As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices–commodities close to the daily lives of all Americans.
By law, anyone can participate in the rule-making process by commenting in writing on rules FDA proposes. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule.
When FDA plans to issue a new regulation or revise an existing one, it places an announcement in the Federal Register on the day the public comment period begins. Published every weekday, the Federal Register is available at many public libraries and colleges, and on the FDA Web site. Issues open to public comment often are reported by the news media and can also be found at regulations.gov. Instructions for finding Federal Register documents and submitting comments are found on the Federal Dockets Management System Instruction Sheet.
Also noted is the “comment period,” which specifies how long the agency will accept public comments. Usually, the file–or docket–stays open for comments at least 60 days, though some comment periods have been as short as 10 days or as long as nine months. Weekends and holidays are included in the comment period.
The Federal Dockets Management System Instruction Sheet tells how to submit comments electronically at regulations.gov.
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.