On October 16, the Food and Drug Administration (FDA) released a Request for Information (RFI) on “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” and announced a public meeting. This is the next step in a process initiated in July of this year by the Office of Science and Technology Policy (OSTP). At that time, a memorandum was issued directing the agencies that regulate biotechnology to update the Coordinated Framework, a comprehensive federal policy governing the safety of biotechnology. The agencies involved in regulating these products include: the Environmental Protection Agency (EPA), FDA, and the U.S. Department of Agriculture (USDA). For the purposes of the Framework, biotechnology is defined as “products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.” Human drugs and medical devices are not covered by the policy.
Specific information about the RFI and public meeting details are available below.
Request for Information
Five specific questions are asked in the RFI. The questions focus on the themes of transparency, coordination, predictability, and efficiency. Additionally, helping consumers understand the role of federal regulation of genetically-modified organisms (GMOs) is of importance to the coordinating body.
The RFI questions are as follows:
- “What additional clarification could be provided regarding which biotechnology product areas are within the statutory authority and responsibility of each agency?
- What additional clarification could be provided regarding the roles that each agency plays for different biotechnology product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment?
- How can Federal agencies improve their communication to consumers, industry, and other stakeholders regarding the authorities, practices, and bases for decision-making used to ensure the safety of the products of biotechnology?
- Are there relevant data and information, including case studies, which can inform the update to the CF or the development of the long-term strategy regarding how to improve the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?
- Are there specific issues that should be addressed in the update of the CF or in the long-term strategy in order to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?”
Public Meeting Details:
- Title: Modernizing the Regulatory System for Biotechnology Products
- Stated Purpose: The EPA, FDA, and USDA will “provide an overview of their current approaches to regulating products of biotechnology” and “invite stakeholder ”
- Participating Agencies: OSTP, EPA, FDA, and USDA
- When: October 30, 2015
- Where: FDA White Oak Campus, Building 31 Conference Center, 10903 New Hampshire Ave, Silver Spring, MD 20993
Sources and Additional Information:
- The Federal Register notice of the Request for Information where formal comments can be submitted is available at https://www.federalregister.gov/articles/2015/10/06/2015- 25325/clarifying-current-roles-and-responsibilities-described-in-the-coordinated-framework- for-the.
- The federal register notice of the public meeting is available at https://www.federalregister.gov/articles/2015/10/16/2015-26311/clarifying-current-roles-and- responsibilities-described-in-the-coordinated-framework-for-the.
- To register for the public meeting, please visit http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm463783.htm#registratio n.