Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington

by the Centers for Medicare & Medicaid Services on 09/30/2019.

This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site law, Chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 4 years.

Black Lung Benefits Act: Quality Standards for Medical Testing

by the Workers Compensation Programs Office on 09/27/2019.

The Black Lung Benefits Act provides benefits to miners who are totally disabled due to pneumoconiosis arising out of coal mine employment and to certain miners' survivors. Determining benefits entitlement necessarily entails evaluating the miner's physical condition, particularly his or her respiratory system. These evaluations usually involve...

Providing Regulatory Submissions for Medical Devices in Electronic Format-Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

by the Food and Drug Administration on 09/26/2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Providing Regulatory Submissions for Medical Devices in Electronic Format--Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic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...

Clinical Laboratory Improvement Advisory Committee (CLIAC)

by the Centers for Disease Control and Prevention on 08/30/2019.

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 space available. The meeting room accommodates approximately 250 people. The public is also welcome to view the meeting by...

Statement of Organization, Functions, and Delegations of Authority

by the Centers for Disease Control and Prevention on 08/28/2019.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications

by the Food and Drug Administration on 07/25/2019.

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.

Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health

by the Food and Drug Administration on 07/02/2019.

The Food and Drug Administration (FDA or Agency) is issuing a final rule to amend its regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH or the Center) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the...

Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments Categorization

by the Food and Drug Administration on 06/26/2019.

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 of information, including...

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability

by the Food and Drug Administration on 05/07/2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.'' This guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a...

Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Extension of Comment Period

by the Centers for Medicare & Medicaid Services on 04/08/2019.

This document extends the comment period for the notice of proposed rulemaking with comment entitled ``Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance'' that appeared in the February 4, 2019 Federal Register. The comment period for the proposed rule, which...

Announcement of the Approval of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (Formerly Known as the American Osteopathic Association/Healthcare Facilities Accreditation Program) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

by the Centers for Medicare & Medicaid Services on 03/29/2019.

This notice announces the approval of the application of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (AAHHS/HFAP) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty...

Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications

by the Food and Drug Administration on 03/26/2019.

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 of information, including...

Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988

by the Centers for Medicare & Medicaid Services on 02/22/2019.

This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty and subspecialty areas listed in this notice under CLIA. We have determined that COLA meets or exceeds the applicable CLIA...

Clinical Laboratory Improvement Advisory Committee (CLIAC)

by the Centers for Disease Control and Prevention on 02/22/2019.

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 space available. The meeting room accommodates approximately 100 people. The public is also welcome to view the meeting by...

The Least Burdensome Provisions: Concept and Principles; Guidance for Industry and Food and Drug Administration Staff; Availability

by the Food and Drug Administration on 02/05/2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``The Least Burdensome Provisions: Concept and Principles.'' FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining...

Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance

by the Centers for Medicare & Medicaid Services on 02/04/2019.

This proposed rule would update proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This proposed rule would also make additional technical changes to PT referral...

Notice To Announce of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge

by the National Institutes of Health on 01/29/2019.

The National Institutes of Health (NIH) is supplementing and amending a Notice previously published in the Federal Register on September 8, 2016 titled ``Announcement of Requirements and Registration for ``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test'' Challenge.'' This Notice serves to provide additional details to Step 2...

Medicare Program; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees

by the Centers for Medicare & Medicaid Services on 12/31/2018.

This notice with comment period announces the increase of certain fees established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The Public Health Service Act (PHSA) requires the Secretary to impose certificate fees to cover the general costs of administering the CLIA program, as well as additional fees, including...

Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information

by the Centers for Medicare & Medicaid Services on 12/20/2018.

This request for information (RFI) seeks public comment regarding the appropriateness of the practices of some Medicare- approved Accrediting Organizations (AOs) to provide fee-based consultative services for Medicare-participating providers and suppliers as part of their business model. We wish to determine whether AO practices of consulting...

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

by the Food and Drug Administration on 11/30/2018.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This draft guidance document describes studies and criteria that FDA recommends be used when submitting premarket notifications...