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U.S. Department of Health and Human Services

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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 - 2012

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TimeTargetPercent
Oct 2011100N/A
Nov 2011100100
Dec 2011100N/A
Jan 2012100TBD
Feb 2012100TBD
Mar 2012100TBD
Apr 2012100TBD
May 2012100TBD
Jun 2012100TBD
Jul 2012100TBD
Aug 2012100TBD
Sep 2012100TBD

No petition responses were due in October or December 2011

505(q) petition responses due during the month

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/A0
Nov 2011N/A1
Dec 2011N/A0
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

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.