How to Comment FDA Proposed Regulations

 
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.
   

Learn more about the FDA and its regulations in the following ECA courses:

• How to Pass EU and FDA Inspections – GMP-Compliance Auditor in Barcelona, Spain, from 4-6 October 2006,
• FDA Compliance in Analytical Laboratories in Prague, Czech Rep., from 4-6 October 2006,
• GMP and FDA Compliance in Quality Assurance Units in Prague, Czech Rep., from 8-10 November 2006 and
• Successful HPLC Management in a GMP-/FDA-Regulated Environment in Prague, Czech Rep., from 22-23 November 2006.

 
Author
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

Source: http://www.fda.gov/opacom/backgrounders/voice.html