Opportunity Information: Apply for PAR 14 209
Apply for PAR 14 209
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre Clinical Research (R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on May 7, 2014 and posted on May 7, 2014.
- Applicants must submit their applications by May 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture 3. (i) SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR (ii) SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees. If the concern is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
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Opportunity Summary:
The NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44) opportunity (Funding Opportunity Number PAR-14-209) is a National Institutes of Health (NIH) discretionary grant program designed to help small businesses move beyond a standard SBIR/STTR Phase II project and into the next, more expensive and execution-heavy stage of development. The core purpose is to provide additional, follow-on funding for projects that are nearing key commercialization milestones, especially when the work ahead involves activities tied to eventual Federal regulatory agency approval (for example, preclinical development steps that support an IND-enabling package, device validation work aligned with FDA expectations, or other regulatory-critical studies). It also supports projects aimed at developing complex research tools, where the pathway to a market-ready product can require extended development, validation, and user adoption work beyond what a typical Phase II budget and timeline can sustain.
This FOA is specifically positioned as a “Phase IIB†style renewal mechanism for prior SBIR Phase II efforts, meaning it is not intended for brand-new concepts but rather for advancing technologies that have already been de-risked through earlier SBIR/STTR funding and now need additional resources to cross the gap from promising prototype or preclinical proof-of-concept to a product that is attractive to buyers, partners, and regulators. NINDS (the National Institute of Neurological Disorders and Stroke) uses this mechanism to strengthen the bridge to commercialization in the neuroscience and neurological disorders space, where development timelines can be long, regulatory expectations can be demanding, and the cost of high-quality preclinical studies or tool validation can be substantial.
A major theme of the announcement is leveraging outside investment and strategic partnerships to accelerate commercialization. The FOA explicitly promotes relationships between NIH SBIR/STTR awardees and independent third-party investors and/or strategic partners, such as venture capital groups, corporate partners, foundations, or other non-federal sources that can provide capital, development support, manufacturing expertise, regulatory guidance, market access, or distribution channels. A key expectation is that the level of independent third-party funding secured or anticipated during the project period should equal or exceed the amount of NINDS funding being requested across the Phase IIB period. In practical terms, applicants are expected to show that the project has real market pull and credible financial or strategic backing, and that NIH funds will be used as part of a broader, investor-aligned development plan rather than as the sole driver of progress.
Because commercialization readiness is central to the program, applicants are required to submit a Commercialization Plan, consistent with SF424 instructions for SBIR Phase II applications. This plan is not a formality; it is meant to lay out how the technology will realistically reach the market, what the target customers and use cases are, the competitive landscape, intellectual property position, regulatory path (when applicable), manufacturing and scale-up considerations, reimbursement or adoption barriers (if relevant), and concrete milestones that connect the proposed R44 work to a credible endpoint such as licensing, acquisition, strategic partnership expansion, or revenue-generating product launch. The Commercialization Plan must also include details on third-party funding already secured or expected during the award period, reinforcing that the project is being advanced in parallel with external validation and support.
Eligibility is limited to U.S. small business concerns that meet SBIR requirements. The business must be organized for profit and have a place of business in the United States, operating primarily in the U.S. or making a significant contribution to the U.S. economy through taxes or use of American products, materials, or labor. The applicant organization can take several legal forms (including proprietorships, partnerships, LLCs, corporations, joint ventures, associations, trusts, or cooperatives), with special limits on foreign participation in joint ventures. The small business size standard applies: including affiliates, the organization must have no more than 500 employees. Ownership and control requirements follow SBIR rules, including options that allow majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms under certain conditions, with the additional certifications and compliance requirements referenced in the announcement.
Administratively, the FOA is a grant mechanism under the R44 activity code and is categorized under health funding activities, aligned with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The opportunity does not require cost sharing or matching as a formal grant requirement, but it effectively demands significant non-federal financial participation through the third-party investment expectation described above. The announcement was posted and created on May 7, 2014, with an original and final closing date of May 7, 2017, and an archive date of June 7, 2017, meaning it is a historical FOA rather than an open, currently active competition. For reference and full details, NIH listed the additional information link at http://grants.nih.gov/grants/guide/pa-files/PAR-14-209.html, and provided the NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues.
Overall, PAR-14-209 is best understood as a commercialization-focused extension pathway for prior SBIR/STTR Phase II neuroscience-related projects that are ready to take on regulatory-aligned preclinical development or substantial tool maturation work, and that can demonstrate strong external investor/partner engagement. The program’s structure is built to ensure that NINDS funding is paired with real-world market validation and capital, so that the supported technologies have a clearer, faster route from lab-stage progress to products that can be deployed, sold, licensed, or partnered at scale.
FAQs: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44) - PAR-14-209
What is PAR-14-209?
PAR-14-209 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) that provides SBIR Phase IIB-style renewal funding under the R44 grant mechanism. It is designed to help eligible small businesses extend prior SBIR/STTR Phase II work into a more advanced, commercialization-focused development stage.
What is the main purpose of this award?
The purpose is to support follow-on, execution-heavy development activities that typically go beyond what a standard Phase II budget and timeline can cover. The program focuses on helping projects move closer to commercialization milestones, especially where the next steps are costly and tied to regulatory expectations or significant product maturation needs.
Is this funding intended for brand-new ideas or early-stage concepts?
No. This opportunity is positioned as a Phase IIB-style renewal mechanism for prior SBIR Phase II efforts. It is meant for advancing technologies that have already been de-risked through earlier SBIR/STTR funding and now need additional resources to cross the gap to commercialization readiness.
What kinds of projects does this FOA aim to support?
The FOA emphasizes two broad categories of work:
- Regulatory-aligned preclinical development (for example, preclinical steps supporting an IND-enabling package, device validation work aligned with FDA expectations, or other regulatory-critical studies).
- Complex research tool development where extended development, validation, and user adoption work is needed to reach a market-ready product beyond a typical Phase II effort.
How is commercialization addressed in this program?
Commercialization readiness is central. Applicants are required to submit a Commercialization Plan (consistent with SF424 instructions for SBIR Phase II applications) explaining how the technology will realistically reach the market and how the proposed R44 work connects to credible commercialization endpoints such as licensing, acquisition, expanded strategic partnerships, or product launch leading to revenue.
What is a key expectation related to outside funding or partnerships?
A major theme is leveraging independent third-party investors and/or strategic partners. A key expectation is that the amount of independent third-party funding secured or anticipated during the project period should be equal to or greater than the amount of NINDS funding requested across the Phase IIB period.
What types of third-party investors or partners are encouraged?
The FOA explicitly promotes relationships with independent third-party investors and/or strategic partners such as venture capital groups, corporate partners, foundations, or other non-federal sources that can provide capital or commercialization-relevant support (development resources, manufacturing expertise, regulatory guidance, market access, or distribution channels).
Does the FOA require cost sharing or matching funds as a formal grant requirement?
No formal cost sharing or matching requirement is stated. However, the FOA effectively expects substantial non-federal participation through the third-party funding level that should equal or exceed the NINDS amount requested.
What must be included in the Commercialization Plan?
Based on the information provided, the Commercialization Plan is expected to cover practical details including:
- How the technology will reach the market
- Target customers and use cases
- Competitive landscape
- Intellectual property position
- Regulatory path (when applicable)
- Manufacturing and scale-up considerations
- Reimbursement or adoption barriers (if relevant)
- Concrete milestones connecting the R44 work to endpoints such as licensing, acquisition, partnership expansion, or revenue-generating product launch
- Details on third-party funding already secured or expected during the award period
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns that meet SBIR requirements. The applicant must be organized for profit, have a place of business in the United States, and operate primarily in the U.S. (or make a significant contribution to the U.S. economy through taxes or use of American products, materials, or labor).
What legal entity types can apply?
The applicant organization may be structured as a proprietorship, partnership, limited liability company (LLC), corporation, joint venture, association, trust, or cooperative. The FOA notes special limits on foreign participation in joint ventures.
Is there a company size limit?
Yes. The SBIR small business size standard applies: including affiliates, the organization must have no more than 500 employees.
Are there ownership and control requirements?
Yes. Ownership and control requirements follow SBIR rules. The FOA also references options allowing majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms under certain conditions, along with additional certifications and compliance requirements mentioned in the announcement.
What is the funding mechanism and activity code for this opportunity?
This is an NIH discretionary grant using the R44 activity code, described as a Phase IIB-style renewal mechanism for SBIR Phase II projects.
What NIH/NINDS program area does it fall under?
It is aligned with health funding activities and is associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Is this funding opportunity currently open?
No. The opportunity is historical. It was posted/created on May 7, 2014, with an original and final closing date of May 7, 2017, and an archive date of June 7, 2017.
Where can someone find the full archived announcement details?
NIH provided an information page at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-209.html.
Who is listed for help with access or linking issues?
The NIH Office of Extramural Research (OER) webmaster contacts were referenced for access or linking issues (as described in the opportunity summary).
Why does NINDS use this Phase IIB-style renewal approach?
The FOA is framed as a way to strengthen the bridge to commercialization in neuroscience and neurological disorders, where timelines can be long, regulatory expectations demanding, and costs for high-quality preclinical studies or tool validation can be substantial.
What is the overall takeaway about what PAR-14-209 was designed to do?
It was designed as a commercialization-focused extension pathway for prior SBIR/STTR Phase II neuroscience-related projects that are nearing key milestones and can show credible investor/partner engagement, with NIH funds used as part of a broader development and commercialization plan rather than as the only source of momentum.
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