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U.S. Department of Health and Human Services

About FDA

Delivery and Installation of Critical Scientific Equipment at White Oak Facilities

Description: This key project tracks the delivery and installation of critical scientific equipment for the new CBER laboratories at the White Oak campus. The procurement and delivery of the biological safety cabinets, mobile casework, vacuum pumps, water polishers and biocontainment cage units is necessary to establish operational BSL-2 and BSL-3 labs and the Vivarium.

Public Health Outcome: These labs support the advancement of cell, gene and tissue therapies, blood and blood component products, vaccines, allergenic products and other important biologics. Helping to establish these laboratories is instrumental in supporting the efforts of CBER scientists to ensure safe and effective biological products.

Accomplishment: The CBER ADR office successfully completed the delivery and installation of the following critical equipment:

  • 139 water polishing units for the BSL-2 and BSL-3 laboratories;
  • 48 high density freezers for the White Oak Freezer Farm;
  • 20 biocontainment cage units for the BSL-3 suites and WO Vivarium;
  • 75 Metro Shelving units for cold room and BSL-3 storage;
  • 229 mobile lab desk cabinets for the BSL-2 laboratories.

    The delivery and installation of equipment was completed by September 30, 2014. This critical scientific equipment not only supports CBER’s mission but also helps to establish CBER laboratories as a state-of- the art Life Science Research Facility.

    Additionally, the CBER ADR office completed the migration of LN2 and -80C laboratory materials into high density freezers subsequently transported to the White Oak Freezer Farm. The LN2 and -80C Freezer Farm migration was a lengthy process that involved multiple levels of coordination to ensure an efficient and reliable transfer of reagents critical to the success of CBER’s regulatory science programs.

    Lastly, together with the CBER Safety Program, CBER was successful in getting the BSL-3 laboratories operational. The completion of the BSL-3 labs was delayed due to construction and repair issues beyond our control and labs were finally certified in April 2015. During that time we worked with employees to carefully develop SOPs, train individuals, and make sure all labs were functional with the proper equipment. Our select agent program underwent a USDA inspection in April and we should receive our inspection report shortly. The move to the White Oak campus has been extremely beneficial to CBER. The proximity to the other centers will foster more collaboration and help advance our regulatory science research programs. We have also improved and expanded our general and specialized laboratories and core technology facilities. We have ten BSL-3 laboratory suites that will enable CBER to better support pandemic influenza preparedness and conduct research on infectious agents of concern such as anthrax, rabies, dengue virus, Chikungunya virus, tuberculosis, prions, and HIV. The new White Oak Vivarium now has the capacity to generate and breed transgenic animals and perform various imaging techniques including MRI, CT, IVIS, Digital X-rays and Ultrasounds. We also have capabilities for state-of-the-art cell analysis with our flow cytometry and confocal microscopy core facilities. Together the improved laboratory infrastructure will advance CBER’s regulatory science program in support of the FDA’s regulatory mission by allowing CBER scientists to be proactive in addressing gaps in scientific knowledge in emerging technologies and emerging infectious diseases, thus facilitating development of innovative medical products, while also having the technologic and scientific expertise to react to public health and regulatory crises.

  • Briefing Status: COMPLETED

    Prior Briefing Status: ON TRACK

    Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

    A. Delivery of key equipment for LSB2: water polishers, high density freezers, animal cage racks, metro shelving, and mobile pedestals

    6/1/2014

    Completed 2/7/2014

    B. Installation of key equipment for LSB2: water polishers, high density freezers, animal cage racks, metro shelving, and mobile pedestals (1)

    6/1/2014

    Completed 9/30/2014

    C. Preparing for the BSL-3and Select Agent Programs

    9/1/2014

    Completed 9/15/2014

    D. Migration of the Freezer Farm

    9/1/2014

    Completed 9/15/2014

    Footnotes

    • (1) The dates for milestone B and milestone C were adjusted due to a construction delay. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

    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.