# Enable FDA E2B(R3): IND Aggregate Reports

To conform with FDA guidance for reporting cases with no patient involvement, Safety now supports populating the nullFlavor `NA` in the FDA.D.11.r.1 Patient Race Code and FDA.D.12 Patient Ethnicity Code data elements of FDA E2B(R3) reports. This is useful, for example, when reporting IND Aggregate or IND Summary cases to the FDA. Using the new _FDA Summary Type_ field, users can select _Aggregate_ or _Summary_ to indicate that Vault should export the nullFlavor instead of the NCI Concept Identifier for the race and ethnicity of the patient.

Although this feature is Auto-on, some components may require additional configuration. After configuring this feature, see <a href="/en/gr/01287/#fda-summary-type">Case Field Reference</a> and <a href="/en/gr/725757/">E2B Generation: FDA E2B(R3) Mapping</a> for more information.


## Update the Case Layout

<a href="/en/gr/26387/#how-to-add-object-fields">Add</a> the _FDA Summary Type_ field to the _Details_ section of applicable layouts for the _Case_ object type on the _Case_ object.