Department of Health and Human Services October 28, 2016 – Federal Register Recent Federal Regulation Documents

This final notice announces our decision to approve the request of Rockwall Regional Hospital, Limited Liability Company (LLC) doing business as (d/b/a) Texas Health Presbyterian Hospital Rockwall (Texas Health Rockwall) for an exception to the prohibition on expansion of facility capacity.

The Office of the Assistant Secretary for Administration (ASA) within the Department of Health and Human Services (HHS) is deleting eighteen (18) systems of records established pursuant to the Privacy Act of 1974, as amended (5 U.S.C. 552a), because HHS has determined that they duplicate other systems of records or are obsolete.

The Food and Drug Administration (FDA) is announcing the issuance of four Emergency Use Authorizations (EUAs) (the Authorizations) for four in vitro diagnostic devices for detection and/ or diagnosis of Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, Inc., Luminex Corporation, InBios International, Inc., and Roche Molecular Systems, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, 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 Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

The Food and Drug Administration (FDA or we) 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.

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 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 communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health.

This rule amends the Department of Health and Human Services (HHS's) Freedom of Information Act (FOIA) regulations. The regulations have been revised in order to incorporate changes made to the FOIA by the Electronic FOIA Act of 1996 (E-FOIA Act), the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act), and the FOIA Improvement Act of 2016 (FOIA Improvement Act). Additionally, the regulations have been updated to reflect changes to the organization, to make the FOIA process easier for the public to navigate, to update HHS's fee schedule, and to make provisions clearer.