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Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking...
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Electronic Import Entries; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The present revisions are necessary to correct editorial errors and to...
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Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections
On August 31, 2016, the Food and Drug Administration (FDA or Agency) published an amended final rule that listed inaccurate cross- references to FDA's drug establishment registration and drug listing regulations. This document corrects the inaccurate cross-references used in the final regulations.
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New Animal Drugs; Approval of New Animal Drug Applications
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2020. FDA is informing the public of the availability of summaries of the basis of...
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Medical Devices; Technical Amendments
The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete office with updated information. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to...
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Securing Updated and Necessary Statutory Evaluations Timely; Administrative Delay of Effective Date; Correction
The Department of Health and Human Services (HHS or Department) is postponing, pending judicial review, the effective date of a final rule entitled ``Securing Updated and Necessary Statutory Evaluations Timely'' (SUNSET final rule) and published in the Federal Register of January 19, 2021. This document also corrects certain errors in the SUNSET...
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Implementation of Executive Order on Access to Affordable Life-Saving Medications; Final Rule; Delay of Effective Date
This final rule implements a further delay until July 20, 2021, of the effective date of the rule entitled ``Implementation of Executive Order on Access to Affordable Life-saving Medications'' published in the Federal Register on December 23, 2020. This rule was scheduled to take effect on March 22, 2021, after a delay from its original...
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Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Additional Delayed Effective Date
As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (``Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving...
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New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2020. FDA is informing the public of the availability of summaries of the basis of approval...
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Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correction
This document corrects technical errors in the final rule that appeared in the December 28, 2020, Federal Register entitled, ``Medicare Program; CY 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program...
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Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date; Public Comment Period
Consistent with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, titled ``Regulatory Freeze Pending Review,'' this document delays the effective date of the final rule titled, ``Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary' '' published...
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New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2020. FDA is informing the public of the availability of summaries of the basis of approval and of...
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Health and Human Services Grants Regulation
The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (D.D.C. Feb. 2, 2021), has postponed the effectiveness of portions of the final rule making amendments to the Uniform Administrative Requirements, promulgated on January 12, 2021. Those provisions are now effective August 11, 2021.
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Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19); Correction
This document corrects technical and typographical errors in the final rule with comment period and interim final rule with comment period published in the Federal Register on December 29, 2020, titled ``Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for...
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Enforcement Discretion Regarding Online or Web-Based Scheduling Applications for the Scheduling of Individual Appointments for COVID-19 Vaccination During the COVID-19 Nationwide Public Health Emergency
This Notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy, Security, and Breach Notification Rules promulgated under the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical...
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New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications (NADAs) for lack of compliance with the reporting requirements in an FDA regulation.
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New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.
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National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table; Delay of Effective Date
In accordance with the Presidential directive as expressed in the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action delays until April 23, 2021, the effective date of the rule entitled ``National Vaccine Injury Compensation Program: Revisions to the...
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Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Delayed Effective Date
As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (``Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving...
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Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correcting Amendment
This document corrects a typographical error in the final rule that appeared in the December 28, 2020 Federal Register (hereinafter referred to as the CY 2021 PFS final rule). The effective date was January 1, 2021.