{"abstract":"The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to the public docket FDA-2008-N-0567, between June 20, 2018, and November 21, 2018, has analyzed whether the foodborne trematode infection clonorchiasis 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 clonorchiasis in developed countries. The Agency has determined at this time that clonorchiasis does not meet the statutory criteria for addition to the tropical diseases list under the FD&C Act. Although clonorchiasis disproportionately affects poor and marginalized populations, it is an infectious disease for which there is a significant market in developed nations; 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/2020/07/15/2020-15253.html","cfr_references":[],"citation":"85 FR 42868","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"July 15, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-N-0567"],"dockets":[],"document_number":"2020-15253","effective_on":null,"end_page":42871,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/07/15/2020-15253.xml","html_url":"https://www.federalregister.gov/documents/2020/07/15/2020-15253/notice-of-decision-not-to-designate-clonorchiasis-as-an-addition-to-the-current-list-of-tropical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-15253?publication_date=2020-07-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-07-15/2020-15253/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":437,"last_updated":"2026-04-27 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-07-15/pdf/2020-15253.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-15253.pdf?1594730737","publication_date":"2020-07-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/07/15/2020-15253.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"053 Reference 52 - Global Report UNAIDS Report on the Global AIDS Epidemic 2013","document_id":"FDA-2008-N-0567-0140"},{"title":"009 Reference 8 - Chikungunya 2015 Final Data for the United States","document_id":"FDA-2008-N-0567-0116"},{"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":"017 Reference 16 - Severe Manifestations of Chikungunya Virus in Critically Ill Patients During the 2013-2014 Caribbean Outbreak","document_id":"FDA-2008-N-0567-0108"},{"title":"018 Reference 17 - Neglected Tropical Diseases","document_id":"FDA-2008-N-0567-0107"},{"title":"019 Reference 18 - Lymphocytic Choriomenengitis, Lassa Fever, and South American Hemorrhagic Fevers","document_id":"FDA-2008-N-0567-0106"},{"title":"027 Reference 26 - Essential Medicines and Health Products - WHO Publishes List of Top Emerging Diseases Likely To Cause Major Epidemics","document_id":"FDA-2008-N-0567-0098"},{"title":"025 Reference 24 - Burden of serious fungal infections in Nepal","document_id":"FDA-2008-N-0567-0094"},{"title":"028 Reference 27 - Predictors of Pneumocystis carinii pneumonia in HIV-infected persons","document_id":"FDA-2008-N-0567-0091"}],"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","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":"2020-07-17T08:30:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":42868,"subtype":null,"title":"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","toc_doc":"Clonorchiasis","toc_subject":"Decision Not to Designate an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act:\n","topics":[],"type":"Notice","volume":85}