Department of Health and Human Services April 17, 2014 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a Tribal Consultation to consult on ACF programs and tribal priorities.

This notice reopens the application period and provides information on new dates for the submission of the Comprehensive ESRD Care initiative letters of intent and application. The letter of intent submission date for End-stage Renal Disease Seamless Care Organizations (ESCOs) that include a dialysis facility from a large dialysis organization (LDO) is June 23, 2014, and the submission deadline for the LDO application is June 23, 2014. The letter of intent submission date for ESCOs that include a non-LDO facility is September 15, 2014, and the submission deadline for the non-LDO application is September 15, 2014.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff.'' This guidance is intended, in part, to improve the quality of information submitted by sponsors in an IDE application or supplement to an IDE application and to ensure consistency in the review of those submissions. This draft guidance is intended to clarify FDA's regulations and policies regarding live case presentations using unapproved or uncleared investigational devices in the United States. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or we) 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 proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions in FDA's cosmetic labeling regulations.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel influenza A (H7N9) virus (detected in China in 2013). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Quidel Corporation. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the April 19, 2013, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the novel influenza A (H7N9) virus. On the basis of such determination, the Secretary of HHS also declared on April 19, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel influenza A (H7N9) virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.