September 11, 2017
Authored and Edited by Meredith H. Boerschlein; Mark J. Feldstein, Ph.D.
Early in 2017, President Trump issued two Executive Orders (EO) directed to the reduction of Federal regulations at executive branch agencies, including FDA. The first, EO 13771 entitled “Reducing Regulation and Controlling Regulatory Costs,” directs agencies to repeal at least two regulations for each new regulation issued. It also imposes restrictions on the costs of new regulations. The second order, EO 13777 “Enforcing the Regulatory Reform Agenda,” directs each agency to create a Regulatory Reform Task Force to evaluate existing regulations and identify those meriting repeal, replacement, or modification. The task force must, at minimum, target outdated, costly or inconsistent regulations, or regulations that negatively impact jobs or job creation.
In response to EOs 13771 and 13777, FDA seeks comments and information on regulations related to products regulated by FDA’s Center for Veterinary Medicine (CVM). CVM regulates the manufacture and distribution of food, food additives, and drugs given to pets as well as animals from which human foods are derived. Additionally, CVM takes enforcement action against unsafe veterinary devices.
To help supplement and inform FDA’s own review, it is soliciting public comments on ways to change regulations while still fulfilling its public health mission and complying with statutory obligations. Specifically, FDA requests interested stakeholders to comment, including with supporting technical, scientific, or economic data, on regulations needing to be repealed, replaced, or modified.
The request includes several questions to guide commenters:
FDA is accepting comments submitted by December 7, 2017.
Agencies could see many changes with the Executive Branch’s new policy concerning Federal regulations. FDA’s request for comments on CVM regulations to further the two EOs is intended to allow those most directly impacted by any reforms—including consumers, researchers, trade associations, and health care providers—an opportunity to actively partake in the process.
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