ICR Documents

Supporting Statement A Document Date Uploaded CMS-10110_Supporting_Statement_A_(2026 version_24).docx 04/07/2026 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Response to Public Comments PRA Comment Response.pdf Supplementary Document 04/07/2026 Response to Comments (30-day notice) CMS_10110_Comment Response 30 day ICR.docx Supplementary Document 06/16/2026 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received Kurth, Kelsey BMS Comments CMS 10110.docx PC_202604-0938-003_050726_032310_1.pdf Other -- Reginfo.gov Simple 05/07/2026 05/07/2026 Roche, Jacqueline Comment - mlk-wu0h-nksv.pdf Johnson & Johnson Other -- web Simple 02/13/2026 02/13/2026 Cobourn, C Comment - ml8-kxgz-zc81.pdf Helio Other -- API Simple 02/04/2026 02/04/2026 Keeton, Alex Comment - mm9-9h6c-2sao.pdf Association for Accessible Medicines Other -- Web Simple 03/02/2026 03/02/2026 Weiser, Christopher PC_202604-0938-003_050726_044806_1.pdf Teva Comments_CMS–10110_PRA.pdf Teva Pharmaceuticals Other -- Reginfo.gov Simple 05/07/2026 05/07/2026 Yu, Sylvia Comment - mm9-m1vm-p4si.pdf Pharmaceutical Research & Manufacturers of America (PhRMA) Other -- Web Simple 03/02/2026 03/02/2026 Gawlik, Yola Comment - mm9-ggaq-9ihz.pdf Amgen Inc. Other -- Web Simple 03/02/2026 03/02/2026 Buckley, Rich Comment - mm9-c4st-223i.pdf McKesson Corporation Other -- Web Simple 03/02/2026 03/02/2026 Lewis, Christopher Comment - mm5-icnx-06c8.pdf Viatris Inc. Other -- Web Simple 02/27/2026 02/27/2026 Anonymous 202604-0938-003 Comment Final.pdf Other -- Reginfo.gov Simple 05/06/2026 05/06/2026 Collard, Craig Comment - mma-3u1d-09ha.pdf Heron Therapeutics, Inc. Other -- Web Simple 03/02/2026 03/02/2026 Anonymous PC_202604-0938-003_050726_051943_1.pdf Heron - Comment on ICR ASP Reporting Requirements - 5.7.26.pdf Other -- Reginfo.gov Simple 05/07/2026 05/07/2026 Langer, Andrew Comment - mm9-pr42-obo8.pdf CPAC Foundation Center for Regulatory Freedom Other -- Web Simple 03/02/2026 03/02/2026 Watson, Renee Gilead - Comments on BFSF Certification ICR_05072026.pdf Other -- Reginfo.gov Simple 05/07/2026 05/07/2026 Kuntz and Cosgrove, Comment - mlt-z5wp-r1xq.pdf Biotechnology Innovation Organization Other -- web Simple 02/19/2026 02/19/2026 Blout, Jeffrey Comment - mm5-1c1a-5orr.pdf Bioventus Other -- API Simple 02/27/2026 02/27/2026 Garver, Jennifer PC_202604-0938-003_050626_095910_1.pdf PhRMA -- ASP ICR Comment Letter (5.7.26 FINAL).pdf Pharmaceutical Research and Manufacturers of America Other -- Reginfo.gov Simple 05/06/2026 05/06/2026 Silverman, R Comment - mke-jzg4-6xi2.pdf Zydus Pharmaceuticals (USA) Inc. Other -- API Simple 01/14/2026 01/14/2026 Cosgrove on behalf of BIO, Andy BIO Comment on ASP Reporting FINAL 5-7-26.pdf PC_202604-0938-003_050726_045726_1.pdf BIO BIO Other -- Reginfo.gov Simple 05/07/2026 05/07/2026 Kelly, Patrick Comment - mm9-miot-vm18.pdf Healthcare Distribution Alliance Other -- Web Simple 03/02/2026 03/02/2026 Cavanagh, Hillary Comment - mm9-ll4k-n3x8.pdf AbbVie Other -- Web Simple 03/02/2026 03/02/2026 Jafery, Farruq Comment - mm9-gajc-diyq.pdf Novo Nordisk, Inc. Other -- Web Simple 03/02/2026 03/02/2026 Alliance, Healthcare Distribution PC_202604-0938-003_050726_101252_1.pdf HDA Comment Letter - ASP ICR - 05.06.2026.pdf Other -- Reginfo.gov Simple 05/07/2026 05/07/2026 Kurth, Kelsey Comment - mm9-c3tq-fdcw.pdf Bristol Myers Squibb Other -- Web Simple 03/02/2026 03/02/2026 Wiegand, Stefanie PC_202604-0938-003_050726_041450_1.pdf Comments on 202604-0938-003 ICR.pdf Amgen, Inc. Other -- Reginfo.gov Simple 05/07/2026 05/07/2026 Anonymous Comment - mm9-toad-n88i.pdf The Part B Access for Seniors and Physicians Coalition (“ASP Coalition”) Other -- Web Simple 03/02/2026 03/02/2026 Anonymous PC_202604-0938-003_050626_043534_1.pdf JJ Comments 30-day ASP BFSF ICR 5-6-26.pdf Johnson & Johnson Other -- Reginfo.gov Simple 05/06/2026 05/06/2026