Opportunity Information: Apply for PA 09 204
Apply for PA 09 204
- The National Institutes of Health in the education food and nutrition health sector is offering a public funding opportunity titled "Development and Validation 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 93.361 Nursing Research 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Jun 4, 2009 and posted on Jun 3, 2009.
- Applicants must submit their applications by Sep 7, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: County governments Special district governments City or township governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Small businesses Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification).
- 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:
The NIH funding opportunity "Development and Validation of Disease Biomarkers (R01)" (PA-09-204) is a discretionary research grant announcement designed to support projects that move beyond biomarker discovery and focus instead on rigorous validation of already-identified candidate biomarkers in humans. It is sponsored by multiple NIH components, including the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Nursing Research (NINR), and the Office of Dietary Supplements (ODS). The central idea is to help the field establish trustworthy, clinically meaningful biomarkers for specific diseases where biomarkers are missing, scarce, or where current standard measures are too invasive or too expensive to use widely in practice or clinical research.
The scientific scope centers on well defined human diseases and conditions affecting the liver, kidney, urologic tract, digestive system, and hematologic systems, along with endocrine and metabolic disorders, diabetes (including its complications), obesity, and related conditions. The announcement emphasizes that a biomarker is any measurable indicator of a disease process, and it highlights the practical value of biomarkers as potential substitutes for "hard" clinical endpoints. In other words, a well validated biomarker could serve as a reliable readout of disease activity or therapeutic response, enabling faster and more efficient evaluation of drugs, devices, or biobehavioral interventions, and improving translational research by bridging basic findings to patient care.
Projects responsive to this FOA are expected to validate candidate biomarkers in clearly characterized patient populations, rather than proposing early stage discovery work. Typical supported activities include designing and conducting validation studies in appropriate cohorts, determining how well a biomarker correlates with disease presence, severity, progression, or treatment response, and establishing performance characteristics that make the biomarker credible for broader use. The FOA also invites work that strengthens the practical utility of biomarkers by developing new technologies to monitor them and by creating, refining, or standardizing assays so that measurements are reliable, reproducible, and feasible across settings. The intent is to reduce uncertainty around biomarker measurement and interpretation so that validated markers can be adopted with confidence in research and, potentially, clinical workflows.
The primary mechanism of support is the NIH Research Project Grant (R01), which is typically used for mature, hypothesis-driven or milestone-driven projects with a clear validation plan and sufficient preliminary justification. The announcement notes that smaller, exploratory projects in the same general scientific space may be more appropriate for an R21, but those applications would need to go through the NIH Parent R21 announcement rather than this R01 FOA. Funding levels and the number of awards are not guaranteed; awards depend on congressional appropriations, NIH institute budgets, and the availability of funds, as well as the scientific merit and competitiveness of the applications received.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants span state, local, and tribal governments; public and private institutions of higher education; nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (including small businesses); independent school districts; public housing authorities/Indian housing authorities; faith-based and community-based organizations; and a range of specialized institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, U.S. territories or possessions, and foreign organizations. The FOA does not require cost sharing or matching.
Key administrative details include a posted date of June 3, 2009, with the opportunity ultimately closing on September 7, 2012, and being archived on October 8, 2012. The program is associated with CFDA numbers 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), 93.273 (Alcohol Research Programs), 93.361 (Nursing Research), and 93.847 as listed in the source. For applicants needing the complete instructions and requirements, NIH provided a full announcement link (PA-09-204) and contact support through the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.
Frequently Asked Questions (FAQs)
What is the name and number of this NIH funding opportunity?
The funding opportunity is titled "Development and Validation of Disease Biomarkers (R01)" and the announcement number is PA-09-204.
What is the main purpose of PA-09-204?
This FOA supports research projects that move beyond biomarker discovery and focus on rigorous validation of already-identified candidate biomarkers in humans. The goal is to establish trustworthy, clinically meaningful biomarkers for diseases where biomarkers are missing or limited, or where existing standard measures are too invasive or too expensive for broad use.
Which NIH components sponsor or participate in this FOA?
The FOA is sponsored by multiple NIH components, including the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Nursing Research (NINR), and the Office of Dietary Supplements (ODS).
What types of diseases and conditions are within the scientific scope?
The scope focuses on well defined human diseases and conditions affecting the liver, kidney, urologic tract, digestive system, and hematologic systems, as well as endocrine and metabolic disorders, diabetes (including complications), obesity, and related conditions.
How does this FOA define a biomarker?
A biomarker is described as any measurable indicator of a disease process. The FOA emphasizes biomarkers as potentially practical substitutes for "hard" clinical endpoints when properly validated.
Why are validated biomarkers important according to this announcement?
Validated biomarkers can serve as reliable readouts of disease activity or therapeutic response, which can enable faster and more efficient evaluation of drugs, devices, or biobehavioral interventions. They can also strengthen translational research by helping bridge basic findings to patient care.
Does this FOA support biomarker discovery?
No. Projects are expected to validate already-identified candidate biomarkers in clearly characterized patient populations rather than propose early-stage discovery work.
What is the expected study setting (human or non-human)?
The FOA is centered on validation of candidate biomarkers in humans, including validation in clearly characterized patient populations.
What kinds of activities or aims are considered responsive?
Examples of responsive work include designing and conducting validation studies in appropriate cohorts; determining how well a biomarker correlates with disease presence, severity, progression, or treatment response; and establishing performance characteristics that support credible broader use.
Are assay development and standardization activities allowed?
Yes. The FOA invites work that strengthens practical utility by creating, refining, or standardizing assays so measurements are reliable, reproducible, and feasible across settings.
Does the FOA allow development of technologies to monitor biomarkers?
Yes. The FOA invites efforts to develop new technologies to monitor biomarkers as part of improving practical utility and adoption.
What is meant by "performance characteristics" in the context of this FOA?
The FOA highlights establishing characteristics that make the biomarker credible for broader use, such as how well it correlates with disease-related outcomes and how reliably it can be measured and interpreted across settings.
What funding mechanism is used for this opportunity?
The primary mechanism is the NIH Research Project Grant (R01).
Is this opportunity intended for mature projects?
Yes. The R01 mechanism is described as typically used for mature, hypothesis-driven or milestone-driven projects with a clear validation plan and sufficient preliminary justification.
If a project is smaller or exploratory, should it use this FOA?
The FOA notes that smaller, exploratory projects in the same general scientific space may be more appropriate for an R21, but those would need to be submitted through the NIH Parent R21 announcement rather than this R01 FOA.
Are awards and funding levels guaranteed?
No. The FOA states that funding levels and the number of awards are not guaranteed. Awards depend on congressional appropriations, NIH institute budgets, availability of funds, and the scientific merit and competitiveness of applications.
Is cost sharing or matching required?
No. The FOA does not require cost sharing or matching.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic and non-domestic organizations, including state, local, and tribal governments; public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (including small businesses); independent school districts; public housing authorities/Indian housing authorities; faith-based and community-based organizations; specialized institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions; U.S. territories or possessions; and foreign organizations.
Are foreign (non-U.S.) organizations eligible?
Yes. The eligibility description explicitly includes non-domestic (foreign) organizations.
When was this FOA posted, and when did it close?
The posted date was June 3, 2009. The opportunity closed on September 7, 2012.
What does it mean that the opportunity is archived?
The FOA is listed as archived on October 8, 2012, indicating the announcement is no longer active for new submissions under that posting.
What CFDA numbers are associated with this program?
The program is associated with CFDA numbers 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), 93.273 (Alcohol Research Programs), and 93.361 (Nursing Research). The source also lists 93.847.
Where can applicants find full instructions and requirements?
Applicants are directed to the full NIH announcement link for PA-09-204 for complete instructions and requirements.
Who should be contacted for technical access or linking issues with the announcement?
For technical access or linking issues, NIH provided contact support through the NIH Office of Extramural Research (OER) webmaster.
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