Don’t know how to Comment on Proposed Regulations and Submit Petitions

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. FDA rules have considerable impact on the nation’s health, industries and economy. These rules are not created arbitrarily or in a vacuum. They are formed with the public’s help.

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.

FDA gathers public comments mainly through two channels: proposed rules and petitions.

Proposed Rules

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. Instructions for finding Federal Register documents and submitting comments are found on on the Federal Dockets Management System Instruction Sheet.

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.

When submitting a comment by mail or in person, you do not need to follow any special style. If the comment is written legibly or typed on standard 8-1/2 inch by 11 inch paper, however, FDA can process the comment more effectively.

Comment Online

The Federal Dockets Management System Instruction Sheet tells how to submit comments electronically at regulations.gov.

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

  • Clearly indicate if you are for or against the proposed rule or some part of it and why. FDA regulatory decisions are based largely on law and science, and agency reviewers look for reasoning, logic, and good science in comments they evaluate.
  • Refer to the docket number, listed in Federal Register notice.
  • Include a copy of articles or other references that support your comments. (Electronic attachments will not be forwarded if the “Comment” box is left empty.)
  • Only relevant material should be submitted. If an article or reference is in a foreign language, it must be accompanied by an English translation verified to be accurate. 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 must be postmarked, electronically submitted or delivered in person by the last day of the comment period.

When a comment is received, 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 at regulations.gov or 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.

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