CTP Ombudsman
On this page:
- What is an Ombudsman?
- What does the CTP Ombudsman do?
- What to do before contacting the CTP Ombudsman?
- What issues will the CTP Ombudsman handle?
- Will our conversation be confidential?
- Who is the CTP Ombudsman?
Contact FDA Ombudsman
The FDA Ombudsman
Phone: 301-796-8530
Email: [email protected]
Contact CTP Ombudsman
Nathan Hurley, Ombudsman
Arielle Patno, Associate Ombudsman
Phone: 301-796-3095
Email: [email protected]
Contact FDA
1-877-287-1373
[email protected]
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center
Building 71, Room G335
Silver Spring, MD 20993-002
What is an Ombudsman?
An Ombudsman is a neutral resource who investigates and settles disputes and resolves complaints. The Center for Tobacco Products (CTP) Ombudsman’s Office serves as a one-stop-shop for informal advice or consultation for stakeholders who have complaints or inquires.
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What does the CTP Ombudsman do?
The Ombudsman’s Office maintains its independence, impartiality, and neutrality, while advocating for fairness. We respond to inquiries and are charged to investigate complaints from all stakeholders who contact us, including the tobacco industry, law firms or consultants representing industry, advocacy groups, public and private research institutions, health care providers, consumers, and government personnel (local, state and federal).
The CTP Ombudsman’s Office provides a “safe space” for stakeholders to voice their questions, concerns, or complaints about FDA regulation of tobacco products. Using our thorough understanding of Center operations, we can help to facilitate communications between external stakeholders and FDA staff.
The Ombudsman reports directly to the Office of the Center Director, on ways to assure that CTP’s procedures, policies, and decisions are fair. We also act as a source of early detection for emerging system-wide issues.
What to do before contacting the CTP Ombudsman?
The stakeholder should first attempt to resolve the matter with the specific CTP office or division that made the decision being disputed. In the event the dispute is not resolved, the stakeholder may raise the matter with the Ombudsman’s office.
What issues will the CTP Ombudsman handle?
- Answer inquiries and acknowledge complaints on CTP’s regulatory process or redirect to the appropriate party
- Discuss dispute resolution options including appeals under 21 CFR 10.75
- Participate in meetings as an unbiased resource to stakeholders
- Facilitate the resolution of disputes of scientific, regulatory, or procedural nature between CTP and stakeholders
The Ombudsman’s Office cannot get involved in matters that are in active litigation.
Will our conversation be confidential?
The Ombudsman’s Office follows a code of ethics and operating principles drawn from those established by the Coalition of Federal Ombudsmen, the United States Ombudsman Association, and the International Ombudsman Association. If you contact the Ombudsman’s Office, we will keep your name, company, organization, or other identifying information confidential, unless your specific concern requires collaboration with an additional CTP office. We will obtain your permission to share information and the specifications of your case. FDA has a very strict non-retaliation policy that protects stakeholder complaints about the Agency or any of its employees.
Your information will no longer be kept confidential if required by law or a threat against yourself or another person is made.
Who is the CTP Ombudsman?
Since 2016, Nathan Hurley has served as the Ombudsman for the Center for Tobacco Products. He came to CTP’s Office of Science in 2010 and has held the roles of Staff Assistant, Regulatory Health Project Manager (RHPM) and Lead RHPM. Nathan has observed, contributed to and developed a solid foundation in the growing processes and procedures shaping the Center.