What is an Ombuds?
An Ombuds is a person in an organization charged with investigating complaints and assisting in dispute resolution while operating in a neutral and confidential role. The ombuds investigates complaints made by individuals inside and outside an organization, reports the findings, and helps to achieve equitable solutions. There are a number of different terms for this position such as “ombuds” and “ombudsman.”
What is the Role of the CVM Ombuds?
The Center for Veterinary Medicine (CVM) Ombuds investigates and seeks to resolve issues related to science and policy decisions for products under the jurisdiction of CVM.
The CVM Ombuds:
- assists in resolving disputes with affected persons and groups both inside and outside CVM that arise during Center activities such as the regulatory review process and compliance related actions that remain unresolved or are resolved unsatisfactorily.
- handles complaints concerning the way in which the Center’s regulatory policies and certain administrative policies and procedures are implemented, and works to ensure that these are being applied fairly and equitably.
- assesses the effectiveness of the Center’s current science-based programs, 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 Ombuds parallels that of the FDA Office of the Ombudsman, but provides an avenue for resolving complaints involving CVM programs closer to the source.
What is the Complaint/Dispute Resolution Process?
The CVM Ombuds 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.
It is preferred that differences of opinion be resolved at the lowest organizational level possible. Anyone attempting to resolve differences of opinion or disputes involving issues related to scientific or 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 Ombuds should be contacted.
The CVM Ombuds does not handle matters that are already involved in litigation.
CVM has procedures in place for handling disputes involving science/policy issues that originate internally and externally. The Ombuds 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.
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.
- Guidance for Industry #163: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP – Final Guidance
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. If informal methods are unsuccessful more formal methods should be employed as described in PPM Guides 1240.2110 and 1240.2115.
- Staff Manual Guide (SMG) 9010.1 Scientific Dispute Resolution
- Staff Manual Guide (SMG) 9010.2 Cross-Center Dispute Resolution
- Staff Manual Guide (SMG) 9010.3 Authorship Dispute Resolution at FDA
When and How to Contact the CVM Ombuds
The CVM Ombuds may be contacted as follows:
- For information on and clarification of CVM’s internal and external dispute resolution processes for issues related to science and policy involving products under the Center’s jurisdiction.
- For complaints and disputes involving scientific controversies that have not been resolved through the established agency channels of supervision or review as per 21 CFR 10.75.
- For questions involving specific Center policies and procedures and general questions involving veterinary product jurisdiction issues.
- For general complaints or comments on current CVM science-based programs, policies and procedures, regulations and guidance documents and for suggestions on how they can be improved.
- When an applicant does not know where or how to begin an appeal, little progress is being made going up the chain of command, or about a matter that has not been resolved in the supervisory chain of command procedure.
- For assistance when a complainant believes that CVM has not followed proper good guidance practices as per 21 CFR §10.115.
- When a complainant has concerns about raising an issue with the Center. In a memo dated June 29, 1995, from the Commissioner of the FDA, all FDA employees were reminded that companies are free to vigorously challenge agency positions and requirements, and to freely voice their views. By letter of the same date, the Commissioner assured members of Congress that any act or threat of retaliation by any FDA employee is totally unacceptable and will not be tolerated. Anyone who believes that retaliation has occurred, or is likely to occur, is urged to contact the CVM Ombuds, Center management, or FDA’s Office of the Ombudsman concerning the agency’s Non-Retaliation Policy.
How to Contact The CVM Ombuds
FDA Center for Veterinary Medicine
7500 Standish Place HFV-1
Rockville, MD 20855