In my last post, I reviewed the new guidance on the processes available to resolve disagreements arising from official actions or decisions made by members of CDRH. One of those processes is citizen petitions, and because I was interested in how these were used, I reached out to the CDRH Ombudsman’s office (as suggested in the guidance). Deputy Ombudsman Ken Skodacek responded with clear instructions on how to use the Regulations.gov website to find a list of petitions and related correspondence. Here’s a couple of ways to search the site:

1. Open the page and search for “citizen petition”. The search tool will return a list of all citizen petitions.
2. Narrow your search using the filter tools on the left side of the page. Ken suggested using Narrow by Agency and entering FDA.
3. You can use the sort by field in the top left corner to put the latest petitions first. 
4. Ken also suggested searching on “CDRH citizen petition” to enable filtering by division.

Open any of the petition entries to see the attachments and in the left hand column information about the document (including a list of related documents) and the submitter. The FDA receives petitions from a wide variety of stakeholders (patients, physicians, companies, and legal representatives of all of these). It’s also clear the search tool could help one research other types of submissions. I encourage you to check out this resource, and my thanks to Ken Skodacek for answering my question.

Text Copyright © 2019 Katrina Rogers