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ORA Ombudsman

                        
                ORA Ombudsman Frequently Asked Questions
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          ORA OmbudsmanContact ORA ORA Ombudsman
  			An Objective Neutral Resource
	
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    PrintOmbudsman Program was created to enhance the operations of the FDA Office of Regulatory Affairs (ORA) by serving as a confidential, neutral resource to improve communication channels, resolve disputes, and foster positive relationships with internal and external stakeholders including industry, government, and the public.

The ombudsman assists stakeholders in identifying and evaluating options; explaining the appropriate process for resolution; referring concerns, when possible, to the appropriate office or program; and monitoring outcomes. Stakeholders can request ombudsman assistance with issues involving:

Dispute resolution
	Mediation/facilitated discussions
	Complaints relating to an action or lack of action by ORA
	Requests for supervisory review of a decision
	General regulatory questions or concerns
	Claims of retribution or unfair treatmentProgram Standards of Practice

Core Standards of the Ombudsman: Independence, Informality, Impartiality, and Confidentiality (when warranted).

The ORA Ombudsman abides by ethical principles and standards established by the Coalition of Federal Ombudsmen, the U.S. Ombudsman Association, and the International Ombudsman Association. These include standards for ensuring confidentiality, neutrality, and informality.

Interactions with the FDA can sometimes be confusing, daunting, and complicated. You should find interactions with the staff professionals at ORA helpful and the decision made based on sound policy and regulation. Occasionally, miscommunication could occur due to a lack of feedback, disagreement between the two sides of an issue, or maybe one side has information overload. The ombudsman helps mitigate these and other concerns without the external stakeholder fearing adverse administrative or retaliatory consequences (please refer to the FDA Non-Retaliation Policy). The ombudsman advocates for fairness, efficiency, and effectiveness of ORA operations.

Learn more:

Meet the ORA Ombudsman
	ORA Ombudsman Frequently Asked Questions
	ORA Ombudsman Frequently Requested Contacts
	ORA Ombudsman Information Sheet - A flyer about the ORA Ombudsman Program suitable for sharing with all ORA stakeholders
	ORA Ombudsman Annual ReportsContact ORA Ombudsman

Toll free 844-871-4536ORAOmbudsman@fda.hhs.gov

Take Our Survey

We value your feedback about your interactions with the FDA’s Office of Regulatory Affairs (ORA) Ombudsman Program (OOP). Please take a few minutes to take our survey.

                                                                                  Content current as of:
      04/26/2023ORA Ombudsman                
                          

                        ORA Ombudsman Frequently Asked Questions
          ORA Ombudsman Frequently Requested Contacts
          ORA Ombudsman Annual Reports
 
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