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The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
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Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
In accordance with an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020, from June 18, 2021, to October 16, 2021.
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Food Additives Permitted in Feed and Drinking Water of Animals; Silicon Dioxide
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 silicon dioxide as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed components (ingredients, intermediate premixes, premixes,...
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Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program
This final rule will revise regulations for the Medicare Advantage (MA or Part C) program, Medicare Prescription Drug Benefit (Part D) program, and Medicare Cost Plan program to implement certain sections of the Bipartisan Budget Act of 2018 and the 21st Century Cures Act. In addition, it will enhance the Part C and D programs, codify several...
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Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption From the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' Given the public...
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Child Support
This rule is intended to eliminate regulations that are outdated or unnecessary and to make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement (FEM) final rule, published on December 20, 2016, including to amend the compliance date for review and adjustment of child support orders. The Office of...
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Nondiscrimination in Health and Health Education Programs or Activities, Delegation of Authority
The Department of Health and Human Services (``the Department'' or ``HHS'') is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act (``ACA''). After considering public comments, in this final...
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Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This...
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Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2
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> mushroom powder as a nutrient supplement in specific food categories. This action is in response to a petition filed by Oakshire Naturals, LP.
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Confidentiality of Substance Use Disorder Patient Records
This final rule makes changes to the Department of Health and Human Services' (HHS) regulations governing the Confidentiality of Substance Use Disorder Patient Records. These changes were prompted by the need to continue aligning the regulations with advances in the U.S. health care delivery system, while retaining important privacy protections...
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Control of Communicable Diseases; Importation of Human Remains
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this Final Rule (FR) to amend two provisions within its Foreign Quarantine regulations to best protect the public health of the United States. The provisions in this Final Rule clarify various safeguards to prevent the...
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Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.'' The guidance does not alter FDA's current thinking on the regulatory...
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Medical Devices; Exemptions From Premarket Notification: Class II Devices
The Food and Drug Administration (FDA or the Agency) is publishing an order setting forth the Agency's final determination to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the list of...
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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of 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 January, February, and March 2020. FDA is informing the public of the availability of summaries of the basis of approval...
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New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor's request because the product is no longer manufactured or marketed.
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Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The final rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.
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Medicare Program; FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)
This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System hospital or critical access hospital. In...
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Medicare Program; FY 2021 Hospice Wage Index and Payment Rate Update
This final rule updates the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2021. This rule also revises the hospice wage index to reflect the current Office of Management and Budget area delineations, with a 5 percent cap on wage index decreases. In addition, this rule responds to comments on the modified election...
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Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Value-Based Purchasing Program for Federal Fiscal Year 2021
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2021. We are also making changes to the case-mix classification code mappings used under the SNF PPS and making two minor revisions in the regulation text. Additionally, we are adopting the recent...