Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2008-N-0567] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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. DATES: May 22, 2026. ADDRESSES: Submit electronic comments on additional diseases suggested for designation to https://www.regulations.gov . Submit written comments on additional diseases suggested for designation to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with t…
Other Federal Register documents from the same docket.
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
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Notice of Decision Not To Designate Clonorchiasis as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Citation: 91 FR 30312
