On this page:
- What is an Ombuds?
- What purpose does the CTP Ombuds serve?
- What issues will the CTP Ombuds handle?
- Will our conversation be confidential?
- Who are the CTP Ombuds?
Contact FDA Ombudsman
The FDA Ombudsman
Contact CTP Ombudsman
Nathan Hurley, Ombuds
Arielle Patno, Associate Ombuds
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 Ombuds?
An Ombudsman (Ombuds) is a neutral resource that investigates and settles disputes and resolves complaints. The Center for Tobacco Products (CTP) Ombuds Team serves as a one-stop-shop for informal advice or consultation for stakeholders who have complaints or inquires.
What purpose does the CTP Ombuds Team serve?
The CTP Ombuds Team primarily listens. We provide a “safe space” for stakeholders to voice their questions, concerns, or complaints about FDA regulation of tobacco products. We will ask clarifying questions, determine desired outcomes, discuss options forward, and help to facilitate communications between external stakeholders and FDA staff using our thorough understanding of center operations.
The CTP Ombuds Team reports directly to the Team of the Center Director on ways to assure that CTP’s procedures, policies, and decisions are fair. We act as a source of early detection for emerging system-wide issues. While maintaining independence operating outside the business chain of command, the CTP Ombuds Team responds to inquiries and is charged to investigate complaints from all stakeholders who contact us, including tobacco manufacturers and retailers, law firms or consultants representing the tobacco industry, public health groups, research institutions, health care providers, consumers, and government personnel (local, state and federal).
What issues will the CTP Ombuds handle?
Externally, the CTP Ombuds Team answers inquiries, acknowledges complaints about CTP’s regulatory process, redirects contacts to the appropriate office, discusses dispute resolution options including appeals under 21 CFR 10.75, and participates in meetings as an unbiased resource to stakeholders. The CTP Ombuds Office does not engage in a matter that is in litigation.
Internally, the CTP Ombuds Team works toward CTP’s mission and goals, assists in guidance development, and facilitates Scientific Dispute Resolution internal to CTP.
The Ombuds Team will not engage in matters involved in litigation.
Will our conversation be confidential?
All Ombuds follow a code of ethics and operating principles drawn from those established by the Coalition of Federal Ombuds, the United States Ombuds Association, and the International Ombuds Association. If you contact the CTP Ombuds Team, 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 are the CTP Ombuds Team?
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.
Arielle Patno, the CTP Associate Ombuds, has held the position since 2019. She came to CTP’s Office of Science in 2015 as an RHPM. Prior to joining FDA, Arielle worked on contracts as a Clinical Research Assistant with NIH’s Division of AIDS, Veteran’s with spinal cord injuries, Parkinson’s Disease patients and Stoke patients.