Legal Status
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Clinical Laboratory Improvement Program
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 authorized Federal regulatory standards for all clinical laboratory testing performed on humans in the U.S., except clinical trials and basic research.The CLIA program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans to provide information for the diagnosis, prevention, or treatment of disease or impairment, and for the assessment of health. An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. The Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA program. Other Health and Human Services agencies' articles may also appear in these search results.
Showing 1-20 of 571 results since 1994. View 551 more results.
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Regulatory Relief To Support Economic Recovery; Request for Information (RFI)
Under an Executive Order that directs federal agencies to address the economic emergency created by the COVID-19 pandemic by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law and with protection of the public health and safety, with...
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Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the issuance and reissuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued, and in some cases reissued, the Authorizations listed in this document under the...
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Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
This interim final rule with request for comments (IFC) discusses CMS's implementation of section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for Coronavirus Disease 2019 (COVID-19) vaccine and its administration. This IFC implements requirements in the CARES...
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Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
On March 13, 2020, the President declared a national emergency in response to the public health emergency (PHE) caused by the SARS- CoV-2 virus, otherwise known as COVID-19. The CARES Act was published in response to the PHE that requires ``every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a...
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Framework for Conditional Sailing and Initial Phase COVID-19 Testing Requirements for Protection of Crew
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces a framework for a phased resumption of cruise ship passenger operations. CDC also announces requirements for the initial phases of this framework regarding testing of crew members for COVID-19, an integral part of the...
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Securing Updated and Necessary Statutory Evaluations Timely
The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department's regulations have...
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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 collection of information, including...
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No Sail Order and Suspension of Further Embarkation; Third Modification and Extension of No Sail Order and Other Measures Related to Operations
The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a third modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on July 16, 2020. This Order applies to cruise ships defined as commercial, non-cargo,...
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Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 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 entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring...
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Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2021 and to implement certain recent legislation. We are also making changes relating to Medicare graduate medical...
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Clinical Laboratory Improvement Advisory Committee (CLIAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the webcast lines available. Check the CLIAC website on the day of the meeting for the web conference link www.cdc.gov/cliac.
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Request for Information (RFI): Testing for Coronavirus Disease 2019 (COVID-19)-Surge Capacity
The Office of the Assistant Secretary for Health (OASH) in the Department of Health and Human Services (HHS) seeks to obtain information regarding the ability of Clinical Laboratory Improvement Amendments (CLIA)-certified/accredited commercial, academic, medical center, and public health laboratories to feasibly provide additional COVID-19...
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Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
This interim final rule with comment period (IFC) revises regulations to strengthen CMS' ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility...
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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 collection of information, including...
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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 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information...
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No Sail Order and Suspension of Further Embarkation; Second Modification and Extension of No Sail Order and Other Measures Related to Operations
The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a second modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on April 15, 2020. This Order applies to cruise ships defined as commercial, non-cargo,...
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Providing Regulatory Submissions for Medical Devices in Electronic Format-Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; 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 entitled ``Providing Regulatory Submissions for Medical Devices in Electronic Format--Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA...
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Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories; Extension of Comment Period
On May 15, 2020, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) published a notice in the Federal Register requesting public comment on the Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health...
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Request for Letters of Interest (LOI) for NCI-MATCH Laboratories
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed...
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Request for Letters of Interest (LOI) for Pediatric Focused NCI-MATCH Laboratories
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed...
Showing 1-20 of 571 results since 1994. View 551 more results.
View more Health & Public Welfare searches.