Complaints/Disputes

Complaints/Dispute 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) and assists in facilitating its effective implementation.
 

Anyone attempting to resolve differences of opinion or disputes involving scientific issue 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 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.  The CVM Ombudsman’s role is described in the following guides and guidance documents for external and internal Scientific Dispute Resolution (SDR).
 

External SDR 

• CVM Update - CVM Dispute Resolution Final Guidance Available, July 19, 2005
• Guidance for Industry #79 - Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM) - Final Guidance, July 2005
• FR Notice - Docket No. 2003D-0167, CVM 2003135.  Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability.  Pages  47370-47372 [FR Doc. 05-14137] July 19, 2005
• Guidance for Industry #163: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP – Final Guidance, January 2006

Internal SDR

• CVM Policy and Procedures Manual Guide 1240.2120 – Product Manager
• CVM Policy and Procedures Manual Guide 1240.2110 – Procedures for Resolving Scientific/Data Disagreements within CVM 
• CVM Policy and Procedures Manual Guide 1240.2115- Procedures for Internal CVM Review of Science or Policy Issues Related to Significant Decisions of High Impact 

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 resolving complaints involving CVM programs closer to the source. The CVM Ombudsman is located in the Office of the Center Director and reports directly to the Deputy Director, Tracey H. Forfa.
 

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 general information as to whether products currently fall under the CVM’s jurisdiction and who to contact for further guidance or when review is required in order to make a determination for specific products.
 

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 or 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. 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 a Member of the International Ombudsman Association (IOA).  The IOA is a non-profit, international association for professional organizational ombuds people. With regard to safeguarding both the practice and appearance of neutrality and confidentiality, the CVM Ombudsman generally adheres to IOA’s Standards of Practice and to the Code of Ethics which states:
 

“The ombudsman holds all communications with those seeking assistance in strict confidence, and does not disclose confidential communications unless given permission to do so.  The only exception, to this privilege of confidentiality is where there appears to be imminent risk 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), an organization whose goals include supporting, assisting, advancing and edifying those who serve Federal institutions as Ombudsmen.