Statement of Organization, Functions, and Delegations of Authority

by the Centers for Disease Control and Prevention on 09/27/2016.

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

by the National Institutes of Health on 09/08/2016.

Through the ``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test'' Challenge (the ``Challenge''), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR) are searching for novel and innovative in vitro...

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

by the Food and Drug Administration on 09/07/2016.

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; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications

by the Food and Drug Administration on 07/18/2016.

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.

Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System

by the Centers for Medicare & Medicaid Services on 06/23/2016.

This final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which significantly revises the Medicare payment system for clinical diagnostic laboratory tests. This final rule also announces an implementation date of January 1, 2018 for the private payor rate-based fee schedule required by PAMA.

Request for Nominations of Candidates To Serve on the Clinical Laboratory Improvement Advisory Committee (CLIAC) and Request for Suggested Meeting Topics for CLIAC

by the Centers for Disease Control and Prevention on 06/07/2016.

Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2016

by the Centers for Medicare & Medicaid Services on 05/09/2016.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.

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

by the Food and Drug Administration on 04/27/2016.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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, including each...

Announcement of the Re-Approval of the American Society of Histocompatibility and Immunogenetics (ASHI) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

by the Centers for Medicare & Medicaid Services on 04/22/2016.

This notice announces the application of the American Society for Histocompatibility and Immunogenetics (ASHI) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas: General Immunology;...

Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

by the Food and Drug Administration on 04/18/2016.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Radiation Biodosimetry Medical Countermeasure Devices.'' FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for...

Cooperative Research and Development Agreement (CRADA) Opportunity for Development of an Assay To Detect Genetic Markers Related to Elevated Serum Tryptase in Familial Tryptasemia and Mast Cell Activation Disorders

by the National Institutes of Health on 04/08/2016.

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), Department of Health and Human Services (HHS) seeks to enter into a CRADA with a commercial partner to collaborate on the development and commercialization of an assay to detect a genetic variation related to mast cell...

Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications

by the Food and Drug Administration on 04/01/2016.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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, including each...

Clinical Laboratory Improvement Advisory Committee

by the Centers for Disease Control and Prevention on 03/02/2016.

Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop; Request for Comments

by the Food and Drug Administration on 01/14/2016.

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Patient and Medical Professional Perspectives on the Return of Genetic Test Results.'' The purpose of this public workshop is to understand patient and provider perspectives on receiving potentially medically relevant genetic test results. The topic(s)...

Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development

by the Food and Drug Administration on 12/29/2015.

The Food and Drug Administration (FDA or the Agency) is announcing the Web site location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in Fiscal Year (FY) 2016. In addition, FDA has established a docket, where interested persons may comment...

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016

by the Centers for Medicare & Medicaid Services on 11/16/2015.

This major final rule with comment period addresses changes to the physician fee schedule, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.

Meeting: Clinical Laboratory Improvement Advisory Committee

by the Centers for Disease Control and Prevention on 10/21/2015.

2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications

by the Health and Human Services Department on 10/16/2015.

This final rule finalizes a new edition of certification criteria (the 2015 Edition health IT certification criteria or ``2015 Edition'') and a new 2015 Edition Base Electronic Health Record (EHR) definition, while also modifying the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that...

Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System

by the Centers for Medicare & Medicaid Services on 10/01/2015.

This proposed rule would significantly revise the Medicare payment system for clinical diagnostic laboratory tests and would implement other changes required by section 216 of the Protecting Access to Medicare Act of 2014.

Occupational Exposure to Beryllium and Beryllium Compounds

by the Occupational Safety and Health Administration on 08/07/2015.

The Occupational Safety and Health Administration (OSHA) proposes to amend its existing exposure limits for occupational exposure in general industry to beryllium and beryllium compounds and promulgate a substance-specific standard for general industry regulating occupational exposure to beryllium and beryllium compounds. This document proposes...