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

---
identifier: "/us/fr/2023-09264"
source: "fr"
legal_status: "authoritative_unofficial"
title: "A Risk-Based Approach to Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Correction"
title_number: 0
title_name: "Federal Register"
section_number: "2023-09264"
section_name: "A Risk-Based Approach to Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Correction"
positive_law: false
currency: "2023-05-02"
last_updated: "2023-05-02"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2023-09264"
document_type: "notice"
publication_date: "2023-05-02"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "88 FR 27521"
fr_volume: 88
docket_ids:
  - "Docket No. FDA-2019-D-0362"
fr_action: "Notice of availability; correction."
---


#  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.