Regulatory Counsel

0910-AG92 201410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health Under the Food and Drug Administration Safety and Innovation Act

This final rule establishes a list of "qualifying pathogens" that have the potential to pose a serious threat to public health. This rule is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as fast-track status and additional exclusivity periods.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 317.2 21 USC 355E 21 USC 371(a) Statutory Final 07/09/2014 Generating Antibiotic Incentives Now (title VIII), FDASIA Per title VIII of FDASIA, the final rule must be published no later than July 9, 2014. To meet this deadline, the proposed rule must publish by August 19, 2013. No NPRM 06/12/2013 78 FR 35155 NPRM Comment Period End 08/12/2013 Final Action 06/05/2014 79 FR 32464 No No None No No No No Kristiana Brugger Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3600 kristiana.brugger@fda.hhs.gov Center for Drug Evaluation and Research, WO 51, Room 5252, 10903 New Hampshire Avenue, Silver Spring MD 20993