Opportunity Information: Apply for PA 18 344

The NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required), Funding Opportunity Number PA 18 344, is a discretionary NIH grant mechanism designed to support early-stage, high-potential research projects that are still in the exploratory or developmental phase. The R21 mechanism is meant for ideas that are promising but not yet fully proven, where investigators may need initial funding to test feasibility, generate preliminary evidence, or develop an approach far enough to justify a larger, more definitive study later on. NIH explicitly notes that these projects can involve considerable risk, but the payoff could be significant, such as a breakthrough finding or the creation of a novel technique, agent, methodology, model, or application that meaningfully advances biomedical, behavioral, or clinical research.

A key feature of this specific Parent announcement is that it requires at least one clinical trial to be proposed. In other words, applicants must include clinical trial activity as NIH defines it, rather than submitting a purely preclinical or observational research plan. The proposed work also needs to fit within the programmatic interests and scientific mission of one or more participating NIH Institutes and Centers (ICs). Because the R21 Parent announcement is used across NIH, the scientific fit is essential: applicants are expected to align their aims with the priorities of the IC that would potentially support the award. It is also important to pay attention to institute-specific participation rules noted in related NIH notices. Some ICs will only accept applications through this announcement if the proposed clinical trial is a mechanistic study that meets NIHs definition of a clinical trial, meaning the trial is designed to understand biological or behavioral mechanisms rather than primarily to establish clinical efficacy in the traditional sense. This makes it especially important for applicants to verify which ICs are participating for their topic area and what limitations or preferences apply before investing heavily in an application.

From a funding standpoint, the opportunity lists an award ceiling of $200,000. As an exploratory/developmental mechanism, the R21 is generally oriented toward smaller, time-limited projects compared with larger NIH awards, and it is commonly used to support proof-of-concept clinical trial work, early testing of innovative interventions, pilot randomized studies, or other trial designs appropriate to demonstrating feasibility, acceptability, safety signals, or mechanistic insight. The ultimate goal is often to position the research team for a subsequent, larger application (for example, an R01 or a later-stage clinical trial program) once the early clinical trial results and supporting data are in hand.

Eligibility is broad and includes many types of domestic U.S. organizations, such as state, county, and local governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; special district governments; and public housing or Indian housing authorities. It also includes federally recognized Native American tribal governments and tribal organizations that are not federally recognized, as well as a wide range of nonprofit entities (both 501(c)(3) and non-501(c)(3)). For-profit organizations (other than small businesses) and small businesses may also apply. Beyond these categories, the announcement explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) entities. This breadth reflects NIHs intent to support innovative early clinical trial research across many institutional settings, including community-based and international contexts when appropriate.

The opportunity is administered by the National Institutes of Health and is associated with multiple CFDA numbers spanning NIHs research and training portfolios, reflecting participation across different NIH components. The source information indicates an original closing date of January 7, 2019, and a creation date of November 3, 2017, which signals that the listing reflects a specific posting window; however, Parent NIH funding opportunities often have multiple standard due dates across years, so applicants typically need to confirm the currently active submission dates and the most current version of the announcement and related notices on the NIH and grants.gov pages. Overall, this R21 Clinical Trial Required Parent opportunity is best understood as NIHs mechanism for funding early, potentially transformative clinical trial work that is innovative, somewhat exploratory by nature, and tightly aligned with the mission and requirements of an appropriate NIH Institute or Center.

  • The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.172, 93.173, 93.242, 93.273, 93.279, 93.307, 93.361, 93.846, 93.855, 93.866.
  • This funding opportunity was created on 2017-11-03.
  • Applicants must submit their applications by 2019-01-07. (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: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, 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, Small businesses, Others.
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FAQs: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) - PA 18 344

What is this funding opportunity?

This is the NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required), Funding Opportunity Number PA 18 344. It is a discretionary NIH grant mechanism intended to support early-stage, high-potential research projects that are still exploratory or developmental in nature and that include at least one clinical trial.

What is the purpose of the R21 mechanism under this announcement?

The R21 mechanism is designed to help investigators pursue promising ideas that are not yet fully proven. It supports work such as testing feasibility, generating preliminary evidence, or developing an approach far enough to justify a larger, more definitive study later (for example, a future R01 or later-stage clinical trial program).

Does this opportunity require a clinical trial?

Yes. A key feature of this Parent announcement is that applicants must propose at least one clinical trial as NIH defines it. Applications that are purely preclinical or purely observational (with no NIH-defined clinical trial activity) would not meet this requirement based on the description provided.

What kinds of projects are a good fit for this R21 clinical trial opportunity?

The R21 mechanism commonly supports smaller, time-limited exploratory clinical trial work such as proof-of-concept studies, early testing of innovative interventions, pilot randomized studies, or other trial designs appropriate for demonstrating feasibility, acceptability, early safety signals, or mechanistic insight.

Are high-risk projects allowed or encouraged?

Yes. NIH explicitly notes that R21 projects can involve considerable risk. The emphasis is on the potential payoff, such as a breakthrough finding or creation of a novel technique, agent, methodology, model, or application that advances biomedical, behavioral, or clinical research.

What is the maximum award amount mentioned for this opportunity?

The opportunity lists an award ceiling of $200,000.

How does this R21 relate to future NIH funding (like an R01)?

The R21 is often used to generate early clinical trial results and supporting data that can position a team for a subsequent, larger application, such as an R01 or a later-stage clinical trial program, once feasibility or early outcomes are established.

Do applicants need to align with a specific NIH Institute or Center (IC)?

Yes. The proposed work needs to fit within the programmatic interests and scientific mission of one or more participating NIH Institutes and Centers (ICs). Because this is a Parent announcement used across NIH, scientific and mission fit with an appropriate IC is essential.

Do all NIH Institutes and Centers accept all types of clinical trials under this Parent announcement?

No. Some ICs only accept applications through this announcement if the proposed clinical trial is a mechanistic study that meets NIH's definition of a clinical trial, meaning it is designed to understand biological or behavioral mechanisms rather than primarily to establish clinical efficacy in the traditional sense.

What should applicants do about institute-specific rules or limitations?

Applicants are expected to pay attention to institute-specific participation rules noted in related NIH notices and verify which ICs are participating for their topic area, including any limitations or preferences, before investing heavily in an application.

Who is eligible to apply?

Eligibility is broad. Eligible applicants include many domestic U.S. organizations such as state, county, and local governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; special district governments; and public housing or Indian housing authorities.

Are tribal governments and tribal organizations eligible?

Yes. Eligibility includes federally recognized Native American tribal governments, as well as tribal organizations that are not federally recognized.

Are nonprofit organizations eligible?

Yes. A wide range of nonprofit entities are eligible, including 501(c)(3) and non-501(c)(3) nonprofits.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) and small businesses may also apply.

Are minority-serving institutions and community-based organizations eligible?

Yes. The announcement explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, HBCUs, TCCUs, and faith-based or community-based organizations.

Are federal agencies eligible to apply?

Yes. Eligible applicants include eligible federal agencies, as stated in the eligibility description provided.

Are U.S. territories and possessions eligible?

Yes. The opportunity includes eligibility for U.S. territories or possessions.

Are non-U.S. (foreign) entities eligible to apply?

Yes. The eligibility description explicitly includes non-U.S. (foreign) entities.

Who administers this opportunity?

This opportunity is administered by the National Institutes of Health (NIH).

What does it mean that this is a "Parent" NIH announcement?

Based on the description provided, this is a Parent announcement used across NIH, meaning multiple NIH components can participate. As a result, the specific scientific fit and any institute-specific participation rules become especially important for determining where an application might be assigned and considered.

Are the submission dates fixed to a single deadline?

The source information indicates an original closing date of January 7, 2019, and a creation date of November 3, 2017. However, the description also notes that Parent NIH funding opportunities often have multiple standard due dates across years, so applicants typically need to confirm currently active submission dates and the most current version of the announcement and related notices on NIH and grants.gov.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with multiple CFDA numbers spanning NIH research and training portfolios, reflecting participation across different NIH components (specific CFDA numbers are not listed in the provided text).

What is the main takeaway for applicants considering this opportunity?

This R21 Clinical Trial Required Parent opportunity is intended for innovative, exploratory, potentially transformative clinical trial work that includes at least one NIH-defined clinical trial and is tightly aligned with the mission and requirements of an appropriate NIH Institute or Center, including any institute-specific limitations (such as mechanistic-trial-only participation).

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Applicants also applied for:

Applicants who have applied for this opportunity (PA 18 344) also looked into and applied for these:

Funding Opportunity
Environmental Exposures and Health: Exploration of Non-Traditional Settings (R21 Clinical Trial Optional) Apply for PA 18 160

Funding Number: PA 18 160
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $200,000
Environmental Exposures and Health: Exploration of Non-Traditional Settings (R01 Clinical Trial Optional) Apply for PA 18 142

Funding Number: PA 18 142
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Independent Scientist Award (Parent K02 - Independent Clinical Trials Not Allowed) Apply for PA 18 371

Funding Number: PA 18 371
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Midcareer Investigator Award in Patient-Oriented Research (Parent K24 - No Independent Clinical Trials) Apply for PA 18 394

Funding Number: PA 18 394
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
NIH Exploratory/Developmental Research Grant Program ( Parent R21 Clinical Trial Not Allowed) Apply for PA 18 489

Funding Number: PA 18 489
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $200,000
Ruth L. Kirschstein National Research Service Award (NRSA) Individual Senior Fellowship (Parent F33) Apply for PA 18 672

Funding Number: PA 18 672
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Innovative Basic Research on Adducts in Cancer Risk Identification and Prevention (R01 Clinical Trial Not Allowed) Apply for PAR 18 704

Funding Number: PAR 18 704
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Innovative Basic Research on Adducts in Cancer Risk Identification and Prevention (R21 Clinical Trial Not Allowed) Apply for PAR 18 703

Funding Number: PAR 18 703
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $200,000
Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R01 - Clinical Trial Not Allowed) Apply for PAR 18 845

Funding Number: PAR 18 845
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Electronic Nicotine Delivery Systems (ENDS): Basic Mechanisms of Health Effects (R21 - Clinical Trial Not Allowed) Apply for PAR 18 846

Funding Number: PAR 18 846
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Superfund Hazardous Substance Research and Training Program (P42 Clinical Trial Optional) Apply for RFA ES 18 002

Funding Number: RFA ES 18 002
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $1,750,000
Emerging Global Leader Award (K43 Independent Clinical Trial Required) Apply for PAR 19 038

Funding Number: PAR 19 038
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01 Clinical Trial Not Allowed) Apply for PAR 19 039

Funding Number: PAR 19 039
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $300,000
Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01 Clinical Trial Optional) Apply for PAR 19 040

Funding Number: PAR 19 040
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Promoting Research on Music and Health: Fundamentals and Applications (R21 Clinical Trials Optional) Apply for RFA NS 19 009

Funding Number: RFA NS 19 009
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Immuno-Oncology Translation Network (IOTN): Cancer Immunoprevention Research Projects (UG3/UH3) Apply for RFA CA 19 012

Funding Number: RFA CA 19 012
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $500,000
Emerging Global Leader Award (K43 Independent Clinical Trial Required) Apply for PAR 19 051

Funding Number: PAR 19 051
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
Research Project Grant (Parent R01 Clinical Trial Required) Apply for PA 19 055

Funding Number: PA 19 055
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: Case Dependent
NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) Apply for PA 19 053

Funding Number: PA 19 053
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $200,000
NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) Apply for PA 19 054

Funding Number: PA 19 054
Agency: National Institutes of Health
Category: Education, Environment, Health
Funding Amount: $200,000

 

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