Finalization of Statutory Interpretation. As FDA explained in the proposed rule (78 FR 35155 at 35156) and affirms in this final rule, the statutory standard for inclusion on FDA’s list of qualifying pathogens is different from the statutory standard for QIDP designation. QIDP designation, by definition, requires that the drug in question be an ‘‘antibacterial or antifungal drug for human use intended to treat serious or life- threatening infections’’ (section 505E(g) of the FD&C Act). ‘‘Qualifying pathogens’’ are defined according to a different statutory standard; the term means ‘‘a pathogen identified and listed by the Secretary . . . that has the potential to pose a serious threat to public health’’ (section 505E(f) of the FD&C Act) (emphasis added). That is, a drug intended to treat a serious or life- threatening bacterial or fungal infection caused by a pathogen that is not included on the list of ‘‘qualifying pathogens’’ may be eligible for designation as a QIDP, while a drug that is intended to treat an infection caused by a pathogen on the list may not always be eligible for QIDP designation. After reviewing the comments to the docket on this point (see section IV.A), FDA’s understanding of these statutory standards remains unchanged. To alleviate confusion regarding this issue, FDA also clarifies that vaccine applications are ineligible for QIDP designation under the GAIN title of FDASIA. Vaccines are biological products whose applications for approval are submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). QIDPs, however, must be human drugs whose applications are submitted pursuant to section 505(b) of the FD&C Act. Thus, under the law, vaccines are ineligible for QIDP designation. As stated in the proposed rule (78 FR 35156) and affirmed in this final rule, FDA intends the list of qualifying pathogens to reflect the pathogens that, as determined by the Agency, after consulting with other experts and considering the factors set forth in FDASIA (see section 505E(f)(2)(B)(i) of the FD&C Act), have the ‘‘potential to pose a serious threat to public health’’ (section 505E(f)(1) of the FD&C Act). FDA does not intend for this list to be used for other purposes, such as the following: (1) Allocation of research funding for bacterial or fungal pathogens; (2) setting of priorities in research in a particular area pertaining to bacterial or fungal pathogens; or (3) direction of epidemiological resources to a particular area of research on bacterial or fung...
