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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.
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State who you are and how the proposal affects you. (Economic costs and
back-up data are more compelling than generalities.)
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Give supporting statements for your position and present new data and scientific
findings, if possible.
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Whether you agree or disagree, you may suggest alternatives to the proposal
or to requirements that are part of the proposal.
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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.
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