The primary purpose of this meeting was to illustrate current federal roles and responsibilities regarding biotechnology products. This was accomplished by reviewing case studies of hypothetical products. There were several question and answer sessions to clarify the information presented during the case studies. The information presented at this meeting about the current Federal roles and responsibilities regarding biotechnology products will be made available for public comment in the Federal Register later this year. The agenda for this meeting provided time for public comments. Public comments made at this meeting were submitted to the docket as part of the official meeting transcript.

This public meeting was recorded into three separate YouTube videos. To view and listen to the videos of this public meeting please click on the URLs below:

• Part 1 – Modernizing the Regulatory System for Biotechnology Products Second Public Meeting, March 9, 2016
• Part 2 – Modernizing the Regulatory System for Biotechnology Products Second Public Meeting, March 9, 2016
• Part 3 – Modernizing the Regulatory System for Biotechnology Products Second Public Meeting, March 9, 2016

• Final Agenda: Modernizing the Regulatory System for Biotechnology Products (PDF)(3 pp, 47 K, March 9, 2016)
• Modernizing the Regulatory System for Biotechnology Products Second Public Meeting - Presentation (PDF)(54 pp, 332 K, March 9, 2016)
• Final March 9, 2016 Meeting Transcript (PDF)(175 pp, 888 K)