A Risk-Based Approach to Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 12, 2023. The document announced the availability of a final guidanc...
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Federal Register
of April 12, 2023. The document announced the availability of a final guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers; Guidance for Industry.” The notice of availability for this final guidance was published with an incorrect OMB control number. This document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Mona Shing, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3355, Silver Spring, MD 20993-0002, 301-796-0910.
1. On page 22040, in the first column, in the last sentence of “II. Paperwork Reduction Act of 1995,” the OMB control number 0910-0733 is corrected to read: “. . .and the collections of information in FDA's guidance for industry entitled “Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” have been approved under OMB control number 0910-0014.” The correction changes the OMB control number from a number that was discontinued to an active one.
Use this for formal legal and research references to the published document.
88 FR 27521
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“A Risk-Based Approach to Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Correction,” thefederalregister.org (May 2, 2023), https://thefederalregister.org/documents/2023-09264/a-risk-based-approach-to-monitoring-of-clinical-investigations-questions-and-answers-guidance-for-industry-correction.