Opportunity Information: Apply for RFA HD 17 017
The NIH funding opportunity titled "Developmental Mechanisms of Human Structural Birth Defects (P01)" (RFA-HD-17-017; CFDA 93.865) supports large, team-based Program Project Grant (P01) applications aimed at explaining how major congenital structural malformations arise. The central emphasis is on understanding developmental biology and genetic causes of significant human birth defects by bringing together basic science, translational work, and clinical research in a tightly integrated way. The FOA is designed for projects where collaboration is not just beneficial but essential, meaning the different parts of the program are expected to interact, share expertise and resources, and produce a combined outcome that is stronger than three independent studies.
A defining feature of this FOA is its required structure. Each funded program project must include exactly three component research projects plus the necessary shared cores. The three projects must be unified by one clear central theme and should converge on a specific major developmental defect or malformation. The defect under study must be meaningfully comparable between humans and the chosen animal model(s), whether the similarity is genetic (shared causal genes or variants), mechanistic (shared developmental pathways), biological (shared tissue or organ development processes), or phenotypic (similar observable malformation features). The FOA explicitly allows either mammalian or non-mammalian model systems, as long as the model is relevant to the shared scientific question and strengthens the overall program.
The FOA also sets clear expectations for the scientific balance across the three projects. At least one component project must be basic research conducted in an animal model system, and at least one component project must be clinical or translational in nature. In other words, applicants need to demonstrate a full pipeline that connects fundamental developmental mechanisms to human disease understanding, such as linking animal-model experiments on embryologic processes to human patient data, clinical phenotyping, genomics, or translational studies that move discoveries toward improved diagnosis, risk assessment, or mechanistic interpretation of human variants.
To reinforce integration, the three projects are expected to share more than a general topic area. They should be connected by a common developmental gene, biological process, mechanism, pathway, or phenotype. This requirement pushes applicants to design a coordinated program where each project answers a different part of a single overarching problem, for example: one project defining how a pathway shapes organ development in an animal model, another identifying or validating human genetic variants affecting that pathway, and a third translating those insights into improved clinical interpretation, genotype-phenotype relationships, or patient stratification. The shared cores are intended to support these cross-project needs, such as shared genomics, bioinformatics, imaging, phenotyping, model organism resources, or biostatistics, depending on what best enables synergy.
Eligibility is broad and includes many U.S.-based organizational types such as public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses as well as small businesses), and multiple levels of government (state, county, city/township, special districts), as well as certain housing authorities and tribal entities. The FOA also highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Foreign institutions are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible. However, foreign components as defined under the NIH Grants Policy Statement are allowed, meaning a U.S. applicant can include certain well-justified international collaborations or resources within NIH policy limits.
Administratively, this is an NIH discretionary grant opportunity using the P01 program project mechanism within the health-related funding category. The original closing date listed is 2016-12-16, with an anticipated number of awards of about two. The overarching goal is to fund a small number of highly integrated, high-impact programs that can meaningfully advance understanding of the mechanisms and genetic architecture of important human structural birth defects by deliberately connecting model organism discovery science with human clinical and translational investigation.Apply for RFA HD 17 017
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Developmental Mechanisms of Human Structural Birth Defects (P01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
- This funding opportunity was created on 2016-08-15.
- Applicants must submit their applications by 2016-12-16. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 2 candidate(s).
- 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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Frequently Asked Questions (FAQs)
1) What is this NIH funding opportunity?
This opportunity is the NIH funding announcement "Developmental Mechanisms of Human Structural Birth Defects (P01)" (RFA-HD-17-017; CFDA 93.865). It supports Program Project Grant (P01) applications focused on explaining how major congenital structural malformations arise.
2) What is the main purpose of the FOA?
The central emphasis is on understanding developmental biology and genetic causes of significant human structural birth defects. The FOA is intended to fund integrated programs that deliberately connect basic science, translational work, and clinical research to advance mechanistic understanding of human malformations.
3) What kind of grant mechanism is used?
The FOA uses the NIH P01 Program Project Grant mechanism, which is designed for large, team-based, multi-project programs with shared cores and a unifying central theme.
4) How many component research projects are required?
Each funded program project must include exactly three component research projects, plus any necessary shared cores.
5) Does the FOA require a specific structure beyond having multiple projects?
Yes. A defining feature is the required structure: exactly three component projects unified by one clear central theme, supported by shared cores that enable cross-project synergy.
6) What does NIH mean by "integration" and "synergy" in this FOA?
The FOA is designed for programs where collaboration is essential, not optional. The three projects are expected to interact, share expertise and resources, and generate a combined outcome that is stronger than three independent studies.
7) Do the three projects need to focus on the same birth defect?
Yes. The three projects should converge on a specific major developmental defect or malformation, and be unified by a single overarching theme.
8) What makes an acceptable shared scientific link across the three projects?
The projects should be connected by more than a general topic area. Acceptable shared links include a common developmental gene, biological process, mechanism, pathway, phenotype, or other tightly shared scientific focus that binds the program into one coordinated effort.
9) Are animal models required?
Yes. At least one component project must be basic research conducted in an animal model system.
10) Are clinical or translational studies required?
Yes. At least one component project must be clinical or translational in nature, demonstrating a bridge from fundamental mechanisms to human disease understanding.
11) Can the program include both basic and clinical work?
That balance is expected. Applicants need to demonstrate a full pipeline connecting developmental mechanisms (for example, embryologic processes studied in an animal model) to human patient data, clinical phenotyping, genomics, or translational studies aimed at improving diagnosis, risk assessment, or interpretation of human variants.
12) Do the animal model findings need to be comparable to humans?
Yes. The defect under study must be meaningfully comparable between humans and the chosen animal model(s). The comparability can be genetic (shared causal genes or variants), mechanistic (shared developmental pathways), biological (shared organ/tissue development processes), or phenotypic (similar observable malformation features).
13) Are non-mammalian model systems allowed?
Yes. The FOA explicitly allows either mammalian or non-mammalian model systems, as long as the model is relevant to the shared scientific question and strengthens the overall program.
14) What are "shared cores" and why are they included?
Shared cores are centralized resources intended to support multiple component projects and promote integration. The FOA anticipates cores that enable cross-project needs such as genomics, bioinformatics, imaging, phenotyping, model organism resources, or biostatistics, depending on what best drives synergy.
15) Can the three projects be independent studies on the same topic area?
No. The FOA emphasizes that the outcome should be stronger than three independent studies. Projects are expected to be coordinated, interactive, and built around shared resources and a tightly linked scientific rationale.
16) What is an example of the kind of cross-project design NIH is looking for?
The FOA describes coordinated designs such as: one project defining how a pathway shapes organ development in an animal model, another identifying or validating human genetic variants affecting that pathway, and a third translating those insights into improved clinical interpretation, genotype-phenotype relationships, or patient stratification.
17) Who can apply (in general terms)?
Eligibility is broad for U.S.-based applicant organizations. Eligible types include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses and other than small businesses), and various levels of U.S. government (state, county, city/township, and special districts), among others.
18) Are tribal and community-focused entities eligible?
Yes. The FOA highlights eligibility for tribal entities and additional categories such as Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations.
19) Are minority-serving institutions included in the eligible applicant categories?
Yes. The FOA specifically mentions categories such as HBCUs, Hispanic-serving Institutions, AANAPISIs, and other designated eligible institutional types.
20) Can foreign institutions apply as the applicant organization?
No. Foreign institutions are not eligible to apply as applicant organizations for this FOA.
21) Can a U.S. applicant include a non-U.S. component?
No. Non-U.S. components of U.S. organizations are not eligible under this FOA.
22) Are international collaborations allowed at all?
Yes, in a limited way. Foreign components (as defined under the NIH Grants Policy Statement) are allowed when included by a U.S. applicant and when they are well-justified and consistent with NIH policy limits.
23) What is the estimated number of awards?
The anticipated number of awards is about two.
24) What is the listed closing date?
The original closing date listed for this FOA is 2016-12-16.
25) What is the overall funding intent of NIH for this FOA?
NIH intends to fund a small number of highly integrated, high-impact programs that can meaningfully advance understanding of developmental mechanisms and the genetic architecture of important human structural birth defects by connecting model organism discovery science with human clinical and translational investigation.
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