Department of Health and Human Services July 26, 2007 – Federal Register Recent Federal Regulation Documents

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement the act. These regulations describe the procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Emergency Use Authorization of Medical Products.'' The guidance explains FDA's policies for authorizing the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency. This guidance finalizes the draft guidance published in the Federal Register of July 5, 2005 (70 FR 38689).

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)'' dated July 2007. The draft guidance document discusses certain cell selection devices that minimally manipulate autologous PBSCs at the point of care for specific clinical indications, and the applicability of the requirements to such PBSCs. The guidance also discusses the submission of data intended to support approval of cell selection devices.