let your voice be heard

[Guest guest]

http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm PetitionsAnother 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. For example, a drug company might request a change in labeling for one of its products; a food company might ask that its product be exempted from some provision of a regulation; or a consumer group might petition FDA to tighten regulation of a certain product.Petitions 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, biological products, animal drugs, or certain medical devices, or for a food to be categorized as GRAS (generally recognized as safe). Procedures for preparing environmental impact statements can be found in Title 21, Part 25 of the Code of Federal Regulations. If an environmental impact statement is not required, petitions should include

a statement to that effect.The following official certification statement --"The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition."Identifying information-- The petition must be signed and include the petitioner's address and phone number.In addition, some petitions may require information on:Economic impact--This information is required only if FDA requests it after review of the petition.FDA currently does not accept e-mailed petitions. Petitions must be mailed or delivered to: Division of Dockets Management, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.Ultimately, FDA management decides whether to grant a petition. But first, agency staffers evaluate it, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied, the petitioner can take the matter to court.For more information on submitting petitions, and sample formats, consult Title 21 of the Code of Federal Regulations, Sections 10.30, 10.33, and 10.35.Besides accepting public comments and petitions, FDA also schedules public meetings

and hearings to discuss and explain its proposals. These usually are held with industry representatives or consumer groups, but anyone interested may attend and, with advance notice, may comment on a proposal. Meetings often are held in the Washington, D.C., area, but sometimes are set in other areas across the country. Meetings for the public to present views are announced in the Federal Register.Questions about the comment, petition or hearing process should go to FDA Dockets Management, . Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday.Top