Standards Development for Regenerative Medicine Therapies

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The Food and Drug Administration intends to negotiate on a sole source basis with NEXIGHT Group, LLC, 8405 Colesville Rd, Silver Spring, MD 20910-3317, for Standards Development for Regenerative Medicine Therapies.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 541990, All Other Professional, Scientific, and Technical Services, $17.0M.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

DESCRIPTION OF REQUIREMENT

In December 2016, Congress passed, and President Obama signed into law the 21st Century Cures Act (Cures Act)1. Title 3 Section 3036 of the Cures Act adds section 506G to the FD&C Act and directs FDA, in consultation with the National Institute of Standards and Technology (NIST) and stakeholders to facilitate an effort to coordinate and prioritize the development of standards and consensus definition of terms, through a public process, to support, through regulatory predictability, the development, evaluation, and review of regenerative medicine therapies and regenerative advanced therapies, including with respect to the manufacturing processes and controls of such products. For the purposes of this requirement, regenerative medicine therapies are defined as specified in Section 3033 of the Cures Act as cell therapies, therapeutic tissue engineering products, human cell and tissue products, or combination products with any such therapies or products, except for those regulated solely under section 361 of the

Public Health Service Act (PHS Act) (42 U.S.C. 264) and Title 21 of the Code of Federal Regulations, Part 1271 (21 CFR Part 1271). In addition, as described in FDA's draft guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, as FDA interprets section 506(g), gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues may meet the definition of a regenerative medicine therapy.

The scientific and manufacturing novelty of many regenerative medicine therapies present unique challenges for meeting regulatory requirements with respect to product testing, performance characteristics, testing methodologies, scientific protocols, product quality, ingredient specifications, and compliance criteria. Increased development and use of standards have the potential to transform product development, contribute to regulatory predictability, and facilitate the overall development of regenerative medicine therapies. Standards development is an ongoing priority for the CBER efforts to promote development of regenerative medicine therapies, which are often developed for the treatment of serious or life- threatening diseases with unmet medical needs. The FDA/CBER, Office of Tissues and Advanced Therapies (OTAT) requires Standards Development for Regenerative Medicine Therapies to assist in supporting the requirements and goals set forth in the 21st Century Cures Act as it relates to the needs for standards development in regenerative medicine.

Stakeholder interest in standards for regenerative medicine has expanded exponentially under the current contract with Nexight/SCB. As the FDA standards program for regenerative medicine therapies evolves, continued engagements with stakeholders and assessments of needed standards is crucial.

The goals of this contract are to support new efforts for the FDA standards program for regenerative medicine therapies including the identification of needed standards and the development of standards for which the outcome a feasibility assessment was positive for development of a particular standard, maintaining a publicly available web-based portal to keep stakeholders informed on standards activities, and developing landscape reports on the state of standards. An option year is also being sought to ensure momentum on the progress being made during the 2022 contract.

ESTIMATED PERIOD OF PERFORMANCE

September 22, 2022 through September 21, 2023 (base year), September 22, 2023 through September 21, 2024 (option year)

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a detailed description of the relevant experience (including contract numbers, descriptions, period of performances, etc.), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, FDA-RFP-1251666. Responses must be submitted electronically to Kimberly DeLong, Contracting Officer, at Kimberly.delong@fda.hhs.gov. U.S. Mail and fax responses will not be accepted.