What does the CTP Ombudsman do?
The role of the CTP Ombudsman is to look into complaints from outside FDA, and to facilitate the resolution of disputes between CTP and the tobacco industry. While providing this assistance, he maintains his independence, impartiality and neutrality. He is an advocate for fairness.
As a primarily external Ombudsman, he is the focal point for:
- addressing complaints
- assisting in resolving disputes of a scientific, regulatory, or procedural nature.
- discussing appeal and dispute resolution options
- responding to inquiries
The Ombudsman is available to provide an empathetic ear to listen to your issues and concerns even if they do not rise to the level of a complaint or dispute. He can also help to facilitate a dialogue or discussion between stakeholders and CTP staff.
In addition he is also very proactive in his outreach to the tobacco industry and other stakeholders by attending, making presentations at, and networking at external meetings and conferences, including the CTP Stakeholder Discussion Series meetings.
Based on the nature of the contacts he receives from the public, the Ombudsman advises the Office of the Center Director, where he is located, on ways to assure that CTP’s procedures, policies and decisions are of the highest quality and are fair and equitable.
The Ombudsman is also an internal Ombudsman who will play a role in the resolution of internal scientific disputes in regulatory decision-making between CTP managers and staff.
Relation to FDA Office of the Ombudsman
The function of the CTP Ombudsman parallels that of the FDA Office of the Ombudsman, located in the Office of the FDA Commissioner, but provides an avenue for resolving issues involving CTP programs at a level closer to the source. Because the FDA Office of the Ombudsman has agency-wide jurisdiction, it is appropriate to contact that Office when an issue involves more than one FDA Center, when an effort to resolve a dispute or an appeal of a decision was not successful at the Center level, or at any time when involvement by someone outside CTP might be useful.
When to Contact the CTP Ombudsman
Complaints and Disputes: The Ombudsman will do his best to respond to you in a timely and effective manner. Although you may contact him at any time, you should, if possible, first try to resolve any complaint or dispute within the responsible CTP Office. The Ombudsman does not get involved in matters that are in litigation.
General Comments and Suggestions
The Ombudsman is interested in hearing from you about the effectiveness of CTP’s programs and about problems that may be getting in the way of carrying out the Center’s regulatory responsibilities. He welcomes such input because it helps CTP to continually assess and improve the work that it does.
If you contact the Ombudsman you may prefer to keep your identity confidential and may ask to keep your name, the name of your company or even the nature of your complaint confidential. Generally, he can keep this information confidential if you request him to do so. Naturally, a pledge of confidentiality may preclude the Ombudsman from facilitating a resolution to a specific problem. If so, he will explain this to you, and not proceed to look into a matter unless you release him from the pledge. There are a few areas, however, in which confidentiality cannot be preserved, such as allegations of criminal activity, which must be reported to the FDA Office of Criminal Investigations. Even in these situations, though, the identity of a confidential source may be protected from disclosure to the public. Also, FDA has a very strict non-retaliation policy that protects anyone who complains about the Agency or any of its employees.
How to Contact the Ombudsman
E-mail address: CTPOmbudsman@fda.hhs.gov