Influencing the FDA: What is the Comment Period?
Welcome back! In a previous blog we were following the Food and Drug Administration’s (FDA) updated guidance documents for the Mycobacterium Tuberculosis (Mtb) and Sepsis, which are currently in their comment period to the public. With these guidance documents up for discussion, how and when does the FDA allow the industry stakeholders to collaborate and propose changes? Let’s dive in and learn more about this process!
FDA publishes rules to regulate foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices that are formed with the public’s help through proposed rules and petitions, as it impacts all our lives. When the FDA proposes a new or updated rule, the public is encouraged to participate in this process by commenting in writing and submitting them to the FDA for consideration. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule [1] .
When FDA issues a new regulation or revises an existing one, it’s announced in the Federal Register, which is published by the Office of Federal Register, National Archives and Records Administration (NARA). The publication occurs on the day the public comment period starts. The Federal Register is the official daily publication where Federal agencies publish documents that include proposed rules, final rules, public notices, and Presidential actions [2] . To search for FDA Federal Register documents, dockets, daily listings, and understand how to submit electronic comments, check out the Federal Dockets Management System Instruction Sheet here [3] .
So what is the “comment period”? This is the timeframe in which FDA will accept the public/stakeholders’ comments. It varies and can be open for 10 days, 60 days, or some as long as nine months (with weekends and holidays included), because time is of the essence!
Did you know that once the comment has been logged and placed in that docket, it becomes a public record? That’s right! It becomes available for anyone to examine for noncommercial use with some limitations, under the Freedom of Information Act (FOIA) [4] .
Another way the public and stakeholders can influence the FDA is to petition them to issue, change, or cancel a regulation, or to take other action. Petitions typically take longer for review and evaluation, from several weeks or even over a year, it all boils down to the complexity of the request. FDA will then either grant or deny the petition and will notify the person(s) of their decision. If the person(s) don’t agree, they may also take legal action for a court hearing. FDA currently does not accept e-mailed petitions. Petitions can be sent electronically to FDA via www.regulations.gov
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 [1] .
As FDA has opened the comment period, this allows the public opportunities to collaborate, share their voice, and influence the FDA’s thoughts and decisions in our industry with all of us as a community working together. We help strengthen and shape current, and future regulations with continued efforts for saving lives!
Check back for more updates! See you next time!
Reference:
[2] https://www.federalregister.gov/reader-aids/using-federalregister-gov
[3] https://www.fda.gov/regulatory-information/federal-register-fr-notices/how-use-regulationsgov
[4] https://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm