REGULATORY UPDATE: FDA Extends Collection of Information Related to Establishment Registration

The Food and Drug Administration (FDA) extended a collection of information request related to the agency's regulations governing the registration of establishments and listing of products for manufacturers of human blood and blood products and licensed devices (21 CFR Part 607). The new deadline to submit comments is July 22.

Based on an evaluation of calendar year 2022 data from the Center for Biologics Evaluation and Research's (CBER) Blood Establishment Registration and Product Listing system, the estimated reporting burden reflects an overall decrease of 36 hours. The FDA attributed this adjustment to a decrease in product listing updates and an increase in the number of initial registrations.

For more information on the electronic blood establishment registration (eBER) system, visit the FDA's Blood Establishment Registration and Product Listing web page.