{"abstract":"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.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/05/22/2026-10268.html","cfr_references":[],"citation":"91 FR 30312","comment_url":"http://www.regulations.gov/commenton/FDA-2008-N-0567-0198","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"May 22, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0567"],"dockets":[{"supporting_documents":[{"title":"049 Reference 48 - Epidemiology of Cryptococcal Meningitis in the US","document_id":"FDA-2008-N-0567-0144"},{"title":"053 Reference 52 - Global Report UNAIDS Report on the Global AIDS Epidemic 2013","document_id":"FDA-2008-N-0567-0140"},{"title":"030 Reference 29 - Use of a Reduced (4-Dose) Vaccine Schedule for Postexposure Prophylaxis to Prevent Human Rabies","document_id":"FDA-2008-N-0567-0137"},{"title":"041 Reference 40 - Cost of Rabies Prevention","document_id":"FDA-2008-N-0567-0126"},{"title":"042 Reference 41 - Cryptococcosis- Epidemiology, Fungal Resistance, and New Alternatives for Treatment","document_id":"FDA-2008-N-0567-0125"},{"title":"048 Reference 47 - The Changing Epidemiology of Cryptococcosis - An Update from Population-Based Active Surveillance in 2 Large Metropolitan Areas, 1992-2000","document_id":"FDA-2008-N-0567-0119"},{"title":"014 Reference 13 - Morbidity and Impaired Quality of Life 30 Months After Chikungunya Infection","document_id":"FDA-2008-N-0567-0111"},{"title":"015 Reference 14 - Burden of Chikungunya in India - Estimates of DALY Lost in 2006 Epidemic","document_id":"FDA-2008-N-0567-0110"},{"title":"018 Reference 17 - Neglected Tropical Diseases","document_id":"FDA-2008-N-0567-0107"},{"title":"028 Reference 27 - Predictors of Pneumocystis carinii pneumonia in HIV-infected persons","document_id":"FDA-2008-N-0567-0091"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-05-22","updated_at":"2026-05-30T00:01:28.423-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2008-N-0567-0198","allow_late_comments":true,"id":"FDA-2008-N-0567-0198","comment_end_date":null,"regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":116,"id":"FDA-2008-N-0567","title":"Designating Additions to the Current List of Tropical Diseases in Section 1102 of the Food and Drug Administration Amendments Act"}],"document_number":"2026-10268","effective_on":null,"end_page":30318,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/22/2026-10268.xml","html_url":"https://www.federalregister.gov/documents/2026/05/22/2026-10268/notice-of-decision-not-to-designate-hepatitis-delta-virus-diseases-as-an-addition-to-the-current","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-10268?publication_date=2026-05-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-22/2026-10268/mods.xml","not_received_for_publication":null,"page_length":7,"page_views":{"count":293,"last_updated":"2026-06-15 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-22/pdf/2026-10268.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10268.pdf?1779367510","publication_date":"2026-05-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/22/2026-10268.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"049 Reference 48 - Epidemiology of Cryptococcal Meningitis in the US","document_id":"FDA-2008-N-0567-0144"},{"title":"053 Reference 52 - Global Report UNAIDS Report on the Global AIDS Epidemic 2013","document_id":"FDA-2008-N-0567-0140"},{"title":"030 Reference 29 - Use of a Reduced (4-Dose) Vaccine Schedule for Postexposure Prophylaxis to Prevent Human Rabies","document_id":"FDA-2008-N-0567-0137"},{"title":"041 Reference 40 - Cost of Rabies Prevention","document_id":"FDA-2008-N-0567-0126"},{"title":"042 Reference 41 - Cryptococcosis- Epidemiology, Fungal Resistance, and New Alternatives for Treatment","document_id":"FDA-2008-N-0567-0125"},{"title":"048 Reference 47 - The Changing Epidemiology of Cryptococcosis - An Update from Population-Based Active Surveillance in 2 Large Metropolitan Areas, 1992-2000","document_id":"FDA-2008-N-0567-0119"},{"title":"014 Reference 13 - Morbidity and Impaired Quality of Life 30 Months After Chikungunya Infection","document_id":"FDA-2008-N-0567-0111"},{"title":"015 Reference 14 - Burden of Chikungunya in India - Estimates of DALY Lost in 2006 Epidemic","document_id":"FDA-2008-N-0567-0110"},{"title":"018 Reference 17 - Neglected Tropical Diseases","document_id":"FDA-2008-N-0567-0107"},{"title":"028 Reference 27 - Predictors of Pneumocystis carinii pneumonia in HIV-infected persons","document_id":"FDA-2008-N-0567-0091"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2008-N-0567","supporting_documents_count":116,"docket_id":"FDA-2008-N-0567","document_id":"FDA-2008-N-0567-0198","regulation_id_number":null,"title":"Designating Additions to the Current List of Tropical Diseases in Section 1102 of the Food and Drug Administration Amendments Act","checked_regulationsdotgov_at":"2026-06-15T04:01:09Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2008-N-0567-0198","significant":null,"signing_date":null,"start_page":30312,"subtype":null,"title":"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","toc_doc":"Decision not to Designate Hepatitis Delta Virus Diseases as an Addition","toc_subject":"Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act","topics":[],"type":"Notice","volume":91}