How do you submit comments to FDA's proposed rules and regulations?
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:
- 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.
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 or delivered in person by the last day of the
comment period.
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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