Opportunity Information: Apply for PAR 13 023
Apply for PAR 13 023
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory/Developmental Projects in Translational Research (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Nov 19, 2012 and posted on Nov 19, 2012.
- Applicants must submit their applications by Jan 7, 2015. (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 $250,000.00 in funding.
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Small businesses Private institutions of higher education City or township governments County governments Independent school districts For profit organizations other than small businesses State governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NINDS Exploratory/Developmental Projects in Translational Research (R21) funding opportunity (PAR-13-023) is a National Institutes of Health grant program designed to push promising neurological therapeutics out of the early concept stage and into the concrete, regulated preclinical work needed to begin human testing. The central purpose of the announcement is to fund the specific research activities that move a candidate therapy toward a formal FDA submission, whether that submission is an Investigational New Drug (IND) application for drugs and many biologics, an Investigational Device Exemption (IDE) for certain medical devices intended for clinical study, or a 510(k) submission for devices that can pursue clearance by demonstrating substantial equivalence to an existing product. In practical terms, the FOA is meant to support the kinds of studies that make a therapeutic candidate "clinic-ready" from a preclinical standpoint, so that the next step can realistically be a clinical trial pathway rather than another cycle of exploratory academic research.
A key emphasis of the program is translational rigor and a clear line of sight to regulatory milestones. Projects are expected to be built on a strong biological rationale for why the therapeutic approach should work in the target neurological disorder, and that rationale should be backed by supporting data generated from well-designed experiments. The FOA stresses methodological rigor, which generally means applicants need to show careful experimental design, appropriate controls, sound statistical planning, and reproducibility-minded practices. The intent is not to fund open-ended discovery, but to underwrite focused development work that reduces the remaining scientific and technical risk in a way that would satisfy regulators and position the program for clinical evaluation.
The scope is explicitly limited to preclinical development of therapeutic drugs, devices, and biologics for neurological disorders. Activities that fit this translational preclinical lane are the kinds of enabling studies commonly required for FDA submissions, such as late-stage pharmacology, preclinical safety and toxicology planning or execution, dosing and formulation refinement, device prototyping and verification work tied to regulatory expectations, manufacturing and quality considerations that support a regulated package, and other development tasks that directly contribute to an IND, IDE, or 510(k)-ready dossier. The FOA also signals that successful R21 projects should naturally lead into a subsequent, larger, more comprehensive effort (for example, a cooperative agreement in translational research) that would complete any remaining steps needed to reach the actual submission.
Just as important as what is included is what is not. The announcement excludes diagnostics and rehabilitation strategy development, even if those efforts are clinically valuable, because the program is specifically targeted at therapeutic development. It also excludes clinical research, basic research, and studies aimed primarily at understanding disease mechanisms. In other words, if a project is centered on explaining biology, identifying targets, or running human studies, it falls outside the boundaries of this FOA. The program is meant for teams that already have a candidate therapeutic concept with enough preliminary support to justify moving into regulated preclinical development, not for teams still deciding what the therapeutic should be or why it might work.
From an administrative standpoint, this is a discretionary NIH grant using the R21 mechanism, categorized under health and aligned with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The award ceiling listed for the opportunity is $250,000, and the program does not require cost sharing or matching funds, which lowers the barrier for academic and smaller organizational applicants to participate. The posting date was November 19, 2012, with an original and current closing date of January 7, 2015, and an archive date of February 7, 2015, indicating the opportunity has been closed and archived in its posted form.
Eligibility is broad and includes a wide range of domestic and international organizations. Eligible applicants include public and state-controlled institutions of higher education, private institutions of higher education, nonprofits both with and without 501(c)(3) status, small businesses, and for-profit organizations other than small businesses, as well as various levels of government entities such as state, county, city or township governments, special district governments, and independent school districts. It also includes Native American tribal governments (federally recognized) and other tribal organizations, public housing authorities/Indian housing authorities, and additional categories such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander serving institutions. The FOA also allows non-U.S. entities (foreign organizations and foreign institutions) to apply, permits non-domestic components of U.S. organizations, and allows foreign components as defined under NIH Grants Policy, which reflects an openness to strong translational science regardless of geography, so long as the work aligns with NIH policies and the program scope.
Overall, PAR-13-023 is best understood as a bridge program for neurological therapeutics: it funds the preclinical, regulatory-facing experiments and development tasks that turn a plausible therapeutic candidate into one that is credibly positioned for FDA submission and near-term clinical testing. Applicants are expected to arrive with a well-justified approach and supportive data, then use the award to complete targeted, rigorous preclinical development steps that de-risk the program and set up a direct handoff into a subsequent effort that can finish and file the IND, IDE, or 510(k) package.
Frequently Asked Questions (FAQs)
What is the NINDS Exploratory/Developmental Projects in Translational Research (R21) opportunity (PAR-13-023)?
PAR-13-023 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) using the R21 mechanism. It is designed to move promising neurological therapeutics beyond early concepts and into regulated, FDA-relevant preclinical development work that positions a candidate for human testing.
What is the main goal of this FOA?
The central goal is to fund specific, targeted preclinical activities that advance a therapeutic candidate toward a formal FDA submission. The FOA is meant to support the development work needed to make a candidate therapy "clinic-ready" from a preclinical standpoint, so the next realistic step is entry into a clinical trial pathway rather than another round of exploratory research.
What kinds of FDA submissions does the program aim to support?
The FOA is oriented around work that contributes directly to a package appropriate for an FDA submission, including an Investigational New Drug (IND) application (for drugs and many biologics), an Investigational Device Exemption (IDE) (for certain devices intended for clinical study), or a 510(k) submission (for devices seeking clearance by showing substantial equivalence to an existing product).
What types of projects are within the scope of PAR-13-023?
The scope is explicitly limited to preclinical development of therapeutic drugs, devices, and biologics for neurological disorders. Projects should focus on regulated, translational preclinical development tasks that directly reduce scientific and technical risk and support a credible regulatory path.
What are examples of activities that may be supported under this FOA?
Examples described include enabling studies commonly required for FDA submissions, such as late-stage pharmacology, preclinical safety and toxicology planning or execution, dosing and formulation refinement, device prototyping and verification work tied to regulatory expectations, and manufacturing and quality considerations that support a regulated submission package.
Is this program intended for basic research or discovery science?
No. The FOA stresses that it is not meant to fund open-ended discovery. Projects centered on basic research, early discovery, or work aimed primarily at understanding disease mechanisms fall outside the boundaries of this opportunity.
Does the FOA support clinical research or human studies?
No. The announcement excludes clinical research. The focus is on preclinical development work intended to support an IND, IDE, or 510(k)-ready dossier.
Are diagnostics projects eligible under PAR-13-023?
No. Diagnostics are explicitly excluded because the program is specifically targeted at therapeutic development rather than diagnostic development.
Are rehabilitation strategy development projects eligible?
No. Rehabilitation strategy development is excluded, even if clinically valuable, because the FOA is limited to therapeutic development in a translational preclinical context.
What does the FOA mean by "translational rigor"?
Based on the description provided, translational rigor includes a strong biological rationale supported by data from well-designed experiments, careful experimental design, appropriate controls, sound statistical planning, and reproducibility-minded practices. The expectation is that the work reduces risk in a way that aligns with regulatory milestones.
What stage of therapeutic development is this program meant to fund?
This FOA is positioned as a bridge from a supported therapeutic concept to regulated preclinical development. It is meant for teams that already have a candidate therapeutic concept with enough preliminary support to justify targeted development work, rather than teams still identifying targets or establishing why an approach might work.
What is the expected outcome of a successful R21 project under this FOA?
The FOA indicates that successful projects should naturally lead into a subsequent, larger, more comprehensive effort (for example, a cooperative agreement in translational research) that would complete remaining steps needed to reach an actual IND, IDE, or 510(k) submission.
How is this opportunity categorized administratively?
It is described as a discretionary NIH grant using the R21 mechanism, categorized under health, and aligned with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
What is the maximum award amount listed for this opportunity?
The award ceiling listed is $250,000.
Is cost sharing or matching required?
No. The opportunity does not require cost sharing or matching funds.
What were the key dates for this funding opportunity?
The posting date was November 19, 2012. The original and current closing date was January 7, 2015. The archive date was February 7, 2015, indicating the opportunity is closed and archived in its posted form.
Is this funding opportunity currently open?
No. Based on the provided dates and the archive status, the opportunity has been closed and archived.
Who is eligible to apply?
Eligibility is broad and includes public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (with and without 501(c)(3) status), small businesses, and for-profit organizations other than small businesses. Various government entities are also eligible, including state, county, city or township governments, special district governments, and independent school districts.
Are tribal organizations eligible?
Yes. Eligibility includes Native American tribal governments (federally recognized) and other tribal organizations, as well as tribally controlled colleges and universities (TCCUs).
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed among eligible applicants.
Are minority-serving institutions included in the eligibility list?
Yes. The eligibility list explicitly includes categories such as historically Black colleges and universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, and Asian American and Native American Pacific Islander serving institutions.
Can foreign organizations apply?
Yes. The FOA allows non-U.S. entities (foreign organizations and foreign institutions) to apply, permits non-domestic components of U.S. organizations, and allows foreign components as defined under NIH Grants Policy.
What disease area does this FOA focus on?
The focus is on therapeutic development for neurological disorders, consistent with NINDS and the neuroscience/neurological disorders alignment described in the opportunity.
How should applicants think about alignment with regulatory milestones?
The FOA emphasizes a clear line of sight to regulatory milestones, meaning proposed activities should directly contribute to a regulated preclinical package that supports an IND, IDE, or 510(k) pathway rather than remaining in exploratory or mechanism-focused work.
What kind of prior evidence is implied as necessary before applying?
The FOA expects a strong biological rationale and supportive data from well-designed experiments. It is intended for teams that already have enough preliminary support to justify moving into regulated preclinical development, not for projects still deciding on the therapeutic approach or validating basic concepts.
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