2024-05081. Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 22, 2024. The document announced the availability of a final guidance for industry entitled “Assessing COVID–19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID–19 Prevention or Treatment.” The document was published with an incorrect docket number. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

David Reasner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6373, Silver Spring, MD 20993, 301–837–7667; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911.

SUPPLEMENTARY INFORMATION:

In the Federal Register of February 22, 2024 (89 FR 13351), in FR Doc. 2024–03622, the following correction is made:

On page 13351, in the first column in the header of the document and in the third column in the second line of the first paragraph, “Docket No. FDA–2024–D–0584” is corrected to read “Docket No. FDA–2020–D–1824.”

Dated: March 5, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.