Formal Dispute Resolutions; Appeals Above the Division Level

This information collection approval request supports FDA guidance on the process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research that cannot be resolved at the division level. The guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented.

The latest form for Formal Dispute Resolutions; Appeals Above the Division Level expires 2022-03-31 and can be found here.

CDER - Requests for Formal Dispute Resolution

Federal Enterprise Architecture: Health - Consumer Health and Safety