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  • Debra Topham

The Paradox of Federal Paperwork Reduction – Your Chance to Be Heard!


Few real paradoxes exist. Is it the Chicken or the Egg?

The federal government has no problem with paradoxes. The government passed laws (or rather an executive order), and thus increased the paperwork.  Ironically this executive order aims to reduce paperwork.

Once again the adage, that you have to move backwards to move forward applies. In this case, it is a very good thing.

It’s your chance to be heard. Specifically the FDA and USDA are  formally “seeking seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations.”

Here is the FDA and USDA’s list of requests for paperwork reduction:

Some sample questions include:

  • Is the regulation still current, or is it outdated or unnecessary in some way?

  • Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?

  • Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority?

  • If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.

  • Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.

  • Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.</bullet

If you are curious about President Trump’s executive order 13771, “Reducing Regulation and Controlling Regulatory Costs” the full text is here.

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