Ombudsman is a Scandinavian term that describes a special kind of grievance-handling official who investigates citizen’s complaints against administrative agencies. An ombudsman is an individual who handles disputes while operating in a neutral and confidential role. The ombudsman investigates complaints made by individuals inside and outside an organization, reports the findings and helps to achieve equitable solutions.
The Center for Veterinary Medicine (CVM) Ombudsman investigates and seeks to resolve issues related to science and science-based policy decisions for products under the jurisdiction of CVM. The CVM Ombudsman assists in resolving disputes with affected persons and groups both inside and outside the Center that arise during the regulatory review process and remain unresolved or are resolved unsatisfactorily. CVM has procedures in place for handling disputes that arise on both internal and external science/policy issues. It is preferred that differences of opinion be resolved at the lowest organizational level possible. The Ombudsman may be contacted at any time before or during these procedures for consultation and guidance on the appropriate use of the procedures, to ensure that the process proceeds as smoothly and fairly as possible, or to assist in resolving the dispute.
The Ombudsman also handles complaints concerning the way in which the Center’s science-based regulatory policies and certain administrative policies and procedures are implemented, and works to ensure that these are being applied fairly and equitably. For example, anyone who believes that someone at CVM has not followed proper good guidance practices (as per 21 CFR §10.115) may also ask the Ombudsman for assistance. More detailed information on the role of the organizational ombudsman can be found in an article that appeared in the September/October 2006 issue of the FDA Veterinarian.
External Scientific Dispute Resolution
Persons outside the Agency are encouraged to attempt to resolve any disagreement informally within the responsible reviewing Division by starting with the review team and then elevating it to the Division Director. If informal attempts are unsuccessful, the procedures for a formal appeal process are described in Guidance for Industry #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine. Formal procedures for resolving disagreements are set forth in 21 CFR 10.75 by following the established agency channels of supervision or review.
Internal Scientific Dispute Resolution
Center managers are expected to create an atmosphere in which consultation and open discussion on controversial issues are encouraged. Employees are strongly encouraged to share their views and resolve any differences through discussion with their supervisors through the established agency channels of supervision or review whenever possible. Informal methods using good management practices for resolving conflict should be employed as per CVM's Program Policy and Procedures (PPM) Guide 1240.2120(6). If informal methods are unsuccessful more formal methods should be employed as described in PPM Guides 1240.2110 and 1240.2115.
The Role of CVM’s Ombudsman[ARCHIVED]
from the FDA Veterinarian
CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM(PDF - 61KB) 79 1240.2110 Procedures for Resolving Disagreements within CVM(PDF - 48KB) 1240.2115 Procedures for Internal CVM Review of Science/Policy Issues Related to Significant Decisions of High Impact(PDF - 54KB) 1240.2120 Product Manager(PDF - 42KB)