Notice of Decision Not To Designate Pneumocystis Pneumonia as a Tropical Disease

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to Docket No. FDA-2008-N-0567, has analyzed whether Pneumocystis pneumonia (PCP) 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 PCP in developed countries. The Agency has determined that PCP does not meet the statutory criteria for designation as a tropical disease and declines to designate it as such.