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Number of direct data communications with Review/Policy Divisions within CDER (Office of Generic Drugs (OGD), Office of New Drug Quality Assessment (ONDQA), Office of Biotechnology Products (OBP), Office of Compliance (OC), Office of New Drugs (OND), CDER/Immediate Office (IO)) and Office of the Commissioner within the month)
Dictionary: The Office of Testing and Research (OTR) is tracking the number of research summaries, findings, and/or results OTR provides to CDER and other Agency customers.
These measures has been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 75 |
| Nov 2009 | N/A | 7 |
| Dec 2009 | N/A | 2 |
| Jan 2010 | N/A | 7 |
| Feb 2010 | N/A | 11 |
| Mar 2010 | N/A | 16 |
| Apr 2010 | N/A | 11 |
| May 2010 | N/A | 32 |
| Jun 2010 | N/A | 37 |
| Jul 2010 | N/A | 29 |
| Aug 2010 | N/A | 33 |
| Sep 2010 | N/A | 46 |
FY 2010 Total: 306
Number of Interim and Final Technical Reports sent to Review/Policy Divisions CDER (OGD, ONDQA, OBP, OC, OND, CDER/IO) and Office of the Commissioner within the month
Dictionary: OTR is tracking the number of technical reports OTR provides to CDER and other Agency customers.
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 3 |
| Nov 2009 | N/A | 1 |
| Dec 2009 | N/A | 5 |
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 3 |
| Mar 2010 | N/A | 7 |
| Apr 2010 | N/A | 7 |
| May 2010 | N/A | 6 |
| Jun 2010 | N/A | 4 |
| Jul 2010 | N/A | 8 |
| Aug 2010 | N/A | 6 |
| Sep 2010 | N/A | 7 |
FY 2010 Total: 62
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.







