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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 - 2011

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TimeTargetPercent
Oct 2010100100
Nov 2010100100
Dec 2010100100
Jan 2011100100
Feb 2011100100
Mar 2011100100
Apr 2011100100
May 2011100100
Jun 2011100100
Jul 2011100100
Aug 2011100100
Sep 2011100N/A

No petition responses were due in September 2011

505(q) petition responses due during the month

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A2
Dec 2010N/A1
Jan 2011N/A2
Feb 2011N/A1
Mar 2011N/A2
Apr 2011N/A3
May 2011N/A1
Jun 2011N/A3
Jul 2011N/A1
Aug 2011N/A3
Sep 2011N/A0

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.