To quickly and impartially investigate complaints and resolve disputes between the Center for Biologics Evaluation and Research (CBER) and CBER-regulated industry, health care practitioners, and consumers by offering an independent, confidential, and neutral environment.
Roles and Responsibilities of the CBER Ombudsman
- The CBER Ombudsman receives questions and investigates complaints to informally facilitate timely and equitable resolution of disputes between the Center and regulated industry.
- The CBER Ombudsman functions as the administrative contact for all issues related to Formal Dispute Resolution Requests.
- The CBER Ombudsman also receives feedback from inside and outside the Center regarding the effectiveness of programs and deficiencies in those programs. The CBER Ombudsman analyzes information to ensure that CBER's policy is fairly and evenly applied throughout the Center. The Ombudsman may also advise Center management on ways to address such issues.
The function of the CBER Ombudsman at the Center level is similar to that of the FDA Ombudsman Agency level, but using the CBER Ombudsman provides an avenue for interested parties to get complaints involving CBER programs resolved at a level closer to the source.
The CBER Ombudsman also has an internal function which includes serving a role in the resolution of differences in scientific opinion among Agency staff. This process and relevant procedures are detailed in the following documents:
- CBER Standard Operating Policies and Procedures (SOPP) SOPP 8006: Resolution of Differences in Scientific Judgement in the Review Process
- SMG 9010.1 Scientific Dispute Resolution at FDA
- SMG 9010.2 Cross-Center Dispute Resolution at the FDA
The FDA is committed to resolving differences between sponsors and FDA reviewing divisions with respect to requirements related to review of a submission for drug, device, and biological products as quickly and amicably as possible through the cooperative exchange of information and views.
If you are experiencing a problem with one of our Divisions or Offices, the Ombudsman strongly suggests that whenever possible you first discuss it with the review team and Division or Office Director, as appropriate. A meeting with the review team and Division or Office Director can be a productive way to address your issue. When requesting a formal meeting with CBER personnel, you should refer to the draft Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. If you are not satisfied with the outcome of an informal or formal discussion, you may then take the matter to the CBER Ombudsman to discuss your options, one of which is for the CBER Ombudsman to informally investigate and facilitate resolution. You are encouraged to contact the Ombudsman for informal assistance, but alternatively, you may raise the matter up to the management chain either by contacting the director of the Office to which the Division or Office reports or invoking the formal dispute resolution process.
Information on how to pursue the formal dispute resolution pathway is described in the Guidance for Industry and Review Staff: Formal Dispute Resolution: Sponsor Appeals Above the Division Level and the procedures are further described in SOPP 8005: Formal Dispute Resolution Process. The general expectation is that there will be an orderly progression of interaction with relevant members of the CBER Office responsible for the review or decision at issue, followed by outreach for additional discussion with relevant members of the next organizational level above the level at which action was taken and then engagement with the Center’s Ombudsman, prior to filing a Formal Dispute Resolution Request.
When to Contact the CBER Ombudsman Staff:
There may be several paths available to an individual or company that disagrees with a CBER decision or action, and the CBER Ombudsman can help identify these options and review them with those who reach out requesting informal assistance.
The CBER Ombudsman adheres to principles of impartiality and neutrality. Upon request, communications with the Ombudsman will be considered confidential.
Whereas a sponsor may contact the Ombudsman informally at any time during the review process, a sponsor may avail themselves of the formal dispute resolution process after a division director has rendered an unfavorable decision regarding a sponsor's dispute. Although sponsors may seek informal advice from the Ombudsman at any time, they should not simultaneously engage the Ombudsman in this informal manner and also pursue formal dispute resolution.
Limits as to what the CBER Ombudsman Can Do:
The Ombudsman will NOT:
- Overturn a decision/action
- Force anyone to turn over or modify a decision/action
- Take the position of advocate
- Get involved in matters currently in litigation
How to Contact the CBER Ombudsman Staff:
CBER Ombudsman: Olivia Ziolkowski, J.D., M.P.H.
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993-002
General E-mail: firstname.lastname@example.org