Inactive

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... 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, streamlining their interactions with FDA and CMS/payors. The focus of the companies spans the full spectrum of NIH mission space – from pre-conception through death, and all technology types (biologic and small molecule drugs, medical devices, diagnostics, SAMD, health IT, manufacturing and research tools). The confidential information shared between NIH awardees and it’s contractor to support these consultations is equivalent to the information an awardee might share with their Program Officer, and it is extremely important to SEED that the potential contractor conducting these consultations be non-conflicted with the intent of providing only consultations and not seeking additional work from the NIH portfolio. Each consultation is a critical contribution to an individual research project within the NIH portfolio, and helps NIH achieve its overarching goal of improving the health of the nation. Major themes emerging from these consultation programs provided the framework for SEED’s suite of online educational resources. This resource library includes critical, actionable, information about regulatory and reimbursement/payment activities in the US life sciences ecosystem. The communication style of these resources is based upon intimate knowledge of the general level of awareness of the NIH portfolio on each topic. It is SEED’s intent to continue development of and broadly disseminate awareness of these resources to the global life science innovation ecosystem. The resources align with four primary educational approaches. Knowledge Guides provide a complete overview of a given topic (such as regulatory development of an in vitro diagnostic). These are effectively short textbooks on each topic. White Papers dive into distinct and common processes life science innovators may encounter during the development of a new product. These are action-oriented process descriptions. A Video Library of 8 – 13-minute recordings provide clarity about processes not well described in text such as performing online research in government and public access databases. Case Studies describe realistic innovator journeys through the multiple stages of a regulatory or reimbursement campaign and clarify how and when the information contained in the Knowledge Guides, White Papers, and Short Videos should be implemented. Collectively these resources provide relevant and actionable information about how to develop a new medical product in the United States. Many of the originally proposed resources have been developed and posted online, additional resources are in queue, and periodic review of published resources is ongoing to ensure content remains relevant and embedded links are active. Please see the following links for examples of Regulatory (https://seed.nih.gov/product-development-support/consulting/regulatory-consultation/medical-devices) and Reimbursement (https://seed.nih.gov/product-development-support/consulting/reimbursement-consultation/diagnostics) resources co-developed by the incumbent and SEED. The goals of this procurement are to continue to support SEED with successfully completing the following outcomes: Strengthen SEED’s entrepreneurial education and development activities to enhance outcomes of the NIH Small Business Innovation Research (SBIR), Small Business Technology Transfer (STTR), and other translational research programs. Partner with SEED and NIH Institutes and Centers (ICs) to identify, develop, and execute programs (e.g. webinars, workshops, conferences, meetings) to enhance and improve the outcomes of NIH-funded product development programs. Widely disseminate and support broad adoption of the online resources developed by the incumbent and new resources developed by the successful applicant. Ensure all online resources are periodically reviewed for adherence with current practices of HHS operational divisions as well as industry best practices. Enhance collaboration between HHS operational divisions through direct introductions and knowledge of the organizational and operational cultures of NIH, FDA, CMS, CDC, ARPA-H, HRSA, and ASPR. This procurement aligns with the following HHS and NIH Strategic Objectives: HHS Strategic Objective 4.3: Advance basic science knowledge and conduct applied prevention and treatment research to improve health and development. NIH Strategic Plan Objective 1 | Advancing Biomedical and Behavioral Sciences NIH Strategic Plan Objective 3 | Exemplifying and Promoting the Highest Level of Scientific Integrity, Public Accountability, and Social Responsibility in the Conduct of Science Information Requested: Please submit the following information: Name and address of company and or companies (if there is a teaming arrangement). Corporate capabilities - Experience similar in scope, size, and complexity to the requirements. Relevant experience listing up to three (3) customers (Government/non-Government) within the past 5 years, providing: Contract name Contracting Agency or Department Yearly contract value in dollars Period of performance Description of work, how it relates to OER/SEED requirements. Please state whether your company is a small business or not. Also state if any of the following apply to your company; 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. State your size classification according to the North American Industry Classification System, (NAICS) code for the proposed acquisition. Submission requirements: Page limits (not including a cover letter or introduction page) – Up to four (4) 8 ½” x 11” pages for corporate capabilities and up to three (3) 8 ½” x 11” pages for the relevant experience 1 inch margins (top, bottom and sides) Times New Roman font – 12 point Do not include promotional materials Interested firms responding to this market survey must provide a capability statement demonstrating their experience, skills, and capability to fulfill the Government’s requirements for the above in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b). The capability statement shall be in sufficient enough detail so that the Government can determine the experience and capability of your firm to provide the requirements above. Please specify one primary and one alternate Point of Contact (POC) within your firm, including telephone numbers and email addresses. Only electronic copies of capability statements will be accepted. A determination by the Government to proceed with the acquisition as a set-aside is within the discretion of the Government. Please submit all capability statements to Donald.Ledwig@nih.gov by Friday, January 24, 2025, at 3:00 PM. NO TELEPHONE REQUESTS WILL BE ACCEPTED.