REGULATORY OUTLOOK

If you haven't heard from FDA in a long time and are curious about the status of your request, you may check with FOI office staff or obtain a copy of the FOIA log to see at which FOI office the request is pending. The log, which can be obtained by submitting a separate FOIA request, lists all requests in a particular time period. It also includes specific information, such as the name of the requester, the FDA office the request is assigned to (CDRH, CDER, CBER, etc.), the date the request was received, and the subject of the request.

The log's subject lines can be difficult to read. Some of the information that is provided in the subject lines is cut off because FOI staffers who input the requests run out of room on the electronic forms. In addition, a number of codes that are used can prove confusing because they can't be deciphered easily. Although some of the more common abbreviations include “EIR” (establishment inspection report), “DKT” (docket) and “C/R” (correspondence), there is no hard-and-fast rule for the types of abbreviations that are used in subject lines. In addition, other subject lines may only reference a year and a control number. Those entries represent requests that were submitted in the past. Therefore, for those older FOIA requests, it may be necessary to conduct additional research by reviewing older logs from the year those requests were first submitted to get a more detailed description of the documents that were originally asked for.

Keep in mind that while you will be able to review all of the documents that any competitors are seeking, they will be able to do the same. For example, if you submit an FOIA request asking for all of the 510(k)s that were filed for a particular type of device because your company is considering manufacturing a similar product, a competitor could quickly find that information in the FOIA log and easily discern the nature of the device your company may soon be working on.

Nevertheless, the log can also be helpful in suggesting files you may like to review. By citing a control number of an earlier request, you can submit a follow-on, or piggy-back, request to receive the original request letter and response supplied to a competitor.

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