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HHS/FDA RIN: 0910-AG92 Publication ID: Fall 2013 
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: FDA would establish a list of "qualifying pathogens" that have the potential to pose a serious threat to public health. The proposed rule would implement a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA), which is designed to encourage development of new antibacterial and antifungal drugs, and provides incentives such as fast-track status and new exclusivity periods. FDA is proposing that the following pathogens comprise the list of "qualifying pathogens": Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Enterobacteriaceae, Enterococcus species, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, Neisseria meningitides, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus considered and methodology agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, and Vibrio cholerae. The preamble to the proposed rule describes the factors considered and methodology used to develop this list of qualifying pathogens. 
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.

Action Date FR Cite
NPRM  06/12/2013  78 FR 35155   
NPRM Comment Period End  08/12/2013 
Final Action  06/00/2014 
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