Request for Letters of Interest for NCI-MATCH Laboratories

by the National Institutes of Health on 08/02/2017.

The National Cancer Institute (NCI) in collaboration with the NCI Molecular Analysis for Therapy Choice (MATCH) trial leadership (NCT 02465060) invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next Generation Sequencing (NGS) assays to...

Agency Information Collection Activities: Proposed Collection; Comment Request

by the Centers for Medicare & Medicaid Services on 06/22/2017.

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...

Clinical Laboratory Improvement Advisory Committee

by the Centers for Disease Control and Prevention on 03/09/2017.

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

by the Centers for Disease Control and Prevention on 03/03/2017.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

by the Centers for Medicare & Medicaid Services on 02/17/2017.

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...

Federal Policy for the Protection of Human Subjects

by the Homeland Security Department, the Agriculture Department, the Energy Department, the National Aeronautics and Space Administration, the Commerce Department, the Social Security Administration, the Agency for International Development, the Housing and Urban Development Department, the Labor Department, the Defense Department, the Education Department, the Veterans Affairs Department, the Environmental Protection Agency, the Health and Human Services Department, the National Science Foundation, and the Transportation Department on 01/19/2017.

The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable...

Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies

by the Centers for Medicare & Medicaid Services on 01/13/2017.

This final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care...

Occupational Exposure to Beryllium

by the Occupational Safety and Health Administration on 01/09/2017.

The Occupational Safety and Health Administration (OSHA) is amending its existing standards for occupational exposure to beryllium and beryllium compounds. OSHA has determined that employees exposed to beryllium at the previous permissible exposure limits face a significant risk of material impairment to their health. The evidence in the record...

Agency Information Collection Activities: Proposed Collection; Comment Request

by the Centers for Medicare & Medicaid Services on 12/02/2016.

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...

Establishing a More Effective Fair Market Rent System; Using Small Area Fair Market Rents in the Housing Choice Voucher Program Instead of the Current 50th Percentile FMRs

by the Housing and Urban Development Department on 11/16/2016.

This final rule applies the use of Small Area Fair Market Rents (Small Area FMRs) in the administration of the Housing Choice Voucher (HCV) program for certain metropolitan areas. This final rule provides for the use of Small Area FMRs, in place of the 50th percentile rent, the currently codified regulations, to address high levels of voucher...

Electronic Submission of Labeling for Certain Home-Use Medical Devices

by the Food and Drug Administration on 10/17/2016.

The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic submission of the device label and package insert of certain home-use devices when these devices are listed with FDA. FDA plans to make this device labeling available to the public through...

Clinical Laboratory Improvement Advisory Committee Meeting

by the Centers for Disease Control and Prevention on 10/13/2016.

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

by the Food and Drug Administration on 10/11/2016.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems...

Medical Device User Fee Amendments; Public Meeting; Request for Comments

by the Food and Drug Administration on 10/07/2016.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Medical Device User Fee Amendments.'' The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2018 through 2022. MDUFA authorizes FDA to collect fees and use...

Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities

by the Centers for Medicare & Medicaid Services on 10/04/2016.

This final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These revisions are also an integral...

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.