Standards Development for Regenerative Medicine Therapies

The United States (US) Food and Drug Administration (FDA) intends to award a sole source, firm fixed-price contract to NEXIGHT Group LLC, 8405 Colesville Rd., Silver Spring, MD 20910-3317, under the authority of FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

NEXIGHT Group, LLC will provide Standards Development for Regenerative Medicine Therapies to the U.S. FDA, Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT). OTAT has determined currently required efforts in relation to the "Standards Development for Regenerative Medicine Therapies" are directly affected by existing deliverables end products and must utilize the same procedures and expertise; ensuring consistency and integrity of the overall project.
This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 6.302-1.

This notice of intent is not a request for competitive proposals. Interested parties that believes it can meet the requirement, may submit a capability statement to Mrs. Jennifer Johnson at jennifer.johnson3@fda.hhs.gov before May 22, 2019 at 2:00 pm Central Standard Time (CST). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an award will subsequently be made to NEXIGHT Group LLC. No telephonic inquiries.

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