{"abstract":"The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of \"qualifying pathogens\" that have the potential to pose a serious threat to public health. This final rule implements 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. Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of \"qualifying pathogens:\" Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, 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 described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/06/05/2014-13023.html","cfr_references":[{"chapter":null,"citation_url":null,"part":317,"title":21}],"citation":"79 FR 32464","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective July 7, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-1037"],"dockets":[],"document_number":"2014-13023","effective_on":"2014-07-07","end_page":32481,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/06/05/2014-13023.xml","html_url":"https://www.federalregister.gov/documents/2014/06/05/2014-13023/establishing-a-list-of-qualifying-pathogens-under-the-food-and-drug-administration-safety-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-13023?publication_date=2014-06-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-06-05/2014-13023/mods.xml","not_received_for_publication":null,"page_length":18,"page_views":{"count":7846,"last_updated":"2026-07-27 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-06-05/pdf/2014-13023.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-13023.pdf?1401887034","publication_date":"2014-06-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/06/05/2014-13023.txt","regulation_id_number_info":{"0910-AG92":{"issue":"201404","html_url":"https://www.federalregister.gov/regulations/0910-AG92/establishing-a-list-of-qualifying-pathogens-that-have-the-potential-to-pose-a-serious-threat-to-publ","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","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201404&RIN=0910-AG92&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AG92"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 98 -  Centers for Disease Control and Prevention, “C. gattii Cryptococcosis Statistics” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act","document_id":"FDA-2012-N-1037-0129"},{"title":"Reference 97 - Bayram, Y., H. Korkoca, C. Aypak, et al., “Antimicrobial Susceptibilities of Brucella Isolates from Various Clinical Specimens,”  - Establishing a List of Qualifying Pathogens Under the Food and Drug\nAdministration Safety and Innovation Act","document_id":"FDA-2012-N-1037-0128"},{"title":"Reference 96 - Neofytos, D., D. Horn, E. Anaissie, et al., “Epidemiology and Outcome of Invasive Fungal Infection in Adult Hematopoietic Stem Cell Transplant Recipients: - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration ","document_id":"FDA-2012-N-1037-0127"},{"title":"Reference 95 - Marr, K. A., R. A. Carter, F. Crippa, et al., “Epidemiology and Outcome of Mold Infections in Hematopoietic Stem Cell Transplant Recipients,”  Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Inn","document_id":"FDA-2012-N-1037-0126"},{"title":"Reference 94 - Rees, J. R., R. W. Pinner, R. A. Hajjeh, et al., “The Epidemiologic Features of Invasive Mycotic Infection in the San Francisco Bay Area 1992-1993: Results of a Population-Based Laboratory Active Surveillance,” - Establishing a List of Qual","document_id":"FDA-2012-N-1037-0125"},{"title":"Reference 93 - Ribes, J. A., C. L. Vanover-Sams, and D. J. Baker, “Zygomycetes in Human Disease,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act","document_id":"FDA-2012-N-1037-0124"},{"title":"Reference 92 - Rogers, T. R., “Treatment of Zygomycosis: Current and New Options,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act","document_id":"FDA-2012-N-1037-0123"},{"title":"Reference 91 - Munoz, P., M. Marin, P. Tornero, et al., “Successful Outcome of Scedosporium apiospermum Disseminated Infection Treated with Voriconazole in a Patient Receiving Corticosteroid Therapy,” - Establishing a List of Qualifying Pathogens Under th","document_id":"FDA-2012-N-1037-0122"},{"title":"Reference 90 - Song, M. J., J. H. Lee, and N. Y. Lee, “Fatal Scedosporium prolificans Infection in a Paediatric Patient with Acute Lymphoblastic Leukaemia,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and In","document_id":"FDA-2012-N-1037-0121"},{"title":"Reference 89 -  Cooley, L., D. Spelman, K. Thursky, et al., “Infection with Scedosporium apiospermum and S. prolificans, Australia,” - Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act","document_id":"FDA-2012-N-1037-0120"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-1037","supporting_documents_count":99,"docket_id":"FDA-2012-N-1037","regulation_id_number":null,"title":"Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health; Public Hearing; Request for Comments","checked_regulationsdotgov_at":"2014-06-25T06:00:10Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":32464,"subtype":null,"title":"Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act","toc_doc":"List of Qualifying Pathogens","toc_subject":"Food and Drug Administration Safety and Innovation Act:","topics":["Antibiotics","Communicable diseases","Drugs","Health","Health care","Immunization","Prescription drugs","Public health"],"type":"Rule","volume":79}