federal_register: 2013-13865
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-13865 | Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act | Proposed Rule | The Food and Drug Administration (FDA or Agency) is proposing a regulation to 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). GAIN 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 eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain 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 (e.g., Klebsiella pneumoniae), Enterococcus species, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule describes the factors we considered and the methodology we used to develop this list of qualifying pathogens. | 2013-06-12 | 2013 | 6 | https://www.federalregister.gov/documents/2013/06/12/2013-13865/establishing-a-list-of-qualifying-pathogens-under-the-food-and-drug-administration-safety-and | https://www.govinfo.gov/content/pkg/FR-2013-06-12/pdf/2013-13865.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is proposing a regulation to 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... |