Vatican on Vaccines
Holy Little Saint
We will never forget
FDA Consumer Magazine, November 2004
By Carol Rados
Anyone can submit comments concerning new rules and regulations being considered by the U.S. 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.”
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. Comments can be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, or submitted through an e-mail firstname.lastname@example.org. Comments also can be submitted online at www.fda.gov/dockets/ecomments.
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:
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.
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, issued Monday through Friday. 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 the federal e-rulemaking portal, www.regulations.gov.
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.
Questions about the comment process should be directed to the FDA Division of Dockets Management, (301) 827-6860. Hours are 9 a.m. to 4 p.m. Eastern time, Monday through Friday.
The Federal Register is available at many public libraries and colleges, and on the FDA Web site at www.fda.gov. Under “Reference Room,” click on “Federal Register.”
View proposed FDA regulations:
Online access to the Federal Register:
“Reference Room” link at www.fda.gov
Submit comments online to:
E-mail comments to:
View pending federal government matters open to public comment at the federal e-rulemaking portal:
Print or type on 8 1/2 by 11-inch paper and mail to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Call the Division of Dockets Management:
Hours: Monday through Friday, 9 a.m. to 4 p.m.