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FDA Seeking Comments on Existing Regulations

Arielle Bikard | April 28, 2011

The Food and Drug Administration has called for comments on existing regulations, as required under President Obama's executive order “Improving Regulation and Regulatory Review” on January 18.

The executive order's “retrospective review of significant rules”  requires government agencies to “develop and submit to the Office of Information and Regulatory Affairs a preliminary plan ... under which the agency will periodically review its existing significant regulations” by May 18. Agencies are then required to publish their plans online in an “open” government Website page, in accordance with the Open Government Directive from December 2009, within two weeks following the May deadline.

The FDA is particularly asking for comments “that identify regulatory problems that have the greatest impact on the public health,” said Leslie Kux, assistant commissioner for policy, in an April 26 blog post on the agency's Website.

Kux asks commenters to address the following questions:

  • Where are our regulations ineffective?
  • Do our regulations address current public health challenges?
  • Where do we need to update our regulations?
  • Can we revise them in ways that makes them less burdensome without making them less effective?
  • Where can we be more flexible?
  • How we can put greater emphasis on innovative scientific approaches?
  • Do we have regulatory requirements that are redundant, inconsistent, or needlessly overlap?

Comments on FDA regulations can be submitted on the Federal eRulemaking Portal.