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  1. Office of Regulatory Affairs

ORA Ombudsman

 

ORA Ombudsman Vision & Mission

Vision: To enhance the FDA Office of Regulatory Affairs (ORA) operations by serving as a confidential resource to improve communication channels, resolve disputes, and foster positive relationships with internal and external stakeholders.

Mission: To impartially address, investigate, and resolve concerns, disputes, and other issues that arise between the Office of Regulatory Affairs (ORA) and stakeholders outside of the U.S Food and Drug Administration (FDA), including industry, governmental organizations (local, state, federal, territorial, and tribal), and other members of the public in an informal and neutral manner.

 

What is an Ombudsman?

An ombudsman is a neutral, impartial person who investigates complaints or disputes and attempts to resolve them, usually through recommendations or mediation. The Office of Regulatory Affairs (ORA) Ombudsman Program serves as a one-stop-shop for informal advice or consultation for external stakeholders who have complaints or inquiries.

 

What does the ORA’s Ombudsman do?

The ORA Ombudsman is dedicated to two primary objectives:

  1. Informally address concerns, complaints, and other issues that arise between ORA and stakeholders outside of the agency, including industry, governmental organizations (federal, state, territorial, and tribal), and other members of the public; and
  2. Engage in outreach and education for these stakeholders and employees of ORA to enhance communication and transparency with stakeholders.
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.

 

Why should you contact the ORA Ombudsman?

Interactions with the FDA can sometimes be confusing, daunting, and complicated. Occasionally, miscommunication occurs because the two sides aren’t speaking the same language. The ORA Ombudsman helps mitigate these factors between ORA staff and external parties without those parties fearing adverse administrative or retaliatory consequences (please refer to FDA's Non-Retaliation Policy). When disputes arise, the office is a sounding board that will listen to concerns and solve problems.

The ombudsman provides knowledgeable, comfortable, and confidential (within legal constraints) information about the regulatory process. As an unbiased arbiter, the ombudsman can help resolve issues by facilitating discussions, evaluating options, offering an impartial perspective, engaging in shuttle diplomacy, and providing recommendations, among other options.  The ombudsman can make recommendations for change but does not have the authority to enforce those recommendations.

You can contact the ORA Ombudsman anytime you need assistance resolving an ORA-related process issue that has not been resolved through the established agency channels of supervision.

 

What kinds of issues does the ORA Ombudsman handle?

The ombudsman will listen to your complaints, questions, and comments regarding (but is not limited to):

  • Import detentions and refusals;
  • Concerns about facility inspections;
  • Interactions with district offices or ORA personnel;
  • Interactions with the Office of Criminal Investigations; and
  • ORA laboratory analytical findings and review.

The ORA Ombudsman will also answer your general questions about the ORA process and hear your ORA-related suggestions for improvements. The ombudsman is not an advocate for any of the parties involved in a disagreement but is available as an impartial resource attempting to understand and consider all sides of an issue.  The ORA Ombudsman cannot:

  • Address internal human resource matters;
  • Delay enforcement or other regulatory actions or deadlines;
  • Serve as an advocate in any formal process; or
  • Address matters in litigation.

 

Contact ORA Ombudsman

844-871-4536 (toll free)

[email protected]
Erica Katherine, ORA Ombudsman

 

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