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U.S. Department of Health and Human Services

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Percentage of lot distribution reports received by the Office of Biostatistics and Epidemiology (OBE) in the quarter that were entered into RMS-BLA within 7 days

Dictionary: This measure tracks the number of lot distribution reports received by CBER in the month and uploaded into CBER’s Regulatory Management System – Biologics License Applications database (RMS-BLA) within 7 days. Manufacturers of vaccines and other biological products will electronically submit post-marketing lot distribution data to CBER’s Lot Distribution Database (LDD) for use in post-marketing safety surveillance. Previously, this data was primarily submitted to CBER as paper reports. The conversion to electronic submissions will provide a standardized and consistent presentation of lot distribution information which will improve the accuracy, efficiency and timeliness.

Information is current as of September 30, 2014

Fiscal Year - 2014

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TimeTargetPercent
October – December 2013N/A91
January – March 2014N/A82
April – June 2014N/A95
July – September 2014N/A92

FY 2014 Total: 89%

Number of lot distribution reports received by OBE in the quarter and uploaded to RMS-BLA within 7 days

Fiscal Year - 2014
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TimeTargetNumber
October – December 2013N/A40
January – March 2014N/A53
April – June 2014N/A41
July – September 2014N/A54

FY 2014 Total: 188

Number of lot distribution reports received by OBE in the quarter

Fiscal Year - 2014
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TimeTargetNumber
October – December 2013N/A44
January – March 2014N/A65
April – June 2014N/A43
July – September 2014N/A59

FY 2014 Total: 211

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.