About FDA

CTP Ombudsman

How to Contact the Ombudsman’s Office
Who is CTP’s Ombudsman?

Nathan Hurley is the Acting Ombudsman for the Center for Tobacco Products. Nathan started his federal career as a Park Ranger in the National Park Service after graduating from Shepherd University with a degree in Environmental Science. He came to CTP’s Office of Science in 2010 as a Staff Assistant and worked his way to Lead Regulatory Health Project Manager. In the over 6 years of experience in CTP, Nathan has observed, contributed to and developed a solid foundation in the growing processes and procedures shaping the Center.

Allison Monyei is the Associate Ombudsman for the Center for Tobacco Products (CTP). Allison started her federal career in 2014 as a Regulatory Counsel in CTP’s Office of Compliance and Enforcement. Prior to working at CTP, she worked as an attorney for 3 years with the National Veterans Legal Services Program, advocating on behalf of our nation’s veterans and their families.

What does the CTP Ombudsman do?

CTP established the Ombudsman’s Office in 2010. The Ombudsman’s Office responds to inquiries and looks into complaints from all parties who contact us, including the tobacco industry, law firms or consultants representing industry, advocacy groups, public and private research institutions, health care providers, and consumers. We also facilitate the resolution of disputes between CTP and outside parties and provide general information on the regulatory process. While providing this assistance, the Ombudsman’s Office maintains its independence, impartiality, and neutrality. The Ombudsman’s Office is an advocate for fairness.

Serving as a primarily external Ombudsman’s Office, we:

  • Address complaints
  • Help resolve disputes of a scientific, regulatory, or procedural nature
  • Discuss appeal and dispute resolution options
  • Respond to inquiries

The Ombudsman’s Office is available to listen to issues and concerns even if they do not rise to the level of a complaint or dispute. The Ombudsman’s Office can also help to facilitate a dialogue or discussion between external parties and CTP staff.

Based on the nature of the contacts received from the public, the Ombudsman advises the Office of the Center Director, where the Ombudsman’s Office is located, on ways to assure that CTP’s procedures, policies, and decisions are fair and equitable.

The Ombudsman is also an internal Ombudsman who plays a role in the resolution of internal scientific disputes in regulatory decision-making between CTP managers and staff. However, the Ombudsman’s Office does not address internal human resources issues. CTP staff seeking informal, confidential assistance for workplace conflicts can learn about Conflict Prevention and Resolution here.

Why Should Someone Contact the CTP Ombudsman?

The Ombudsman’s Office provides a “safe space” for external parties to voice their questions, concerns, or complaints about CTP and its regulation of tobacco products. We work to help members of the public, tobacco companies and their representatives, public health advocates, and any other person from outside of CTP who contacts us. Using our deep understanding of Center operations and interacting with FDA staff, we can improve communications and working relationships while also helping to de-escalate conflicts between CTP and outside parties. Because we are confidential, impartial, independent, and informal, we can listen, assess difficult situations, identify options, and ultimately resolve issues at an early stage.

When to Contact Us

The CTP Ombudsman’s Office can help you by:

  • Answering general questions on CTP’s regulatory process
  • Discussing possible ways to help you resolve a problem with CTP
  • Contacting individuals within CTP on your behalf
  • Connecting you with someone who can assist you
  • Encouraging effective communication between CTP and outside entities
  • Acting as a source of early detection for emerging system-wide issues
  • Answering questions about CTP’s regulation of tobacco products or looking into complaints from CTP’s regulated industry, law firms or consultants representing tobacco companies, advocacy groups, public and private research institutions, health care providers, and consumers
  • Facilitating the resolution of disputes between CTP and outside parties
  • Identifying options you have to appeal a CTP decision

The Ombudsman’s Office can provide an empathetic ear for issues and concerns even if they do not rise to the level of a complaint or dispute.

What to Expect From Us

The Ombudsman’s Office will listen carefully to your complaint, ask questions (including about your desired outcome), and review your options for moving forward. This process may be very quick and take only a few minutes, or we might need to take some time to look into the issue. We will keep what you tell us confidential unless we have serious concerns about your or someone else’s safety or unless disclosure is required by law.

Depending on the situation, we may:

  • Seek additional information from CTP employees or offices that know about your case
  • Point you in the direction of applicable laws, regulations, policies, and data
  • Participate in meetings to support effective communication and problem-solving
  • Facilitate conversations between you and CTP
  • Refer you to someone else, either within CTP or elsewhere

The Ombudsman’s Office does its best to respond in a timely and effective manner. Although anyone may contact our office at any time, people should first try, if possible, to resolve any complaint or dispute within the responsible CTP Office. The Ombudsman’s Office cannot get involved in matters that are in active litigation.

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.

Confidentiality

The CTP 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. These include standards for ensuring confidentiality, impartiality, and informality.

If you contact the Ombudsman’s Office, you may want to keep your name, company or organization name, or even the reason for your complaint confidential. Generally, we can keep this information confidential if you ask. However, keeping this information confidential might make it difficult for us to help you with a specific problem. If that happens, we’ll let you know and won’t keep looking into your problem without your permission to share the information about you and the specifics of your case.

However, there are a few areas where we can’t keep your information confidential. The first one is if you make a threat against yourself or another person. Another is if we’re required to share your information by law. However, you should know that FDA has a very strict non-retaliation policy that protects anyone who complains about the Agency or any of its employees.

Contact FDA

1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov


Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002


Courier Deliveries

Page Last Updated: 11/29/2016
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