Opportunity Information: Apply for RFA NS 11 005
Apply for RFA NS 11 005
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical and Data Coordinating Center(s) for Parkinsons Disease Biomarkers Identification Network (PD BIN) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Sep 24, 2010 and posted on Sep 24, 2010.
- Applicants must submit their applications by Jan 18, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public housing authorities/Indian housing authorities State governments Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Private institutions of higher education Independent school districts Native American tribal governments (Federally recognized).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
This NIH opportunity (RFA-NS-11-005) from the National Institute of Neurological Disorders and Stroke (NINDS) supports the creation of a coordinated national research infrastructure called the Parkinsons Disease Biomarker Identification Network (PD BIN). The central goal is to speed the discovery and validation of biological markers that can indicate Parkinsons disease (PD) risk, predict or confirm onset, and track progression over time. By building a reliable, standardized resource of clinical information and biospecimens, the program is meant to remove major bottlenecks in the development of disease-modifying therapies, where objective biomarkers are critical for selecting participants, measuring target engagement, and detecting treatment effects earlier and more accurately than clinical symptoms alone.
The funding mechanism is a cooperative agreement (U01), meaning awardees will work closely with NINDS in a substantial partnership rather than operating as fully independent investigator-initiated projects. The FOA specifically solicits two linked, coordinated applications: one for a Clinical Coordinating Center (CCC) and one for a Data Coordinating Center (DCC). The principal investigators for the CCC and DCC are required to coordinate their submissions, reflecting the expectation that these two centers function as an integrated system. The emphasis is on building and running a multi-site network and establishing common procedures, not on pursuing stand-alone, hypothesis-driven research studies. In fact, individual hypothesis-driven studies are explicitly not a component of this announcement; the focus is the shared platform that future studies can use.
The Clinical Coordinating Center is envisioned as the operational hub for participant-facing work and biospecimen collection across multiple clinical sites. The CCC is responsible for identifying and managing those participating clinical sites, overseeing recruitment and enrollment, and ensuring consistent execution of study procedures. A key deliverable is enrollment of a core cohort consisting of newly diagnosed PD patients and matched control participants. The CCC must ensure high-quality, accurate collection of clinical data and biological specimens, using standardized approaches so that samples and data are comparable across sites and over time. In practice, this implies strong capabilities in protocol implementation, staff training and certification, participant recruitment and retention, regulatory compliance, specimen handling and shipping logistics, and ongoing monitoring to keep data and specimen quality high across the network.
The Data Coordinating Center provides the informatics and data stewardship backbone for PD BIN. The DCC is expected to manage standardized data acquisition and harmonization, implement rigorous quality control procedures, and support secure storage, analysis-ready curation, and long-term preservation of the datasets. A major requirement is dissemination and public accessibility: the network is expected to produce a broadly usable community resource, so the DCC must enable sharing in ways that protect participants while still maximizing scientific utility. That includes developing data dictionaries and common data elements, establishing workflows for data submission and validation from all sites, maintaining documentation and metadata so external users can interpret the resource correctly, and supporting mechanisms for data release and access consistent with NIH expectations for transparency and reuse.
A defining feature of the program is that both the CCC and DCC must be flexible enough to support future add-on projects that build on the core PD BIN cohort and dataset. Those later studies may seek to use the existing data and biospecimens, add new measures, or expand the cohort in targeted ways. The coordinating centers are therefore expected to design governance, operations, and technical systems that can accommodate new protocols, new assay types, evolving biomarker technologies, and additional clinical sites as the network grows. This forward-looking design is central to the FOA: the infrastructure should not be optimized only for a single fixed study, but for a sustained, extensible biomarker pipeline.
Another major expectation is that the biospecimens and data generated through PD BIN will be made into a publicly available resource for biomarker validation and discovery. That means the outputs are not only internal deliverables to NINDS, but community-facing assets intended to accelerate progress across academia, industry, and other stakeholders. The CCC and DCC are jointly expected to advance the overarching scientific objective of identifying and validating PD biomarkers by ensuring the resource is credible, standardized, well-documented, and broadly usable for replication, comparison across studies, and downstream qualification efforts.
In terms of administrative details, this is a discretionary funding opportunity using the U01 cooperative agreement mechanism, in the health category, under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). It does not require cost sharing or matching. The announcement was posted September 24, 2010, with an original and current closing date of January 18, 2011, and an archive date of February 18, 2011. Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses and other than small businesses), state, county, city or township governments, special district governments, public housing authorities, independent school districts, tribal governments and tribal organizations, U.S. territories or possessions, faith-based or community-based organizations, and certain designated institution types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities. The FOA also indicates eligibility can extend to non-U.S. (foreign) entities and regional organizations, as described in the eligibility clarification.
Overall, the opportunity is best understood as an NIH-funded build-out of a national PD biomarker infrastructure: the CCC runs the clinical network and specimen pipeline, the DCC builds the data platform and public access pathway, and together they create a standardized, expandable, multi-site resource centered on newly diagnosed PD patients and matched controls. The intended payoff is a high-quality, publicly accessible dataset and biospecimen collection that the broader research community can use to discover, replicate, and validate biomarkers that ultimately support disease-modifying therapeutic development.
Frequently Asked Questions (FAQs) - NIH RFA-NS-11-005 (Parkinsons Disease Biomarker Identification Network)
What is this funding opportunity (RFA-NS-11-005) about?
This NIH opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) supports building a coordinated national research infrastructure called the Parkinsons Disease Biomarker Identification Network (PD BIN). The program is designed to speed the discovery and validation of biological markers (biomarkers) that can indicate Parkinsons disease (PD) risk, predict or confirm onset, and track disease progression over time.
What is the main goal of PD BIN?
The central goal is to remove major bottlenecks in developing disease-modifying therapies for Parkinsons disease by creating a reliable, standardized resource of clinical information and biospecimens. The resource is intended to enable objective biomarkers that can help select participants for studies, measure target engagement, and detect treatment effects earlier and more accurately than clinical symptoms alone.
What funding mechanism is used, and what does it mean for awardees?
The opportunity uses a cooperative agreement (U01). This means awardees are expected to work closely with NINDS in a substantial partnership, rather than operating as fully independent, investigator-initiated projects.
What applications does the FOA solicit?
The FOA specifically solicits two linked and coordinated applications: one for a Clinical Coordinating Center (CCC) and one for a Data Coordinating Center (DCC). These are expected to function together as an integrated system supporting a multi-site network.
Do the CCC and DCC applications have to be coordinated?
Yes. The principal investigators for the CCC and DCC are required to coordinate their submissions, reflecting the expectation that the two centers will operate as a coordinated national infrastructure.
Is this opportunity intended to fund individual hypothesis-driven research projects?
No. Individual hypothesis-driven studies are explicitly not a component of this announcement. The emphasis is on building and running a shared, standardized platform (the network infrastructure, datasets, and biospecimen resource) that future studies can use.
What is the Clinical Coordinating Center (CCC) expected to do?
The CCC is envisioned as the operational hub for participant-facing work and biospecimen collection across multiple clinical sites. Key responsibilities include identifying and managing participating clinical sites, overseeing recruitment and enrollment, ensuring consistent execution of study procedures, and delivering enrollment of a core cohort made up of newly diagnosed PD patients and matched control participants.
What are the CCC deliverables related to participants and specimens?
A key deliverable is enrollment of a core cohort consisting of newly diagnosed Parkinsons disease patients and matched controls. The CCC must ensure high-quality, accurate collection of clinical data and biological specimens using standardized approaches so samples and data are comparable across sites and over time.
What operational capabilities are implied for the CCC?
Based on the FOA description, the CCC should be capable of protocol implementation across sites, staff training and certification, participant recruitment and retention, regulatory compliance, specimen handling and shipping logistics, and ongoing monitoring to maintain high data and specimen quality across the network.
What is the Data Coordinating Center (DCC) expected to do?
The DCC provides the informatics and data stewardship backbone for PD BIN. It is expected to manage standardized data acquisition and harmonization, implement rigorous quality control, support secure storage, curate analysis-ready datasets, and preserve data long-term.
What are the DCC responsibilities for data sharing and public access?
A major requirement is dissemination and public accessibility. The DCC must enable sharing that protects participants while maximizing scientific utility. This includes developing data dictionaries and common data elements, creating workflows for data submission and validation from all sites, maintaining documentation and metadata so external users can interpret the resource, and supporting mechanisms for data release and access consistent with NIH expectations for transparency and reuse.
Will the PD BIN resource be publicly available?
Yes. A defining expectation is that biospecimens and data generated through PD BIN will be made into a publicly available community resource for biomarker validation and discovery, intended to accelerate progress across academia, industry, and other stakeholders.
Why does the FOA emphasize standardization across sites?
The purpose of standardization is to ensure clinical information and biospecimens are comparable across multiple clinical sites and over time. This comparability supports replication, comparison across studies, and downstream biomarker validation efforts.
How is PD BIN expected to support future studies beyond the core cohort?
Both the CCC and DCC must be designed to support future add-on projects that build on the core cohort and dataset. These later studies may use existing data and biospecimens, add new measures, or expand the cohort. The infrastructure is expected to accommodate new protocols, new assay types, evolving biomarker technologies, and additional clinical sites as the network grows.
Is the infrastructure expected to be fixed to one study design?
No. The FOA emphasizes forward-looking design. The infrastructure should not be optimized only for a single fixed study, but instead be sustained and extensible to support an evolving biomarker pipeline.
What is the relationship between the CCC and DCC in this program?
The CCC and DCC are intended to work jointly to advance PD BINs overarching objective. In practical terms, the CCC runs the clinical network and specimen pipeline, while the DCC builds and maintains the data platform and public access pathway. Together they produce a credible, standardized, well-documented resource.
Does this opportunity require cost sharing or matching?
No. The opportunity does not require cost sharing or matching.
What is the CFDA number and category for this opportunity?
The opportunity is listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders) and is in the health category.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses and other than small businesses), and multiple levels of government entities (state, county, city or township), as well as special district governments, public housing authorities, independent school districts, tribal governments and tribal organizations, U.S. territories or possessions, and faith-based or community-based organizations. The FOA also highlights eligibility for certain designated institution types such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The FOA indicates eligibility can extend to non-U.S. (foreign) entities and regional organizations, as described in the eligibility clarification.
What are the key dates listed in the announcement?
The announcement was posted on September 24, 2010. The original and current closing date is January 18, 2011. The archive date is February 18, 2011.
What is the practical takeaway of this opportunity in plain terms?
This is an NIH-funded build-out of a national Parkinsons disease biomarker infrastructure. The CCC manages the multi-site clinical operations and biospecimen collection for newly diagnosed PD patients and matched controls, while the DCC manages the standardized data platform and public data access. The combined output is intended to be a high-quality, publicly accessible dataset and biospecimen collection that the broader research community can use to discover, replicate, and validate biomarkers supporting disease-modifying therapeutic development.
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