Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets

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The Food and Drug Administration (FDA) is proposing to amend certain regulations relating to citizen petitions, petitions for stay of action, and the submission of documents to the Agency. In particular, the proposed rule would establish new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which concern certain citizen petitions and petitions for stay of action (PSAs) that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA) or 505(b)(2) application. We are making these changes to implement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA).