BIO Submits Comments in Reponse to the Notice of a Request for Information re Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology

In a series of Executive Orders (EOs) and memos, most notably EO 13563, EO 13610 and its memo on principles for regulation and oversight of emerging technologies3, the Administration has clearly described the importance of appropriate regulation to economic growth and innovation, while continuing to meet the requisite objectives of protecting the health of humans, animals and the environment. BIO members concur with the Administration’s view that “regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.” As such, BIO supports the objectives of this initiative, as articulated in the July 2015 memorandum from the Executive Office of the President (EOP), which are to:

BIO is pleased that the Administration continues to reaffirm the principles of good regulation in the document on which comments are requested, Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology (Draft CF Update). If innovation is to flourish, then these principles, which were originally articulated in the 1986 Coordinated Framework and amplified in the 1992 “Federal Oversight” document, must continue to guide the agencies as they consider approaches to appropriate, science-based oversight of future biotechnology products.