Opportunity Information: Apply for PA 09 062

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Probes for Microimaging The Nervous System (SBIR R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.213 Research and Training in Complementary and Integrative Health 93.242 Mental Health Research Grants 93.389 National Center for Research Resources 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.866 Aging Research.
  • This funding opportunity was created on Dec 19, 2008 and posted on Dec 19, 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 NIH funding opportunity titled "Probes for Microimaging The Nervous System (SBIR R43/R44)" (Funding Opportunity Number PA-09-062) supports small businesses that want to build and validate new imaging probes for the brain and broader nervous system. The central goal is to push forward tools that let researchers (and potentially clinicians) see nervous system structure and function at very fine scales by producing signals that can be detected by one or more imaging modalities. In practical terms, NIH is looking for probe technologies that report on the structure or activity of molecules, cellular components, or subcellular elements in neurons or other nervous system cells. The announcement highlights strong interest in genuinely novel probes, but it also welcomes substantial improvements to existing probe approaches if the enhancement is meaningful and well-justified.

A defining feature of this FOA is that it allows project durations and budgets that exceed what is typically permitted under standard SBIR caps, reflecting the reality that probe development often requires iterative chemistry/engineering, biological validation, and imaging demonstration work. Applications can be submitted as SBIR Phase I (R43), Phase II (R44), or as a Fast-Track that proposes Phase I and Phase II in a unified, linked plan. While traditional SBIR guidelines often set Phase I at up to $100,000 total costs for up to 6 months and Phase II at up to $750,000 total costs for up to 2 years, this FOA explicitly permits larger requests: Phase I budgets may request up to $350,000 total costs per year for up to two years, and Phase II budgets may request up to $600,000 total costs per year for up to three years. The FOA does not guarantee a set number of awards; instead, awards depend on available funds and how many applications are both responsive and highly meritorious, with total awards and counts driven by the quality, duration, and costs of the submitted projects.

The scientific scope is broad but clearly centered on probes that enable microimaging of nervous system biology. The probe concept is defined by function: it must generate a detectable signal for at least one imaging method and meaningfully report something about nervous system structure or function at molecular or subcellular resolution. Projects may target probes intended strictly for research use (for example, to map synaptic proteins, track cellular signaling events, or visualize specific subcellular organelles in neurons) or probes designed with clinical utility in mind (for example, probes that could ultimately support diagnosis, monitoring, or image-guided interventions). Because this kind of work can span synthesis, device/physics considerations, biological targeting, and imaging validation, the FOA explicitly anticipates cross-disciplinary teams and approaches, drawing from neuroscience, biology, chemistry, physics, engineering, biotechnology, and bioengineering, often combined within a single project.

Eligibility is limited to United States small business concerns (SBCs) that meet SBIR requirements at the time of award for both Phase I and Phase II. The FOA restates core SBC criteria, including being organized for profit with a place of business in the United States and operating primarily in the U.S. (or contributing significantly to the U.S. economy), meeting ownership and control rules (generally at least 51% owned and controlled by U.S. citizens or permanent resident aliens, or by a qualifying U.S.-owned for-profit business), and having no more than 500 employees including affiliates. It also notes that affiliate relationships and size determinations follow SBA regulations (including 13 C.F.R. Part 121). On the personnel side, the Project Director/Principal Investigator must have primary employment with the small business (more than 50%) at the time of award and throughout the project period, which is a standard SBIR requirement. The FOA also encourages participation by individuals from underrepresented racial and ethnic groups and individuals with disabilities, consistent with NIH-wide inclusion encouragement.

From an application strategy standpoint, a small business can submit more than one application under this FOA as long as each submission is scientifically distinct. Resubmissions are allowed, but they must include an introduction that addresses prior reviewer critiques. The FOA also reflects NIH policy changes around the number of permitted amendments: for applications tied to the January 25, 2009 submission cycle and later, NIH generally permits only one amendment (A1) for new and competing renewal applications, while older "grandfathered" applications submitted before that date could have been eligible for a second amendment (A2) under specific timing limits described in NIH notices. The FOA permits multiple PDs/PIs on an application, which can be important for probe development programs that genuinely require leadership across, for example, chemistry/engineering and neurobiology/imaging validation.

Administratively, this opportunity is a discretionary NIH grant program using the SBIR R43/R44 mechanisms and spans several NIH-related CFDA listings tied to neuroscience, mental health, aging, and related research areas. The FOA was posted December 19, 2008, with an original and final closing date listed as January 7, 2012, and it was archived February 7, 2012. The full announcement is available through NIH at the link provided in the source, and NIH Office of Extramural Research contact support is listed for technical access issues.

Frequently Asked Questions (FAQs)

What is the funding opportunity name and number?

The opportunity is titled "Probes for Microimaging The Nervous System (SBIR R43/R44)" and the Funding Opportunity Number is PA-09-062.

What is the main goal of this NIH SBIR opportunity?

The central goal is to support small businesses developing and validating new imaging probes for the brain and broader nervous system. The focus is on tools that enable researchers (and potentially clinicians) to visualize nervous system structure and function at very fine scales by generating signals detectable by one or more imaging modalities.

What kinds of technologies does NIH mean by "imaging probes" in this FOA?

In this FOA, a probe is defined by what it does: it must generate a detectable signal for at least one imaging method, and that signal must meaningfully report something about nervous system structure or function at molecular, cellular component, or subcellular resolution.

What types of biological targets or readouts are relevant?

The FOA emphasizes probes that report on the structure or activity of molecules, cellular components, or subcellular elements in neurons or other nervous system cells. Examples mentioned include reporting on synaptic proteins, cellular signaling events, or specific subcellular organelles in neurons.

Does the FOA require the probes to be clinical, or can they be research-only?

Both approaches are within scope. Projects may focus on probes intended strictly for research use, or probes designed with clinical utility in mind, such as those that could ultimately support diagnosis, monitoring, or image-guided interventions.

Is NIH only interested in brand-new probe concepts?

The FOA highlights strong interest in genuinely novel probes, but it also welcomes substantial improvements to existing probe approaches when the enhancement is meaningful and well-justified.

Which SBIR mechanisms are supported under this announcement?

Applications may be submitted as SBIR Phase I (R43), SBIR Phase II (R44), or as a Fast-Track submission that proposes Phase I and Phase II in a unified, linked plan.

How do the allowed budgets and project durations compare to typical SBIR limits?

This FOA allows project durations and budgets that exceed typical SBIR caps to reflect the iterative nature of probe development. While traditional SBIR guidelines often cite Phase I as up to $100,000 total costs for up to 6 months and Phase II as up to $750,000 total costs for up to 2 years, this FOA explicitly permits higher requests.

What are the maximum Phase I budget and period allowed under this FOA?

Phase I budgets may request up to $350,000 total costs per year for up to two years.

What are the maximum Phase II budget and period allowed under this FOA?

Phase II budgets may request up to $600,000 total costs per year for up to three years.

Does this FOA guarantee a certain number of awards?

No. The FOA does not guarantee a set number of awards. Awards depend on available funds and on how many applications are responsive and highly meritorious. Total awards and counts are driven by the quality, duration, and costs of submitted projects.

Who is eligible to apply?

Eligibility is limited to United States small business concerns (SBCs) that meet SBIR requirements at the time of award for both Phase I and Phase II.

What are the key small business concern (SBC) eligibility requirements mentioned?

The FOA restates core SBC criteria, including: the business must be organized for profit with a place of business in the United States; it must operate primarily in the U.S. (or contribute significantly to the U.S. economy); it must meet SBIR ownership and control rules (generally at least 51% owned and controlled by U.S. citizens or permanent resident aliens, or by a qualifying U.S.-owned for-profit business); and it must have no more than 500 employees including affiliates.

How are affiliates and size determinations handled?

The FOA notes that affiliate relationships and size determinations follow SBA regulations, including 13 C.F.R. Part 121.

What is the Project Director/Principal Investigator (PD/PI) employment requirement?

The PD/PI must have primary employment with the small business (more than 50%) at the time of award and throughout the project period, consistent with standard SBIR requirements.

Are multiple PDs/PIs allowed on a single application?

Yes. The FOA permits multiple PDs/PIs, which may be important for probe development efforts that require leadership across different disciplines (for example, chemistry/engineering and neurobiology/imaging validation).

Does the FOA encourage certain kinds of applicants or team members?

The FOA encourages participation by individuals from underrepresented racial and ethnic groups and individuals with disabilities, consistent with NIH-wide inclusion encouragement.

What kinds of teams or disciplines does NIH expect for these projects?

The FOA anticipates cross-disciplinary teams and approaches. It explicitly references projects drawing from neuroscience, biology, chemistry, physics, engineering, biotechnology, and bioengineering, often combined within a single project.

Can a small business submit more than one application to this FOA?

Yes. A small business may submit more than one application under this FOA as long as each application is scientifically distinct.

Are resubmissions (amended applications) allowed?

Yes. Resubmissions are allowed, but they must include an introduction that addresses prior reviewer critiques.

How many amendments (resubmissions) are permitted under the NIH policy referenced?

The FOA reflects NIH policy changes stating that for applications tied to the January 25, 2009 submission cycle and later, NIH generally permits only one amendment (A1) for new and competing renewal applications. Older "grandfathered" applications submitted before that date could have been eligible for a second amendment (A2) under specific timing limits described in NIH notices.

When was this FOA posted, and what were the closing details?

The FOA was posted on December 19, 2008. It lists an original and final closing date of January 7, 2012, and it was archived on February 7, 2012.

Where can applicants find the full announcement and who is listed for technical help?

The full announcement is available through NIH at the link provided in the source. For technical access issues, NIH Office of Extramural Research contact support is listed.

Are there specific NIH program areas connected to this opportunity?

Administratively, the FOA spans several NIH-related CFDA listings tied to neuroscience, mental health, aging, and related research areas, and uses the SBIR R43/R44 mechanisms.

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