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HHS/FDA RIN: 0910-AG92 Publication ID: Spring 2014 
Title: 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 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 317.2 
Legal Authority: 21 USC 355E; 21 USC 371(a) 
Legal Deadline:
Action Source Description Date
Final  Statutory  Generating Antibiotic Incentives Now (title VIII), FDASIA  07/09/2014 

Overall Description of Deadline: 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.

Timetable:
Action Date FR Cite
NPRM  06/12/2013  78 FR 35155 
NPRM Comment Period End  08/12/2013   
Final Action  07/00/2014   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Kristiana Brugger
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6262, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2897
Fax:301 847-8437
Email: kristiana.brugger@fda.hhs.gov

 
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