88 FR 84 pg. 27521 - A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers; Guidance for Industry; Correction
Type: NOTICEVolume: 88Number: 84Page: 27521
Page: 27521Docket number: [Docket No. FDA-2019-D-0362]
FR document: [FR Doc. 2023-09264 Filed 5-1-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0362]
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.
[FR Doc. 2023-09264 Filed 5-1-23; 8:45 am]
BILLING CODE 4164-01-P