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Compliance In Focus
Posted by John Lehmann on Fri, May 18, 2012

New Regulatory Reform

It’s pretty well known that the FDA has responsibility for enforcing a broad range of statutory andReform Act regulatory requirements. Did you know Regulatory responsibility also carries over to one of the offices under the Executive Office of the President? This office is the Office of Information and Regulatory Affairs (OIRA). According to the website the office carries out several important functions, including reviewing Federal Regulations, reducing paperwork burdens, and overseeing policies relating to privacy, information quality, and statistical programs.

Earlier this month an act was presented to Congress which could add responsibilities to this Office. The bill, “Regulatory Reform Act of 2012,” would require the OIRA to complete reports to the FDA every four years.

According to the bill text , The Federal Regulatory Reform Report is intended to contain:

  • A list of rules that are determined to be outmoded, duplicative, ineffective, or excessively burdensome.
  • Lists of recommendations to consolidate, modify, simplify, or repeal such rules to make such rules more effective or less burdensome.
  • A description of the justification for (including supporting data) and impact of the recommendations as appropriate and available.
  • An analysis of how the costs outweigh the benefits for such rule. The benefits for such analysis shall include environmental and public health considerations and other considerations with regard to the benefits that the Administrator determines are appropriate.

As pointed out in a recent press-release this effort is different then previous attempts to reform the regulations because  most “originate from within the Executive Branch and focus on how agencies can change certain regulations themselves, the Regulatory Reform Act would seek to change such regulations by legislation.”

What do you think of the purposed bill? Do you think these tasks should be carried out by the FDA only? Feel free to comment below!

Photo Credit: steakpinball



Topics: Regulatory Reform Act of 2012, Office of Information and Regulatory Affairs, FDA


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