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Percentage of 505(q) petition responses due in the month, completed by deadline
Dictionary: Section 914 of the Food and Drug Administration Amendments Act added new section 505(q) to the Federal Food, Drug, Cosmetic Act (the Act). Section 505(q) governs certain citizen petitions and petitions for stay of agency action that request that FDA take any form of action related to a pending application submitted under section 505(b)(2) or 505(j) of the Act. Under section 505(q)(1)(F) of the Act, FDA shall take final agency action on a petition subject to section 505(q) not later than 180 days after the date on which the petition is submitted.
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 | Percent |
|---|---|---|
| Oct 2009 | 100 | 100 |
| Nov 2009 | 100 | 100 |
| Dec 2009 | 100 | 100 |
| Jan 2010 | 100 | 100 |
| Feb 2010 | 100 | 100 |
| Mar 2010 | 100 | 100 |
| Apr 2010 | 100 | 100 |
| May 2010 | 100 | 100 |
| Jun 2010 | 100 | 100 |
| Jul 2010 | 100 | 100 |
| Aug 2010 | 100 | 100 |
| Sep 2010 | 100 | - |
505(q) petition responses due during the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 1 |
| Nov 2009 | N/A | 1 |
| Dec 2009 | N/A | 2 |
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 4 |
| Mar 2010 | N/A | 1 |
| Apr 2010 | N/A | 1 |
| May 2010 | N/A | 2 |
| Jun 2010 | N/A | 2 |
| Jul 2010 | N/A | 1 |
| Aug 2010 | N/A | 4 |
| Sep 2010 | N/A | 0 |
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.
