Opportunity Information: Apply for RFA NS 16 022
Apply for RFA NS 16 022
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Biomarkers for the Lewy Body Dementias (U01)" 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 22, 2016 and posted on Feb 22, 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.)
- 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:
This funding opportunity, titled "Biomarkers for the Lewy Body Dementias (U01)" (RFA-NS-16-022), is a National Institutes of Health initiative administered through HHS/NIH (listed as HHS-NIH11) using a cooperative agreement mechanism (U01). The central aim is to accelerate biomarker development for Lewy Body Dementias (LBD), specifically Dementia with Lewy Bodies (DLB) and Parkinsons Disease with Dementia (PDD), while also strengthening a major existing research infrastructure: the NINDS Parkinsons Disease Biomarkers Program (PDBP). In practical terms, the FOA is structured to both broaden a shared national resource and fund targeted, hypothesis-driven clinical studies that can produce actionable biomarkers for near-term clinical trial use.
A major component of the opportunity is the expansion of the PDBP community resource beyond Parkinsons disease to explicitly include patients with Lewy Body Dementias. That expansion is not just about enrolling more participants; it is about systematically collecting and integrating clinical data and biological specimens in a standardized way so they can be used broadly by the research community. The intent is to make LBD data and biospecimens available within the same kind of coordinated framework that has supported Parkinsons biomarker work, which can improve consistency across sites, enable larger pooled analyses, and reduce duplicated effort across labs. The FOA also emphasizes dissemination, meaning the funded work is expected to add to a resource center function: organizing information and facilitating access so outside investigators can use the resulting datasets and samples to advance the field.
Alongside the resource-building goal, the FOA prioritizes hypothesis-driven clinical research designed to discover and validate biomarkers that meaningfully improve Phase II clinical trials in Lewy Body Dementias. The focus on Phase II is important because this is the stage where trials often need sensitive, reliable indicators to detect target engagement, disease progression, or treatment response without requiring extremely large sample sizes or long follow-up. Biomarkers that can stratify participants, predict progression, confirm diagnosis, or provide objective outcome measures can make trials more efficient, reduce cost, and increase the odds of detecting true therapeutic effects. The announcement explicitly invites projects aimed at generating biomarkers that improve both trial efficiency and trial outcomes, which signals an emphasis on practical translational utility rather than purely exploratory discovery.
Applicants are allowed to propose work that addresses either of the two major goals, or both together, as long as the combination is scientifically justified. That flexibility supports a range of projects, from efforts primarily oriented toward expanding the PDBP LBD cohort and specimen pipeline, to studies centered on a specific biomarker hypothesis, to integrated proposals that both build the shared resource and test biomarker candidates using the newly expanded participant base and specimen collection.
The opportunity falls under the NIH health research activity category and lists CFDA numbers 93.853 and 93.866. Eligibility is broad and includes many common U.S. research and public-sector entities: state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding higher education institutions in those nonprofit categories as specified); for-profit organizations other than small businesses; and small businesses. The announcement also notes an "Others" category with additional eligibility details referenced in the full text, indicating NIH intended inclusivity for qualified organizations that fit special circumstances.
Key administrative details reflect that this was a time-bound solicitation with a single closing date. The FOA was created and posted on February 22, 2016, and the application closing date was May 10, 2016 (both original and current closing dates match). The award ceiling and expected number of awards are not specified in the provided data snippet, which is common in some listings where final budget and award counts depend on appropriations, application volume, and programmatic priorities.
Overall, the grant opportunity is best understood as a coordinated effort to strengthen the national infrastructure for Lewy Body Dementia biomarker research while simultaneously funding focused clinical studies that can yield biomarkers ready to support mid-stage therapeutic trials. It is designed to produce both immediate scientific outputs (validated or promising biomarker candidates) and longer-lasting community value (expanded, accessible datasets and biospecimens integrated into the established NINDS PDBP platform).
Frequently Asked Questions (FAQs): Biomarkers for the Lewy Body Dementias (U01) - RFA-NS-16-022
What is the title and identifier of this funding opportunity?
The funding opportunity is titled "Biomarkers for the Lewy Body Dementias (U01)" and is identified as RFA-NS-16-022.
Which agencies administer this opportunity?
This is a National Institutes of Health (NIH) initiative administered through HHS/NIH (listed as HHS-NIH11).
What is the funding mechanism (grant type) for this opportunity?
The mechanism is a cooperative agreement (U01), which indicates the project is supported through an NIH cooperative agreement rather than a standard research grant mechanism.
What is the central purpose of the FOA?
The central aim is to accelerate biomarker development for Lewy Body Dementias (LBD), specifically Dementia with Lewy Bodies (DLB) and Parkinsons Disease with Dementia (PDD), while also strengthening an existing national research infrastructure: the NINDS Parkinsons Disease Biomarkers Program (PDBP).
Which diseases and patient populations are specifically in scope?
The FOA specifically targets biomarker work relevant to Lewy Body Dementias, including DLB and PDD, and it emphasizes expanding an existing Parkinsons-focused resource to explicitly include patients with LBD.
What are the two main goals of this opportunity?
The FOA is structured around two major goals:
- Expanding the PDBP community resource to include Lewy Body Dementias (not just Parkinsons disease), including standardized collection and integration of clinical data and biospecimens.
- Funding hypothesis-driven clinical research to discover and validate biomarkers that can meaningfully improve Phase II clinical trials in Lewy Body Dementias.
What does it mean to expand the NINDS PDBP resource to include Lewy Body Dementias?
It means explicitly incorporating LBD participants into the PDBP framework and systematically collecting and integrating clinical data and biological specimens in a standardized way so the resulting LBD datasets and biospecimens can be used broadly by the research community.
Is the expansion only about enrolling more participants?
No. The FOA emphasizes that expansion is not simply increasing enrollment. It also includes standardized data and specimen collection, integration of those materials into a coordinated framework, and dissemination to support broad community use.
What kinds of shared resources are expected to result from the PDBP expansion component?
The FOA anticipates that funded work will contribute to a shared national resource by adding LBD clinical data and biospecimens into the established PDBP platform, improving consistency across sites and enabling pooled analyses.
What is meant by "dissemination" in this FOA?
Dissemination refers to expectations that the funded work will support a resource-center-like function by organizing information and facilitating access so that outside investigators can use the resulting datasets and samples to advance biomarker research in LBD.
What type of research is prioritized for biomarker development?
The FOA prioritizes hypothesis-driven clinical research designed to discover and validate biomarkers with practical value for near-term clinical trial use, especially to improve Phase II Lewy Body Dementia trials.
Why does the FOA emphasize Phase II clinical trials?
The FOA highlights Phase II because trials at this stage often need sensitive, reliable indicators of target engagement, disease progression, or treatment response to avoid requiring very large sample sizes or long follow-up. Biomarkers can improve trial efficiency and the ability to detect therapeutic effects.
What trial-related uses of biomarkers does the FOA emphasize?
The FOA points to biomarkers that can help:
- Stratify participants
- Predict progression
- Confirm diagnosis
- Provide objective outcome measures
- Support target engagement, disease progression, or treatment response assessments
Does the FOA support purely exploratory biomarker discovery?
Based on the description provided, the emphasis is on practical translational utility and biomarkers that are actionable for near-term clinical trials, rather than purely exploratory discovery without clear trial relevance.
Can an applicant propose a project focused only on the resource expansion, only on hypothesis-driven biomarker studies, or both?
Yes. Applicants may propose work addressing either of the two major goals or both, as long as the combination is scientifically justified.
What kinds of project structures does this flexibility allow?
The FOA supports a range of projects, including:
- Projects primarily focused on expanding the PDBP LBD cohort and improving the biospecimen pipeline.
- Projects centered on a specific biomarker hypothesis in clinical research.
- Integrated proposals that build the shared resource while also testing biomarker candidates using the expanded participant base and specimen collection.
What is the broader expected impact of this FOA?
The opportunity is designed to produce both:
- Immediate scientific outputs (validated or promising biomarker candidates suitable for mid-stage trials), and
- Long-lasting community value (expanded, accessible LBD datasets and biospecimens integrated into the established PDBP platform).
Who is eligible to apply?
Eligibility is broad and includes many U.S. research, public-sector, and private entities, including:
- State governments
- County governments
- City or township governments
- Special district governments
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Independent school districts
- Federally recognized Native American tribal governments
- Other Native American tribal organizations
- Public housing authorities / Indian housing authorities
- Nonprofits with 501(c)(3) status (as specified, excluding higher education institutions in those nonprofit categories)
- Nonprofits without 501(c)(3) status (as specified, excluding higher education institutions in those nonprofit categories)
- For-profit organizations other than small businesses
- Small businesses
What does the FOA mean by an "Others" eligibility category?
The announcement references an "Others" category with additional eligibility details in the full text, suggesting NIH intended inclusivity for qualified organizations that may fit special circumstances described outside the provided snippet.
What is the activity category and CFDA listing for this opportunity?
The opportunity falls under the NIH health research activity category and lists CFDA numbers 93.853 and 93.866.
When was this FOA posted, and what was the application due date?
The FOA was created and posted on February 22, 2016. The application closing date was May 10, 2016 (the original and current closing dates are the same in the provided information).
Was this a time-bound solicitation or an open/rolling opportunity?
Based on the provided details, this was a time-bound solicitation with a single closing date.
Is the award ceiling listed?
No. The award ceiling is not specified in the provided information.
Is the expected number of awards listed?
No. The expected number of awards is not specified in the provided information.
Why might award amounts or number of awards be missing from the listing?
The description notes that this can be common in some listings where final budget levels and award counts depend on factors like appropriations, application volume, and programmatic priorities.
How does this FOA aim to reduce duplicated effort across research groups?
By supporting standardized collection and integration of LBD clinical data and biospecimens within a coordinated national framework (PDBP), the FOA is intended to improve consistency across sites, enable larger pooled analyses, and reduce the need for separate groups to recreate similar datasets and specimen collections.
What is the practical, near-term focus of the biomarker work described?
The FOA emphasizes biomarkers that are usable in the near term to strengthen Phase II LBD clinical trials by improving efficiency and increasing the chance of detecting real therapeutic effects with feasible sample sizes and timelines.
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