Department of Health and Human Services June 14, 2019 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Systematic Review Data Repository.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry.'' The draft guidance document provides FDA's recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The draft guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider these draft recommendations.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Department of Health and Human Services (``the Department'') 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. The Department proposes to revise its Section 1557 regulation in order to better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.