Opportunity Information: Apply for PA 06 301

  • The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Pilot And Feasibility Clinical Research Studies In Digestive Diseases And Nutrition" and is now available to receive applicants.
  • This funding opportunity was created on Dec 5, 2008 and posted on Mar 31, 2006.
  • Applicants must submit their applications by May 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.)
  • Each selected applicant is eligible to receive up to $200,000.00 in funding.
  • Eligible applicants include: Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Independent school districts Native American tribal governments (Federally recognized) Special district governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses.
  • Foreign institutions are eligible to apply. Eligible agencies of the Federal Government are eligible to apply. Faith based or community based organizations Units of State Tribal government
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Opportunity Summary:

The Pilot And Feasibility Clinical Research Studies In Digestive Diseases And Nutrition funding opportunity (NIH FOA PA 06 301) is designed to spark early-stage, exploratory clinical and epidemiological research that could lead to better ways to treat or prevent digestive and liver diseases, as well as nutrition-related disorders that occur alongside digestive and liver conditions. The emphasis is on pilot and feasibility work, meaning studies that help investigators test new ideas, generate preliminary data, refine clinical approaches, or evaluate whether a larger, more definitive study is practical and justified. Projects might include early evaluations of promising therapies, new prevention strategies, or novel approaches to understanding disease patterns and risk factors in human populations, as long as the focus stays tied to digestive health, liver disease, or nutrition problems linked to these conditions.

This opportunity uses the NIH Exploratory/Developmental Research Grant mechanism (R21), which is specifically intended for innovative, higher-risk early concepts that need initial support to demonstrate potential. Because the types of pilot and feasibility studies can vary widely, NIH notes that award size and project scope may differ from one application to another, and the final number of awards and total dollars distributed depend on the quality of applications received, the proposed timelines, and the budgets requested.

Applicants may request up to a 2-year project period. The combined maximum for direct costs is 275,000 across both years, with flexibility in how funds are split between years (for example, 100,000 in year one and 175,000 in year two). Even with that two-year cap, NIH indicates that typically no more than 200,000 in direct costs should be requested in any single year, so applicants are expected to shape their budget around what is realistically needed to complete a focused pilot study rather than a full-scale clinical program. Importantly, the R21 mechanism under this announcement is not renewable, so it is meant to stand on its own as an initial step, often with the expectation that strong results could later support a larger follow-on application through a different grant mechanism.

Eligibility is broad and includes both domestic and foreign institutions, and it is open to for-profit and nonprofit organizations as well as public and private entities. Examples named in the announcement include universities and colleges, hospitals, laboratories, state and local government units, eligible federal agencies, and a wide range of other eligible applicants such as tribal governments and organizations, school districts, special district governments, public housing authorities/Indian housing authorities, and community-based or faith-based organizations. In short, the program is structured to allow many kinds of organizations with appropriate research infrastructure and compliance capacity to apply, including international institutions.

The opportunity is also open with respect to who can serve as the Project Director/Principal Investigator (PD/PI). Any individual with the expertise, knowledge, and access to resources needed to carry out the proposed research may apply through their institution. NIH explicitly encourages applications from individuals from underrepresented racial and ethnic groups and from individuals with disabilities. Applicants may submit more than one proposal as long as each application is scientifically distinct, meaning the aims, methods, or underlying research questions are clearly different rather than minor variations of the same project.

From an administrative standpoint, this is a discretionary grant opportunity categorized under food and nutrition and health, and it does not require cost sharing or matching funds. The opportunity was posted March 31, 2006, and the public listing notes multiple receipt dates with details provided in the full announcement. The listing includes an original closing structure with multiple receipt dates and shows a current closing date of May 7, 2009, with an archive date of June 7, 2009, indicating the announcement has since been archived. For applicants or researchers trying to understand the historical requirements and full submission details, NIH provided an additional information link to the complete FOA text and included NIH Office of Extramural Research (OER) webmaster contact information for technical access or linking issues.

FAQs: Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (NIH FOA PA 06 301)

What is this funding opportunity?

This opportunity, titled Pilot And Feasibility Clinical Research Studies In Digestive Diseases And Nutrition (NIH FOA PA 06 301), supports early-stage, exploratory clinical and epidemiological research. The goal is to encourage pilot and feasibility work that could lead to improved ways to treat or prevent digestive and liver diseases, as well as nutrition-related disorders that occur alongside digestive and liver conditions.

What types of studies are being encouraged?

The emphasis is on pilot and feasibility studies. Examples described include projects that test new ideas, generate preliminary data, refine clinical approaches, or evaluate whether a larger and more definitive study is practical and justified. Projects may include early evaluations of promising therapies, new prevention strategies, or new approaches to understanding disease patterns and risk factors in human populations, as long as they stay tied to digestive health, liver disease, or related nutrition problems.

Is this strictly a clinical trial program?

The description highlights clinical and epidemiological research in humans. It also references early evaluations of therapies and prevention strategies and work on disease patterns and risk factors. The key requirement stated is that the study focus remains tied to digestive diseases, liver diseases, and/or nutrition-related disorders linked to these conditions.

What grant mechanism is used?

The program uses the NIH Exploratory/Developmental Research Grant (R21) mechanism. This mechanism is intended for innovative, higher-risk early concepts that need initial support to show potential.

What is the maximum project period?

Applicants may request a project period of up to 2 years.

What is the maximum budget allowed?

The combined maximum for direct costs is $275,000 across both years.

Can the budget be split unevenly across the two years?

Yes. The opportunity notes flexibility in how funds are allocated between the two years (for example, $100,000 in year one and $175,000 in year two), as long as the total direct costs do not exceed $275,000.

Is there a typical cap per year even if the total cap is higher?

Yes. NIH indicates that typically no more than $200,000 in direct costs should be requested in any single year, and applicants are expected to request what is realistically needed for a focused pilot study rather than a full-scale clinical program.

Is this R21 renewable?

No. The R21 mechanism under this announcement is described as not renewable. It is intended to stand on its own as an initial step, often with the expectation that strong results could later support a larger follow-on application through a different grant mechanism.

How many awards will be made and how much total funding is available?

The announcement indicates that award size and project scope may vary from application to application, and that the number of awards and total dollars distributed depend on factors such as the quality of applications received, proposed timelines, and the budgets requested.

Who is eligible to apply?

Eligibility is described as broad and includes domestic and foreign institutions. It is open to for-profit and nonprofit organizations and to public and private entities.

What kinds of organizations are explicitly mentioned as eligible?

Examples named include universities and colleges, hospitals, laboratories, state and local government units, eligible federal agencies, tribal governments and organizations, school districts, special district governments, public housing authorities/Indian housing authorities, and community-based or faith-based organizations.

Are international (foreign) institutions allowed to apply?

Yes. The opportunity explicitly states that foreign institutions are eligible, indicating the program is structured to allow international applicants with appropriate research infrastructure and compliance capacity.

Who can serve as the Project Director/Principal Investigator (PD/PI)?

The opportunity is open regarding who can serve as PD/PI. It states that any individual with the expertise, knowledge, and access to resources needed to carry out the proposed research may apply through their institution.

Does NIH encourage applications from any particular groups of investigators?

Yes. NIH explicitly encourages applications from individuals from underrepresented racial and ethnic groups and from individuals with disabilities.

Can an applicant submit more than one application?

Yes. Applicants may submit more than one proposal as long as each application is scientifically distinct. This means the aims, methods, or underlying research questions should be clearly different, not minor variations of the same project.

Is cost sharing or matching required?

No. The listing states that it does not require cost sharing or matching funds.

How is this opportunity categorized?

It is described as a discretionary grant opportunity categorized under food and nutrition and health.

When was the opportunity posted?

The public listing states it was posted on March 31, 2006.

What were the key dates and is the opportunity still open?

The listing notes multiple receipt dates (with details in the full announcement) and shows a current closing date of May 7, 2009, with an archive date of June 7, 2009. This indicates the announcement has been archived.

Where can someone find the full requirements and submission details?

NIH provided an additional information link to the complete FOA text for historical requirements and full submission details.

Who should be contacted for technical problems accessing the FOA information?

The listing includes contact information for the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.

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