Department of Health and Human Services
Food and Drug Administration
- [Docket No. FDA-2020-N-1206]
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice; correction.
SUMMARY:
The Food and Drug Administration (FDA) is correcting a notice correction that appeared in the Federal Register of August 20, 2020. The document announced the correction dates that the support and requirement were to begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), and version 3.3 of the SDTM Implementation Guide (SDTMIG), and for version 2.1 of the Define-Extensible Markup Language (Define-XML). The document erroneously provided the ( printed page 77127) incorrect dates for these electronic study data standards. This document corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Chenoa Conley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-796-0035, cderdatastandards@fda.hhs.gov, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.