United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2023_register executive 2023-12-13 article Notices D09002ee1c794e0ef D09002ee1c794e29d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTMv2.0), version 3.4 of the CDISC Study Data Tabulation Model Implementation Guide (SDTMIGv3.4), and version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide-- Genetox (SENDIG-Genetoxv1.0) and announcing the date that these version updates are required in certain submissions. CBER and CDER are also announcing the date that requirement ends for version 3.2 of the CDISC SDTMIG (SDTMIGv3.2). The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes. The Agency will publish in the technical specifications document entitled "Study Data Technical Conformance Guide" additional details on how to implement new variables. 88 FR 86336 https://www.govinfo.gov/app/details/FR-2023-12-13/2023-27310 2023-27310 fr13de23-42 4164-01-P Docket No. FDA-2023-N-5022 https://www.govinfo.gov/app/details/FR-2023-12-13/2023-27310 https://www.govinfo.gov/content/pkg/FR-2023-12-13/html/2023-27310.htm https://www.govinfo.gov/content/pkg/FR-2023-12-13/pdf/2023-27310.pdf 2 p. 86336 86337 88 FR 86336 Data Standards; Support and Requirement Begins for the Clinical Data Interchange Standards Consortium Version 2.0 of the Study Data Tabulation Model, Version 3.4 of the Study Data Tabulation Model Implementation Guide, and Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide-Genetox; Requirement Ends for the Clinical Data Interchange Standards Version 3.2 of the Study Data Tabulation Model Implementation Guide; Federal Register Vol. 88, Issue NOTICE 2023-27310 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2023-N-5022 4164-01-P 2023-27310 Notice.

The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTMv2.0), version 3.4 of the CDISC Study Data Tabulation Model Implementation Guide (SDTMIGv3.4), and version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide-- Genetox (SENDIG-Genetoxv1.0) and announcing the date that these version updates are required in certain submissions. CBER and CDER are also announcing the date that requirement ends for version 3.2 of the CDISC SDTMIG (SDTMIGv3.2). The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes. The Agency will publish in the technical specifications document entitled "Study Data Technical Conformance Guide" additional details on how to implement new variables.

Support for version CDISC SDTMv2.0, SDTMIGv3.4, and SENDIG- Genetoxv1.0 begins December 13, 2023. CDER: Helena Sviglin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 240- 402-6511, cderdatastandards@fda.hhs.gov. Data Standards: Support and Requirement Begins for the Clinical Data Interchange Standards Consortium Version 2.0 of the Study Data Tabulation Model, Version 3.4 of the Study Data Tabulation Model Implementation Guide etc., CBER-eDATA@fda.hhs.gov cderdatastandards@fda.hhs.gov https://www.fda.gov/media/82716/download https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 88, no. 238 Office of the Federal Register, National Archives and Records Administration 2023-12-13 continuing daily deposited born digital 293 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2023-12-13 P0b002ee1c2f904c6 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13de23 https://www.govinfo.gov/app/details/FR-2023-12-13 https://www.govinfo.gov/content/pkg/FR-2023-12-13/pdf/FR-2023-12-13.pdf https://www.govinfo.gov/content/pkg/FR-2023-12-13/xml/FR-2023-12-13.xml fdlp 86257 86540 DGPO 2023-12-13 2024-05-28 FR-2023-12-13 machine generated eng FR FR-2023-12-13 88 238