Q: How do you submit comments to FDA's proposed rules and regulations?


 A:

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 Website. Issues open to public comment often are reported by the news media and can also be found on FDA's Website.

In the Federal Register, the "notice of proposed rulemaking" describes the planned regulation and provides background on the issue. It also gives the address for submitting written comments and the name of the person to contact for more information.

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.

There is no special form to fill out for comments, nor do submitters have to follow a certain style. But FDA can process comments more effectively if they are presented--either written legibly or typed--on 8-1/2-inch by 11-inch paper.

Here are some other suggestions for making sure your comment has the greatest possible impact:

When FDA receives a comment, it is logged in, numbered, and placed in a file for that docket. It then becomes a public record and is available for anyone to examine in FDA's reading room (Room 1061, 5630 Fishers Lane, Rockville, Md.). Under the Freedom of Information Act (FOIA), visitors to the reading room can receive free copies of comments up to 50 pages if their request is for noncommercial use. After that, each page costs 10 cents. People also can send FDA an FOIA request and have copies of comments mailed to them.

 

Source: Excerpted from BG 96-2, June 11, 2001: How to Comment on Proposed Regulations and Submit Petitions

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