As part of the American Department of Health
and Human Services the Food & Drug Administration (FDA) regularly
issues drafts of rules and regulations. Not everybody is aware of the fact
though that they can comment these drafts, and usually the FDA gives
enough time to do so.
When the FDA intends to publish a new or a revision of an existing
guidance or guideline, it is announced in the Federal Register – which
is also available online: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm).
The announcement sets the beginning of the commenting period.
In the Federal Register the "notice of proposed rulemaking"
describes the planned regulation and also provides background information.
In addition to the "comment period" the notice also includes a
contact person an address to which comments can be sent.
A more convenient way to submit comments is to do this online. That's
why the FDA established the "Dockets Management" website at www.fda.gov/ohrms/dockets/. Going to "Submit Dockets" in
the left column opens a list with documents that can be commented. It is
also possible to get to the desired document by various search options.
The site also contains current ICH drafts and a direct link to the
corresponding Federal Register section, and the authority provides
instructions on how to comment proposals electronically.
All comments the FDA receives are subject to the "Freedom of
Information Act" and can be read in the FDA Offices in Rockville, MD,
USA. It is also possible to order copies.