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CVM Ombudsman

Complaints/Disputes Resolution Process

The CVM Ombudsman is the Center contact for information on the dispute resolution process as published in the November 18, 1998 Federal Register (63 FR 63978, November 18, 1998) | text | | pdf | and assists in acilitating its effective implementation.

Anyone attempting to resolve differences of opinion or disputes involving science and/or science-based policy decisions should follow the supervisory chain of command beginning with the group/team in the responsible reviewing division, then the Division Director and then the Office Director. If the matter remains unresolved or is resolved unsatisfactorily, the Ombudsman should be contacted. The CVM Ombudsman does not handle in matters that are already involved in litigation.

The CVM Ombudsman assesses the effectiveness of the Center’s current science-based programs (e.g. policies and procedures, regulations and guidance documents) based on information/feedback received from both inside and outside the Center, advises the Center Director’s Office of any trends or consistent problems and makes recommendations for change or improvement.

Relation to FDA Ombudsman

The function of the CVM Ombudsman, Dr. Marcia K. Larkins, parallels that of the FDA Office of the Ombudsman, but provides an avenue for interested parties both inside and outside the Center for getting complaints involving CVM programs resolved at a closer level to the source. The CVM Ombudsman is located in the Office of the Center Director and reports directly to the Associate Director for Executive Programs, Cathy Beck.

Product Jurisdiction

Like the FDA Ombudsman, the CVM Ombudsman may handle questions or complaints regarding veterinary product jurisdiction issues. The Center currently has draft Memoranda of Understanding (MOUs) with other agencies such as the United States Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) that are intended to clarify certain product jurisdiction issues. The CVM Ombudsman is the Center’s contact for information as to whether certain products currently fall under the CVM’s jurisdiction or for information on who to contact for further guidance or when review is required in order to make a determination.

Neutrality

The Ombudsman is not an advocate for any of the parties involved in a disagreement but is available as an impartial listener attempting to understand and consider all sides of an issue. This may include an independent investigation in order to get a clearer understanding of the facts. The Ombudsman may provide information on alternative approaches/procedures available or simply help individuals to develop options for resolving a dispute. The Ombudsman can make recommendations for change but does not have the authority to enforce those recommendations.

Confidentiality

Generally, the Ombudsman can maintain confidentiality with regard to any form of dispute resolution communication. (Guidance on this issue is provided in the document entitled “Confidentiality in Federal Dispute Resolution Programs” at 65 FR 83085, December 29, 2000 | text | | pdf |. A complainant may request that their identity (i.e. name, company or organization) or that some or all of the details of the complaint be kept confidential. However, total confidentiality can be restrictive and may prevent a thorough investigation and effective resolution of an issue. The Ombudsman must have the complainant’s concurrence and permission before proceeding with any direct action. Significant issues may still be addressed within the Center by the Ombudsman but conveyed in a way that focuses on the problem and yet maintains anonymity for the complainant.

The CVM Ombudsman is an Associate Member of The Ombudsman Association (TOA). TOA is a non-profit, international association for professional organizational ombudspeople. With regard to safeguarding both the practice and appearance of neutrality and confidentiality, the CVM Ombudsman generally supports and affirms TOA’s Code of Ethics which states:

“The ombudsman as a designated neutral, has the responsibility of maintaining strict confidentiality concerning matters that are brought to his/her attention unless given permission to do otherwise. The only exceptions, at the sole discretion of the ombudsman, are where there appears to be imminent threat of serious harm. …”

Exceptions to confidentiality also include any allegations of criminal activity, which must be reported to the FDA Office of Internal Affairs or Office of Criminal Investigations.

The CVM Ombudsman is also a member of the Coalition of Federal Ombudsmen (CFO).


Web Page Updated by hd - April 18, 2007, 10:03 AM ET




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