Notice of Decision Not To Designate Coccidioidomycosis as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act

摘要

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to the public docket number FDA-2008-N-0567 between October 1, 2018, and June 30, 2019, has analyzed whether coccidioidomycosis meets the statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations, and whether there is "no significant market" for drugs that prevent or treat coccidioidomycosis infections in developed countries. The Agency has determined that coccidioidomycosis does not meet the statutory criteria for designation as a tropical disease eligible for PRV consideration because of the potential market for preventive products (such as vaccines), and therefore declines to designate it as an addition to the list of tropical disease PRV- eligible diseases at this time.