Role of the CDER Ombudsman
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.
Ombudsman's Annual Report
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.
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 our Guidance for Industry--Formal Meetings With Sponsors and Applicants for PDUFA Products, 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:
Virginia Behr will be on extended leave from August 1 until October 31, 2008. During that time,
please contact Ayoub Suliman for all Ombuds issues. His direct phone is (301) 796-0630.
Direct telephone line: 301-796-3436
Fax: (301) 847-8752
White Oak Building 51, Room 6158
10903 New Hampshire Avenue
Silver Spring, MD 20993
E-mail address: firstname.lastname@example.org
Last updated: July 2, 2008