date:Apr 26, 2012
etitions submitted to FDA must contain:
Action requested--What rule, order, or other administrative action does the petitioner want FDA to issue, amend or revoke?
Statement of grounds--The factual and legal grounds for the petition, including all supporting material, as well as information known to the petitioner that may be unfavorable to the petitioner's position.
Environmental impact--This information is generally required if the petition requests approval of food or color additives, drugs, b