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

The Administration on Aging (AoA), Administration for Community Living (ACL), is announcing that the proposed collection of information listed below 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 that a collection of information entitled ``Medical Devices; Exception From General Requirements for Informed Consent'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).

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 Ebola Zaire virus (detected in the West Africa outbreak in 2014). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by the U.S. Department of Defense (DoD). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola 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.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``ANDA Submissions Refuse-to-Receive Standards.'' It finalizes the draft guidance with the same name that published on October 1, 2013. This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements for new strengths). The guidance represents the FDA's current thinking regarding the types of serious deficiencies that may cause FDA to refuse-to-receive the submission.