SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)

Active
Yes
Status
Open
Release Date
July 12th, 2023
Open Date
August 5th, 2023
Due Date(s)
September 5th, 2023January 5th, 2024April 5th, 2024September 5th, 2024January 5th, 2025April 5th, 2025
Close Date
April 6th, 2025
Topic No.
PAR-23-219

Topic

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: Phase IIYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development. This program aims to support 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. The program is open to recipients with Phase II or IIB SBIR/STTR awards that have been active within the last 36 months. The program supports technical assistance activities such as regulatory strategy development, intellectual property strategy development, and manufacturing assistance. It also supports late stage research and development activities such as replication of key studies, optimization of manufacturing processes, and development of clinical trial supplies. The program allows for outsourcing of work to third-party technical assistance providers, but the small business should play a substantive role in the oversight and management of the R&D activities. The funding specifics and project duration can be found in the solicitation notice on grants.nih.gov.

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 recipients 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 recipients 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 Required) (PAR-23-220). 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.

This Notice of Funding Opportunity does not accept clinical trials.

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). Valid applications can include either or both Technical Assistance and Late Stage Research and Development Activities.

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 of Allergy and Infectious Diseases (NIAID)

The National Institute of Allergy and Infectious Diseases (NIAID) welcomes CRP applications from recent Phase II/IIB recipient s that are within its mission but will not provide support for implementation of clinical trials under this FOA. NIAID will consider awards up to $1,000,000 per year for up to 3 years. NIAID is not participating in PAR-23-220

NIAID may decline funding of any CRP application for programmatic or administrative reasons. Potential applicants are strongly encouraged to contact program staff named in the Phase II or IIB award early in the process of preparing a submission. Non-NIAID Phase II recipient s must contact NIAID ( Scientific/Research Contact(s) in Omnibus NOFA #/Link) prior to submission to confirm programmatic interest.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in CRP applications from NIAMS Phase II funded applicants, provided they are within the NIAMS mission. However, NIAMS will not accept applications that include clinical trials. Applicants who wish to submit clinical trial applications to the NIAMS are encouraged to utilize one of the NIAMS clinical trial funding opportunities, which can be found on the NIAMS webpage: http://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in CRP applications from NIBIB Phase II funded applicants in the General Topic Areas listed above, provided they are within NIBIB’s mission and supported scientific program areas. NIBIB may decline funding of any application for programmatic or administrative reasons. Additionally, NIBIB will not support project periods of more than two years. Potential applicants are strongly encouraged to contact program staff early in the process of preparing a submission.Include text below if Phase IIB is an allowable application type; otherwise delete.

National Cancer Institute (NCI)

The National Cancer Institute (NCI) welcomes CRP applications from companies that have active or completed NCI SBIR (Phase II and Phase IIB) or STTR (Phase II) awards. Please note that NCI will provide funding support up to a maximum of $250,000 total costs (direct costs, indirect costs, and fee). Potential applicants are strongly encouraged to contact NCI SBIR Program staff to discuss prior to submission the CRP activities for which support will be requested. The NCI may decline funding of any application for reasons of program balance or budget. NCI does not participate in the SBIR/STTR Commercialization Readiness Pilot Program Technical Assistance and Late-Stage Development (SB1 Clinical Trial Required) NOFO (PAR-23-220 ). For SBIR/STTR Phase II recipient s in need of additional assistance for late-stage development and/or clinical trials, the NCI recommends its SBIR Phase IIB program (https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-23-034.html), which is published as a Request for Applications once per year, typically in the Spring.

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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The NIDDK invites NIDDK Phase II and Phase IIB recipient s to apply to the SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development, provided that the proposed research and development falls within NIDDK’s mission. For Phase II recipient s, especially those developing products that require clinical evaluation or approval by a Federal regulatory agency, the NIDDK strongly encourages potential applicants to apply to NIDDK’s Phase IIB program. The Phase IIB program, including budgetary guidance, is described in the current Program Descriptions and Research Topics document found at the NIH SEED SBIR and STTR Funding Opportunities page: https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities. Potential applicants are strongly encouraged to contact the NIDDK Program Officer for the Phase II or Phase IIB award early in the process of preparing an application.

National Institute of Environmental Health Sciences (NIEHS)

The National Institute of Environmental Health Sciences (NIEHS) is interested in CRP applications from NIEHS Phase II and Phase IIB funded applicants in the General Topic Areas listed above, provided they are within the NIEHS mission. For information about the NIEHS Small Business Program, please visit; https://www.niehs.nih.gov/research/supported/translational/sbir/index.cfm

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 Required NOFO (PAR-23-220 ).

National Human Genome Research Institute (NHGRI)

The National Human Genome Research Institute (NHGRI) is interested in CRP applications from NHGRI Phase II funded applicants in the General Topic Areas listed above, except that NHGRI will not provide support for clinical trials in the CRP FOA. NHGRI will only support proposed CRP projects that are within the NHGRI mission. Applicants are encouraged to contact Scientific/Research staff about anticipated activities prior to submission.

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

National Institute for Neurological Disorders and Stroke (NINDS)

The National Institute for Neurological Disorders and Stroke (NINDS) is interested in CRP applications from NINDS Phase II/IIB funded applicants in the General Topic Areas listed above, provided they are within the NINDS mission. NINDS may decline funding of any application for programmatic or administrative reasons. Please note that NINDS will provide funding support up to a maximum of $300,000 total costs (direct costs, indirect costs, and fee). Potential applicants are strongly encouraged to contact program staff early in the process of preparing a submission.

National Center for Advancing Translational Sciences (NCATS)

The National Center for Advancing Translational Sciences (NCATS) is interested in CRP applications from NCATS Phase II funded applicants, provided they are within the NCATS mission. Applicants are encouraged to contact Scientific/Research staff about anticipated activities prior to submission. Please note that NCATS will not accept applications that include clinical trials. A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions.

National Institute of Dental and Craniofacial Research (NIDCR) NIDCR will consider CRP applications from previous NIDCR Phase II awardees in the General Topic Areas listed above except for those supporting clinical trial-related activities. The Institute might consider certain clinical trial planning activities as described in PAR-21-160 (see: https://grants.nih.gov/grants/guide/pa-files/PAR-21-160.html). Applicants considering projects involving any type of human subjects research are strongly encouraged to contact Scientific/Research staff for consultation before submission.

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