Opportunity Information: Apply for RFA NS 16 020
Apply for RFA NS 16 020
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Development Projects (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866,.
- This funding opportunity was created on Feb 26, 2016 and posted on Feb 26, 2016.
- Applicants must submit their applications by May 10, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $750,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The grant opportunity "Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Development Projects (UH2/UH3)" (RFA-NS-16-020) is a cooperative agreement from the NIH (HHS-NIH11) focused on accelerating the development of biomarkers tied specifically to small vessel cerebrovascular disease as it relates to vascular contributions to cognitive impairment and dementia (VCID), including cases where vascular disease overlaps with Alzheimers pathology (vascular/Alzheimers mixed dementias). The central aim is to move promising biomarker candidates beyond early exploration and into a stage where they are mature enough to justify large-scale, multi-site clinical validation studies and, ultimately, support steps toward FDA biomarker qualification for use in phase II and phase III clinical trials (with those later validation efforts expected to be pursued under separate future funding).
Projects supported under this FOA are intended to evaluate and further develop several categories of biomarker candidates: predictive biomarkers (to help anticipate who is at risk or who may develop disease), diagnostic biomarkers (to help identify or classify disease), target engagement biomarkers (to show whether a treatment is affecting the intended biological target or mechanism), and progression biomarkers (to track disease course and clinical change over time). The emphasis is on biomarkers relevant to small vessel disease mechanisms in humans and on generating evidence that these measures are robust, informative, and suitable for clinical research settings where consistent performance and interpretability are essential.
A defining feature of the program is its phased UH2/UH3 structure, which is designed to balance innovation with disciplined milestone-driven development. During the UH2 phase (years 1-2), awardees pursue their biomarker work as individual projects while also helping establish an interactive consortium. This early phase is meant to set the groundwork for shared standards and collaboration, so that by the time the program transitions to the UH3 phase (years 3-5), the group can operate as a coordinated network. In the UH3 phase, the consortium conducts collaborative, cross-project, multidisciplinary studies aimed at rigorously evaluating and advancing the most promising biomarker candidates. In other words, the program is not just funding isolated studies; it is also building a coordinated pipeline where strong candidates can be compared, refined, and positioned for broad validation and eventual regulatory-relevant use.
The FOA also explicitly ties the biomarker development effort to a dedicated Coordinating Center funded under a companion opportunity (RFA-NS-16-019). That Coordinating Center support signals that the program expects active coordination across projects, likely involving shared approaches to study design, data elements, quality control, and consortium-wide decision-making about which candidates merit deeper development. Because this is a cooperative agreement mechanism, NIH involvement is typically more hands-on than in a standard grant, with substantial programmatic collaboration and shared responsibilities between investigators and the NIH to meet consortium goals.
In terms of who can apply, eligibility is broad and includes many types of domestic organizations: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other eligible tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; and small businesses, along with other applicants as clarified in the FOA text. The activity category is health-related research, with CFDA numbers 93.853 and 93.866 listed. The opportunity was posted and created on February 26, 2016, with an application closing date of May 10, 2016, and it lists an award ceiling of $750,000.
Overall, the opportunity is best understood as a structured, consortium-based biomarker advancement program for small vessel VCID. It is aimed at producing biomarkers that are not merely interesting signals but are credible clinical-research tools, supported by coordinated evidence development, and positioned for later multi-site validation and potential FDA qualification for use in mid-to-late stage clinical trials.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Small Vessel Vascular Contributions to Cognitive Impairment and Dementia (VCID) Biomarkers Development Projects (UH2/UH3)" and is identified as RFA-NS-16-020.
Which agency is offering this funding?
This is an NIH (National Institutes of Health) funding opportunity under HHS-NIH11.
What is the main purpose of RFA-NS-16-020?
The central purpose is to accelerate development of biomarkers specifically tied to small vessel cerebrovascular disease mechanisms in humans as they relate to vascular contributions to cognitive impairment and dementia (VCID), including situations where vascular disease overlaps with Alzheimer's pathology (vascular/Alzheimer's mixed dementias).
What stage of biomarker development is this program trying to support?
The program is intended to move promising biomarker candidates beyond early exploration into a more mature stage where they are strong enough to justify future large-scale, multi-site clinical validation studies. Those later validation efforts are expected to be supported under separate future funding.
Is the goal to complete multi-site clinical validation within this FOA?
No. This FOA focuses on advancing biomarkers to the point where large-scale, multi-site clinical validation studies are justified. Those large validation studies are expected to be pursued under separate future funding opportunities.
Does this program connect biomarker development to FDA biomarker qualification?
Yes. A stated long-term direction is to support steps toward FDA biomarker qualification so that biomarkers could ultimately be used in phase II and phase III clinical trials. The FOA emphasizes getting candidates ready for that later regulatory-relevant pathway.
What types (categories) of biomarkers does this FOA support?
The FOA supports development and evaluation of multiple biomarker categories, including predictive biomarkers, diagnostic biomarkers, target engagement biomarkers, and progression biomarkers.
What are predictive biomarkers in the context of this FOA?
Predictive biomarkers are intended to help anticipate who is at risk or who may develop disease.
What are diagnostic biomarkers in the context of this FOA?
Diagnostic biomarkers are intended to help identify or classify disease.
What are target engagement biomarkers in the context of this FOA?
Target engagement biomarkers are intended to show whether a treatment is affecting the intended biological target or mechanism.
What are progression biomarkers in the context of this FOA?
Progression biomarkers are intended to track disease course and clinical change over time.
Is the FOA focused on small vessel disease in humans specifically?
Yes. The emphasis is on biomarkers relevant to small vessel disease mechanisms in humans and on generating evidence that these measures are robust, informative, and suitable for clinical research settings.
What does "robust and suitable for clinical research settings" mean in this FOA?
Based on the FOA description, it means producing evidence that candidate biomarkers perform consistently, are interpretable, and can function as credible clinical-research tools (not just interesting experimental signals).
What funding mechanism is used for this opportunity?
This opportunity uses a cooperative agreement mechanism with a phased UH2/UH3 structure.
What is the UH2/UH3 phased structure and why is it used?
The phased UH2/UH3 structure is designed to balance innovation with milestone-driven development. It starts with an earlier UH2 phase to develop projects and establish consortium interactions, and then transitions to the UH3 phase for coordinated, collaborative studies across the consortium.
How long is the UH2 phase?
The UH2 phase is years 1 to 2.
What happens during the UH2 phase?
During UH2 (years 1 to 2), awardees pursue their biomarker work as individual projects while also helping establish an interactive consortium and laying groundwork for shared standards and collaboration.
How long is the UH3 phase?
The UH3 phase is years 3 to 5.
What happens during the UH3 phase?
During UH3 (years 3 to 5), the consortium operates as a coordinated network conducting collaborative, cross-project, multidisciplinary studies to rigorously evaluate and advance the most promising biomarker candidates.
Is this FOA intended to fund isolated projects, or a networked program?
It is intended to fund both: individual biomarker projects in the early phase and a coordinated, consortium-based pipeline in the later phase where candidates can be compared, refined, and positioned for broad validation and eventual regulatory-relevant use.
Is there a Coordinating Center associated with this program?
Yes. The FOA explicitly ties biomarker development to a dedicated Coordinating Center funded under a companion opportunity, RFA-NS-16-019.
What does the existence of a companion Coordinating Center imply for applicants?
It signals that active coordination across projects is expected, likely involving shared approaches to study design, common data elements, quality control, and consortium-wide decision-making about which biomarker candidates should receive deeper development.
How does a cooperative agreement differ from a standard research grant in this context?
As described, NIH involvement is typically more hands-on than in a standard grant, with substantial programmatic collaboration and shared responsibilities between investigators and NIH to meet consortium goals.
What research area or activity category does this opportunity fall under?
The activity category is health-related research.
What CFDA numbers are associated with this opportunity?
The opportunity lists CFDA numbers 93.853 and 93.866.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations, including state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other eligible tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; and small businesses, along with other applicants as clarified in the FOA text.
Are for-profit organizations allowed to apply?
Yes. The eligibility list includes for-profit organizations other than small businesses, and it also separately includes small businesses.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status are listed as eligible (excluding higher education institutions within those nonprofit categories as stated in the provided description).
Are universities and colleges eligible to apply?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are included in the eligibility list.
Are government entities eligible to apply?
Yes. State, county, and local governments, special district governments, and independent school districts are included as eligible applicants.
Are tribal governments or tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other eligible tribal organizations are listed as eligible.
What is the award ceiling listed for this opportunity?
The opportunity lists an award ceiling of $750,000.
When was this opportunity posted?
It was posted and created on February 26, 2016.
What was the application closing date listed?
The application closing date listed is May 10, 2016.
What kinds of dementia-related conditions does this FOA mention?
It mentions vascular contributions to cognitive impairment and dementia (VCID) and specifically includes cases where vascular disease overlaps with Alzheimer's pathology (vascular/Alzheimer's mixed dementias).
What is the overall "big picture" goal of this program?
Overall, it is a structured, consortium-based biomarker advancement program aimed at producing biomarkers that are credible clinical-research tools, supported by coordinated evidence development, and positioned for later multi-site validation and potential FDA qualification for use in mid-to-late stage clinical trials.
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