United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2014_register executive 2014-06-05 article Rules and Regulations D09002ee1c7f9fd9d D09002ee1c7f9fdff United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 79 FR 32464 https://www.govinfo.gov/app/details/FR-2014-06-05/2014-13023 2014-13023 fr05jn14-8 RIN 0910-AG92 4160-01-P Docket No. FDA-2012-N-1037 https://www.govinfo.gov/app/details/FR-2014-06-05/2014-13023 https://www.govinfo.gov/content/pkg/FR-2014-06-05/html/2014-13023.htm https://www.govinfo.gov/content/pkg/FR-2014-06-05/pdf/2014-13023.pdf Antibiotics Communicable Diseases Drugs Health Health Care Immunization Prescription Drugs Public Health 18 p. 32464 32481 79 FR 32464 Title 21 Part 317 21 CFR Part 317 RIN 0910-AG92 Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act; Federal Register Vol. 79, Issue RULE 2014-13023 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-07-07 Docket No. FDA-2012-N-1037 4160-01-P 2014-13023 Final rule.

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.

This rule is effective July 7, 2014. Kristiana Brugger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993-0002, 301- 796-3601. 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Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-06-05 P0b002ee18942374f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05jn14 https://www.govinfo.gov/app/details/FR-2014-06-05 https://www.govinfo.gov/content/pkg/FR-2014-06-05/pdf/FR-2014-06-05.pdf https://www.govinfo.gov/content/pkg/FR-2014-06-05/xml/FR-2014-06-05.xml fdlp 32433 32632 DGPO 2014-06-05 2024-06-02 FR-2014-06-05 machine generated eng FR FR-2014-06-05 79 108