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 document that appeared in the Federal Register of July 7, 2020. The document announced the dates that support and requirement will begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model (SDTM) Implementation Guide (IG) 3.3, and for version 2.1 of the Define-Extensible Markup Language (Define-XML). The document provided the 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, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.