2023-09264. A Risk-Based Approach to Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability; correction.

SUMMARY:

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.

SUPPLEMENTARY INFORMATION:

In the Federal Register of April 12, 2023 (88 FR 22038), in FR Doc. 2023–07687, the following correction is made:

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.

Dated: April 27, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.