The Center for Veterinary Medicine (CVM) Ombudsman investigates and seeks to resolve issues related to science and science-based policy decisions and 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 have not been resolved by other means (e.g. CVM Program Policy and Procedures Manual, Guides 1240.2110 and 1240.2120 and/or through the established supervisory chain of command as stipulated in the Code of Federal Regulations Part 21, Section 10.75 (21CFR 10.75)

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 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 May/June 2000 issue of the FDA Veterinarian.

How To Contact The CVM Ombudsman

Marcia K. Larkins, D.V.M
FDA Center for Veterinary Medicine
Ombudsman
7519 Standish Place HFV-7
Rockville, MD 20855
(301) 827-4535
Fax: (301) 827-3957
mlarkins@cvm.fda.gov

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