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 arid format). When FDA considers comments from the public, it's not a simple matter of counting up "for" or "against" options.
Comments on proposed regulations can be mailed to:
Dockets Management Branch,
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Further information can be found at http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm#petitions.