A Risk-Based Approach to Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Correction
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Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 84 (Tuesday, May 2, 2023)</title>
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[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Page 27521]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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]
BILLING CODE 4164-01-P
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