Opportunity Information: Apply for RFA MH 09 161

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Interventions for Neurodevelopmental Disorders (R21/R33)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs.
  • This funding opportunity was created on Mar 6, 2009 and posted on Mar 6, 2009.
  • Applicants must submit their applications by May 12, 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 $2,500,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $225,000.00 in funding.
  • Eligible applicants include: Native American tribal governments (Federally recognized) State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Small businesses.
  • 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 Novel Interventions for Neurodevelopmental Disorders (R21/R33) funding opportunity (RFA-MH-09-161) is an NIH discretionary grant program aimed at jump-starting and maturing new treatment ideas for neurodevelopmental disorders by supporting early-stage development through a phased award structure. The central goal is to create interventions that measurably improve functioning in key domains that are commonly impaired across neurodevelopmental conditions, rather than focusing narrowly on a single diagnosis. NIH is looking for projects that can plausibly lead to broadly usable, cost-effective approaches with the potential to scale across multiple disorders, as long as they clearly target meaningful functional impairments.

The program uses the NIH Exploratory/Developmental Phased Innovation mechanism, which is designed to move projects from early proof-of-concept into a more advanced stage of development within one overall funding framework. The first phase (R21) is intended for initial technical development and proof of principle, essentially establishing that the intervention concept is workable and shows enough promise to justify further investment. The second phase (R33) supports additional development, refinement, application, and evaluation of the intervention's clinical utility. The expectation is that by the end of the R33 phase, the project will have produced results strong enough to support subsequent, larger-scale efficacy testing, such as a more definitive clinical trial or a robust multi-site evaluation.

NIH intentionally casts a wide net regarding what kinds of interventions are eligible. Proposed approaches can include psychopharmacologic strategies, other physiological interventions, cognitive interventions, psychosocial and psychoeducational programs, behavioral approaches, or novel combinations of these modalities. In addition to brand-new concepts, the FOA also encourages applications that take particularly innovative, theory-driven interventions that may already be used in clinical settings but have not yet been adequately evaluated for safety and tolerability. In practical terms, that means applicants can propose to rigorously examine promising real-world practices that have not been subjected to sufficient scientific validation, especially when those practices are grounded in a clear theoretical framework and could plausibly be standardized and disseminated.

This FOA runs in parallel with a companion announcement of identical scientific scope, RFA-MH-09-160, which uses the R34 mechanism. NIH notes that the R34 may be a better fit for projects where the early conceptual groundwork is already complete and proof of principle has been demonstrated, whereas the R21/R33 is positioned to support a more innovation-forward path that still needs initial technical development before moving to more applied testing. In other words, the R21/R33 route is meant to carry projects across a broader developmental span, from early feasibility and prototyping into a more evaluative stage focused on whether the intervention is clinically useful and ready for larger trials.

Administratively, the opportunity was posted March 6, 2009, with an application closing date of May 12, 2009, and an archive date of June 12, 2009. The estimated total funding amount listed is $2,500,000, with an award ceiling of $225,000. It falls under NIH health research and is associated with CFDA numbers 93.242 (Mental Health Research Grants) and 93.273 (Alcohol Research Programs). There is no cost sharing or matching requirement, which means applicants are not expected to provide a defined percentage of project costs from non-federal sources as a condition of the award.

Eligibility is broad and spans many organization types, reflecting NIH's interest in encouraging diverse applicants and settings capable of developing and testing interventions. Eligible applicants include state governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations both with and without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; federally recognized tribal governments and other tribal organizations; and a range of additional eligible entities such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, U.S. territories or possessions, and even non-U.S. (foreign) organizations and regional organizations. The sponsoring agency is the National Institutes of Health, and the full announcement was made available through the NIH grants guide, with technical contact support routed through the NIH Office of Extramural Research webmaster.

Frequently Asked Questions (FAQs)

What is the Novel Interventions for Neurodevelopmental Disorders (R21/R33) opportunity?

It is an NIH discretionary funding opportunity (RFA-MH-09-161) that supports the early development and maturation of new treatment ideas for neurodevelopmental disorders using a phased award structure (R21 followed by R33).

What is the main goal of this funding opportunity?

The central goal is to create interventions that measurably improve functioning in key domains commonly impaired across neurodevelopmental conditions, rather than focusing narrowly on a single diagnosis.

Does the program require the intervention to apply across multiple disorders?

NIH is looking for projects that can plausibly lead to broadly usable, cost-effective approaches that could scale across multiple disorders, as long as they clearly target meaningful functional impairments.

What grant mechanism does this program use?

The program uses the NIH Exploratory/Developmental Phased Innovation mechanism, combining an R21 phase and an R33 phase within one overall funding framework.

What is the purpose of the R21 phase?

The R21 phase is intended for initial technical development and proof of principle, establishing that the intervention concept is workable and shows enough promise to justify further investment.

What is the purpose of the R33 phase?

The R33 phase supports additional development, refinement, application, and evaluation of the intervention's clinical utility.

What outcomes are expected by the end of the R33 phase?

By the end of the R33 phase, the project is expected to produce results strong enough to support subsequent larger-scale efficacy testing, such as a more definitive clinical trial or a robust multi-site evaluation.

What types of interventions are eligible under this FOA?

NIH casts a wide net. Eligible approaches can include psychopharmacologic strategies, other physiological interventions, cognitive interventions, psychosocial and psychoeducational programs, behavioral approaches, or novel combinations of these modalities.

Can an existing clinical practice be proposed, or does the intervention need to be entirely new?

In addition to brand-new concepts, the FOA encourages applications that examine particularly innovative, theory-driven interventions that may already be used in clinical settings but have not been adequately evaluated for safety and tolerability.

What does NIH mean by evaluating real-world practices under this program?

Applicants may propose to rigorously examine promising practices already in use, especially when those practices are grounded in a clear theoretical framework and could plausibly be standardized and disseminated.

Is there a related or companion NIH announcement?

Yes. This FOA runs in parallel with a companion announcement of identical scientific scope, RFA-MH-09-160, which uses the R34 mechanism.

When might the R34 (RFA-MH-09-160) be a better fit than the R21/R33 (RFA-MH-09-161)?

NIH notes that the R34 may be a better fit when the early conceptual groundwork is already complete and proof of principle has been demonstrated, while the R21/R33 supports a more innovation-forward path that still needs initial technical development before more applied testing.

What is the posting date, closing date, and archive date for this opportunity?

The opportunity was posted March 6, 2009. The application closing date was May 12, 2009. The archive date was June 12, 2009.

How much total funding is estimated for this opportunity?

The estimated total funding amount listed is $2,500,000.

What is the award ceiling for this program?

The award ceiling listed is $225,000.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement, meaning applicants are not expected to provide a defined percentage of project costs from non-federal sources as a condition of the award.

What is the sponsoring agency?

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

What CFDA numbers are associated with this opportunity?

This opportunity is associated with CFDA 93.242 (Mental Health Research Grants) and 93.273 (Alcohol Research Programs).

What types of organizations are eligible to apply?

Eligibility is broad. Eligible applicants include state governments; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; federally recognized tribal governments and other tribal organizations; and additional eligible entities such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based and community-based organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations and regional organizations.

Are non-U.S. (foreign) organizations eligible?

Yes. Non-U.S. (foreign) organizations and regional organizations are listed among eligible applicants.

Where was the full announcement made available?

The full announcement was made available through the NIH grants guide.

Where is technical contact support routed for this opportunity?

Technical contact support is routed through the NIH Office of Extramural Research webmaster.

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