Comments made to FDA Re Federal Coordinated Framework for the Regulation of Biotechnology

Federal docket number: FDA-2015-N-3403

COUNCIL FOR RESPONSIBLE GENETICS’ RESPONSES TO REQUEST FOR INFORMATION PUBLISHED AT 80 FED. REG. 60,414 – 60,416 (Oct. 6, 2015):

“Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology”

The Council for Responsible Genetics (“CRG”) is a thirty-two year old science-based nonprofit whose mission is to represent the public interest and foster public debate about the social, ethical and environmental implications of genetic technologies. CRG welcomes the Obama Administration’s initiative to modernize the regulatory system for biotechnology products. As the White House’s July 2, 2015 Memorandum (“Memorandum”) correctly states, this regulatory system “must protect public health, welfare, safety and our environment….” Memorandum, p. 1 (emphasis added). CRG herewith submits its responses to the Notice of Request for Information, 80 Fed. Reg. 60,414 – 60,416 (Oct. 6, 2015) (“RFI”), within the context of this mandatory purpose of the regulatory system, and in light of CRG’s mission of fostering public understanding of, and democratic participation in, decisions concerning the uses and implications of genetic technologies.

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