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Modernizing the Regulatory System for Biotechnology Products: First Public Meeting

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; Public Meeting

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Under the auspices of the National Science and Technology Council, the Food and Drug Administration (FDA or the Agency), along with the Office of Science and Technology Policy (OSTP), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA) (collectively referred to as "we" on this webpage), held a public meeting to discuss the memorandum entitled, "Modernizing the Regulatory System for Biotechnology Products," issued by the Executive Office of the President (EOP) in July, 2015 (see reference 5). The purpose of the meeting was to inform the public about the activities described in the July 2015 memorandum; invite oral comments from interested parties; and provide information about how to submit written comments, data, or other information to the docket (see reference 1).  This meeting was the first of a series of expected public engagement sessions on this topic (see reference 6).

To sign up to be notified of future activities related to modernizing the regulatory system for biotechnology products, visit: Stay Connected: Modernizing the Biotech Regulatory System

Meeting Date: 

October 30, 2015
9:30 AM to 1:00 PM

Meeting Location: 

Food and Drug Administration (FDA)
FDA White Oak Conference Center
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Background Information:
  1. Federal Register notice
  2. National Science and Technology Council.  Office of Science and Technology Policy.  Clarifying Current Roles and Responsibilities in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology. 80 FR 60414, October 6, 2015.
  3. Executive Office of the President. Office of Science and Technology Policy. Coordinated Framework for Regulation of Biotechnology. 51 FR 23302, June 26, 1986.
  4. Executive Office of the President. Office of Science and Technology Policy. Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology Products Into the Environment. 57 FR 6753, February 27, 1992.
  5. Executive Office of the President. Office of Science and Technology Policy, Office of Management and Budget, United States Trade Representative, and Council on Environmental Quality. Modernizing the Regulatory System for Biotechnology Products, July 2, 2015.
  6. Executive Office of the President. Improving Transparency and Ensuring Continued Safety in Biotechnology, blog post, July 2, 2015.
Written Comments:

Regardless of attendance at the public meeting, you can submit electronic or written comments to the public docket by November 13, 2015. Submit electronic comments to Regulations.gov. Submit written comments to the Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments must be identified with the docket number FDA-2015-N-3403. All comments received may be posted without change to Regulations.gov, including any personal information provided.

Presentations
Archived Webcast and Transcripts:

Links to the webcast:

  1. https://collaboration.fda.gov/p5py7tlvqh5/
  2. https://collaboration.fda.gov/p9p5muyxm3v/
  3. https://collaboration.fda.gov/p7f9uxb77ox/

Meeting Transcript

Questions:

If you have questions about the meeting, contact: Office of Policy, Office of the Commissioner, U.S. Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4830, email: BiotechnologyUpdate@fda.hhs.gov.

For questions about the memorandum titled, “Modernizing the Regulatory System for Biotechnology Products,” or related activities described in that memorandum, contact: Office of Science and Technology Policy, Executive Office of the President, Eisenhower Executive Office Building, 1650 Pennsylvania Ave., Washington DC 20504, 202-456-4444; online: Contact the National Science and Technology Council: Emerging Technologies Interagency Policy Coordination Committee

Save the Date: Two Future Public Meetings Announced

 

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