Opportunity Information: Apply for PA 09 045
Apply for PA 09 045
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Development of Biomarkers for Mental Health Research and Clinical Use (SBIR R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213 Research and Training in Complementary and Integrative Health 93.242 Mental Health Research Grants.
- This funding opportunity was created on Dec 11, 2008 and posted on Dec 11, 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 "Development of Biomarkers for Mental Health Research and Clinical Use (SBIR R43/R44)" (Funding Opportunity Number PA-09-045) is designed to help US small businesses create and move toward commercialization of biomarker technologies that are relevant to mental disorders. The core goal is to stimulate research and development that can yield practical, market-ready tools that improve mental health research and, potentially, clinical decision-making. In other words, the FOA is not just looking for academic discovery; it is specifically oriented toward innovations that can realistically be developed into products or services that people will use in real-world mental health settings.
This announcement uses the SBIR grant mechanism, specifically the R43 (Phase I) and R44 (Phase II), and it also allows Fast Track applications that combine Phase I and Phase II in a streamlined path. Phase I is intended to support early feasibility work and proof-of-concept development, while Phase II supports more advanced R and D aimed at strengthening the technology, generating stronger performance data, and positioning the work for commercialization. Awards are not guaranteed; the NIH makes it clear that funding depends on available appropriations and on receiving enough high-quality, competitive applications. The number of awards and total dollars ultimately distributed can vary based on how strong the submitted proposals are, how long the projects run, and what budgets are requested and justified.
The budget and project period rules are described in two layers: the usual SBIR caps and the expanded limits allowed under this specific FOA. Under standard SBIR guidance, Phase I projects typically do not exceed $100,000 total costs over about 6 months, and Phase II projects typically do not exceed $750,000 total costs over about 2 years. However, this FOA permits applicants to request substantially higher amounts if the work requires it. For Phase I, applicants may request up to $350,000 in total costs per year for up to two years. For Phase II, applicants may request up to $600,000 in total costs per year for up to three years. For Phase II competing renewals, budgets must follow the limits described in the broader SBIR/STTR Omnibus Solicitation program descriptions and topic guidance, meaning renewal requests are constrained by additional NIH-wide SBIR rules beyond what is summarized here.
Eligibility is limited to US small business concerns (SBCs). The SBC must be for-profit, have a place of business in the United States, and primarily operate within the US or make a meaningful contribution to the US economy (for example through taxes or use of US labor and materials). It must fit an allowable legal structure (such as LLC, corporation, partnership, sole proprietorship, and certain joint ventures, with joint venture participation by business entities capped at 49%). Ownership and control requirements also apply: generally, the company must be at least 51% owned and controlled by US citizens or permanent residents, or be majority owned by another for-profit business that itself meets that same US ownership/control standard. The firm must also have no more than 500 employees including affiliates, with "affiliate" interpreted using SBA rules where control can occur through ownership, management, or contractual relationships.
The FOA also lays out who may serve as the Project Director/Principal Investigator (PD/PI). NIH invites individuals with the appropriate expertise and resources to propose and lead the work through their small business, and it explicitly encourages applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities. A key SBIR-specific requirement applies to the PD/PI: on an SBIR application, the PD/PI must have primary employment with the small business (more than 50% of their time) at the time of award and for the duration of the project. This requirement matters operationally because it affects staffing plans, leadership structure, and how applicants document personnel commitment.
On submissions, a small business is allowed to submit more than one application as long as each is scientifically distinct, which can be helpful for companies developing multiple biomarker platforms or targeting different disorders, use cases, or validation pathways. Resubmissions are permitted, but they must include an Introduction that responds to the prior peer review critique (the Summary Statement). The FOA references NIH policy changes around the number of allowed amendments: for applications intended for the January 25, 2009 due date and later, original new and competing renewal applications were generally limited to a single amendment (A1). Older, "grandfathered" submissions made before that policy shift could have up to two amendments (A1 and A2), but A2 submissions were expected by January 7, 2011, and would not be accepted after that date. These details mainly matter for understanding the historical submission rules during the active life of the announcement.
Administratively, the opportunity is categorized as a discretionary grant in the health area, offered by the National Institutes of Health. It was posted and created on December 11, 2008, with an original and current closing date of January 7, 2012, and an archive date of February 7, 2012, meaning this specific FOA is now archived rather than active. It lists CFDA numbers 93.242 (Mental Health Research Grants) and 93.213 (Research and Training in Complementary and Integrative Health). The announcement states there is no cost-sharing or matching requirement. For official details, applicants were directed to the full FOA page on grants.nih.gov (PA-09-045) and to NIH Office of Extramural Research support contacts for access or linking issues.
FAQs: Development of Biomarkers for Mental Health Research and Clinical Use (SBIR R43/R44) - NIH (PA-09-045)
What is this NIH funding opportunity?
This opportunity is the NIH Funding Opportunity Announcement (FOA) titled "Development of Biomarkers for Mental Health Research and Clinical Use (SBIR R43/R44)," Funding Opportunity Number PA-09-045. It is a discretionary health-area grant opportunity offered by the National Institutes of Health (NIH) using the SBIR program.
What is the main purpose of PA-09-045?
The core goal is to stimulate research and development by US small businesses to create biomarker technologies relevant to mental disorders and move those technologies toward commercialization. The emphasis is on practical, market-ready tools that can improve mental health research and potentially support clinical decision-making in real-world settings.
Is this FOA focused on academic discovery or commercialization?
It is specifically oriented toward innovations that can realistically be developed into products or services used in real-world mental health settings, not solely academic discovery.
What grant mechanisms are used under this FOA?
This FOA uses the SBIR mechanisms R43 (Phase I) and R44 (Phase II). It also allows Fast Track applications that combine Phase I and Phase II into a streamlined submission path.
What is Phase I (R43) intended to support?
Phase I supports early feasibility work and proof-of-concept development for biomarker technologies relevant to mental disorders.
What is Phase II (R44) intended to support?
Phase II supports more advanced research and development to strengthen the technology, generate stronger performance data, and better position the project for commercialization.
What is an SBIR Fast Track application in this FOA?
Fast Track is an option that combines Phase I and Phase II in a single, more streamlined path (rather than applying to Phase II separately after completing Phase I).
Are awards guaranteed if an application is submitted?
No. The FOA states funding depends on available appropriations and the receipt of high-quality, competitive applications.
How are the number of awards and total funding determined?
The number of awards and total dollars can vary based on factors described in the FOA, including the strength of submitted proposals, project lengths, and the budgets requested and justified.
What are the typical SBIR budget caps mentioned in the FOA?
Under standard SBIR guidance summarized in the FOA, Phase I projects typically do not exceed $100,000 total costs over about 6 months, and Phase II projects typically do not exceed $750,000 total costs over about 2 years.
Does this FOA allow higher budgets than typical SBIR caps?
Yes. The FOA permits applicants to request substantially higher amounts if the work requires it, within the FOA-specific limits.
What are the FOA-specific Phase I (R43) budget and project period limits?
Applicants may request up to $350,000 in total costs per year for up to two years for Phase I under this FOA.
What are the FOA-specific Phase II (R44) budget and project period limits?
Applicants may request up to $600,000 in total costs per year for up to three years for Phase II under this FOA.
Do Phase II competing renewals follow the same budget limits stated above?
No. The FOA indicates that Phase II competing renewal budgets must follow limits described in the broader SBIR/STTR Omnibus Solicitation program descriptions and topic guidance, which can impose additional NIH-wide SBIR constraints beyond what is summarized in this announcement.
Who is eligible to apply?
Eligibility is limited to US small business concerns (SBCs) that meet SBIR requirements, including being for-profit, having a place of business in the United States, and primarily operating in the US or making a meaningful contribution to the US economy (for example through taxes or use of US labor and materials).
What legal structures are allowed for the small business applicant?
The FOA describes allowable legal structures such as LLCs, corporations, partnerships, sole proprietorships, and certain joint ventures. For joint ventures, participation by business entities is capped at 49%.
What are the ownership and control requirements for the small business?
Generally, the company must be at least 51% owned and controlled by US citizens or permanent residents, or majority owned by another for-profit business that itself meets the same US ownership/control standard.
Is there an employee size limit for eligibility?
Yes. The firm must have no more than 500 employees including affiliates.
How does the FOA define or treat affiliates?
The FOA indicates affiliates are interpreted using SBA rules, where control can occur through ownership, management, or contractual relationships.
Who can serve as the Project Director/Principal Investigator (PD/PI)?
NIH invites individuals with the appropriate expertise and resources to propose and lead the work through their small business.
Does the FOA encourage applications from specific groups?
Yes. The FOA explicitly encourages applications from individuals from underrepresented racial and ethnic groups and individuals with disabilities.
What is the SBIR requirement regarding the PD/PI's employment?
For an SBIR application, the PD/PI must have primary employment with the small business (more than 50% of their time) at the time of award and for the duration of the project.
Can a small business submit more than one application under this FOA?
Yes. A small business may submit more than one application as long as each application is scientifically distinct.
Are resubmissions permitted?
Yes. Resubmissions are permitted, but they must include an Introduction that responds to the prior peer review critique (the Summary Statement).
What were the FOA's rules about the number of allowed amendments (resubmissions)?
The FOA references NIH policy changes: for applications intended for the January 25, 2009 due date and later, original new and competing renewal applications were generally limited to a single amendment (A1). Older submissions made before the policy shift could have up to two amendments (A1 and A2), but A2 submissions were expected by January 7, 2011 and were not accepted after that date.
What is the program area or topic focus?
The FOA is focused on developing biomarkers relevant to mental disorders, with an emphasis on tools that support mental health research and potentially clinical use.
Is cost-sharing or matching required?
No. The FOA states there is no cost-sharing or matching requirement.
What agency is offering this opportunity?
The opportunity is offered by the National Institutes of Health (NIH).
What are the CFDA numbers associated with this FOA?
The FOA lists CFDA numbers 93.242 (Mental Health Research Grants) and 93.213 (Research and Training in Complementary and Integrative Health).
When was this FOA posted and when did it close?
It was posted/created on December 11, 2008. The closing date listed is January 7, 2012.
Is PA-09-045 still active?
No. The FOA is archived. It lists an archive date of February 7, 2012, indicating it is no longer active.
Where were applicants directed for official details and help?
For official details, applicants were directed to the full FOA page on grants.nih.gov (PA-09-045). For access or linking issues, the FOA directed users to NIH Office of Extramural Research support contacts.
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