Opportunity Information: Apply for PA 09 064
Apply for PA 09 064
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advanced Neural Prosthetics Research and Development (SBIR U44)" 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 Dec 22, 2008 and posted on Dec 22, 2008.
- Applicants must submit their applications by Jan 7, 2012. (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 Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 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 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 can be no more than 49 percent participation by business entities in the joint venture At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for profit business concern that is at least 51 owned and controlled by another for profit business concern that is at least 51 owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States (except in the case of a joint venture) Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other or (b) a third party/parties controls or has the power to control both. Control can be exercised through common ownership, common management, and contractual relationships. The term affiliates is defined in greater detail in 13 C.F.R. 121.3 2(a). The term number of employees is defined in 13 C.F.R. 121.3 2(t). Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.
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Opportunity Summary:
The Advanced Neural Prosthetics Research and Development (SBIR U44) opportunity (Funding Opportunity Number PA 09 064) is a National Institutes of Health (NIH) funding announcement designed to move neural prosthetics from the research stage into practical, clinically useful medical devices. The central aim is translation: taking promising neural prosthetic concepts and pushing them through the engineering, testing, and early clinical steps needed to show they can work in real-world healthcare settings. A key feature of this program is its emphasis on milestone-driven progress, meaning projects are expected to lay out clear technical and development milestones and then execute against them in a structured way that supports device development and readiness for clinical use.
This FOA supports a wide range of later-stage development activities that are typical bottlenecks for neural interface and neural prosthetic technologies. Supported work can include building and implementing clinical prototype devices, conducting preclinical safety and efficacy testing, and performing design verification and validation. It also explicitly covers regulatory-facing efforts, such as pursuing the approvals needed to initiate a clinical study, along with proof-of-concept or pilot clinical studies intended to demonstrate early feasibility and clinical value. Taken together, the scope is less about basic discovery and more about turning a device into something that can be credibly tested in humans under appropriate oversight, with an eye toward eventual clinical adoption.
The funding mechanism is an SBIR cooperative agreement (U44), used for Phase II and Fast Track applications. A cooperative agreement typically indicates more substantial programmatic involvement from NIH than a standard grant, which aligns with the milestone-based, translational nature of the program. This announcement runs in parallel with a companion FOA (PA 09 063) that uses the U01 cooperative agreement mechanism but has the same scientific scope, offering another pathway for similar work outside the SBIR small business framework.
Award levels depend on available funds and the strength of the applications received, and NIH does not promise a fixed number of awards. For budgeting, Phase II applicants may request up to $1 million in total costs per year for as long as three years. Fast Track applications may include a Phase I portion capped at up to $300,000 in total costs per year for up to two years, followed by Phase II support under the U44 structure. The announcement also allows Phase II competing renewals (for eligible awardees) at up to $1 million in total costs per year for up to three years, supporting continued development beyond the original Phase II period when justified by progress and remaining work.
Eligibility is limited to United States small business concerns (SBCs) applying through the SBIR program. The FOA reiterates the standard SBIR small business requirements: the company must be for-profit, have a place of business in the United States, operate primarily in the United States (or otherwise make a significant contribution to the U.S. economy), and meet ownership and control rules (generally at least 51 percent owned and controlled by U.S. citizens or permanent residents, with specific provisions for certain corporate ownership structures and joint ventures). The business must also have no more than 500 employees including affiliates, with affiliation determined under Small Business Administration rules regarding control through ownership, management, or contractual relationships.
For project leadership, the program allows either a single Principal Investigator or multiple PDs/PIs. The PD/PI must have primary employment with the small business (more than 50 percent) at the time of award and for the duration of the project, which is a standard SBIR requirement to ensure the work is truly led by the small business. The FOA notes that individuals from underrepresented racial and ethnic groups and individuals with disabilities are encouraged to apply, consistent with broader NIH participation goals.
From an application management standpoint, applicant SBCs may submit more than one application as long as each submission is scientifically distinct. Resubmissions are permitted, but they must include an introduction responding to the prior peer review critique. The FOA also reflects NIH’s resubmission policy changes around that period: for applications intended for the January 25, 2009 due date and after, new and competing renewal applications were generally limited to a single amendment (A1), while certain older submissions made before that date were allowed a second amendment (A2) under specific timing constraints. Only Phase II SBIR awardees are eligible to apply for a competing renewal, and that renewal must represent a continuation of the R&D supported under the original Phase II award.
Administratively, this is a discretionary cooperative agreement in the health funding category, listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), with no cost sharing or matching requirement. The announcement was posted December 22, 2008, and the original and current closing date listed is January 7, 2012, with an archive date of February 7, 2012, indicating the FOA is now historical rather than currently open. The full announcement is hosted through the NIH grants guide at the link provided in the source, with NIH Office of Extramural Research contact points for access or technical issues.
Frequently Asked Questions (FAQs): Advanced Neural Prosthetics Research and Development (SBIR U44) - PA-09-064
What is the Advanced Neural Prosthetics Research and Development (SBIR U44) opportunity?
It is a National Institutes of Health (NIH) funding announcement (Funding Opportunity Number PA 09 064) focused on advancing neural prosthetics from research concepts into practical, clinically useful medical devices. The emphasis is on translation and later-stage development rather than basic discovery.
What is the central goal of this FOA?
The central goal is to move promising neural prosthetic technologies through engineering, testing, and early clinical steps so they can be credibly evaluated for real-world healthcare use and eventual clinical adoption.
What does "milestone-driven progress" mean in this program?
Projects are expected to propose clear technical and development milestones and then execute the work in a structured way aligned with device development and readiness for clinical use. The cooperative agreement structure supports this milestone-based approach.
What types of activities does the FOA support?
The FOA supports later-stage development activities commonly needed to advance neural interfaces and neural prosthetics toward clinical use. These can include building clinical prototype devices, performing preclinical safety and efficacy testing, and conducting design verification and validation.
Does the FOA support regulatory-related work?
Yes. The scope explicitly includes regulatory-facing efforts, such as pursuing approvals needed to initiate a clinical study, as well as early proof-of-concept or pilot clinical studies aimed at demonstrating feasibility and clinical value.
Is this FOA intended for basic research or device translation?
Based on the description provided, the FOA is geared toward device translation and development steps needed to prepare a neural prosthetic for appropriate testing in humans, rather than basic discovery research.
What funding mechanism is used?
This opportunity uses an SBIR cooperative agreement mechanism (U44) for Phase II and Fast Track applications. A cooperative agreement generally implies substantial NIH programmatic involvement compared to a standard grant.
What does it mean that this is a cooperative agreement?
It indicates NIH is expected to have more programmatic involvement than in a standard grant. This aligns with the milestone-driven, translational nature of the program as described.
Which SBIR phases are supported under this announcement?
The announcement supports Phase II and Fast Track applications under the U44 mechanism. Fast Track includes a Phase I portion followed by Phase II support.
What is the budget limit for Phase II applications?
Phase II applicants may request up to $1 million in total costs per year for as long as three years, based on the budgeting guidance described.
What is the budget limit for the Fast Track Phase I portion?
Fast Track applications may include a Phase I portion capped at up to $300,000 in total costs per year for up to two years, followed by Phase II under the U44 structure.
Does the FOA allow Phase II competing renewals?
Yes. Phase II competing renewals (for eligible awardees) are allowed at up to $1 million in total costs per year for up to three years, to support continued development beyond the original Phase II period when justified by progress and remaining work.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs) applying through the SBIR program.
What are the key SBIR small business eligibility requirements mentioned?
The company must be for-profit, have a place of business in the United States, operate primarily in the United States (or otherwise make a significant contribution to the U.S. economy), and meet SBIR ownership and control requirements (generally at least 51 percent owned and controlled by U.S. citizens or permanent residents, with specific provisions for certain corporate ownership structures and joint ventures).
Is there an employee size limit for eligible small businesses?
Yes. The business must have no more than 500 employees including affiliates, with affiliation determined under Small Business Administration rules involving control through ownership, management, or contractual relationships.
Can a project have multiple Principal Investigators?
Yes. The FOA allows either a single Principal Investigator or multiple PDs/PIs.
What is the primary employment requirement for the PD/PI?
The PD/PI must have primary employment with the small business (more than 50 percent) at the time of award and for the duration of the project.
Does the FOA encourage applications from specific groups?
Yes. Individuals from underrepresented racial and ethnic groups and individuals with disabilities are encouraged to apply.
Can a single small business submit more than one application?
Yes. Applicant SBCs may submit more than one application as long as each submission is scientifically distinct.
Are resubmissions permitted?
Yes. Resubmissions are permitted, and they must include an introduction responding to the prior peer review critique.
How many resubmissions (amendments) were generally allowed under the policy described?
For applications intended for the January 25, 2009 due date and after, new and competing renewal applications were generally limited to a single amendment (A1). Certain older submissions made before that date were allowed a second amendment (A2) under specific timing constraints.
Who can apply for a Phase II competing renewal?
Only Phase II SBIR awardees are eligible to apply for a competing renewal, and the renewal must represent a continuation of the R&D supported under the original Phase II award.
Is cost sharing or matching required?
No. The announcement specifies there is no cost sharing or matching requirement.
What is the CFDA number associated with this opportunity?
The FOA is listed under CFDA 93.853, described as Extramural Research Programs in the Neurosciences and Neurological Disorders.
How many awards will NIH make?
The number of awards is not fixed. Awards depend on available funds and the strength of applications received, and NIH does not promise a set number of awards.
Is there a companion funding announcement related to this one?
Yes. The announcement runs in parallel with a companion FOA (PA 09 063) using the U01 cooperative agreement mechanism with the same scientific scope, providing another pathway outside the SBIR small business framework.
Is this FOA still open for applications?
No. The provided information indicates the FOA is historical. It was posted December 22, 2008, lists a closing date of January 7, 2012, and an archive date of February 7, 2012.
Where is the full announcement hosted?
The full announcement is hosted through the NIH grants guide (as referenced in the source), with NIH Office of Extramural Research contact points available for access or technical issues.
What health funding category is this cooperative agreement associated with?
It is identified as a discretionary cooperative agreement in the health funding category.
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