Department of Health and Human Services September 21, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Investigational COVID- 19 Convalescent Plasma.'' The guidance document provides recommendations to healthcare providers and investigators on the use of investigational convalescent plasma for the treatment of the Coronavirus Disease 2019 (COVID-19) during the public health emergency. The guidance announced in this notice supersedes the guidance of the same title dated April 2020 and updated in May 2020. The guidance includes a discussion to facilitate the availability of investigational convalescent plasma when blood establishments, hospitals, and healthcare providers collect plasma that does not meet the Conditions of Authorization of the Emergency Use Authorization (EUA). The guidance also provides recommendations for healthcare providers who wish to administer and study convalescent plasma under an investigational new drug (IND) application.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' This proposed information collection was previously published in the Federal Register on June 11, 2020 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.