Anyone can submit comments concerning new rules and regulations being considered by the Food and Drug Administration. And these suggestions can, and do, influence the agency's actions.
The FDA regulates the way that foods, drugs, medical devices, and other health products are produced and sold. FDA regulations have considerable impact on the nation's health, industries, and economy. Violators can be fined, jailed, or forced to close their businesses.
FDA regulations are issued consistent with the Administrative Procedures Act, which governs the rulemaking process for federal agencies. The FDA encourages public comment on the agency's proposed rules because the public has a vested interest in the products it regulates, and because the input provides critical insight into the effects of the regulation on the public. The comments often present the "real world" concerns of those who use the products. For example, several years ago nutritionists, bread manufacturers, and consumer groups provided comments on which ingredients Americans wanted--or didn't want--in white bread. The FDA adopted the standards only after taking into account the public's comments and recommendations.
The FDA allows ample time for public input and carefully considers these comments when it draws up a final rule.
"People don't always understand that FDA's decisions in response to comments aren't just based on the number of comments, or 'majority rules,'" says Edwin V. Dutra Jr., director of the FDA's Regulations Policy and Management Staff. "When a consumer sends in a comment based on sound grounds, that comment can definitely make a difference in the agency's decision-making." How to Comment
When the FDA plans to issue a new regulation or revise an existing one, it places an announcement in the Federal Register--one of the most important sources for information on what the agency is doing--on the day the public comment period begins. The agency also posts the proposal on its Web site at www.fda.gov/ohrms/dockets/. The "notice of proposed rulemaking" describes the planned regulation and provides background on the issue. It also gives the addresses for submitting written and electronic comments and the name of a person to contact for more information.
Also noted is the "comment period," which specifies how long the agency will accept comments from the public. Usually, the file--called a docket--stays open for comments for at least 60 days, though some comment periods are as short as 10 days or as long as nine months.
Anyone can ask agency officials to extend a comment period by submitting a written request if they do not think there is sufficient time to study the proposal and comment on it. But there must be good reason to support the request. If the agency grants the extension and allows more time for the public to comment, a notice is published in the Federal Register.
There is no special form to fill out for comments, nor do submitters have to follow a certain style. But the FDA can process comments most effectively if they are presented--either handwritten or typed--on 8 1/2-by-11-inch paper. Submissions should include the commenter's name and address. Anonymous submissions will not be accepted. The following information is also recommended for making effective comments:
* Clearly indicate whether you are for or against the proposed rule or some part of it, and why. Agency reviewers look for good science and good reasoning in the comments they evaluate. * Refer to the docket number listed in the Federal Register notice. * Include a copy of articles or other references that support the comments. Only relevant material should be submitted. * If an article or reference is in a language other than English, it must be accompanied by an English translation, verified to be accurate. This would include providing the name and address of the translator and a brief statement of his or her qualifications. Translations should be accompanied by a copy of the original publication. * To protect privacy when submitting medical information, delete names or other information that would identify patients. * Comments that are mailed must be postmarked, or e-mails dated, by the last day of the comment period. Comments that are delivered in person must be received by the FDA by the last day of the comment period.
The number of comments received for proposed rules varies. For example, a rule that established reporting procedures for problems with medical devices attracted 300 comments, while a proposal to regulate tobacco generated more than 500,000 comments. Other proposals generate fewer comments, such as the 35 received on a proposal to change generic drug approvals. However, this smaller number of comments still represented a wide range of companies, trade and consumer groups, and others. What Happens Next
When the FDA receives a comment, it is logged, numbered, and placed in a file for that docket. But it also becomes public information, says Jennie C. Butler, director of the Division of Dockets Management. "All information provided is public and may be posted to the Internet," she adds. Under the Freedom of Information Act (FOIA), visitors to the FDA's reading room, Room 1061, 5630 Fishers Lane, Rockville, Md., can receive free copies of up to 50 pages of comments if their request is for noncommercial use. After that, each page costs 10 cents. People also can send the FDA a FOIA request and have copies of comments mailed to them. For many significant proposals, the comments are available electronically over the Internet or may be available on a computer disk through a FOIA request.
After careful consideration of the comments and concerns on a proposed rule, the FDA usually will publish a final rule, unless a decision is made that the proposal should not be finalized. All proposed and final rules issued by the FDA are published in the Federal Register. Pending matters open to public comment often are reported by the news media and also can be found on the FDA's Web site, and at www.regulations.gov, the federal e-rulemaking portal. Other Opportunities to Comment
Occasionally, says Butler, "There are notices just calling for comments on a particular subject, such as the docket on obesity." Typically, this is known as an advance notice of proposed rulemaking, and these also appear in the Federal Register. The advance notice is often used when the agency has less information about an issue, or if it wants help in deciding what approach to take about an issue. Generally, the agency asks some questions, which helps clarify what information it would most like to obtain.
