As part of the Trump Administration's move towards regulatory efficiency, FDA announced yesterday and published today in the Federal Register, the opportunity for public input on the Administration's comprehensive review of its regulations.
FDA will be accepting comments until Thursday, December 7, 2017.
In line with the Administration's promise to alleviate unnecessary regulatory burdens,1 Anna Abram, FDA's Deputy Commissioner for Policy, Planning, Legislation and Analysis, explains that FDA is "taking a closer look to see if we need to revise, update, and in some cases eliminate existing regulations." FDA is seeking input on "how current regulations could be reshaped to achieve our public health objectives through more efficient approaches." Ms. Abram's states that all FDA's regulatory reform efforts will be science-based: "Science will remain FDA's North Star when it comes to our role in devising regulatory policy."
Over the past year, food and beverage companies have been grappling with FSMA implementation and FDA's revised requirements for Nutrition Facts labels and serving sizes, and companies continue to encounter challenges with other recent as well as long-standing FDA regulations. FDA's request for input provides companies the opportunity to give FDA real on-the-ground insights and suggestions regarding how to streamline regulatory requirements to make them more efficient and practical while still achieving FDA's rigorous public health goals. FDA is asking for specific feedback on regulations and has requested stakeholders to consider several questions, including:
- Is the regulation still current, or is it outdated or unnecessary in some way? Is this regulation duplicative of requirements in other FDA regulations or other Federal
- Agency regulations? Have regulated entities had difficulties complying with the regulation? Does the regulation impose requirements that are also provided for in voluntary or
- consensus standards or guidance by third party organizations? Do the entities covered by these standards or guidance take steps to meet the standards and to document that they meet the standards?
- Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records, e.g., reporting, recordkeeping, or labeling requirements?
- Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?
- What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
FDA requests that comments include supporting technical, scientific, economic, or other data. Finally, FDA has requested that comments be submitted in a specific table format shown in the Federal Register.