Standards Development for Regenerative Medicine Therapies

The U.S. Food and Drug Administration (FDA) intends to modify its current contract number HHSF223201710592A with Nexight Group LLC., 8405 Colesville Road, 4th Floor, Silver Spring, MD 20910, for Standards Development for Regenerative Medicine Therapies to add a two-day workshop on the development and use of reference materials/physical standards and documentary standards, publish fact sheets on standards development processes as an output of the 2-day workshop and publish summaries of standards relevant to regenerative medicine advanced therapies under development to create awareness and recruit experts to work on these standards. Nexight has already established an organization consisting of FDA, NIST, and stakeholders, coordinated the development and implementation of the processes and identified and prioritize standards that have a high impact on the quality and safety of regenerative medicine products through webinars and written reports. It is imperative that consistent processes from the previous data are followed to ensure the objective of this requirement is met. Having to recreate what Nexight has already commenced would add additional cost to the government.
The proposed action is for services for which the Government intends to solicit and negotiate with only one source in accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.
The associated North American Industry Classification System (NAICS) Code is 541990-All Other Professional, Scientific, and Technical Services with a small business size standard of $15 million.
This is not a request for competitive proposals. However, any interested party that believes it can meet the requirement stated above may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be submitted to Regina Williams at regina.williams@fda.hhs.gov by 12:00 pm Central Standard Time, on or before September 14, 2018. A determination not to compete this requirement based on responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. If no responsive statements are received before the closing date and time, an award will subsequently be made to Nexight Group LLC..