Opportunity Information: Apply for RFA HD 15 012
Apply for RFA HD 15 012
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Peripheral Blood Biomarkers of Chronic Traumatic Brain Injury in Human Subjects SBIR Direct Phase II (R44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Jun 25, 2014 and posted on Jun 25, 2014.
- Applicants must submit their applications by Aug 29, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 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 percent 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 percent 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 percent 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 percent 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.
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Opportunity Summary:
This funding opportunity, titled "Peripheral Blood Biomarkers of Chronic Traumatic Brain Injury in Human Subjects SBIR Direct Phase II (R44)" (Funding Opportunity Number: RFA-HD-15-012), is a National Institutes of Health (NIH) discretionary grant solicitation aimed specifically at U.S. small businesses through the SBIR Direct Phase II mechanism. The central goal is to push forward applied, clinically grounded research that can show measurable, biologically meaningful protein biomarkers in peripheral blood that track with brain structure or neurological function in people living in the chronic stages of traumatic brain injury. In other words, the program is looking for projects that go beyond general discussions of TBI and instead produce convincing evidence that specific blood-based proteins reflect long-term brain-related changes after injury, with a clear emphasis on human subjects and real-world clinical relevance.
A key scientific focus of the announcement is chronic brain injury (CBI) rather than acute injury. Many TBI-related diagnostic efforts concentrate on the hours and days after trauma, but this FOA is directed at the months-to-years time window when patients may be dealing with lingering or evolving neurological, cognitive, and emotional symptoms. The NIH is signaling interest in biomarkers that can be linked to objective measures of the brain, such as structural or functional indicators that can be captured through neuroanatomical or neuroimaging evidence, and that can help explain or corroborate the changes patients experience long after the initial event. The idea is that blood biomarkers could serve as accessible biological readouts for underlying brain status, helping researchers and clinicians understand trajectories of recovery versus decline.
The intended outcome is not just biomarker detection in isolation, but demonstration that these protein signals are meaningfully related to brain structure or neurological function. The FOA frames this as providing anatomical evidence for changes in neurological, cognitive, or emotional status that may appear or persist years after brain trauma. By tying blood-based proteins to neurological and brain-structure correlates, the funded work is expected to help establish biomarkers as potential surrogate markers, meaning markers that could stand in for more complex or expensive evaluations when monitoring long-term outcomes. In practical terms, that could support better long-term tracking of patient status, inform prognosis, and potentially help measure response in rehabilitation or other interventions, provided the biomarker relationship is strong and reproducible.
From an administrative and funding standpoint, this is an SBIR Direct Phase II award (R44), which typically implies that applicants are expected to have a solid foundation of prior feasibility evidence and are ready to pursue a more advanced development and validation stage without going through a separate Phase I under the same solicitation. The total estimated funding associated with the announcement is listed as $1,500,000, with an award ceiling of $750,000, and there is no cost sharing or matching requirement. The program is categorized under Health, Income Security, and Social Services, and it is associated with CFDA number 93.865 (Child Health and Human Development Extramural Research), reflecting NIH organizational alignment for this topic area.
Eligibility is limited to United States small business concerns (SBCs) meeting standard SBIR requirements at the time of award, including being for-profit, having a U.S. place of business, operating primarily in the U.S. (or contributing significantly to the U.S. economy), and having no more than 500 employees including affiliates. The solicitation details multiple acceptable ownership/control structures commonly recognized in SBIR policy, including majority ownership by U.S. citizens or permanent residents, and certain SBIR-allowed majority venture-backed structures, as long as no single venture capital operating company, hedge fund, or private equity firm owns more than 50 percent of the concern. Joint ventures can qualify as well, but must follow the stated ownership requirements and relevant registration/proposal rules.
Timeline information indicates the opportunity was posted and created on June 25, 2014, with an original and current closing date of August 29, 2014, and an archive date of September 29, 2014. While those dates show this specific listing is historical, the details still clearly communicate the type of research NIH was seeking: blood-based protein biomarkers with demonstrable linkage to brain structure or function in chronic-stage TBI patients, with the broader aim of producing clinically meaningful surrogate measures for long-term recovery or deterioration.
For applicants and interested parties who want the full text of the announcement and the detailed requirements that typically accompany NIH FOAs (such as expected study design elements, review criteria, human subjects protections, and data expectations), the additional information link is provided as: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-15-012.html. The contact pathway listed is through the NIH Office of Extramural Research (OER) webmaster channels for access or linking issues (FBOWebmaster@OD.NIH.GOV), which reflects that the published entry is a summarized record pointing to the full FOA documentation.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this grant?
The opportunity is titled "Peripheral Blood Biomarkers of Chronic Traumatic Brain Injury in Human Subjects SBIR Direct Phase II (R44)." The Funding Opportunity Number (FOA) is RFA-HD-15-012.
Which agency is offering this funding opportunity?
This is a National Institutes of Health (NIH) discretionary grant solicitation.
What type of award mechanism is being used?
The mechanism is SBIR Direct Phase II (R44), which is intended for U.S. small businesses pursuing a more advanced development and validation stage and typically presumes prior feasibility evidence.
Who is eligible to apply?
Eligibility is limited to United States small business concerns (SBCs) that meet standard SBIR requirements at the time of award, including being for-profit, having a U.S. place of business, operating primarily in the U.S. (or contributing significantly to the U.S. economy), and having no more than 500 employees including affiliates.
Are there specific ownership or control requirements for eligible small businesses?
Yes. The solicitation describes multiple SBIR-acceptable ownership/control structures, including majority ownership by U.S. citizens or permanent residents and certain SBIR-allowed majority venture-backed structures, provided that no single venture capital operating company, hedge fund, or private equity firm owns more than 50 percent of the concern.
Can joint ventures apply?
Yes. Joint ventures can qualify, but they must follow the stated SBIR ownership requirements and the relevant registration and proposal rules referenced by the solicitation.
What is the main scientific goal of the program?
The central goal is to advance applied, clinically grounded research that demonstrates measurable, biologically meaningful protein biomarkers in peripheral blood that track with brain structure or neurological function in people living in the chronic stages of traumatic brain injury (TBI).
What kinds of biomarkers are being sought?
The FOA emphasizes protein biomarkers measured in peripheral blood. The expectation is not only detection, but convincing evidence that specific blood-based proteins reflect long-term brain-related changes after injury.
Does the program focus on acute TBI or chronic TBI?
The focus is chronic brain injury (CBI) rather than acute injury, emphasizing the months-to-years time window after trauma when symptoms may linger or evolve.
What does the FOA mean by "clinically grounded" research?
Based on the description provided, the intent is for projects to be tied to real-world clinical relevance and human subjects data, and to go beyond general discussions by producing evidence that blood-based proteins correspond to objective brain-related measures.
What kind of evidence is expected to link blood biomarkers to the brain?
The announcement signals interest in biomarkers linked to objective measures of the brain, including structural or functional indicators supported by neuroanatomical or neuroimaging evidence, and correlated with neurological function.
Is biomarker detection alone sufficient for this opportunity?
No. The intended outcome is demonstration that protein biomarker signals are meaningfully related to brain structure or neurological function, not just detection in isolation.
What is the intended practical impact of successful projects?
The FOA describes an aim of helping establish biomarkers as potential surrogate markers that could stand in for more complex or expensive evaluations when monitoring long-term outcomes, supporting long-term tracking, prognosis, and potentially measuring response in rehabilitation or other interventions if the relationship is strong and reproducible.
What is the total estimated funding associated with this announcement?
The total estimated funding associated with the announcement is listed as $1,500,000.
What is the award ceiling for a single award?
The award ceiling is $750,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
How is this opportunity categorized?
It is categorized under Health, Income Security, and Social Services.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.865 (Child Health and Human Development Extramural Research).
When was this opportunity posted, and what were the closing dates?
The listing indicates it was posted/created on June 25, 2014. The original and current closing date is August 29, 2014, and the archive date is September 29, 2014.
Is this a current or historical funding opportunity?
The dates provided indicate this specific listing is historical.
Where can applicants find the full text of the announcement and detailed requirements?
The full FOA is linked at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-15-012.html
Who should be contacted for access or linking issues related to the announcement record?
The contact pathway listed is through the NIH Office of Extramural Research (OER) webmaster channels: FBOWebmaster@OD.NIH.GOV.
Does the opportunity explicitly require human subjects involvement?
Yes. The title and description emphasize human subjects and clinically relevant evidence in people living in the chronic stages of TBI.
What timeframe after injury is the FOA concerned with?
The FOA is concerned with the chronic stage, described as months-to-years after the initial traumatic event.
What patient changes are these biomarkers intended to help explain or corroborate?
The description highlights neurological, cognitive, and emotional status changes that may appear or persist years after brain trauma, and the desire for anatomical or functional evidence that aligns with those changes.
What distinguishes this opportunity from many other TBI diagnostic efforts?
Many diagnostic efforts focus on the hours and days after trauma (acute injury). This FOA is directed at chronic-stage TBI and seeks blood biomarkers tied to objective brain measures long after the initial event.
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