FDA-INT-1224405_Final.pdf

Standards Development for Regenerative Medicine Therapies Notice of Intent to Sole Source

FDA-INT-1224405

Date Posted: July 7, 2020

Response Date: July 22, 2020, 12:00 PM CT

Classification Code: B599 -- Special Studies/Analysis- Other

NAICS Code: 541990 -- All Other Professional, Scientific and Technical Services

The U. S. 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 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items.

NEXIGHT Group, LLC will provide Standards Development for Regenerative Medicine Therapies to the FDA, Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) by:

Conducting feasibility assessments to accelerate the process for which standards are published.

Updating the Landscape Report through engagement with the regenerative medicine community to ensure content remains reflective of current community needs.

Engaging regenerative medicine subject matter experts to coordinate drafting and comment adjudication of draft standards.

Enhancing current website by creating a portal which will be more interactive, and allow for real-time commenting on draft standards by RM stakeholders Developing one pilot curriculum to assist with standards implementation and conformity assessment to standards.

Reporting activities via a monthly progress report to the Contracting Officer Representative (COR) Providing FDA with a strategic plan on how the 5-year sustainability plan will be implemented for

Nexight and any subcontractors

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. The services will assist OTAT in supporting its requirements and goals to: (1) increase the number of regenerative medicine standards being advanced in the field, (2) accelerate the advancement and availability of regenerative medicine standards, and (3) elevate U.S. leadership in standards development.

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) requiring the dissemination of information on proposed contract actions.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement before July 22, 2020 at 12:00 pm Central Standard Time (CT) to:

Jennifer Johnson

Contract Specialist Email: Jennifer.Johnson3@fda.hhs.gov *No telephonic inquiries

A determination by the Government not to compete, 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.