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FOIA Direct Final Rule Withdrawn by FDA

January 24, 2005

The FDA has withdrawn a direct final rule to incorporate exemptions from the Freedom of Information Act (FOIA) into the agency's public information regulations because of what the agency called "significant adverse" comments from the public.

The direct final rule, published in the Sept. 2, 2004, Federal Register, would have added FOIA exemptions one, two and three to its public information regulations.

The exemptions allow for immunity from disclosure if the information pertains to classified, national defense or foreign policy matters; internal personnel practices and rules; and information exempted from other statutes, respectively.

Comments from Facility Automation Management Engineering (FAME) Systems denounced the rule, saying that given the recent congressional scrutiny and "increases in the body of evidence that the FDA is knowingly operating outside of its legal statutory authorities and, quite literally, knowingly aiding in the obstruction of the agency's mandate to protect the health of the public that have been uncovered through FOIA requests under the current rules, it is easy to see why the FDA is anxious to change those rules in a manner that reduces transparency and public access."

FAME Systems went on to advise the FDA to avoid taking such steps in order to "preserve the limited level of public trust that the public still has in the agency and its actions."