Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Small Business Guide to FDA
(last revised on 03/31/04)

HOW TO COMMENT ON PROPOSED REGULATIONS

Before you comment on regulations proposed by FDA, you may obtain more information about a proposal by contacting the person designated in the Federal Register statement. A Comprehensive list of proposed regulations open for comment from all federal agencies may be viewed at http://www.regulations.gov. At this website you may enter and directly send your comments on any proposed regulation. Whether you agree or disagree with the proposed regulations, you will want to communicate your comments in the most effective way possible. The following points will help you do this:

  • Give the title, date of publication, and docket number for the proposal.
  • State who you are and how the proposal affects you. (Economic costs and back-up data are more compelling than generalities.)
  • Give supporting statements for your position and present new data and scientific findings, if possible.
  • Whether you agree or disagree, you may suggest alternatives to the proposal or to requirements that are part of the proposal.
  • The more substantive your comments, the more weight they will carry. The same thing is true for petitions (see petition content and format). When FDA considers comments from the public, it's not a simple matter of counting up "for" or "against" options.

Send your comments on proposed regulations to Dockets Management Branch, Room 1-23, 12420 Parklawn Dr., Rockville, MD 20857; (301) 827-6860.