Description:
The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies that benefit society. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II and Phase IIB it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II or Phase IIB award, it is expected that the SBC will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. Some projects initiated with SBIR or STTR funding require support beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death,” between the end of the SBIR/STTR Phase II award and the commercialization stage. A number of NIH Institutes and Centers (ICs) participate in the Phase IIB program, which provides additional support to mitigate the funding gap with a second Phase II award. However, Phase IIB programs can be limited in the amount of outsourcing allowed and some projects require technical assistance and R&D studies that are typically outsourced to contract research organizations (CROs) (e.g. regulatory assistance, IND/IDE enabling studies, toxicology, manufacturing, clinical trials). Some SBCs also require additional funding beyond the Phase IIB to commercialize a technology or attract third party funding. In addition, SBIR/STTR awards may not support activities important for commercialization, such as product development and market planning, market research, and costs related to license agreements and partnerships.
The SBIR and STTR programs were reauthorized and extended through 2025 under Public Law 114-328, Section 1834, Public Law 115-232 and Public Law 117-183 including the reauthorization of the Commercialization Readiness Pilot (CRP) Program to the NIH. This Notice of Funding Opportunity (NOFO) aims to implement the CRP Program at NIH. The goal of this NOFO is to facilitate the transition of previously funded SBIR/STTR Phase II/IIB projects to the commercialization stage by providing additional support for later stage research and development (R&D) and product development not typically supported through Phase II or Phase IIB grants or contracts, often because they are normally outsourced to CROs.
This NOFO supports New “Type 1” Applications from recipient s with Phase II or IIB SBIR/STTR awards that have been active within the last 36 months, including those that will be active at the requested start date.
Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH are eligible for this program, as described in Section III.1.
Phase II and Phase IIB recipient s with funding from a non-participating NIH Institute/Center should note that some NIH Institutes/Centers participate in the following:
The Phase IIB Competing Renewal supports those Phase II projects that require extraordinary time and effort in the research and development phase. See https://seed.nih.gov/sites/default/files/HHS_Program_Descriptions.pdf for more information)
The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed) (PAR-23-219 ).
Scientific/Technical Scope
NIH ICs participating in this NOFO may accept applications based on any topic within their mission or based on specific topics. While general topic areas are listed below, applicants should read the specific interests of the ICs carefully prior to submission.
Topic areas appropriate for this NOFO include, but are not limited to, the following:
Technical Assistance:
Development of a regulatory strategy, including assembling the documentation needed to support a meeting request, filing of Investigational New Drug (IND) or Investigational Device Exemption (IDE), or relevant marketing applications to the Food and Drug Administration (FDA) or other relevant US Regulatory Agency.
Development of an intellectual property strategy, including analysis of the patent landscape in the US and abroad.
Technical assistance associated with manufacturing, including industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs).
Other technical assistance through a third-party technical assistance provider, including market research.
Late Stage Research and Development Activities:
Independent replication/confirmation of key studies.
Systematic research on development and optimization of industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs) and applicable FDA requirements, including measures and activities to control manufacturing of upstream and downstream processes, batch compounding, dosage form production, in-process sampling, testing, process validation and related production requirements.
Activities to bring the development process under Design and Quality Systems Control.
Animal studies to develop surgical techniques relevant to a device.
In vitro and animal testing to meet FDA recognized ISO/ASTM Standards.
Optimization of the device design with respect to the human functional anatomy.
Device, software, and firmware design verification and validation activities.
GLP compliant large animal studies.
Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical trials and eventual market approval.
Process optimization and synthesis, including development of analytical methods to determine drug purity and development of a clinical trial formulation.
IND/IDE enabling studies, including toxicology.
Chemistry, Manufacturing, and Control (CMC) activities for IND-enabling pharmacology/toxicology tests.
Pharmacokinetic/ADME (absorption, distribution, metabolism, excretion) studies.
Tumorigenicity, immunogenicity, mutagenicity and teratogenicity evaluations.
GMP manufacturing of clinical trial supplies.
Optimization of delivery systems.
Development and validation of biochemical assays required for clinical trials (e.g., pharmacokinetic, pharmacodynamic, and/or immunogenicity assays).
Clinical studies and clinical trials (Note: not every Institute or Center at NIH supports clinical trials through this NOFO . Please see below the section of Interests of Specific Institutes/Centers).
Unlike typical SBIR and STTR research and development grants or contracts, companies have the option of out-sourcing a significant portion of the work requested through the CRP, provided the expert services are appropriate for the work proposed and well justified in the application. The SBC should perform a substantive role in the oversight and management of the R&D proposed, including appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant. Therefore, NIH expects the SBC to request enough funds to enable management of the activities. The remainder of the funds can be distributed among the subcontractors, consultants and SBC depending on the type of work proposed.
CRP awards cannot be used to pay filing fees associated with filing patents or FDA submissions.
CRP applicants cannot request the separate Technical and Business Assistance (TABA) funding allowed in Phase I and II projects.
Interests of Specific Institutes/Centers
For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) will support proposed CRP projects that align with NIAAA's mission. Applicants are encouraged to contact the NIAAA Program Coordinator about anticipated activities, including possible human subjects research, prior to submission. For more information about NIAAA's SBIR/STTR program, please visit https://www.niaaa.nih.gov/research/niaaa-sbir.
National Institute on Deafness and Other Communication Disorders (NIDCD)
The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in CRP applications in the General Topic Areas listed above, provided their projects are within the NIDCD mission areas. NIDCD will only accept CRP applications from NIDCD SBIR and STTR Phase II or Phase IIB recipient s and may decline funding of any application for programmatic or administrative reasons. Potential applicants are strongly encouraged to contact program staff noted in the Phase II award early in the process of preparing a submission. Annual budget requests exceeding $1,750,000 total costs per year will not be accepted.
National Eye Institute (NEI)
The National Eye Institute (NEI) is interested in CRP applications from NEI Phase II SBIR-funded applicants in the General Topic Areas listed above, provided they are within the NEI mission. The NEI will only accept CRP applications from SBIR Phase II or SBIR Phase IIB recipient s, but NEI may decline funding of any application for programmatic or administrative reasons. Applicants who wish to submit CRP applications to the NEI are strongly encouraged to contact Scientific/Research staff.
National Heart Lung and Blood Institute (NHLBI)
The NHLBI will accept CRP applications from NHLBI Phase II and Phase IIB funded institutions, provided they are within the NHLBI mission. NHLBI also participates in the SBIR/STTR Commercialization Readiness Pilot (CRP) Program: Technical Assistance and Late-Stage Development (SB1, Clinical Trial Not Allowed) NOFO (PAR-23-219 ).
National Institute of Mental Health (NIMH)
The National Institute of Mental Health (NIMH) is interested in CRP applications from NIMH Phase II and Phase IIB funded applicants in the General Topic Areas listed above. NIMH will only support proposed CRP projects that are within the NIMH mission. For information about NIMH's Small Business Program, please visit http://www.nimh.nih.gov/funding/small-business-research-programs.shtml.
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
