About FDA

Number and percent of debarment referrals OE received and recommended

Measure was implemented starting January 2011

Dictionary: The Food and Drug Administration (FDA) oversees the clinical investigators who conduct research involving new drugs, biologics, and medical devices to ensure that their conduct does not compromise the safety of clinical trial participants or the integrity of clinical trial data. FDA can debar or disqualify investigators who have engaged in misconduct such as submitting fraudulent data. Debarred or disqualified investigators cannot engage in certain activities related to clinical research. Recent changes were made to the debarment process to improve the timeliness of reviews and to reduce a significant backlog. The Office of Enforcement (OE) receives intelligence regarding persons who may be subject to debarment from a variety of sources, including a quarterly list from the Office of Criminal Investigations (OCI). OE researches and reviews each individual case. After review, if debarment is appropriate, OE sends a debarment recommendation package to the Office of Chief Council (OCC). The debarment process occurs in multiple steps including initial review and recommendation, review and approval, notice to debaree, an opportunity for a hearing, a final decision and debarment order. Many of these activities are outside of OE’s responsibility and control. The timeliness of the initial review and recommendation are critical to the entire process and are OE’s responsibility. OE will measure the number of these initial notifications and the timeliness of OE’s review and recommendation process with a target of 90 days or less.

• FY 2011
• FY 2012
• All

Number of debarment recommendations OE referred to Office of Chief Council (OCC)

Measure was implemented starting January 2011

Dictionary: Recent changes were made to the debarment process to improve the timeliness of reviews and to reduce a significant backlog. The Office of Enforcement (OE) receives intelligence regarding persons who may be subject to debarment from a variety of sources, including a quarterly list from the Office of Criminal Investigations (OCI). OE researches and reviews each individual case. After review, if debarment is appropriate, OE sends a debarment recommendation package to the Office of Chief Council (OCC). The debarment process occurs in multiple steps including initial review and recommendation, review and approval, notice to debaree, an opportunity for a hearing, a final decision and debarment order. Many of these activities are outside of OE’s responsibility and control. The timeliness of the initial review and recommendation are critical to the entire process and are OE’s responsibility. OE will measure the number of these initial notifications and the timeliness of OE’s review and recommendation process with a target of 90 days or less.

Percent of debarment recommendations referred to OCC within 90 days of OE’s receipt of notification

Measure was implemented starting January 2011

Dictionary: Recent changes were made to the debarment process to improve the timeliness of reviews and to reduce a significant backlog. The Office of Enforcement (OE) receives intelligence regarding persons who may be subject to debarment from a variety of sources, including a quarterly list from the Office of Criminal Investigations (OCI). OE researches and reviews each individual case. After review, if debarment is appropriate, OE sends a debarment recommendation package to the Office of Chief Council (OCC). The debarment process occurs in multiple steps including initial review and recommendation, review and approval, notice to debaree, an opportunity for a hearing, a final decision and debarment order. Many of these activities are outside of OE’s responsibility and control. The timeliness of the initial review and recommendation are critical to the entire process and are OE’s responsibility. OE will measure the number of these initial notifications and the timeliness of OE’s review and recommendation process with a target of 90 days or less.