2020-22142. Investigational COVID-19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a notice that published in the Federal Register of September 21, 2020. The document announced the withdrawal of a final guidance for industry entitled “Investigational COVID-19 Convalescent Plasma,” which was issued in April 2020 and updated in May 2020. FDA withdrew the guidance because the Agency issued a new guidance for industry of the same title. The document was published with the incorrect docket number for the guidance for industry that was withdrawn. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Shruti Modi, 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:

Correction

In the Federal Register of September 18, 2020 (85 FR 593120), appearing on page 59320 in FR Doc. 2020-20801, the following correction is made:

On page 59320, in the third column, the Docket No. “FDA-2020-D-1825” is corrected to read “FDA-2020-D-1137.”

Dated: October 1, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.