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

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In response to a suggestion by Gilead Sciences, Inc. (Gilead) that was submitted to the public docket FDA-2008-N-0567 on February 14, 2022, the Food and Drug Administration (FDA or Agency) has analyzed whether hepatitis delta virus (HDV) infection meets the statutory criteria for designation as a "tropical disease" under Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the Agency has analyzed whether there is "no significant market in developed nations" for drugs for HDV infections and whether HDV "disproportionately affects poor and marginalized populations," both of which are statutory criteria for designation as a "tropical disease." At this time, the Agency cannot conclude that HDV infection meets the statutory criteria for addition to the list of tropical diseases under the FD&C Act; therefore, FDA declines to add it to the list of tropical diseases.