ICR Documents

Supporting Statement A Document Date Uploaded CMS-10844 SBE ICR_Supporting_Statement_Clean.docx 05/26/2023 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Crosswalk (60day to 30day changes) SBE ICR_Crosswalk_508.pdf Supplementary Document 04/24/2023 Response to comment document (60day) SBE ICR_Comment and Response Summary_508.pdf Supplementary Document 05/26/2023 Crosswalk (30day changes) SBE ICR_Crosswalk_Clean.docx Supplementary Document 05/26/2023 Response to comment document (30day) SBE ICR_Comment_Response_Summary_Clean.docx Supplementary Document 05/26/2023 Comment Summary Table Comment Summary Table_v2.docx Supplementary Document 05/26/2023 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received Kuntz, Crystal SBE ICR Comments FINAL.pdf PC_202304-0938-016_052423_114114_1.pdf BIO Other -- Reginfo.gov Simple 05/24/2023 05/24/2023 Dube, Tim PCMA comments on CMS-10844 Small Biotech Exception - 30 day - May 24 2023.pdf PC_202304-0938-016_052423_103832_1.pdf PCMA Other -- Reginfo.gov Simple 05/24/2023 05/24/2023 Tube, Tim PCMA.pdf Vice President, Regulatory Affairs PCMA Email Simple 03/27/2023 03/27/2023 Rubin, Peter No Patient Left Behind (NPLB).pdf Executive Director No Patient Left Behind (NPLB) Email Simple 03/27/2023 03/27/2023 Flannelly, Barry Incyte Corporation.pdf Executive Vice President & General Manager Incyte Corporation Email Simple 03/27/2023 03/27/2023 Turner, Chevese Haystack Project.pdf CEO Haystack Project Email Simple 03/27/2023 03/27/2023 Morrissey, Michael Exelixis.pdf President and Chief Executive Officer Exelixis Email Simple 03/27/2023 03/27/2023 Kuntz, Crystal Biotechnology Innovation Organization (BIO).pdf Vice President, Healthcare Policy & Research Biotechnology Innovation Organization (BIO) Email Simple 03/27/2023 03/27/2023 Davison, Rebecca BeiGene - Comment Letter to CMS re_ Small Biotech Exception ICR_FINAL.pdf BeiGene Other -- Reginfo.gov Simple 05/24/2023 05/24/2023