Opportunity Information: Apply for PAR 18 691
Apply for PAR 18 691
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Innovative Therapies and Tools for Screenable Disorders (R21 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350, 93.865.
- This funding opportunity was created on 2018-03-01.
- Applicants must submit their applications by 2021-05-07. (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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Opportunity Summary:
The Innovative Therapies and Tools for Screenable Disorders (R21 Clinical Trial Optional) funding opportunity (PAR-18-691) is a National Institutes of Health (NIH) discretionary grant program designed to speed up early-stage research on treatments and practical tools for serious genetic and metabolic conditions that can be detected through newborn screening. The core idea is straightforward: newborn screening only achieves its public health value when there is something meaningful that can be done for the child once a condition is found. Because the availability and demonstrated benefit of treatment is often a deciding factor in whether a disorder is added to a screening panel, this program focuses on generating the kinds of therapeutic and translational evidence that can make early detection clinically worthwhile.
The FOA emphasizes two broad categories of target conditions. First are disorders already identified through newborn screening that are potentially fatal or severely disabling without timely intervention. Second are "high priority" genetic conditions that are not currently recommended for screening but could realistically become screenable in the near future, especially if stronger treatment options or clearer benefit data were available. In this context, "high priority" does not just mean scientifically interesting; it specifically refers to conditions where earlier identification would likely change outcomes in a major way, but the field still needs better interventions, better proof of benefit, or better real-world tools to deliver care quickly and effectively.
As an R21 mechanism, the program is oriented toward exploratory and developmental work rather than large, definitive programs. Projects supported under R21 awards typically aim to establish feasibility, generate preliminary efficacy or performance data, validate a promising approach, or overcome a key technical barrier that is currently preventing translation into routine practice. The "Clinical Trial Optional" label signals that applicants may propose a clinical trial if it is appropriate to the research question, but a trial is not required. This flexibility allows teams to propose anything from preclinical therapeutic development through early human testing or proof-of-concept clinical evaluation, depending on what is needed to move the field forward for a given disorder.
The opportunity falls under the broad federal activity area of Health, Income Security and Social Services and is associated with CFDA numbers 93.350 and 93.865. The listed award ceiling is $200,000, which aligns with the R21 emphasis on tightly focused, milestone-driven studies that can produce actionable results and set the stage for larger follow-on funding. The source information provided does not specify the number of expected awards. The original closing date shown for this particular listing was 2021-05-07, and the FOA record indicates a creation date of 2018-03-01.
Eligibility is intentionally broad and includes many types of public, private, and community-based institutions. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing and Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and even non-U.S. (foreign) entities. Taken together, that eligibility list signals NIH interest in encouraging participation from a wide range of organizations, including those that serve underrepresented communities and those that may be positioned to work directly with affected families and health systems.
In practical terms, a strong application under this FOA would be expected to stay tightly aligned with newborn screening impact: it should connect the proposed therapy or tool to the real-world need for early identification, rapid initiation of treatment, and measurable improvement in health outcomes for infants and children. The program is meant to help close the common gap between "we can detect it early" and "we can actually change the course of the disease," especially for conditions where early treatment could prevent death, severe disability, or lifelong complications.
Frequently Asked Questions (FAQs)
What is the Innovative Therapies and Tools for Screenable Disorders (R21 Clinical Trial Optional) opportunity?
This is a National Institutes of Health (NIH) discretionary grant funding opportunity focused on speeding up early-stage research on treatments and practical tools for serious genetic and metabolic disorders that can be detected through newborn screening. It is listed as PAR-18-691.
What is the main purpose of this funding opportunity?
The program is designed to help ensure newborn screening leads to real clinical benefit. The underlying premise is that screening delivers public health value only when there is something meaningful that can be done once a condition is identified. The FOA supports research intended to strengthen treatments, tools, and translational evidence so early detection can reliably improve outcomes.
What kinds of disorders does the FOA focus on?
The FOA emphasizes two broad categories: (1) disorders already identified through newborn screening that may be fatal or severely disabling without timely intervention, and (2) "high priority" genetic conditions not currently recommended for newborn screening but that could become screenable in the near future if better treatments, clearer benefit data, or practical tools for rapid care delivery were available.
What does "high priority" mean in this context?
What is an R21 award, and what does it typically support?
An R21 is an exploratory and developmental research mechanism. Under this FOA, R21 projects are generally expected to be tightly focused and milestone-driven, aiming to establish feasibility, generate preliminary efficacy or performance data, validate a promising approach, or overcome a key technical barrier that is preventing translation into routine practice.
Are clinical trials required under this FOA?
No. The FOA is labeled "Clinical Trial Optional," meaning applicants may propose a clinical trial if it fits the research question, but a clinical trial is not required.
What types of projects could be considered a good fit?
Projects can range from preclinical therapeutic development to early human testing or proof-of-concept clinical evaluation, as long as they are intended to move the field forward for a disorder relevant to newborn screening and are aimed at bridging the gap between early detection and meaningful clinical action.
How should an application connect to newborn screening to be competitive?
Based on the FOA description, a strong application would stay tightly aligned with newborn screening impact by clearly linking the proposed therapy or tool to early identification, rapid initiation of treatment, and measurable improvement in health outcomes for infants and children.
What gap is this program trying to close?
The program targets the common disconnect between the ability to detect a disorder early and the ability to change the course of the disease after detection. It supports work that can enable prevention of death, severe disability, or lifelong complications through earlier and more effective intervention.
What is the maximum award amount (award ceiling) listed for this opportunity?
The listed award ceiling is $200,000, consistent with the R21 emphasis on focused studies that generate actionable results and support follow-on funding.
Does the information provided state how many awards NIH expects to make?
No. The source information provided does not specify the number of expected awards.
What is the federal activity area associated with this opportunity?
The opportunity is associated with the federal activity area of Health, Income Security and Social Services.
Which CFDA numbers are associated with this funding opportunity?
The opportunity is associated with CFDA numbers 93.350 and 93.865.
What is the FOA number and title?
The FOA is PAR-18-691, titled "Innovative Therapies and Tools for Screenable Disorders (R21 Clinical Trial Optional)."
What were the creation date and the closing date shown in the provided listing?
The FOA record indicates a creation date of 2018-03-01, and the original closing date shown for the listing was 2021-05-07.
Who is eligible to apply?
Eligibility is broad and includes many types of organizations, including:
- State, county, city or township, and special district governments
- Independent school districts
- Public and state-controlled universities
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Tribal organizations that are not federally recognized
- Public housing authorities and Indian housing authorities
- Nonprofits with and without 501(c)(3) status
- For-profit organizations other than small businesses
- Small businesses
- U.S. territories or possessions
- Regional organizations
- Eligible federal agencies
- Non-U.S. (foreign) entities
Are organizations serving underrepresented communities specifically mentioned as eligible?
Yes. The FOA highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, and faith-based or community-based organizations.
Can non-U.S. (foreign) entities apply?
Yes. The eligibility list explicitly includes non-U.S. (foreign) entities.
Does this opportunity support tools as well as therapies?
Yes. The FOA is framed around both treatments and practical tools intended to improve outcomes for disorders relevant to newborn screening, particularly by enabling rapid initiation of care and effective delivery in real-world settings.
Is this funding aimed at large, definitive research programs?
No. As an R21 mechanism, it is oriented toward early-stage, exploratory, and developmental work rather than large, definitive programs.
What kinds of results is the R21 structure aiming to produce?
The description emphasizes actionable, translational outputs such as feasibility demonstrations, preliminary efficacy or performance data, validation of a promising approach, or removal of a technical barrier that is preventing routine clinical translation.
Why does the FOA emphasize treatment availability for newborn screening?
Because the availability and demonstrated benefit of treatment is often a deciding factor in whether a disorder is added to a screening panel. The FOA supports research that can generate therapeutic and translational evidence that makes early detection clinically worthwhile.
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| Role of Gut Microbiome in Regulating Reproduction and Its Impact on Fertility Status in Women Living with and Without HIV (R01 - Clinical Trial Optional) Apply for PA 18 838 Funding Number: PA 18 838 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $499,999 |
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