THIS IS A SOURCES SOUGHT NOTICE (SSN) ONLY. THIS IS NOT A REQUEST FOR PROPOSAL, QUOTATION OR INVITATION TO BID NOTICE AND DOES NOT CONSTITUTE A COMMITMENT BY THE GOVERNMENT.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all qualified business sources; (2) If a small business source please provide if; HUBZone small businesses; service-disabled, veteran owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; economically disadvantaged women-owned small business, or small disadvantaged businesses; and (3) provide source size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible. If an organization that is considered a small business under an applicable NAICS code, please provide that NAICS code. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the U.S. Government and will not be returned.

All responding firms are requested to identify their firm’s size and type of business. Teaming arrangements and joint ventures may be considered for any subsequent procurement based on the Government’s market research.

This market research is being conducted to identify sources that have prime contractor experience with optimized regulatory and commercialization support and education. The long-term strategic outcome of this project is to improve navigation of the laboratory-to-market pipeline by biomedical innovators funded through the NIH Small Business and translational product development programs by providing targeted regulatory and commercialization support and education. This includes support of both individual innovators and the NIH innovation ecosystem as a whole by providing subject matter expertise and developing educational resources to provide durable regulatory and reimbursement support.

The National Institutes of Health (NIH) funds research aimed at improving the health of individuals, and the NIH Office of Extramural Research (OER) ensures scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio. OER is committed to accelerating the commercialization (i.e. lab to market) path for promising federally funded science and technologies with the potential to improve patients’ lives. This goal is required from the legislation establishing the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. Catalyzing new technology and solution development is an element of the NIH Wide Strategic Plan, Fiscal Years 2021 – 2025 and the HHS Strategic Plan, Fiscal Years 2022 – 2026 (Strategic Objective 4.2:  Invest in the research enterprise and the scientific workforce to maintain leadership in the development of innovations that broaden our understanding of disease, healthcare, public health, and human services resulting in more effective interventions, treatments, and programs). 

The Small business Education and Entrepreneurial Development (SEED) office within the NIH OER supports the NIH innovator community by providing funding and resources to help advance discoveries to products that improve patient health. SEED’s community is comprised of both academic and small business awardees, as well as the NIH staff who administer these awards.

Academic innovators have access to commercialization resources through several programs, most notably the NIH Research and Evaluation and Commercialization Hubs (REACH) awards. The REACH program comprises 5 proof-of-concept hubs and provides commercialization support to eligible institutions, including funding, mentoring, and feedback from federal and industry experts. Over the past 36 months, SEED in collaboration with the incumbent provided written feedback to 78 innovators participating in the REACH program.  Contribution of regulatory and payment perspectives for these very early-stage projects is critical to help the REACH program awardees make final funding decisions and ensure the subawards proceed in the most effective way to validate proof of feasibility for the proposed technologies.

Access to subject matter experts for one-on-one consultations is a cornerstone of many of SEED’s programs including the consultation program, company showcase program, TABA Needs Assessment Report Review program, and SOW development program. Over the past 36 months, SEED has worked closely with the incumbent to provide 124 regulatory and 50 reimbursement consultations. These calls have provided innovators with information directly relevant to their unique product or service, streamlin