Opportunity Information: Apply for PAR 16 112
Apply for PAR 16 112
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Biomarkers Discovery In Parkinsonism (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
- This funding opportunity was created on Feb 24, 2016 and posted on Feb 24, 2016.
- Applicants must submit their applications by Sep 06, 2018. (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:
Biomarkers Discovery In Parkinsonism (U01) is a National Institutes of Health (NIH) funding opportunity from HHS/NIH (specifically within the NINDS portfolio) designed to support hypothesis-driven studies that discover human biomarkers relevant to Parkinson's disease (PD) and related Parkinsonian syndromes. It sits under the NINDS Parkinson's Disease Biomarkers Program (PDBP), meaning projects are expected to fit into a broader, coordinated effort to identify measurable biological indicators that can improve how these disorders are detected, classified, and understood in people.
The scientific focus is on biomarker discovery rather than general exploratory work, with an emphasis on clear hypotheses and study designs that can produce interpretable, clinically meaningful signals. The FOA highlights three main areas of interest. First, it encourages biomarker discovery in genetically causal Parkinson's disease, with particular attention to defined PD subtypes. This includes work in genetic cohorts, biologically defined cohorts within idiopathic PD, and studies centered on ethnic subgroups of idiopathic PD, reflecting an interest in biological and population heterogeneity and the possibility that different subgroups may require different biomarker strategies. Second, it prioritizes biomarkers that can help distinguish synucleinopathies (for example, PD and Multiple System Atrophy) from tauopathies (for example, Progressive Supranuclear Palsy and Corticobasal Degeneration), since these conditions can overlap clinically but differ in underlying pathology and may require different treatment approaches and trial enrollment strategies. Third, it supports efforts to improve diagnostic differentiation between idiopathic PD (and its subtypes) and other disorders that can mimic it, including essential tremor, which is a common real-world diagnostic challenge and a frequent source of misclassification in early disease.
A defining feature of this opportunity is the strong expectation of broad sharing of biospecimens and associated data. Because the FOA is embedded in the PDBP framework, applicants are expected to contribute to community resources and enable downstream validation, replication, and secondary analyses. In practical terms, this makes data management, standardization, and sharing plans central to competitiveness, not peripheral add-ons. The program is signaling that biomarker discovery is most valuable when results can be tested across sites and cohorts, and when samples and datasets can be used to accelerate progress beyond a single funded project.
From an administrative standpoint, this is a discretionary NIH cooperative agreement (U01), which typically means NIH program staff will have substantial involvement during the life of the award compared with a traditional investigator-initiated grant mechanism. Applicants should expect a more collaborative project structure, clearer deliverables, and ongoing coordination aligned with the PDBP goals. A required element for all proposed studies is a detailed timeline with milestones. These milestones are used not only during peer review to judge feasibility and rigor, but also after award to evaluate progress and to inform decisions about continued funding in non-competing years. In other words, the grant is structured around measurable outputs and adherence to an agreed-upon project plan.
Eligibility is broad and includes many types of domestic organizations: state, county, city, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses, with additional eligibility details referenced in the full announcement text. The funding opportunity number is PAR-16-112. It was posted on February 24, 2016, with an application closing date of September 6, 2018 (original and current closing dates listed the same). The activity category is Health, with CFDA number 93.853. Award ceiling and expected number of awards are not specified in the provided listing, so applicants would need to consult the full FOA or NIH guidance for budget and award expectations.
In sum, this FOA is aimed at rigorous, hypothesis-driven biomarker discovery work that can (1) parse biologically meaningful PD subtypes including genetically defined forms and underrepresented populations, (2) separate synucleinopathies from tauopathies, and (3) sharpen differential diagnosis between PD and related movement disorders such as essential tremor. The cooperative agreement structure, mandatory milestone-based timeline, and strong data and biospecimen sharing expectations are central requirements and are intended to make discoveries reproducible, comparable across cohorts, and useful for the broader Parkinson's research and clinical trial ecosystem.
Frequently Asked Questions (FAQs): Biomarkers Discovery In Parkinsonism (U01) - PAR-16-112
What is the Biomarkers Discovery In Parkinsonism (U01) funding opportunity?
Biomarkers Discovery In Parkinsonism (U01) is a National Institutes of Health (NIH) funding opportunity within the HHS/NIH portfolio, specifically aligned with the National Institute of Neurological Disorders and Stroke (NINDS). It supports hypothesis-driven studies to discover human biomarkers relevant to Parkinson's disease (PD) and related Parkinsonian syndromes.
Which NIH program does this opportunity fall under?
This opportunity sits under the NINDS Parkinson's Disease Biomarkers Program (PDBP). Projects are expected to align with the broader PDBP effort to identify measurable biological indicators that can improve how Parkinsonian disorders are detected, classified, and understood in people.
What is the primary scientific emphasis of this FOA?
The emphasis is on biomarker discovery (not general exploratory research) with clear, testable hypotheses and study designs capable of producing interpretable and clinically meaningful signals.
What are the main scientific areas of interest highlighted in the FOA?
The FOA highlights three main areas: (1) biomarker discovery in genetically causal Parkinson's disease with attention to defined PD subtypes and population heterogeneity, (2) biomarkers that distinguish synucleinopathies from tauopathies, and (3) improved diagnostic differentiation between idiopathic PD (and its subtypes) and disorders that mimic PD, including essential tremor.
Does the FOA support biomarker discovery in genetically causal Parkinson's disease?
Yes. The FOA encourages biomarker discovery in genetically causal PD, with particular attention to defined PD subtypes. It also notes interest in genetic cohorts, biologically defined cohorts within idiopathic PD, and studies focused on ethnic subgroups of idiopathic PD.
Why does the FOA emphasize PD subtypes and ethnic subgroups?
Based on the FOA description, the emphasis reflects interest in biological and population heterogeneity. Different subgroups may require different biomarker strategies, and clearer subgroup definition may improve detection, classification, and understanding of disease in people.
What does the FOA mean by distinguishing synucleinopathies from tauopathies?
The FOA prioritizes biomarkers that can help separate synucleinopathies (such as PD and Multiple System Atrophy) from tauopathies (such as Progressive Supranuclear Palsy and Corticobasal Degeneration). These conditions can overlap clinically but differ in underlying pathology, which can affect treatment approaches and clinical trial enrollment strategies.
Are Parkinson's disease and Multiple System Atrophy specifically mentioned as targets?
Yes. PD and Multiple System Atrophy are given as examples of synucleinopathies in the FOA summary.
Are Progressive Supranuclear Palsy and Corticobasal Degeneration specifically mentioned as targets?
Yes. Progressive Supranuclear Palsy and Corticobasal Degeneration are given as examples of tauopathies in the FOA summary.
Does this FOA address real-world diagnostic confusion with essential tremor?
Yes. The FOA explicitly supports efforts to improve diagnostic differentiation between idiopathic PD (and its subtypes) and other disorders that can mimic it, including essential tremor, which is described as a common diagnostic challenge and a frequent source of misclassification in early disease.
What kind of sharing is expected for biospecimens and data?
A defining feature is the strong expectation of broad sharing of biospecimens and associated data. Because projects are embedded in the PDBP framework, applicants are expected to contribute to community resources that enable downstream validation, replication, and secondary analyses.
How important are data management and sharing plans for competitiveness?
They are central. The FOA signals that data management, standardization, and sharing plans are not peripheral; they are a core part of what makes an application competitive and consistent with the PDBP approach.
Why does the program emphasize sharing and standardization?
The FOA description indicates biomarker discovery is most valuable when results can be tested across sites and cohorts, and when samples and datasets can be used beyond a single funded project to accelerate progress.
What is the award mechanism, and what does it imply?
The mechanism is a discretionary NIH cooperative agreement (U01). In general, a cooperative agreement implies substantial involvement by NIH program staff during the award compared with traditional investigator-initiated mechanisms, with more collaboration, clearer deliverables, and ongoing coordination aligned to PDBP goals.
Are milestones required in the application?
Yes. A required element is a detailed timeline with milestones. These milestones are used during peer review to judge feasibility and rigor, and after award to evaluate progress and inform decisions about continued funding in non-competing years.
How are milestones used after an award is made?
Milestones are used to evaluate progress and to inform decisions about continued funding in non-competing years. The FOA structure emphasizes measurable outputs and adherence to an agreed-upon project plan.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations, including: state, county, city, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The listing notes that additional eligibility details are referenced in the full announcement text.
Is this opportunity limited to academic institutions?
No. Based on the eligibility list provided, a wide range of organization types may apply, including government entities, nonprofits, for-profits (with specified exclusions), tribal organizations, housing authorities, and small businesses, in addition to higher education institutions.
What is the funding opportunity number?
The funding opportunity number is PAR-16-112.
When was this opportunity posted?
It was posted on February 24, 2016.
What is the application closing date listed for this opportunity?
The application closing date listed is September 6, 2018. The provided listing states that the original and current closing dates are the same.
What is the activity category and CFDA number?
The activity category is Health, and the CFDA number is 93.853.
Is the award ceiling specified in the provided information?
No. The provided listing does not specify an award ceiling.
Is the expected number of awards specified in the provided information?
No. The provided listing does not specify the expected number of awards.
Where should applicants look for budget and award expectation details?
The summary indicates applicants would need to consult the full FOA or NIH guidance for budget and award expectations, since those details are not specified in the provided listing.
What does it mean that this FOA is "hypothesis-driven"?
In the context of the provided description, "hypothesis-driven" means studies are expected to start from clear hypotheses and use study designs that can produce interpretable results, rather than broadly exploratory work without a specific, testable framework.
What outcomes is the FOA trying to enable in the Parkinson's research ecosystem?
Based on the summary, the FOA aims to produce biomarker discoveries that are reproducible and comparable across cohorts, and that are useful for improving detection and classification, supporting downstream validation and replication, and strengthening clinical trial strategies (including enrollment decisions) for Parkinsonian disorders.
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