Fogarty International Center; Notice of Meeting
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Fogarty International Center; Notice of Meeting
National Institute on Aging; Notice of Meeting
National Institute on Aging; Notice of Meeting
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
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 inviting public comment on an extension request for an approved information collection request: ASPE ...
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 program between CMS and participating State-Based Administering Entities (AEs), titled "Determining ...
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 information collection "Questionnaire and Data Collection Testing, Evaluation, and Research for the ...
National Institute on Aging; Notice of Meeting
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Center for Scientific Review; Notice of Closed Meeting
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." The draft guidance document provides recommendations for how an individualized human genome editing ...
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 draft guidance for sponsors submitting IDE applications to the Center for Devices and Radiological ...
Health Data, Technology, and Interoperability: ONC Deregulatory Actions To Unleash Prosperity
This final rule focuses on deregulatory actions identified in HHS regulations regarding health information technology standards, implementation specifications, and certification criteria and regarding certification programs for health information technology. This final rule reduces burden, offers flexibility to both ...
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), Federal Agencies are required to publish notice in the Federal Register concerning each proposed ...
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 of 1995.
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 Agencies are required to publish notice in the Federal Register concerning each proposed collection ...
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) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product ...
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) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product ...
Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir)
The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
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), Federal Agencies are required to publish notice in the Federal Register concerning each proposed ...
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be ...
Submission for OMB Review; 30-Day Comment Request; The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research
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.
Center for Scientific Review; Notice of Closed Meetings
Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ...
Patient Protection and Affordable Care Act, Exchange Pre-Eligibility Verification
This proposed rule would implement new requirements specified under the Working Families Tax Cut (WFTC) legislation related to Exchange eligibility and verification. This proposed rule contains related updates to provisions affecting inconsistency periods, inconsistency verification procedures, annual eligibility ...
Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request; Organ Procurement and Transplantation Network Board of Directors and Committee Member Applications and Forms
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 ...
U.S.-Origin Statements on Seafood; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "U.S.-Origin Statements on Seafood." The draft guidance, when finalized, will provide examples of U.S.-origin statements in seafood product labeling that FDA would consider to be truthful and not ...
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork ...
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork ...
Requirement for Attestation for All Airline or Other Aircraft Passengers Arriving in the United States From Any Foreign Country and Controlled Free Pratique for Airlines Confirming That Such Passengers 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 it is issuing an Order under Sections 361, 365, 368, and 369 of the Public Health Service Act, and associated implementing regulations, prohibiting the boarding of any passenger who is not ...
Center for Scientific Review; Notice of Closed Meetings
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Fogarty International Center; Notice of Meeting
Submission for Office of Management and Budget Review; Office of Refugee Resettlement (ORR) Unaccompanied Alien Child Health Forms
The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting to move the Serious Medical Procedure Request (SMR) Form (Office of Management and Budget (OMB) #: 0970-0561, expiration December 31, 2026) under the Medical Assessment Form and Dental Assessment Form (OMB #: ...
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ISEMBYLD (apitegromab-mstn)
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) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for FDA Regulated Products
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 ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
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 ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; Correction of Notices-ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; DAYVIGO
The Food and Drug Administration (FDA) is announcing corrections to the notices of Determination of Regulatory Review Period for Purposes of Patent Extension for ANDEMBRY; ANZUPGO; ANKTIVA; BIZENGRI; BRINSUPRI; and DAYVIGO. The original determinations were announced in the Federal Registers of August 10, 2026 ...
Proposed Information Collection Activity; Child Care and Development Fund Plan Preprint for States/Territories for Federal Fiscal Year (FFY) 2028-2030 (ACF-118) and extension of Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025-2027
The Administration for Children and Families (ACF) is requesting an extension without changes of the form ACF-118: Child Care and Development Fund (CCDF) Plan Preprint for States/Territories for FFY 2025-2027 (Office of Management and Budget #: 0970-0114, expiration March 31, 2027), and an additional 3-year extension ...
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Amended Notice of Meeting
Questions and Answers Regarding Mandatory Cosmetics Recalls; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry." The guidance document provides answers to common questions that might arise about FDA's mandatory recall authority for ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: Advanced Nursing Education Program Specific Form OMB No. 0906-0089-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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR Part 60 Regulations and Forms, OMB No. 0906-0081-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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under ...
HHS Approval of Entities That Certify Medical Review Officers
This notice publishes a list of HHS approved Medical Review Officers (MROs) certification entities. The most recent HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 10, 2023, (Oral Fluid) and February 1, 2024, (Urine), address the role and qualifications ...
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Action Levels for Cadmium in Processed Food Intended for Babies and Young Children." The draft guidance, when finalized, will establish action levels for cadmium in certain processed ...
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current ...
Request for Public Comment: 60-Day Notice for Reinstated Collection: Division of Urban Indian Affairs Uniform Data System and Budget Formulation
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the public to comment on the information collection titled, "Division of Urban Indian Affairs (DUIA) Uniform Data System and Budget Formulation," Office of Management and Budget (OMB) Control Number 0917-0007. The IHS is ...
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
No Adjustment to HHS Civil Monetary Penalty Amounts for 2026
The Department of Health and Human Services (HHS or the Department) is notifying the public that there will be no Civil Monetary Penalty (CMP) inflation adjustment for 2026 in accordance with the April 17, 2026, guidance from the Office of Management and Budget (OMB). HHS will continue to use the 2025 civil monetary ...
Center for Scientific Review; Notice of Closed Meetings
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Title V Maternal and Child Health Services Block Grant to States Program: Guidance and Forms for the Title V Application/Annual Report, OMB No. 0915-0172-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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System, OMB No. 0915-0298-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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
Regulatory Considerations for Prescription Drug Use-Related Software; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Regulatory Considerations for Prescription Drug Use-Related Software." This final guidance describes FDA's application of its drug labeling authorities to certain software outputs that are ...
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 program between CMS and the Department of Veterans Affairs (VA), Veterans Health Administration ...
Agency Information Collection Activities: Proposed Collection; Public Comment Request; Information Collection Request Title: SAMHSA Data Security Requirements for Accessing Confidential Data (OMB No. 0930-0396)
Substance Abuse and Mental Health Services (SAMHSA), within the Department of Health and Human Services, has submitted the following information collection requirement to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This is the first notice for public ...
Center for Scientific Review; Notice of Closed Meetings
New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry." The guidance focuses on frequently asked questions about the new ...
Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026
This proposed rule would implement section 6219 (Adjustments to Medicare Part D Cost-Sharing Reductions for Low-Income Individuals), section 6220 (Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act), and section 6224 (Modernizing and Ensuring Pharmacy Benefit Manager Accountability) of the ...
Agency Forms Undergoing Paperwork Reduction Act Review
Agency Forms Undergoing Paperwork Reduction Act Review
National Cancer Institute; Notice of Meeting
National Cancer Institute; Notice of Meeting
National Cancer Institute; Notice of Partially Closed Meeting
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Center for Scientific Review; Notice of Closed Meetings
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Program Forms-OMB No. 0915-0285-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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
National Cancer Institute; Amended Notice of Meeting
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
Center For Scientific Review; Amended Notice of Meeting
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
Electronic Common Technical Document (eCTD); Data Standards; Supporting Forward Compatibility for eCTD 4.0
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Forward Compatibility for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.
Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 3.2.2 and Version 4.0
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing the date FDA will begin rejecting electronic submissions that fail new Electronic Common Technical Document (eCTD) Version 3.22 (v3.22) and Version 4.0 (v4.0) based ...
Submission for Office of Management and Budget Review; Unaccompanied Refugee Minors Program ORR-3 Report and ORR-4 Report
The Office of Refugee Resettlement (ORR) is requesting a three-year extension with revisions of the Unaccompanied Refugee Minors (URM) Program ORR-3 Report and ORR-4 Report (Office of Management and Budget #0970-0034, expiration 11/30/2026). Revisions were made to reduce burden and streamline information collection.
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Fit-for-Purpose Rare Disease Framework Initiative". Convened by the Reagan-Udall Foundation for, and in collaboration with FDA, the meeting will focus on developing a fit-for-purpose framework for the development and ...
Meeting of the Advisory Council for the Elimination of Tuberculosis
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 lines ...
Center for Scientific Review; Amended Notice of Meeting
National Institute on Drug Abuse; Notice of Closed Meeting
Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the issuance of four Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Elanco US Inc. for application on ...
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces it is issuing an Order under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain ...
Request for Nominations for Voting Members on a Public Advisory Committee; Tobacco Products Scientific Advisory Committee (TPSAC)
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. FDA seeks to include the views of qualified individuals on its advisory committees and therefore encourages nominations of ...
Center For Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
Further Reducing Bureaucracy and Burden From the Administration for Native Americans
The Department of Health and Human Services, Administration for Children and Families proposes to further amend the Native American Programs Act regulations to streamline the part.
Statement of Delegation of Authority
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products
The Food and Drug Administration (FDA, Agency, or we) 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.
Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cellular, Tissue, and Gene Therapies Advisory ...
Request for Public Comment: 60-Day Notice for Proposed Information Collection: Indian Health Service Purchased/Referred Care Proof of Residency
In compliance with the Paperwork Reduction Act (PRA) of 1995, which requires a 60-day public comment period on proposed information collection projects, the Indian Health Service (IHS) invites the public to take this opportunity to comment on the information collection titled, "Purchased/Referred Care (PRC) Proof of ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards
The Food and Drug Administration (FDA or we) 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements
The Food and Drug Administration (FDA, Agency, or we) 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.
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in food for laying hens and breeder chickens. This action is in response to a food additive ...
Health Center Program Performance Period Extensions; Correction
HRSA published a document in the Federal Register on September 24, 2026, concerning performance period extensions for health centers scheduled to compete for a January, February, or March FY 2027 Service Area Competition. The document did not include one service area that was not eligible for a performance period ...
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork ...
Agency Forms Undergoing Paperwork Reduction Act Review
Agency Forms Undergoing Paperwork Reduction Act Review
Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director Notice of Proposed Reorganization
The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director (OD), National Institutes of Health (NIH) is seeking public comment regarding its proposal to establish the Office of the NIH Chief Artificial Intelligence Officer (OCAIO) within DPCPSI and move the Office ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement, OMB No. 0915-0338-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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
The Food and Drug Administration (FDA or we) is issuing a final rule to amend our standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content. Reducing sodium may help reduce the risk ...
Announcing Solicitation of Written Comments To Inform the Physical Activity Guidelines for Americans, 2nd Edition Supplement: 2027 Steps and Muscle-Strengthening Guidance
The Department of Health and Human Services (HHS) announces the solicitation of public comments to inform the development of the Physical Activity Guidelines for Americans, 2nd edition Supplement: 2027 Steps and Muscle-Strengthening Guidance (2027 Steps and Muscle- Strengthening Guidance).
2025-2026 IACC Summary of Advances
The Interagency Autism Coordinating Committee (IACC) is preparing its Summary of Advances, a statutorily mandated report that highlights the most consequential autism research of the past year. The Committee is seeking suggested research articles to highlight for this report. On behalf of the IACC, the National ...
National Institute of Environmental Health Sciences; Notice of Meeting
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions from applicants and ...
Center for Scientific Review; Notice of Closed Meetings
Center For Scientific Review; Notice of Closed Meetings
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen)
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) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications, Procedures and Requirements
The Food and Drug Administration (FDA, Agency, or we) 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MONOFERRIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expanded Access to Investigational Drugs for Treatment Use
The Food and Drug Administration (FDA, Agency, or we) 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.
Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) oral solution, 10 milligrams (mg)/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug ...
Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsules, 50 Milligrams, 100 Milligrams, 200 Milligrams, and 400 Milligrams
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 208833 for Celecoxib capsules, 50 milligrams (mg), 100 mg, 200 mg, and 400 mg, held by Amneal Pharmaceuticals of New York, LLC, 50 Horseblock Rd., Brookhaven, NY 11719 (Amneal). Amneal requested ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data System for Organ Procurement and Transplantation Network, OMB No. 0906-0110-Revision
In compliance with of 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 ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Applicant Organizational National Provider Identifiers and Centers for Medicare & Medicaid Services Certification Numbers Form
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 ...
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing ...
Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The Food and Drug Administration (FDA) is classifying the system for detection of nucleic acid from non-viral microorganism(s) causing sexually transmitted infections using home-collected specimens into class II (special controls). The special controls that apply to the device type are identified in this order and ...
Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the infant ...
Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit
The Food and Drug Administration (FDA) is classifying the hematopoietic cell enrichment kit into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hematopoietic cell enrichment kit. We are ...
Agency Information Collection Activities: Proposed Collection; Comment Request
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry titled "Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants." The draft guidance states that, at this time ...
Challenges and Solutions in Lot-Level Food Traceability; Public Meeting
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting titled "Challenges and Solutions in Lot- Level Food Traceability." The purpose of the meeting is to provide a forum for the public to share information on continued implementation of the "Requirements for Additional Traceability ...
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Antibody Specifically Binding to Severe Fever With Thrombocytopenia Syndrome Virus Antigen and Use Thereof
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Korea National Institute of Health, located in Cheongju-si, Chungcheongbuk-do, South Korea ...
Removal of Obsolete Portion of Regulation Relating to Care and Treatment of Ineligible Individuals
The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or "the Department") is issuing this final rule to remove obsolete language appearing in the Code of Federal Regulations (CFR). The language refers to an outdated process for determining what the IHS will charge for care to ...
Removal of Obsolete/Suspended Regulations
The Indian Health Service (IHS) of the Department of Health and Human Services (HHS or "the Department") is issuing this final rule to remove regulations appearing in the Code of Federal Regulations (CFR). The regulations duplicate other regulations in the CFR, and have never been implemented by the IHS, and were ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
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 ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices: (Medical Product Safety Network (MedSun))
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.
Agency Information Collection Activities Comment Request
Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis
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 Advisory Council for the Elimination of Tuberculosis (ACET). The ACET consists of 10 experts including the ...
National Institute of Neurological Disorders and Stroke; Notice of Meeting
National Heart, Lung, and Blood Institute; Notice of Meeting
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes
This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic ...
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Notice of Closed Meetings
Clinical Center; Notice of Closed Meeting
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 13, 2023 (88 FR 62799). The notice announced the determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The notice ...
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 7, 2026. The document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 8, 2026. The document indicated that FDA was withdrawing ...
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination to exempt certain class II clinical toxicology test systems from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k) requirements, subject to certain limitations, is ...
Transparency in Coverage
These final rules set forth requirements that amend the regulations under the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code regarding price transparency reporting requirements for non- grandfathered group health plans and health insurance issuers offering ...
Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System
The Food and Drug Administration (FDA) is classifying the high throughput DNA sequencing for hereditary cancer predisposition assessment test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for ...
Determination PRALIDOXIME CHLORIDE (Autoinjector) (Pralidoxime Chloride) Solution, 600 Milligrams/2 Milliliters (300 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that PRALIDOXIME CHLORIDE (AUTOINJECTOR) (pralidoxime chloride) solution, 600 milligrams (mg)/2 milliliters (mL) (300 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated ...
Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry
The Food and Drug Administration (FDA) is classifying the hyperoxia monitoring device adjunct to pulse oximetry into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the hyperoxia monitoring ...
Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation
The Food and Drug Administration (FDA) is classifying the focused ultrasound system for non-thermal, mechanical tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the focused ...
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; FAYUVI (rebisufligene etisparvovec-hopf)
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) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product ...
Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information
The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, ...
National Cancer Institute; Notice of Meeting
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council) and the U.S. Department of Health and Human Services Alzheimer's Disease and Related Dementias Summit. The Advisory Council provides advice on how to prevent or reduce the burden of ...
Center for Scientific Review; Amended Notice of Meeting
Center for Scientific Review; Amended Notice of Meeting
Center for Scientific Review; Notice of Closed Meetings
Center For Scientific Review; Notice of Closed Meetings
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Submission for Office of Management and Budget Review; Federal Case Registry
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting a three-year extension of the Federal Case Registry (FCR) (Office of Management and Budget (OMB) # 0970-0421, expiration November 30, 2026) There are no changes requested to the FGR.
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 previously approved information collection project "Generic Clearance for the Collection of Qualitative Feedback on Agency ...
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 revision of a currently approved information collection project "AHRQ Consumer Assessment of Healthcare Providers and Systems (CAHPS) Database for Health ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Agency Forms Undergoing Paperwork Reduction Act Review
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork ...
Agency Forms Undergoing Paperwork Reduction Act Review
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork ...
Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants; Correction
This document corrects a technical error in the payment advisory that appeared in the August 13, 2026, Federal Register titled "Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians--Request for Current Billing Information for Qualifying APM Participants".
Reforming Federal Reporting and Assessments in Child Welfare
ACF proposes to remove regulations that implement title IV-B of the Social Security Act (the Act) because they are outdated and refer to dates that have passed, have been superseded by subsequent amendments to the Act, duplicate or restate requirements already in title IV-B of the Act or other Federal law, and/or ...
Submission for Office of Management and Budget Review; Mental Health Assessment Form and Onsite Health Intervention Form
The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) is requesting a 3-year extension with changes of the Mental Health Assessment Form and Onsite Health Intervention Form (formerly Public Health Investigation Form: Non-TB Illness, and Public Health Investigation Form: Active TB, OMB ...
Center For Scientific Review; Notice of Closed Meetings
Global Benchmark for Efficient Drug Pricing (GLOBE) Model
This final rule implements the Global Benchmark for Efficient Drug Pricing Model (GLOBE Model), a new mandatory Medicare payment model under section 1115A of the Social Security Act. The GLOBE Model will test whether a payment model that uses an alternative method for calculating Medicare Part B drug inflation rebate ...
Proposed Information Collection Activity; U.S. Repatriation Forms
The Administration for Children and Families (ACF) is requesting a 3-year extension of the U.S. Repatriation Program forms (OMB #0970-0474, expiration 1/31/2027). There are several changes requested to the thirteen forms. Burden estimates have also been updated.
Center for Scientific Review; Notice of Closed Meetings
Patient Safety Organizations: Delisting for Cause for the Hospital Rep Safety Solutions Corp. PSO
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be "delisted" by the Secretary if it is ...
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Notice of NIH Tribal Consultations and Listening Session
In accordance with the National Institutes of Health (NIH), Tribal Consultation Policy, the NIH will hold two Tribal Consultations and one Tribal listening session at the National Congress of American Indians (NCAI) Annual Convention. The first consultation will discuss two new proposed initiatives of the NIH All of ...
Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Antimicrobial Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional 2 years beyond ...
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Dermatologic and Ophthalmic Drugs Advisory Committee for ...
Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update; Correction
This document corrects technical errors in the final action that appeared in the July 31, 2026 Federal Register titled "Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update".
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program; Correction
This document corrects technical errors in the final rule that appeared in the August 3, 2026 Federal Register titled "Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program".
Period for Refugee Cash Assistance and Refugee Medical Assistance; Correction
The Office of Refugee Resettlement (ORR) published a notice in the Federal Register of July 14, 2026, extending the eligibility time period for Refugee Cash Assistance (RCA) and Refugee Medical Assistance (RMA). After further review of the considerations listed 45 CFR 400.211, ORR determined that the eligibility ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program
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.
Availability of Two Draft Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on a draft of the updated Toxicological Profiles for Cadmium and Hexachlorocyclopentadiene. This action provides an opportunity for the public and ...
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or ...
Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees
The Food and Drug Administration (FDA or Agency) is requesting nominations for qualified individuals to serve as voting members of FDA's standing public advisory committees and panels (collectively, advisory committees). This notice covers scientific, technical, professional, and other voting-member positions in which ...
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the ...
Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction
This document corrects technical errors in the final rule that appeared in the August 3, 2026 Federal Register titled "Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements".
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Center for Scientific Review; Notice of Closed Meetings
Center For Scientific Review; Amended Notice of Meeting
Recharter for the Council on Graduate Medical Education
In accordance with the Federal Advisory Committee Act (FACA), the Department of Health and Human Services is hereby giving notice that the Council on Graduate Medical Education (COGME or Council) has been recharted. The effective date of the charter renewal is September 30, 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 Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently ...
Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that ISTURISA (osilodrostat) tablets, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for osilodrostat tablets, 10 mg if ...
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027; Correction
This document corrects technical errors in the final rule that appeared in the July 31, 2026 Federal Register titled "Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027."
Center for Scientific Review; Notice of Closed Meeting
Notice of Supplemental Award; Maternal Health Research Collaborative for Minority-Serving Institutions Coordinating
HRSA is announcing a supplemental award to Morgan State University (MSU), a current HRSA awardee for the Maternal Health Research Collaborative for Minority Serving Institutions (MH-RC-MSI) Coordinating Center (CC). HRSA administers this grant using funding made available by the Department of Health and Human ...
Autism Longitudinal Data Project and Linking the Boston Birth Cohort and Pregnancy to Early Life Longitudinal Data System and Community-Level Health Databases: A Longitudinal Cohort of Mother-Child Dyads
HRSA administers this grant using funding made available by the Health and Human Services Assistant Secretary for Planning and Evaluation (ASPE) from the Patient Centered Outcomes Research Trust Fund (PCORTF) and awarded for this purpose to JHU. ASPE/PCORTF supports this multi-agency data linkage project to build ...
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards; Correction
This document corrects technical and typographical errors in the final rule that appeared in the Federal Register on August 4, 2026 titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and ...
Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SULFADIAZINE (sulfadiazine) ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 010401 for MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), held by FHTA LLC (FHTA). FHTA agreed to withdrawal of approval of this application and has waived its opportunity for a hearing.
Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response To Honor Our Living Donors Act
On July 1, 2026, HRSA published a notice in the Federal Register to solicit comments on proposed modifications to the Living Organ Donation Reimbursement Program (LODRP or Program) eligibility guidelines in response to the Honor Our Living Donors (HOLD) Act. The HOLD Act, enacted in February 2026, prohibits ...
Statement of Organization, Functions, and Delegations of Authority
This document revises and restates the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC). Issuance of this Statement of Organization rescinds all prior Statements of Organization.
AIM Incarcerated Women Resource Kit
In fiscal year (FY) 2026, a Congressional Report accompanying the Consolidated Appropriations Act, 2026 (Pub. L. 119-75) included additional funding for the Innovation on Maternal Health program specifically to "support the development and implementation of a resource kit for providers, as well as correctional custody ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Marrow Donor Program Patient Support Center Survey
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 ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects and Institutional Review Boards
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), Federal Agencies are required to publish notice in the Federal Register concerning each proposed ...
Submission for OMB Review; 30-Day Comment Request;
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.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (Office of the Director)
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.
Center for Scientific Review; Notice of Closed Meetings
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork ...
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork ...
Agency Forms Undergoing Paperwork Reduction Act Review
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF), System No. 09-80-0321, ORR ...
Center for Scientific Review; Amended Notice of Meeting
Center for Scientific Review; Notice of Closed Meetings
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low- burden, and ...
Draft NIH Policy on Sharing Summary Level Study Results With Clinical Research Participants
NIH seeks public input on its proposed NIH Policy on Sharing Summary Level Study Results with Clinical Research Participants, including ways to promote and enable the research community to share summary level study results with clinical research participants.
Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft ...
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application (NDA) 219694 for Atropine Sulfate Ophthalmic Solution, 0.01%
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the ...
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review ...
Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice
The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by Doehler GmbH, c/o Hogan Lovells Cadwalader, proposing that we amend our color additive regulations to provide for the safe use of calcium sulfate in various foods at levels consistent with good ...
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>2</INF> inactive bakers yeast as a source of vitamin D<INF>2</INF> in specific food categories. We are taking this action in response to a food additive petition filed by Lallemand Inc. ...
Jeffrey Thies: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeffrey Thies for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Thies was convicted of ...
Naveed Aslam: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Naveed Aslam from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. ...
Privacy Act of 1974; Matching Program
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), is providing notice of the re-establishment of a matching program between CMS and the Do Not Pay Working System, which is administered by the ...
Health Center Program Performance Period Extensions
Health centers with a current period of performance of January 1, 2023, through December 31, 2026; February 1, 2023, through January 31, 2027; or March 1, 2023, through February 28, 2027, are required to apply to continue serving their service area through a fiscal year 2027 Service Area Competition in response to a ...
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Announcement of the Intent To Award a Single-Source Cooperative Agreement to International Rescue Committee in New York, New York
The ACF, ORR, Refugee Program Bureau announces the intent to solicit and award a single-source cooperative agreement up to $20,000,000 to International Rescue Committee (IRC), in New York, New York, for the National Virtual Program for Professional Advancement. The proposed project period is September 30, 2026, ...
Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
The Department of Health and Human Services (HHS) is opening a public docket to solicit input, supporting data, and comments to assist HHS as it considers how best to regulate deceased donor islet cells and/or deceased donor islet cell products for the treatment of Type 1 diabetes (T1D). The purpose of this ...
Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards
This request for information (RFI) solicits input from interested parties for purposes of establishing standards for reasonable and relevant pharmacy contract terms and conditions under the Medicare prescription drug benefit. Section 6223(a) of the Consolidated Appropriations Act, 2026 (CAA, 2026) amends section ...
Patient Protection and Affordable Care Act; Temporary Moratoria on Certain Agent and Broker Registration To Participate in the Exchanges
This interim final rule with comment period (IFC) codifies the Department of Health and Human Services' (HHS) authority to impose a temporary moratorium pausing the registration of agents and brokers that do not have a current Plan Year registration with the Federally- facilitated Exchanges at the time the moratorium ...
Center for Scientific Review; Amended Notice of Meeting
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research for the benefit of the public health.
Sanjay Kumar: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sanjay Kumar for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Kumar was convicted of a ...
National Cancer Institute; Notice of Meeting
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration, OMB No. 0915-0379-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 public review of this ICR will be provided to OMB. OMB will accept further comments from the public ...
Nonclinical Testing Terminology
The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule that substitutes references to "animal" tests or studies with "nonclinical" tests or studies, adds a definition of the terms "nonclinical test" and "nonclinical study," and makes other comparable or conforming amendments in certain ...
Nonclinical Testing Terminology
The Food and Drug Administration (FDA, Agency, or we) is proposing to substitute references to "animal" tests or studies with "nonclinical" tests or studies, add a definition of the terms "nonclinical test" and "nonclinical study," and make other comparable or conforming amendments in certain safety and reporting ...
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Generic Information Collection Request for Health Resources and Services Administration Hotlines, Chatlines, and Online Portals
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 ...
Submission for OMB review; 30-Day Comment Request; the Impact and Costs of Promoting Objectivity in Research 42 CFR Part 50 Subpart F and Responsible Prospective Contractors 45 CFR Part 94 (Office of the Director)
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.
Center for Scientific Review; Amended Notice of Meeting
National Institute of Environmental Health Sciences; Notice of Meeting; Request for Public Input
Center for Scientific Review; Amended Notice of Meeting
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
The Food and Drug Administration (FDA, Agency, or we) 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
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 ...
Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
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 ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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 ...
Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
The Food and Drug Administration (FDA or Agency) is announcing year five of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP). This program facilitates the expedited CMC development of products under an investigational new drug application (IND) based on the anticipated clinical ...
Data Intermediaries and Approaches To Strengthen Public Health Data Exchange
The Centers for Disease Control and Prevention (CDC) seeks broad public input on how data intermediaries can be used to support secure, scalable, standards-based public health data exchange. CDC invites public comment to inform the evaluation and to explore how data intermediaries can advance broader goals to prevent ...
Request for Information on Electromagnetic Fields (EMFs), Radiofrequency (RF) Radiation, and Wireless Radiation Exposure
Consistent with the Department of Health and Human Services' emphasis on evaluating environmental factors that may affect human health, particularly among children and other potentially vulnerable populations, HHS seeks information on electromagnetic field (EMF) emissions and exposure, particularly RF and wireless, ...
Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
The Office of the Assistant Secretary for Health (OASH) is extending the solicitation period for nominations for appointment to the National Vaccine Advisory Committee (NVAC) that appeared in the Federal Register of August 12, 2026. All nominations received will be provided to the Assistant Secretary for Health for ...
Notice of Supplemental Funding, Medicare Rural Hospital Flexibility Program Evaluation Cooperative Agreement
HRSA is awarding supplemental funding under the Medicare Rural Hospital Flexibility (Flex) Program Evaluation Cooperative Agreement to one award recipient in fiscal year 2026 to expand analysis, evaluation, and dissemination activities that support Critical Access Hospitals (CAHs) and State Flex Programs.
Notice of Supplemental Funding, State Offices of Rural Health Coordination and Development Program
HRSA is awarding supplemental funding under the State Offices of Rural Health (SORH) Coordination and Development Program to one award recipient in fiscal year 2026 to support expanded technical assistance, capacity-building, and coordination activities for SORH and rural stakeholders nationwide.
Center for Scientific Review; Amended Notice of Meeting
Center for Scientific Review; Notice of Closed Meetings
Notice of Supplemental Funding, Rural Quality Improvement Technical Assistance Program
HRSA is awarding supplemental funding under the Rural Quality Improvement Technical Assistance Program to one award recipient in fiscal year 2026 to advance efforts to improve health care and quality of care in rural areas by supporting quality measure implementation, data reporting, and the use of data to drive ...
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under ...
Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health ...
Agency Forms Undergoing Paperwork Reduction Act Review
Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document
The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that ...
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report (OD)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comments on proposed data collection projects, the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and ...
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review ...
Notice of Supplemental Funding, Delta Region Community Health Systems Development Program
HRSA is awarding supplemental funding under the Delta Region Community Health Systems Development Program to one award recipient in fiscal year (FY) 2026 to provide technical assistance (TA) to rural health care organizations in the Delta region. This supplemental funding will support hospitals and clinics that ...
Healthy Start Self-Measured Blood Pressure Monitoring
Through the Supporting Healthy Start Performance Project cooperative agreement (HRSA-24-038), HRSA provides funding to the National Institute for Children's Health Quality (NICHQ) to provide technical assistance and support to Healthy Start Initiative (Healthy Start) award recipients. HRSA will provide supplemental ...
Infant-Toddler Court Program-National Resource Center
HRSA is providing supplemental award funds of $2,750,000 in federal fiscal year (FY) 2026 to ZERO TO THREE National Center for Infant, Toddler and Families, Inc., the current recipient of the Infant-Toddler Court Program (ITCP)--National Resource Center (NRC) cooperative agreement (HRSA-22-074). These funds will ...
Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products." This draft guidance has been developed for veterinary use by the International Cooperation on ...
National Library of Medicine; Notice of Partially Closed Meeting
Center for Scientific Review; Amended Notice of Meeting
National Center for Advancing Translational Sciences; Amended Notice of Meeting
Notice of Supplemental Funding, National Rural Health Policy, Community, and Collaboration Program
HRSA will provide additional award funds to the National Rural Health Policy, Community, and Collaboration Program recipient, the National Rural Health Association, to identify, engage, educate, and collaborate with rural stakeholders on national rural health issues and promising practices to improve health care in ...
Notice of Supplemental Funding, National Rural Health Information Clearinghouse Program
HRSA will provide additional award funds to the National Rural Health Information Clearinghouse Program recipient under HRSA-25-009, the University of North Dakota, to provide information, data, and tools related to rural health to support improving health care in rural areas.
Notice of Supplemental Funding; Rural Residency Planning and Development Technical Assistance Program
HRSA will provide additional award funds to the Rural Residency Planning and Development Technical Assistance (RRPD-TA) Program recipient, the University of North Carolina at Chapel Hill, to provide additional technical assistance on rural graduate medical education and support the improvement of health care in rural ...
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method." The guidance document provides recommendations on ...
Agency Information Collection Activities: Proposed Collection; Comment Request
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a ...
Medicare and Medicaid Programs; Application From DNV Healthcare USA Inc. (DNV) for Continued CMS-Approval of its Hospital Accreditation Program
This notice acknowledges the approval of an application from DNV Healthcare USA Inc. (DNV) for continued CMS recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Proposed Information Collection Activity; Diaper Distribution Demonstration and Research Pilot Beneficiary and Organizational Survey and Beneficiary Report
The Office of Community Services (OCS), Administration for Children and Families (ACF), Department of Health and Human Services, is proposing to continue to collect data to understand diaper need and outcomes for beneficiaries of the Diaper Distribution Demonstration and Research Pilot (DDDRP). This collection (Office ...
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2027
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on ...
Medicare Program; Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Level II Coding
This notice announces the second biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026 to discuss the CMS preliminary coding, Medicare benefit category, and Medicare payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and ...
Center for Scientific Review; Notice of Closed Meetings
Opportunity To Co-Sponsor Events With the Office of Research Integrity
The Office of Research Integrity (ORI) announces an ongoing opportunity for non-federal public and private sector entities to co- sponsor conferences, workshops, symposia, meetings, roundtables, or other similar events (collectively, "Events") with ORI. ORI co- sponsors a limited number of Events with non-federal ...
Government-Owned Inventions; Availability for Licensing
The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which is owned by an agency of the U.S. Government and is available for licensing to achieve ...
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Amended Notice of Meeting
Center for Scientific Review; Amended Notice of Meeting
Agency Information Collection Request; 30-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, submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. OMB will accept further comments from the public ...
Order Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease Exists
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces it is issuing an Order under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
The Food and Drug Administration (FDA, Agency, or we) 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.
Proposed Collection; 60-Day Comment Request; NIH Intramural Reporting of Research Misconduct (IRRM) Web Form (Office of the Director/Office of Intramural Research)
The NIH Intramural Research Program (IRP) relies on a trustworthy research record to sustain public confidence and advance public health. NIH maintains procedures in compliance with NIH policy and 42 CFR part 93 to evaluate allegations of research misconduct, including falsification, fabrication, and plagiarism, ...
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pathogen-Agnostic Sequencing
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. In addition, the Committee will meet to ...
World Trade Center Health Program; Petition 048a-Peripheral Artery Disease; Finding of Insufficient Evidence
The Administrator of the World Trade Center (WTC) Health Program has received a petition (Petition 048a) to add "peripheral vascular disease" (referred to herein as "peripheral artery disease") to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information ...
World Trade Center Health Program; Petitions 048 and 051a-Stroke; Finding of Insufficient Evidence
The Administrator of the World Trade Center (WTC) Health Program has received two petitions (Petitions 048 and 051a) to add "stroke" to the List of WTC-Related Health Conditions. Upon reviewing the scientific and medical literature, including information provided by the petitioners, the Administrator has determined ...
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Engineered Cell Therapies for the Treatment of HPV 16 E6-Expressing Cancers
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the patents and patent applications listed in the Supplementary Information section of this notice ...
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Amended Notice of Meeting
Proposed Information Collection Activity; Multistate Financial Institution Data Match With Federally Assisted State Transmitted Levy
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting a 3-year extension of the Multistate Financial Institution Data Match (MSFIDM) with Federally Assisted State Transmitted (FAST) Levy (Office of Management and Budget #: 0970-0196, expiration January 31, 2027). ...
Center for Scientific Review; Notice of Closed Meetings
Center for Scientific Review; Amended Notice of Meeting
National Cancer Institute; Notice of Closed Meeting
Center for Scientific Review; Notice of Closed Meetings
Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments
The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect feedback on statistical considerations for rare disease clinical investigations. This docket is open in conjunction with a Rare disease Innovation, Science, and Exploration (RISE) Workshop on the same topic. Feedback ...
Agency Forms Undergoing Paperwork Reduction Act Review
Agency Forms Undergoing Paperwork Reduction Act Review
Announcing the Intent To Award a Single-Source Supplement for Expanding Outreach and Professional Training To Engage Older Adults With Behavioral Health Conditions in Evidence-Based Health Promotion Programs
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Lake Erie College of Osteopathic Medicine (LECOM) for Expanding Outreach and Professional Training to Engage Older Adults with Behavioral Health Conditions in ...
Solicitation for Nominations To Serve on the Advisory Council To Support Grandparents Raising Grandchildren
The Administration for Community Living (ACL) seeks nominations for individuals to serve on the Advisory Council to Support Grandparents Raising Grandchildren.
Solicitation for Nominations To Serve on the Family Caregiving Advisory Council
The Administration for Community Living (ACL) seeks nominations for individuals to serve on the Family Caregiving Advisory Council.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Customer Service Satisfaction Surveys
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.
Office of the National Coordinator for Health Information Technology; Health Information Technology Advisory Committee; Amended Notice of Meeting
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Proposed Collection; 60-Day Comment Request; NIH Electronic Application System for NIH Certificates of Confidentiality (CoC)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Science Policy (OSP), in the Office of the Director (OD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects ...
Draft NIH Biosafety Policy for Research Involving Biohazards
As the world's largest public funder of biomedical research, the National Institutes of Health (NIH) is committed to ensuring that gold-standard science is conducted under gold-standard biosafety conditions. To achieve this goal, NIH is proposing a new policy that modernizes and strengthens biosafety practices to ...
National Heart, Lung, and Blood Institute; Notice of Meeting
Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cardiovascular ...
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), federal agencies are required to publish notice in the Federal Register concerning each proposed ...
Notice of Supplemental Funding, Appalachian Region Healthcare Support Program
HRSA is providing additional funding under the Appalachian Region Healthcare Support Program to one award recipient in fiscal year (FY) 2026. This supplemental funding will support additional technical assistance (TA) to help rural healthcare organizations located in the rural counties served by the Appalachian ...
Notice of Supplemental Funding, Infant-Toddler Court Program-State Awards
HRSA is providing additional award funds to 11 current ITCP-- State Award recipients previously funded under HRSA-22-73 to support the continuation and expansion of existing activities to build state and local capacity and implement the infant-toddler court approach in federal fiscal year (FY) 2026.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Health Network Development Program Performance Improvement and Measurement System, OMB No. 0906-0010-Revision
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, ...
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate
The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking
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), Federal Agencies are required to publish notice in the Federal Register concerning each proposed ...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
The Food and Drug Administration (FDA or the Agency) 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.
Notice of Supplemental Funding, Rural Hospital Stabilization Pilot Program
HRSA is awarding supplemental funding under the Rural Hospital Stabilization Pilot Program to two award recipients in fiscal year (FY) 2026 to provide in-depth technical assistance (TA) to rural hospitals to enhance and/or expand service lines to meet local needs and keep health care services available locally.
National Institute on Aging; Amended Notice of Meeting
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Center for Scientific Review; Notice of Closed Meetings
Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposing that the food additive regulations be amended to provide for the safe use of hydrolyzed lignin as a source of neutral detergent soluble fiber in food for ...
Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human ...
Center for Scientific Review; Notice of Closed Meetings
National Center for Advancing Translational Sciences; Notice of Public Online Roundtable
The National Center for Advancing Translational Sciences (NCATS) will host a public online roundtable to share the latest updates on how NCATS is advancing translational science research and provide an opportunity for an interactive discussion with NCATS director Dr. Joni Rutter.
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for ...
Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for ...
Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the ...
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for ...
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of ...
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the implanted tibial ...
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the vaginal hydrogel packing system. We are taking ...
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
The Food and Drug Administration (FDA) is classifying the whole room microbial reduction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the whole room microbial reduction device. We ...
Notice of Supplemental Funding, Medicare Rural Hospital Flexibility Program
HRSA is providing additional fiscal year 2026 funding under the Medicare Rural Hospital Flexibility (Flex) Program using the program's established funding methodology, including a baseline increase for all recipients and an additional adjustment for states with newly designated Critical Access Hospitals (CAHs). This ...
Announcing the Intent To Award a Single-Source Supplement to the Senior Medicare Patrol (SMP) Resource Center
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Northeast Iowa Area Agency on Aging (NEI3A) for the SMP Resource Center. The administrative supplement for FY 2026 will be in the amount of $226,000, bringing the ...
Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding ...
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus Vaccines
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products
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 ...
Privacy Act of 1974; System of Records
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), titled "Hospice Item Set (HIS) System," System No. 09-70-0548. The amended System of Records Notice ...
Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office ...
Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications
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 ...
Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANZUPGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office ...
Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office ...
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under ...
Reorganization of the National Center for Immunization and Respiratory Diseases
CDC has modified its structure. This notice announces the reorganization of the National Center for Immunization and Respiratory Diseases (NCIRD). NCIRD has consolidated offices, retitled divisions and branches, and modified mission and function statements.