Alcohol, Tobacco, Firearms, and Explosives Bureau September 1, 2015 – Federal Register Recent Federal Regulation Documents

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 Middle East Respiratory Syndrome Coronavirus (MERS-CoV). FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by altona Diagnostics GmbH. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the May 29, 2013, determination by the Department of Health and Human Services (HHS) Secretary 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 MERS-CoV. On the basis of such determination, the Secretary of HHS also declared on May 29, 2013, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of MERS-CoV 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 (GFI #225) entitled ``Electronic Exchange of Documents: Electronic File Format'' (VICH GL53). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to cover the electronic file format specifications for individual documents and collections of multiple related documents that do not need subsequent modification during the regulatory procedure and are utilized for electronic exchange between industry and regulatory authorities in the context of regulatory approval of veterinary medicinal products.