{"url_path":"/register/2026-09-15/2026-18805","section_key":"summary","section_title":"Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments","topic":"register","document":{"doc_type":"Notice","doc_date":"2026-09-15","source_url":"https://www.federalregister.gov/documents/2026/09/15/2026-18805/statistical-considerations-for-the-design-of-rare-disease-clinical-investigations-establishment-of-a","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Health and Human Services Department"},"word_count":101,"has_tables":false,"body_markdown":"# Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments\n\n**Type:** Notice\n**Published:** 2026-09-15\n**Citation:** 91 FR 58456\n**Agencies:** Health and Human Services Department, Food and Drug Administration\n**Source:** https://www.federalregister.gov/documents/2026/09/15/2026-18805/statistical-considerations-for-the-design-of-rare-disease-clinical-investigations-establishment-of-a\n\n## Abstract\nThe Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect feedback on statistical considerations for rare disease clinical investigations. This docket is open in conjunction with a Rare disease Innovation, Science, and Exploration (RISE) Workshop on the same topic. Feedback is welcome both on the attached pre-read documents and on the content covered in the Workshop itself."}