Opportunity Information: Apply for PA 07 052
Apply for PA 07 052
- The National Institutes of Health in the employment, labor and training food and nutrition health sector is offering a public funding opportunity titled "Development of Disease Biomarkers (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273 Alcohol Research Programs 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on May 28, 2009 and posted on Nov 21, 2006.
- Applicants must submit their applications by Sep 7, 2009 Multiple Receipt Dates See Link to Full Announcement for details.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments Independent school districts State governments County governments City or township governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses.
- Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply.
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Opportunity Summary:
The Development of Disease Biomarkers (R01) opportunity (Funding Opportunity Number PA-07-052) is a National Institutes of Health (NIH) discretionary grant program designed to move promising disease biomarkers from the candidate stage into validated, clinically meaningful tools. The central goal is to support research that confirms whether proposed biomarkers truly track disease processes in clearly defined human patient populations. The program emphasizes conditions in the liver, kidney, urological tract, digestive and hematologic systems, as well as endocrine and metabolic disorders, including diabetes (and its complications) and obesity. A key motivation behind the announcement is that many of these diseases still have no reliable biomarkers, or the biomarkers that exist require procedures that are too invasive, too expensive, or otherwise impractical for routine use. By strengthening the evidence base for biomarkers, the program aims to make it easier to diagnose disease, monitor progression, and evaluate how well therapies are working.
A major theme in the announcement is the practical value of biomarkers as substitutes for "hard" clinical endpoints. Hard endpoints are outcomes like organ failure, hospitalization, major complications, or mortality that are definitive but often take a long time to occur and can require large, expensive studies to measure. A validated biomarker can sometimes function as a surrogate or intermediate outcome that changes earlier and more conveniently, helping researchers and clinicians assess therapeutic effects faster, more safely, and at lower cost. This FOA is therefore positioned as a bridge between discovery research and real-world application, supporting the kind of rigorous validation work needed before biomarkers can be relied upon in clinical trials or clinical care.
Projects considered responsive generally fall into three related categories. First are studies that validate candidate biomarkers in well characterized groups of patients, meaning the disease definitions, inclusion criteria, and clinical phenotypes are clearly specified so that biomarker performance can be judged in a meaningful context. Second are efforts to develop or refine technologies that can measure biomarkers more effectively, particularly approaches that enable easier monitoring over time or reduce the need for invasive sampling. Third are projects focused on establishing robust, reliable assays for biomarkers that have enough prior evidence to justify formal validation, including work that improves accuracy, reproducibility, sensitivity, specificity, and standardization across settings. Overall, the emphasis is on moving beyond early hints of association and producing convincing evidence that a biomarker is dependable and useful.
The funding mechanism is the NIH Research Project Grant (R01), which is typically used for mature, hypothesis-driven projects with a well developed research plan and sufficient preliminary justification. The announcement notes that it runs in parallel with a companion funding opportunity of identical scientific scope that uses the R21 mechanism (PA-06-146), which is commonly geared toward earlier-stage or exploratory work. In practical terms, this R01 version is meant for applicants prepared to conduct a more substantial validation program rather than a smaller proof-of-concept effort.
The NIH does not specify a fixed budget or a set number of awards for this announcement. Instead, award size, duration, and total program funding are expected to vary depending on what applicants propose and how applications score in terms of scientific quality, feasibility, project period, and cost. This structure signals that the agency anticipates a wide range of study designs and resource needs, from targeted validation cohorts to multi-site efforts or projects requiring specialized assay development and performance testing.
Eligibility is broad and includes many organization types across academia, government, nonprofit, and industry. Eligible applicants include public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status, outside of universities), for-profit organizations (including small businesses and other for-profits), and various levels of government such as state, county, and city or township governments. Independent school districts and special district governments are also listed. Tribal governments (federally recognized) and other tribal organizations are eligible, as are public housing authorities and Indian housing authorities. The announcement explicitly states that foreign institutions may apply, eligible federal agencies may apply, and faith-based or community-based organizations may apply as well, which underscores the intention to attract a diverse pool of capable research performers.
Key administrative details include the original posting date of November 21, 2006, with multiple receipt dates rather than a single deadline, and a current closing date listed as September 7, 2009, with an archive date of October 8, 2009. The Catalog of Federal Domestic Assistance (CFDA) numbers associated with the opportunity include 93.273 (Alcohol Research Programs), 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health), and 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), reflecting the NIH program areas involved. There is no cost-sharing or matching requirement stated for applicants.
Applicants are directed to the full announcement for complete requirements and submission details at http://grants.nih.gov/grants/guide/pa-files/PA-07-052.html. For access or linking issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
FAQs: Development of Disease Biomarkers (R01) - NIH (PA-07-052)
What is the Development of Disease Biomarkers (R01) funding opportunity?
It is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number PA-07-052) that supports research to move promising disease biomarkers from the candidate stage into validated, clinically meaningful tools.
What is the main goal of this program?
The central goal is to support research that confirms whether proposed biomarkers truly track disease processes in clearly defined human patient populations, producing evidence strong enough for biomarkers to be relied upon in research and clinical settings.
Which diseases or clinical areas are emphasized?
The opportunity emphasizes diseases and conditions involving the liver, kidney, urological tract, digestive system, hematologic systems, and endocrine and metabolic disorders, including diabetes (and its complications) and obesity.
Why is NIH emphasizing biomarker validation in this announcement?
The announcement notes that many diseases in these areas still lack reliable biomarkers, or existing biomarkers require procedures that are too invasive, too expensive, or otherwise impractical for routine use. The program aims to strengthen the evidence base so biomarkers can better support diagnosis, monitoring, and therapy evaluation.
What does the FOA mean by "hard" clinical endpoints?
Hard clinical endpoints are definitive outcomes such as organ failure, hospitalization, major complications, or mortality. They are meaningful but can take a long time to occur and often require large, expensive studies to measure.
How can a validated biomarker help compared to hard clinical endpoints?
A validated biomarker can sometimes serve as a surrogate or intermediate outcome that changes earlier and more conveniently than hard endpoints, helping assess therapeutic effects faster, more safely, and at lower cost.
What kinds of projects are considered responsive to this opportunity?
Responsive projects generally fall into three related categories: (1) validating candidate biomarkers in well-characterized patient groups with clearly specified disease definitions and phenotypes; (2) developing or refining technologies that measure biomarkers more effectively, including easier monitoring over time or less invasive sampling; and (3) establishing robust assays for biomarkers with enough prior evidence to justify formal validation, improving accuracy, reproducibility, sensitivity, specificity, and standardization.
Does this funding support early discovery of new biomarkers?
Based on the description provided, the emphasis is on moving beyond early hints of association and producing convincing evidence that a biomarker is dependable and useful, positioning the program as a bridge between discovery research and real-world application.
What does "well characterized groups of patients" mean in this context?
It means studies should use clearly defined human patient populations where disease definitions, inclusion criteria, and clinical phenotypes are specified so biomarker performance can be evaluated in a meaningful context.
Is technology development allowed under this FOA?
Yes. One responsive area is developing or refining technologies to measure biomarkers more effectively, particularly approaches that enable easier longitudinal monitoring or reduce the need for invasive sample collection.
What type of grant mechanism is used for this opportunity?
This opportunity uses the NIH Research Project Grant (R01) mechanism, which is typically used for more mature, hypothesis-driven projects with a well-developed research plan and sufficient preliminary justification.
Is there a related NIH opportunity using a different mechanism?
Yes. The announcement states it runs in parallel with a companion opportunity of identical scientific scope using the R21 mechanism (PA-06-146), which is commonly oriented toward earlier-stage or exploratory work.
How is the R01 version positioned relative to the companion R21?
The R01 version is meant for applicants prepared to conduct a more substantial validation program rather than a smaller proof-of-concept effort.
Is there a fixed budget cap or a fixed number of awards?
No. NIH does not specify a fixed budget or a set number of awards for this announcement. Award size, duration, and total program funding are expected to vary based on proposed projects and application merit.
What factors influence award size and duration under this FOA?
The announcement indicates that award size and duration may vary depending on what applicants propose and how applications score in scientific quality, feasibility, project period, and cost.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, nonprofits (with or without 501(c)(3) status, outside of universities), for-profit organizations (including small businesses), and many government entities (state, county, city or township, independent school districts, and special district governments).
Are tribal entities eligible?
Yes. Tribal governments (federally recognized) and other tribal organizations are listed as eligible applicants.
Are foreign institutions allowed to apply?
Yes. The announcement explicitly states that foreign institutions may apply.
Can federal agencies apply?
Yes. The announcement states that eligible federal agencies may apply.
Are faith-based or community-based organizations eligible?
Yes. The announcement explicitly states that faith-based or community-based organizations may apply.
Is there any cost-sharing or matching requirement?
No cost-sharing or matching requirement is stated in the information provided.
When was this FOA originally posted?
The original posting date is November 21, 2006.
Is there a single application deadline?
No. The opportunity is described as having multiple receipt dates rather than a single deadline.
What is the listed closing date and archive date?
The closing date is listed as September 7, 2009, and the archive date is October 8, 2009.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.273 (Alcohol Research Programs), 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health), and 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
Where can applicants find the full announcement and official instructions?
Applicants are directed to the full announcement at http://grants.nih.gov/grants/guide/pa-files/PA-07-052.html for complete requirements and submission details.
Who should be contacted for access or linking issues with the announcement page?
The listed contact is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
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