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Roles and Responsibilities of the CBER Ombudsman

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An Ombudsman is a person in an organization charged with investigating complaints and assisting in dispute resolution. In CBER, the position of Ombudsman was established to investigate and act on complaints, both internal and external, regarding CBER's regulatory and managed review processes. The Ombudsman is also responsible for maintaining an effective appeals process, and in general responds to problems affecting products under CBER's jurisdiction that have not been resolved through other means. In addition, the CBER Ombudsman collects and analyzes information from inside and outside the Center to assess the effectiveness of programs, to identify deficiencies in those programs, and to ensure that CBER's policy is fairly and evenly applied throughout the Center. The Ombudsman may also advise the Center Director on ways to correct such problems.

The function of the CBER Ombudsman parallels that of the FDA Ombudsman, but provides an avenue for interested parties both inside and outside the Center for getting complaints involving CBER programs resolved at a level closer to the source. The CBER Ombudsman reports directly to the Center Director.

Product Jurisdiction

CBER, CDRH, and CDER have entered into agreements that are intended to clarify product jurisdiction issues. These Intercenter Agreements, as codified in Title 21, Code of Federal Regulations, Part 3, describe the allocation of responsibility for categories of products or specific products. These agreements are nonbinding determinations designed to provide useful guidance to the public. When a combination product is not covered by a guidance document or for a product where jurisdiction is unclear or in dispute, a sponsor may request a designation of the agency component with primary jurisdiction.

Like the FDA Ombudsman, the CBER Ombudsman serves as product jurisdiction liaison to handle not only complaints but also questions about inter-center product jurisdiction. The CBER Ombudsman is the Center contact to determine whether CBER, CDRH, or CDER has primary responsibility for premarket review and regulation of a product that constitutes a combination drug, device, or biological product under section 503(g)(1) of the Food Drug & Cosmetic Act and whether the Center has primary jurisdiction due to a determination of primary mode of action. The CBER product jurisdiction liaison also serves as a member of the Tissue Reference Group.

Dispute Resolution - External

The Food and Drug Administration is committed to resolving differences between sponsors and FDA reviewing divisions with respect to safety and efficacy requirements for drug, device, and biological products as quickly and amicably as possible through the cooperative exchange of information and views.

When administrative or procedural disputes arise regarding biological products, the sponsor should first attempt to resolve the matter with the division and then with the office, if necessary, in the FDA's Center for Biologics Evaluation and Research which is responsible for review of the product. If the dispute is not resolved, the sponsor may raise the matter with the person designated as ombudsman, whose function is to investigate what has happened and to facilitate a timely and equitable resolution.

When scientific or medical disputes arise during the drug investigation process, sponsors should discuss the matter directly with the responsible reviewing officials. If necessary, sponsors may request a meeting with the appropriate reviewing officials and management representatives in order to seek a resolution. Requests for such meetings should be directed to the director of the Division which is responsible for review of the product. The FDA will make every attempt to grant requests for meetings that involve important issues and that can be scheduled at mutually convenient time. If a sponsor is not satisfied with the outcome of that discussion, the matter may be taken to the director of the Office to which the Division reports. The Ombudsman is prepared to mediate disputes or arrange for mediation if the issue remains unresolved.

Dispute Resolution - Internal

CBER must reach an institutional position with respect to quality, safety, and efficacy requirements for the biological products it regulates. The process requires that reviewers, supervisors, and management work together. In most cases, consensus is usually achieved through discussion as the reviews proceed. If consensus does not occur during the review process, management must resolve the differences. In all cases, it is essential that the views of all persons involved in the review process be respected and that the official administrative record of the review reflect differences of opinion if they exist. If a disagreement arises at any level of the review process and remains unresolved, the reviewing official who disagrees with the drafted conclusions or recommendations must prepare a separate memorandum to the file explaining (1) the nature of the difference in opinion, (2) the reasons for the differing opinion, and (3) the recommended changes in the findings or recommendations. The document must remain in the file with the reviewer's documentation.

If the difference of opinion remains unresolved, the supervisor may not direct the reviewer to change a review. The supervisor will forward a copy of the memorandum relating to any differences of opinion to the reviewer, division director, and , if appropriate, office director for informational purposes. The Division Director is responsible for meeting with a reviewer and supervisor, if requested by either party, to consider the merits of all points of view and decide the issue if consensus cannot be achieved. The Office Director will meet with the parties involved in the disagreement, if requested by any of the individuals. If the division and office director disagree and the disagreement raises issues of general concern, unresolved scientific or regulatory issues may be presented to the CBER Ombudsman, and they may be discussed in an appropriate policy forum. If the issue remains in dispute, the Center Director or the Center Director's designee will arbitrate.

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How to Contact the Ombudsman

Mailing Address:
CBER Ombudsman (HFM-4)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448

 

 
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