Federal Register #FDA-2008-N-0567

FDA Decision: No Tropical Disease Designation for Hepatitis Delta Virus (HDV)

This notice from the Food and Drug Administration (FDA) addresses a request regarding disease designation: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEM/Vendor Mentioned: - Gilead Sciences, Inc. (submitted the suggestion) - Products/Services Requested: - No products or services are being requested or procured in this notice - Key Details: - The FDA reviewed a suggestion to designate hepatitis delta virus (HDV) infection as a tropical disease under the Federal Food, Drug, and Cosmetic Act - The review considered statutory criteria, including market presence in developed nations and impact on marginalized populations - The FDA determined HDV does not meet the criteria and will not be added to the list of tropical diseases - The notice outlines the process for suggesting additional diseases for designation - No procurement, contract, or award is involved in this notice

Description

The Food and Drug Administration (FDA) has reviewed a suggestion by Gilead Sciences, Inc. regarding the designation of hepatitis delta virus (HDV) infection as a tropical disease under Section 524 of the Federal Food, Drug, and Cosmetic Act. The FDA analyzed whether HDV meets the statutory criteria of having no significant market in developed nations and disproportionately affecting poor and marginalized populations. After evaluation, the FDA determined that HDV infection does not meet these criteria and therefore will not be added to the list of tropical diseases. The notice provides information on the process for requesting additional diseases to be added to the list and references supporting documents.

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