People also can send FDA an FOIA request and have copies of comments mailed to them. Petitions Another way to influence the way FDA does business is to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly. Petitions require careful preparation by the submitter. FDA spends considerable time and staff resources processing petitions.
Individuals sometimes submit petitions, but most come from regulated industry or consumer groups.
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. A statement that to the best of the petitioner's knowledge, the petition includes all information relevant to the petition, favorable or not. The petition must be signed and include the petitioner's address and phone number. Procedures for preparing environmental impact statements can be found in Title 21 of the Code of Federal Regulations, Sections 25.24 and 25.31. If an environmental impact statement is not required, petitions should include a statement to that effect.