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U.S. Department of Health and Human Services

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Percentage of 60-day statutory deadlines met for RPD designation requests in the month

Dictionary: OOPD will track the time it takes to complete the review of each RPD request that has a 60-day statutory deadline. These applications with statutory deadlines include RPD requests received at the same time as an orphan drug designation request or fast track request. OOPD’s goal is to provide all applicants with a complete and comprehensive review in a timely manner to monitoring the incoming workload and to allocate available resources appropriately. The target review percentages per the noted review periods will continue to ensure quality service to OOPD RPD applicant customers.

Information is current as of March 31, 2019.

Fiscal Year - 2019

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TimeTargetNumber of Requests
Oct 2018N/A100
Nov 2018N/A100
Dec 2018N/A100
Jan 2019N/A100
Feb 2019N/A100
Mar 2019N/A100
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 100%

Footnotes

  • This measure started being tracked in April 2016.

Number of 60-day statutory deadline reviews completed in 60 days or less

Fiscal Year - 2019
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TimeTargetNumber of Requests
Oct 2018N/A0
Nov 2018N/A3
Dec 2018N/A1
Jan 2019N/A3
Feb 2019N/A2
Mar 2019N/A3
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 12

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.

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