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U.S. Department of Health and Human Services

About FDA

Number and percent of debarment referrals OE received and recommended

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 - 2012

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TimeTargetNumber of referrals received
Oct 2011N/A0
Nov 2011N/A0
Dec 2011N/A89
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 89

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

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 - 2012

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TimeTargetNumber of referrals referred to OCC
Oct 2011N/A6
Nov 2011N/A1
Dec 2011N/A1
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 8

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

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 - 2012

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TimeTargetPercent referred to OCC within 90 days
Oct 20111000
Nov 20111000
Dec 20111000
Jan 2012100TBD
Feb 2012100TBD
Mar 2012100TBD
Apr 2012100TBD
May 2012100TBD
Jun 2012100TBD
Jul 2012100TBD
Aug 2012100TBD
Sep 2012100TBD

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.