Opportunity Information: Apply for PA 07 025

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Non Invasive Methods for Diagnosis and Progression of Diabetes, Kidney, Urological, Hematological and Digestive Diseases (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
  • This funding opportunity was created on Dec 5, 2008 and posted on Nov 20, 2006.
  • Applicants must submit their applications by 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: County governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses Special district governments Public and State controlled institutions of higher education City or township governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public housing authorities/Indian housing authorities.
  • Foreign institutions are eligible to apply. Eligible agencies of the Federal Government can apply. Faith based or community based organizations can apply.
Apply for PA 07 025

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Opportunity Summary:

The NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is soliciting Research Project Grant (R01) applications under the funding opportunity titled "Non Invasive Methods for Diagnosis and Progression of Diabetes, Kidney, Urological, Hematological and Digestive Diseases (R01)" (Funding Opportunity Number PA-07-025). The central aim is to push forward imaging and other non-invasive or minimally invasive technologies that can be used in people to detect and characterize disease, improve diagnosis, identify individuals at elevated risk or with a predisposition to disease, and monitor responses to treatment over time. A major theme is enabling better ways to study both normal and diseased tissues in vivo, meaning directly in living systems, rather than relying on invasive biopsies or indirect measures that may miss early or subtle changes.

Scientifically, the FOA emphasizes the development and application of advanced approaches that can capture meaningful biological signals related to disease onset and progression. NIDDK is particularly interested in technologies that produce robust surrogate markers that could serve as clinical trial endpoints, which is a practical need in many chronic diseases where definitive outcomes may take years to develop. In other words, the program is looking for measurable indicators that can reliably reflect whether a disease is getting better or worse, or whether a treatment is working, without requiring long follow-up periods or highly invasive testing. Alongside surrogate markers, the FOA encourages methods that improve the resolution and specificity of tissue characterization, including the ability to distinguish normal physiology from early pathology.

The diseases and conditions within scope are broad but unified by NIDDKs mission areas. These include type 1 diabetes and type 2 diabetes, obesity, and a wide range of kidney, liver, urologic, hematologic, digestive, endocrine, and metabolic diseases, as well as their complications. The opportunity is therefore relevant to investigators working across multiple organ systems, especially where current clinical tools are limited by invasiveness, lack of sensitivity to early disease, or inability to track dynamic physiological processes in real time.

On the technology side, NIDDK highlights molecular imaging and functional imaging as especially relevant, along with imaging methods that provide high spatial resolution, high chemical resolution, or high time resolution. The FOA also calls out newer spectroscopic approaches and sensor array technologies aimed at monitoring metabolic or physiological events, which can include techniques designed to measure biochemical changes, tissue composition, perfusion, oxygenation, metabolism, or other functional properties that shift as disease develops or responds to therapy. The common denominator is that these approaches should reduce patient burden compared with traditional invasive diagnostics while producing clinically meaningful information that can support diagnosis, prognosis, risk stratification, or treatment monitoring.

In terms of funding mechanism and structure, this program uses the NIH R01 mechanism, which is intended for more mature, hypothesis-driven or well-justified research projects that typically involve substantial development, validation, and application. The FOA notes that it runs in parallel with an opportunity of the same scientific scope that uses the R21 exploratory/developmental mechanism (PA-06-142), which signals that NIDDK is supporting both earlier-stage, higher-risk concept development (R21) and more fully developed projects positioned for broader validation and impact (R01).

Budget size, project duration, and the number of awards are not fixed because NIDDK expects applications to vary widely in scope and cost depending on the disease target, technology platform, and level of validation proposed. As a result, the total funding and award count will ultimately depend on the number of applications received, their scientific quality, the requested durations, and the proposed costs.

Eligibility is broad and includes many types of domestic organizations such as state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), independent school districts, and special district governments. Importantly, the announcement specifies that foreign institutions are eligible to apply, and eligible federal agencies may also apply. Faith-based and community-based organizations are also permitted, expanding the potential applicant pool beyond traditional academic medical centers.

Administratively, this is a discretionary grant opportunity listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), with no cost sharing or matching requirement. It was posted on November 20, 2006, and uses multiple receipt dates rather than a single deadline, meaning applicants must refer to the full announcement for the applicable submission cycles and due dates. The full FOA is linked through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PA-07-025.html, and the NIH Office of Extramural Research (OER) webmaster contacts are provided for access or linking issues.

Frequently Asked Questions (FAQs)

1) What is the title of this NIH funding opportunity?

The funding opportunity is titled "Non Invasive Methods for Diagnosis and Progression of Diabetes, Kidney, Urological, Hematological and Digestive Diseases (R01)."

2) What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number is PA-07-025.

3) Which NIH Institute is offering this opportunity?

This opportunity is offered by the NIH National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

4) What grant mechanism is being used?

This program uses the NIH Research Project Grant (R01) mechanism.

5) What is the central aim of the FOA?

The central aim is to advance imaging and other non-invasive or minimally invasive technologies that can be used in people to detect and characterize disease, improve diagnosis, identify individuals at elevated risk or with a predisposition to disease, and monitor responses to treatment over time.

6) What is meant by studying tissues "in vivo" in this FOA?

In this context, "in vivo" refers to studying normal and diseased tissues directly in living systems, rather than relying on invasive biopsies or indirect measures that may miss early or subtle changes.

7) What types of technologies are emphasized?

The FOA emphasizes imaging and related approaches, including molecular imaging and functional imaging, as well as technologies that provide high spatial resolution, high chemical resolution, or high time resolution. It also encourages newer spectroscopic approaches and sensor array technologies aimed at monitoring metabolic or physiological events.

8) Is the FOA limited to imaging only?

No. While imaging is a major focus, the FOA also highlights other non-invasive or minimally invasive approaches such as spectroscopic methods and sensor array technologies that can measure metabolic or physiological events.

9) What kinds of measurements or biological signals are of interest?

The FOA is interested in approaches that capture meaningful biological signals related to disease onset and progression. Examples described include measuring biochemical changes, tissue composition, perfusion, oxygenation, metabolism, and other functional properties that change as disease develops or responds to therapy.

10) What does the FOA mean by "surrogate markers" and why are they important?

The FOA highlights the need for robust surrogate markers that could serve as clinical trial endpoints. These are measurable indicators intended to reflect disease status or treatment response, which can be especially valuable in chronic diseases where definitive outcomes may take many years to appear.

11) What scientific theme ties the disease areas together?

The unifying theme is alignment with NIDDK mission areas, with an emphasis on better non-invasive or minimally invasive methods to detect disease earlier, characterize tissue more precisely, stratify risk, and monitor progression or treatment response over time.

12) Which diseases and conditions are within scope?

The FOA scope includes type 1 diabetes, type 2 diabetes, obesity, and a wide range of kidney, liver, urologic, hematologic, digestive, endocrine, and metabolic diseases, as well as their complications.

13) What kinds of clinical or translational needs is this FOA trying to address?

The FOA is aimed at reducing reliance on invasive biopsies and overcoming limitations of current clinical tools, particularly where existing methods are invasive, not sensitive enough to detect early disease, or unable to track dynamic physiological processes in real time.

14) What types of applications is the R01 mechanism intended to support here?

Within this program description, the R01 mechanism is positioned for more mature, hypothesis-driven or well-justified research projects that may involve substantial development, validation, and application of the proposed non-invasive or minimally invasive technologies.

15) Is there a related NIH opportunity for earlier-stage or exploratory projects?

Yes. The FOA notes that it runs in parallel with an opportunity of the same scientific scope using the R21 exploratory/developmental mechanism (PA-06-142), supporting earlier-stage, higher-risk concept development, while this R01 supports more fully developed projects.

16) Are budget size and project duration fixed?

No. Budget size, project duration, and the number of awards are not fixed. NIDDK expects applications to vary widely based on the disease target, technology platform, and proposed level of validation.

17) What factors will influence the total funding and number of awards?

According to the description provided, the total funding and award count will depend on the number of applications received, their scientific quality, the requested durations, and the proposed costs.

18) Is cost sharing or matching required?

No. The opportunity states that there is no cost sharing or matching requirement.

19) What is the CFDA number associated with this program?

The opportunity is listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).

20) When was this opportunity posted?

The opportunity was posted on November 20, 2006.

21) Is there a single application deadline?

No. The opportunity uses multiple receipt dates rather than a single deadline, so applicants are directed to consult the full announcement for the applicable submission cycles and due dates.

22) Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations such as state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), independent school districts, and special district governments.

23) Are foreign institutions eligible to apply?

Yes. The announcement specifies that foreign institutions are eligible to apply.

24) Are federal agencies eligible to apply?

Yes. The announcement indicates that eligible federal agencies may apply.

25) Are faith-based and community-based organizations allowed to apply?

Yes. The announcement states that faith-based and community-based organizations are permitted to apply.

26) Where can applicants find the full FOA text?

The full FOA is linked through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PA-07-025.html

27) Who is listed for help with access or linking issues to the FOA?

The NIH Office of Extramural Research (OER) webmaster contacts are provided in the announcement for access or linking issues.

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