Ombudsman is one of the stranger words in our language, on the tongue, in print or in meaning. It came from Sweden and is derived from old Norse, meaning, literally, 'administrative man'. . . not exactly the stuff of which legends are made. It has come to denote someone in any organization who receives complaints, investigates and acts on them, who mediates disputes, and in general attends to problems involving interpersonal working relationships. In CDER, the Ombudsman has responsibilities in addition to resolving disputes. These include getting feedback from inside and outside the Center about the effectiveness of programs and about problems that impede CDER's performance of its mission or conflict with its values/operating principles. The Ombudsman also advises the Center Director on ways to correct such problems.
The CDER Ombudsman handles not only complaints but also questions about inter-center product jurisdiction. The CDER Ombudsman is the Center contact for jurisdictional issues involving drug/device and drug/biological products. Please refer to the links below regarding product jurisdiction such as the Intercenter Agreements, and the FDA's Office of Combination Products.
- FDA's Office of Combination Products: http://www.fda.gov/oc/combination
- Intercenter Agreement Between CBER and CDRH: http://www.fda.gov/oc/ombudsman/bio-dev.htm
- Intercenter Agreement Between CDER and CDRH: http://www.fda.gov/oc/ombudsman/drug-dev.htm
- Intercenter Agreement Between CDER and CBER: http://www.fda.gov/oc/ombudsman/drug-bio.htm
Ombudsman's Annual Report
Relation to FDA Ombudsman
The function of the CDER Ombudsman parallels that of the FDA Ombudsman, but permits those both inside and outside the Center an avenue for getting complaints involving CDER programs resolved at a level closer to the source. The CDER Ombudsman is in the Center Director's Office of Executive Programs.
Customer Service
Anyone having interactions with the Center should find our staff professional, fair, honest, courteous and helpful. When requesting a meeting with CDER personnel, you should refer to MAPP 4512.1
, which outlines procedures and time frames. We will make every effort to honor the time frames stated in that document.
When to Contact the Ombudsman
General Comments and Suggestions: You may want to provide feedback to the Center about the effectiveness of its programs or offer suggestions on how to improve our operations. We welcome such input, and by putting your thoughts in writing or by discussing them with the Ombudsman, you can contribute to improving the public health and to streamlining government.
Complaints: We will do our best to respond to all complaints in a timely and effective manner. If you are experiencing problems with a matter involving one of our Divisions, we strongly suggest that you first discuss it with the director of that Division. If you are not satisfied with the outcome of that discussion, you may take the matter to either the director of the Office to which the Division reports or to the Ombudsman. (See also MAPP 4151.1
on Resolving Scientific Disputes) You may also want to consider resolving differences of a scientific, regulatory or procedural nature through mediation. The Ombudsman is prepared to mediate disputes or arrange for such mediation.
Confidentiality: Some people who contact the Ombudsman would prefer to keep their identity unknown to others in the Center. There are a few matters in which confidentiality cannot be preserved, such as allegations of criminal activity, which must be reported to the FDA Offices of Internal Affairs or Criminal Investigations. Generally, though, your contact with the Ombudsman can be kept confidential, if requested. Naturally, a pledge of confidentiality usually hinders the Ombudsman from effecting a resolution to the specific problem at hand. Nevertheless, it is always better for CDER to know about the existence of a problem, and we will make every attempt to satisfactorily address it.
The most commonly stated reason for seeking confidentiality is the fear of retaliation. Retaliation or the threat of retaliation is regarded as a very serious violation of the rules of employee conduct, and it will not be tolerated. Commissioner's memo on retaliation
How to Contact the Ombudsman:
Warren Rumble
Direct telephone line: 301-594-5480
Fax: (301) 827-4312Address:
CDER Ombudsman (HFD-1)
Suite 500
5515 Security Lane
Rockville, MD 20852E-mail address: ombudsman@cder.fda.gov
Last updated: April 28, 2006
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