Document ID: FDA-2019-D-0362-0028
Agency: fda
Document Type: Notice
Title: A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers; Guidance for Industry; Correction
Posted Date: 2023-05-02T04:00Z

[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Page 27521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09264]

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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.

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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]
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