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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.

Timetable:

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 Email: kristiana.brugger@fda.hhs.gov