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U.S. Department of Health and Human Services

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.

Fiscal Year - 2011

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Measure was implemented starting January 2011

TimeTargetNumber of referrals received
Jan 2011N/A3
Feb 2011N/A0
Mar 2011N/A17
Apr 2011N/A1
May 2011N/A1
Jun 2011N/A59
Jul 2011N/A3
Aug 2011N/A0
Sep 2011N/A0

FY 2011 9-month Total: 84

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.

Fiscal Year - 2011

Skip graphic and jump to text data

Measure was implemented starting January 2011

TimeTargetNumber of referrals referred to OCC
Jan 2011N/A1
Feb 2011N/A0
Mar 2011N/A1
Apr 2011N/A2
May 2011N/A1
Jun 2011N/A2
Jul 2011N/A3
Aug 2011N/A0
Sep 2011N/A0

FY 2011 9-month Total: 10

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.

Fiscal Year - 2011

Skip graphic and jump to text data

Measure was implemented starting January 2011

TimeTargetPercent referred to OCC within 90 days
Jan 2011100N/A
Feb 2011100N/A
Mar 201110020
Apr 2011100N/A
May 2011100N/A
Jun 2011100100
Jul 2011100100
Aug 2011100N/A
Sep 2011100N/A

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.