Opportunity Information: Apply for RFA AA 11 004
Apply for RFA AA 11 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Biomarkers of Alcohol Consumption and Alcohol induced Tissue Injury (SBIR R43/R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs.
- This funding opportunity was created on Aug 27, 2010 and posted on Aug 26, 2010.
- Applicants must submit their applications by Nov 2, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Small businesses.
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Opportunity Summary:
The NIH funding opportunity titled "Biomarkers of Alcohol Consumption and Alcohol induced Tissue Injury (SBIR R43/R44)" (Funding Opportunity Number RFA-AA-11-004) is a discretionary grant program designed to push forward practical, clinically relevant biomarkers related to alcohol use and alcohol-related harm. The core aim is to support small business concerns in discovering and developing measurable biological indicators that can (1) objectively reflect alcohol consumption, (2) detect early-stage alcohol-induced organ or tissue injury before severe disease is established, and (3) identify fetal alcohol exposure. In plain terms, the program is looking for better, more reliable ways to measure alcohol use and its biological impacts using tests that could eventually be used in clinical care, public health, research trials, or prenatal and pediatric contexts where exposure identification matters.
A major emphasis of the announcement is on modern discovery approaches, especially high-throughput technologies that can screen large numbers of potential signals and identify multi-marker "signatures" rather than relying on a single indicator. This points to methods such as broad omics-style discovery (for example, proteomic, metabolomic, lipidomic, transcriptomic, epigenetic, or similar platforms) and other scalable screening strategies that can uncover patterns strongly associated with drinking behavior or early tissue injury. The opportunity is not limited to discovery alone; it explicitly encourages projects that can move promising candidates quickly toward real-world use. That means proposals that include a credible pathway from biomarker identification to assay development, verification/validation steps, and eventually a marketable, clinically useful diagnostic or monitoring test are especially aligned with the intent of the FOA.
The mechanism of support is the Small Business Innovation Research (SBIR) program using the R43/R44 activity codes, which cover Phase I, Phase II, and Fast-Track applications. Phase I generally supports early feasibility and proof-of-concept work, while Phase II supports more advanced R&D such as optimization, expanded validation, and preparation for commercialization. The Fast-Track option is meant to speed the transition from Phase I to Phase II for projects with strong preliminary results and a well-structured development plan. The FOA also notes that it runs in parallel with a related solicitation, RFA-AA-11-005, which uses the Small Business Technology Transfer (STTR) R41 mechanism, signaling that NIH is pursuing the same scientific goals through both SBIR and STTR pathways depending on the applicant's collaboration model.
Eligibility is limited to small businesses. There is no cost sharing or matching requirement, which lowers barriers for early-stage companies that may not have substantial non-federal capital available. The program falls under the health funding activity category and is associated with CFDA number 93.273 (Alcohol Research Programs). The sponsoring agency is the National Institutes of Health, aligning this opportunity with NIH's broader interest in objective measures that can improve diagnosis, risk stratification, early intervention, and evaluation of treatment outcomes for alcohol-related conditions.
In terms of funding scale, NIH estimated a total of $2,000,000 available for fiscal year 2011 to support approximately 2 to 4 awards under this announcement, with future funding dependent on annual appropriations. The listed award ceiling is $200,000, which typically corresponds to certain SBIR budget conventions (often associated with Phase I levels), though actual allowable budgets in SBIR can vary based on the specific FOA terms and NIH guidelines. Key dates indicate the opportunity was posted in late August 2010, with an original and current closing date of November 2, 2010, and an archive date of December 3, 2010, meaning this particular solicitation is historical rather than currently open.
Practically speaking, the opportunity is tailored for companies developing diagnostic tools, lab assays, point-of-care tests, or analytic platforms that can turn complex biological signals into usable clinical outputs. Strong applicants would typically present a clear use case (for example, monitoring alcohol intake objectively in clinical trials, detecting early liver or other organ injury related to alcohol, or identifying fetal exposure), a rigorous strategy for discovery and validation, and a realistic commercialization plan that addresses how the biomarker(s) will be translated into a reproducible assay that clinicians or laboratories can actually adopt. For anyone needing the complete official announcement language, the FOA provides an NIH Grants Guide link and NIH Office of Extramural Research (OER) contact information for access or technical issues.
Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The funding opportunity is titled "Biomarkers of Alcohol Consumption and Alcohol induced Tissue Injury (SBIR R43/R44)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AA-11-004.
What type of grant program is this?
This is a discretionary grant program offered through the NIH Small Business Innovation Research (SBIR) mechanism using R43/R44 activity codes.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What is the main goal of this SBIR opportunity?
The main goal is to support small business concerns in discovering and developing practical, clinically relevant biomarkers that objectively measure alcohol consumption and detect alcohol-related biological harm, including early-stage tissue or organ injury and fetal alcohol exposure.
What kinds of biomarkers is NIH looking for under this announcement?
The announcement emphasizes measurable biological indicators that can: (1) objectively reflect alcohol consumption, (2) detect early-stage alcohol-induced organ or tissue injury before severe disease is established, and (3) identify fetal alcohol exposure.
Does the opportunity focus only on biomarker discovery, or also on development and translation?
It is not limited to discovery. The opportunity explicitly encourages projects that move promising biomarker candidates toward real-world use, including assay development, verification/validation steps, and progress toward a marketable and clinically useful diagnostic or monitoring test.
What kinds of scientific approaches are emphasized?
A major emphasis is on modern discovery approaches, especially high-throughput technologies that can screen large numbers of potential signals and identify multi-marker signatures (patterns) rather than relying on a single indicator.
Are "omics" approaches considered responsive to this FOA?
Yes. The description highlights broad discovery platforms such as proteomics, metabolomics, lipidomics, transcriptomics, epigenetic approaches, and similar scalable screening strategies that can uncover patterns strongly associated with drinking behavior or early tissue injury.
What are the SBIR activity codes used in this opportunity?
The opportunity uses SBIR R43/R44, which cover Phase I, Phase II, and Fast-Track applications.
What is supported in Phase I versus Phase II?
Phase I generally supports early feasibility and proof-of-concept work. Phase II generally supports more advanced research and development such as optimization, expanded validation, and preparation for commercialization.
What is the Fast-Track option in this FOA?
The Fast-Track option is intended to speed the transition from Phase I to Phase II for projects with strong preliminary results and a well-structured development plan.
Who is eligible to apply?
Eligibility is limited to small businesses (small business concerns).
Is there a cost sharing or matching requirement?
No. The announcement states there is no cost sharing or matching requirement.
What is the CFDA number associated with this program?
The CFDA number is 93.273 (Alcohol Research Programs).
How much funding did NIH estimate would be available?
NIH estimated a total of $2,000,000 available for fiscal year 2011 under this announcement, with future funding dependent on annual appropriations.
How many awards were anticipated?
NIH anticipated approximately 2 to 4 awards.
What is the listed award ceiling?
The listed award ceiling is $200,000.
Is this funding opportunity currently open?
No. The key dates indicate this solicitation is historical: it was posted in late August 2010, had a closing date of November 2, 2010 (original and current), and an archive date of December 3, 2010.
When was the application due date for this FOA?
The closing date listed is November 2, 2010.
When was the FOA archived?
The archive date listed is December 3, 2010.
What kinds of products or deliverables does this opportunity appear designed to support?
It is tailored for companies developing diagnostic tools, laboratory assays, point-of-care tests, or analytic platforms that can translate biological signals into usable clinical outputs.
What kinds of real-world use cases are aligned with the intent of the FOA?
Examples described include objective monitoring of alcohol intake in clinical trials, early detection of alcohol-related liver or other organ injury, and identification of fetal alcohol exposure in prenatal or pediatric contexts where exposure identification matters.
Does the FOA prefer single biomarkers or multi-marker signatures?
The announcement places emphasis on identifying multi-marker signatures, reflecting a preference for patterns of markers discovered through high-throughput methods rather than relying on a single indicator.
Is there a related NIH solicitation connected to this one?
Yes. The FOA notes it runs in parallel with a related solicitation, RFA-AA-11-005, which uses the Small Business Technology Transfer (STTR) R41 mechanism and pursues the same scientific goals through a different small business pathway.
Where can someone find the complete official announcement language or get help accessing it?
The FOA indicates that the complete official announcement language is available via the NIH Grants Guide link, and that NIH Office of Extramural Research (OER) contact information is provided for access or technical issues.
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