Opportunity Information: Apply for RFA AT 09 004

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Translational Tools for Clinical Studies of CAM Interventions (SBIR R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213 Research and Training in Complementary and Integrative Health.
  • This funding opportunity was created on Apr 13, 2009 and posted on Apr 13, 2009.
  • Applicants must submit their applications by Aug 17, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $1,250,000.00 to eligible and selected applicants.
  • Eligible applicants include: Small businesses.
Apply for RFA AT 09 004

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Opportunity Summary:

The NIH grant opportunity titled "Translational Tools for Clinical Studies of CAM Interventions (SBIR R43/R44)" is aimed at helping small businesses build better research tools that make it easier to run rigorous clinical studies on complementary and alternative medicine (CAM) approaches that large numbers of Americans already use. The central idea is straightforward: because practices like massage and other manual therapies, meditation and other mind-body approaches, yoga, and acupuncture are widely used for health and symptom relief, the research community needs stronger, more practical, and better-validated tools to study whether these approaches are safe, whether they work, and how effective they are in real-world clinical settings. The announcement points to National Health Interview Survey data as evidence of broad public use, and it emphasizes that chronic pain, back pain, and musculoskeletal pain are among the most common reasons people turn to these interventions. In other words, the FOA is trying to close the gap between widespread public use and the ability of researchers to evaluate these interventions with the same level of rigor commonly expected in conventional clinical research.

This FOA is specifically focused on "translational tools," meaning resources that bridge the practical realities of CAM interventions with the requirements of well-designed clinical studies. It invites projects that develop, improve, and validate tools that can support strong study design and measurement, including tools that help evaluate safety, efficacy, and clinical effectiveness. While the announcement does not list specific tool types in the excerpt, the intent is to support practical innovations that make CAM trials more reproducible, measurable, and scientifically credible, such as improved methods for standardizing interventions, measuring adherence and fidelity, capturing relevant outcomes, or otherwise strengthening how these therapies are tested in human studies. A key boundary is also made clear: the FOA is not meant for tool development related to natural products like herbs or other herbal therapies. The emphasis is on intervention types such as mind-body practices, manual therapies, yoga, and acupuncture rather than dietary supplements or botanical product research.

The funding mechanism is the Small Business Innovation Research (SBIR) program using the R43/R44 activity codes, which cover Phase I, Phase II, and Fast Track applications. That means eligible applicants are small business concerns, and projects can be proposed at an early feasibility stage (Phase I), a more advanced development and validation stage (Phase II), or through a combined Fast Track path that moves from Phase I to Phase II with an integrated plan. The FOA also notes it runs in parallel with a separate NIH announcement of the same scientific scope that uses the R01 mechanism (RFA-AT-09-002), which is a more traditional research grant route typically used by academic and other research institutions. This parallel structure signals that NIH is encouraging both small-business driven development and more traditional investigator-initiated research to advance the same overall goal: stronger clinical research infrastructure for commonly used CAM interventions.

In terms of funding scale and expected awards, the announcement estimated approximately $1.25 million in total funding to support about five projects in fiscal year 2010, with future funding dependent on annual appropriations. The opportunity is classified as discretionary funding and uses the grant instrument type. It falls under the health funding activity category and is associated with CFDA number 93.213 (Research and Training in Complementary and Integrative Health). There is no cost sharing or matching requirement indicated, which typically reduces barriers for small businesses that might otherwise struggle to provide significant non-federal matching funds.

Administrative details in the source data indicate the opportunity number is RFA-AT-09-004, it was posted on April 13, 2009, and it had an application closing date of August 17, 2009, with the archive date listed as September 17, 2009. The sponsoring agency is the National Institutes of Health, and the full announcement was hosted through the NIH grants site. Contact information provided in the excerpt is geared toward technical or access issues with the online announcement, directing applicants to the NIH Office of Extramural Research (OER) webmaster email for help with accessing or linking to the FOA.

Frequently Asked Questions (FAQs)

What is the name of this NIH funding opportunity?

The opportunity is titled "Translational Tools for Clinical Studies of CAM Interventions (SBIR R43/R44)." It is associated with opportunity number RFA-AT-09-004.

What is the main goal of this FOA?

The FOA aims to help small businesses develop, improve, and validate practical research tools that make it easier to run rigorous clinical studies on complementary and alternative medicine (CAM) interventions that many Americans already use. The focus is on strengthening the tools needed to evaluate safety, efficacy, and real-world clinical effectiveness.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

What kind of applicants is this opportunity intended for?

This FOA uses the Small Business Innovation Research (SBIR) mechanism, so it is intended for eligible small business concerns.

What funding mechanism and activity codes does it use?

This opportunity is offered under the SBIR program using the R43/R44 activity codes. These cover Phase I, Phase II, and Fast Track applications.

What types of projects does this FOA encourage?

The FOA encourages projects that develop, refine, and validate "translational tools" that bridge the practical realities of CAM interventions with the requirements of well-designed clinical studies. The intent is to support innovations that make CAM trials more reproducible, measurable, and scientifically credible.

What does "translational tools" mean in this context?

In this FOA, "translational tools" refers to resources that help translate widely used CAM practices into clinical research settings with strong study design and measurement. These tools are meant to support rigorous evaluation of safety, efficacy, and clinical effectiveness in human studies.

What kinds of CAM interventions are highlighted as being in scope?

The FOA highlights intervention types such as massage and other manual therapies, meditation and other mind-body approaches, yoga, and acupuncture.

Why is NIH focusing on tools for CAM clinical studies?

The FOA points to broad public use of CAM approaches (referencing National Health Interview Survey data) and emphasizes that chronic pain, back pain, and musculoskeletal pain are common reasons people use these interventions. The overall goal is to close the gap between widespread public use and the research community's ability to evaluate these approaches with the same rigor expected in conventional clinical research.

Does the FOA list specific tool types that applicants must develop?

No specific tool types are listed in the excerpt provided. However, the intent is to support practical tools that strengthen how CAM therapies are tested in clinical studies, such as tools that help standardize interventions, measure adherence and fidelity, capture relevant outcomes, or otherwise improve reproducibility and measurement.

Are natural products (like herbs and herbal therapies) included?

No. A key boundary in the FOA is that it is not meant for tool development related to natural products such as herbs or other herbal therapies. The emphasis is on approaches like mind-body practices, manual therapies, yoga, and acupuncture rather than botanical or dietary supplement research.

What phases of SBIR are supported?

The FOA supports Phase I, Phase II, and Fast Track applications under the SBIR R43/R44 mechanism.

Is there a related NIH opportunity using a different mechanism?

Yes. The FOA notes it runs in parallel with a separate NIH announcement of the same scientific scope using the R01 mechanism (RFA-AT-09-002), which is typically used by academic and other research institutions.

What is the estimated funding amount and expected number of awards?

The announcement estimated approximately $1.25 million in total funding to support about five projects in fiscal year 2010. Future funding was noted as dependent on annual appropriations.

Is this discretionary or mandatory funding?

The opportunity is classified as discretionary funding.

What is the instrument type for this opportunity?

The instrument type is a grant.

What funding activity category does it fall under?

It falls under the health funding activity category.

What CFDA number is associated with this opportunity?

The opportunity is associated with CFDA 93.213, "Research and Training in Complementary and Integrative Health."

Is cost sharing or matching required?

No cost sharing or matching requirement is indicated in the provided information.

When was the opportunity posted and when did it close?

It was posted on April 13, 2009. The application closing date listed is August 17, 2009.

Is this opportunity archived?

Yes. The archive date listed is September 17, 2009.

Where was the full announcement hosted?

The full announcement was hosted through the NIH grants site.

Who should be contacted for technical or access issues related to the online announcement?

The provided contact information is for technical or access issues with the online announcement, directing users to the NIH Office of Extramural Research (OER) webmaster email for help accessing or linking to the FOA.

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