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U.S. Department of Health and Human Services

About FDA

Establish the FDA Institutional Biosafety Committee (IBC)

Description: The IBC is a standing committee established to provide peer review of the safety of research plans, procedures, personnel training and environmental risks of work involving Recombinant DNA molecules (DNA sequences that result from the use of laboratory methods (molecular cloning) to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms), both synthetic and naturally occurring, pathogens and toxins at the FDA as required under the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) “Guidelines for Research Involving Recombinant DNA Molecules” and ESEM policy. The committee will also consider and make recommendations to management if need be, on Dual Use Research of Concern (DURC). According to the National Science Advisory Board for Biosecurity (NSABB), dual use research of concern is “Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or material.”

Information is current as of October 16, 2013.

Accomplishment: In the spring of 2013 the Deputy Commissioner and Chief Operating Officer appointed members to the FDA Institutional Biosafety Committee from among the scientific staffs of CBER, CDER, CDRH, CFSAN, and CVM who were nominated by the respective Centers and the surrounding community as required by the NIH Office of Biotechnology Activities. The IBC reviews the agency Biosafety Program and IBC application documents describing work by FDA personnel involving pathogens, infectious agents, toxins, and recombinant and synthetic nucleic acids for safety and regulatory compliance.

On July 16, 2013 FDA/ESEM was notified that the FDA IBC had successfully registered with the NIH Office of Biotechnology Activities as required under the NIH Guidelines for Research with Recombinant and Synthetic Nucleic Acid Molecules. The FDA is required to “report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH/OBA within thirty days” of the event, and submit an annual report of changes to the membership (if any) and of significant incidents involving recombinant or synthetic nucleic acid molecules (if any) prior to the end of June. The Agency Biosafety Officer is the designated NIH point of contact responsible for submitting the annual report to the NIH OBA.

The IBC meets monthly and as needed to effectively support the mission of the agency.

Briefing Status: Completed

Prior Briefing Status: On Track

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Identify and Appoint IBC Members - CBER/CDER to provide support and candidates.

2/28/2013

Completed 3/1/2013

B. Train IBC Members and Lab Personnel - Centers to provide financial and management support as necessary to ensure training is complete.

3/31/2013

Completed 3/20/2013

C. Approve and Post IBC Application - Submit application to NIH Office of Biotechnology Activities for approval of FDA IBC.

4/30/2013

Completed 7/16/2013

D. Begin Application Review - Prioritize review of current protocols at FDA Centers not covered by NIH IBC. Begin review of protocols that will be moving to FDA at the White Oak (WO) Campus.

7/31/2013

Completed 8/2/2013

E. Become Fully Operational - FDA IBC to begin providing review of applicable laboratory operations at FDA.

9/30/2013

Completed 9/12/2013

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.