Opportunity Information: Apply for PAR 13 285
Apply for PAR 13 285
- 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 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Jul 25, 2013 and posted on Jul 25, 2013.
- Applicants must submit their applications by Sep 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Small businesses County governments Independent school districts Private institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments For profit organizations other than small businesses Special district 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 Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
- 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH Funding Opportunity Announcement PAR-13-285, titled "Developmental Mechanisms of Human Structural Birth Defects (P01)," supports program project (P01) grants aimed at uncovering how congenital structural malformations arise, with a strong emphasis on developmental biology and human genetics. The opportunity is designed for teams that can work across disciplines and intentionally connect basic science discoveries to translational and clinical questions. The goal is not simply to run several related projects in parallel, but to build an interactive, synergistic program where the combined work produces insights that would be difficult to achieve through separate, independent studies.
A central feature of this FOA is the required integration of animal-model research with human-focused clinical or translational research. Each application must include at least one project that performs basic research using an animal model system, and at least one project that is clinical or translational in nature. The expectation is that investigators will use animal models to test developmental mechanisms, pathways, and candidate genes in ways that are experimentally tractable, while human studies ground the work in real-world patient biology and clinical relevance. The program should focus on a specific structural malformation or a defined class of anomalies, and the condition chosen must be comparable between animals and humans in a meaningful way, such as shared genetics, conserved developmental mechanisms, similar biological pathways, or closely aligned phenotypes. In other words, the unifying theme needs to be something that truly translates across species rather than a loose association.
To control costs and keep programs tightly focused, each P01 under this announcement is limited in structure. The required configuration is three main research projects supported by shared cores, with the option to add a smaller developmental or pilot project. This structure signals that NIH wants applications that are coherent and tightly coordinated, with cores providing essential shared resources (for example, specialized assays, animal-model support, imaging, biostatistics, genomics, or clinical coordination) that enable strong cross-project integration. The optional developmental/pilot component is meant to seed new directions, generate preliminary data, or bring in novel technologies that can enhance the overall program without expanding the grant into an overly large collection of loosely related efforts.
From an eligibility standpoint, the FOA is broad and open to many types of domestic applicants, including public and private institutions of higher education, nonprofits with or without 501(c)(3) status, state and local governments, tribal governments and tribal organizations, public housing authorities, special district governments, independent school districts, and for-profit organizations (including small businesses and other for-profits). The announcement also highlights eligibility for a range of mission-driven and capacity-building institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, among others. Foreign (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components are allowed as defined by NIH policy, which typically means limited, justified international collaboration within an otherwise eligible U.S.-based application.
Administratively, this is an NIH discretionary grant opportunity in the health and human development space, tied to CFDA 93.865 (Child Health and Human Development Extramural Research), and it does not require cost sharing or matching. The FOA was posted July 25, 2013, and its final due date was September 7, 2016, with an archive date of October 8, 2016, indicating it is no longer active for new submissions under that specific announcement. The full archived announcement is available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/pa-files/PAR-13-285.html, and the NIH Office of Extramural Research webmaster contact is provided for access or technical linking issues.
In practical terms, the strongest proposals for this FOA would be expected to present a sharply defined birth-defect focus, a clear mechanistic hypothesis about developmental disruption, and a plan showing how the three projects and shared cores work together as a single program. Reviewers would be looking for true synergy, such as human genetic findings driving targeted experiments in animal models, animal-model mechanistic results informing biomarker development or clinical stratification, and shared resources that accelerate all projects while reinforcing the common theme.
Frequently Asked Questions (FAQs)
What is NIH FOA PAR-13-285?
PAR-13-285 is an NIH Funding Opportunity Announcement titled "Developmental Mechanisms of Human Structural Birth Defects (P01)." It supports Program Project (P01) grants focused on understanding how congenital structural malformations arise, with a strong emphasis on developmental biology and human genetics.
What is the main purpose of this funding opportunity?
The purpose is to uncover developmental mechanisms behind human structural birth defects by building an interactive, cross-disciplinary research program that intentionally connects basic science to translational and clinical questions. The expectation is that the combined program generates insights that would be difficult to achieve through separate, independent studies.
What kind of grant mechanism does this FOA use?
This opportunity uses the NIH Program Project Grant mechanism (P01), which is designed to support multiple, closely related projects that share a unifying theme and operate as a coordinated, synergistic program.
What does NIH mean by an "interactive, synergistic program" in this FOA?
This FOA is not aiming to fund several related projects running in parallel. Instead, it expects meaningful integration across projects, where discoveries and resources are shared, findings in one project drive experiments in another, and the overall program produces outcomes that are greater than the sum of its parts.
Is integration of animal model research and human research required?
Yes. A central feature of PAR-13-285 is required integration between animal-model research and human-focused clinical or translational research.
How many animal and human-focused projects must be included?
Each application must include at least one project that performs basic research using an animal model system and at least one project that is clinical or translational in nature.
Why does the FOA require both animal-model and human clinical/translational projects?
The FOA expects animal models to enable experimentally tractable testing of developmental mechanisms, pathways, and candidate genes, while human studies ensure the work is grounded in patient biology and clinical relevance.
What research focus is expected for the overall program?
The program should focus on a specific structural malformation or a defined class of anomalies, rather than a broad or loosely connected set of birth defects.
How should the chosen birth defect translate across animals and humans?
The condition must be comparable between animals and humans in a meaningful way. Examples of meaningful comparability described in the FOA include shared genetics, conserved developmental mechanisms, similar biological pathways, or closely aligned phenotypes. The unifying theme should genuinely translate across species rather than being a loose association.
What is the required overall structure of a P01 application under this FOA?
To control costs and keep programs tightly focused, each P01 under this announcement is limited to three main research projects supported by shared cores, with the option to add a smaller developmental or pilot project.
Are shared cores required, and what are they for?
Yes. Shared cores are part of the required structure and are intended to provide essential shared resources that enable strong cross-project integration and efficiency across the program.
What are examples of shared core functions mentioned or implied in the FOA description?
Examples include specialized assays, animal-model support, imaging, biostatistics, genomics, and clinical coordination. The core concept is that these resources should materially support multiple projects and strengthen integration around the program theme.
Is a developmental or pilot project required?
No. The developmental/pilot component is optional.
What is the purpose of the optional developmental/pilot project?
Its purpose is to seed new directions, generate preliminary data, or bring in novel technologies that enhance the overall program without turning the P01 into a large collection of loosely related efforts.
What types of organizations are eligible to apply?
Eligibility is broad for domestic applicants and includes public and private institutions of higher education, nonprofits with or without 501(c)(3) status, state and local governments, tribal governments and tribal organizations, public housing authorities, special district governments, independent school districts, and for-profit organizations (including small businesses and other for-profits).
Are mission-driven or capacity-building institutions specifically noted as eligible?
Yes. The announcement highlights eligibility for institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, among others.
Are foreign (non-U.S.) organizations eligible to apply?
No. Foreign (non-U.S.) entities are not eligible to apply under this announcement.
Can a U.S. organization include non-U.S. components?
Non-U.S. components of U.S. organizations are not eligible to apply as applicants under this FOA. However, foreign components are allowed as defined by NIH policy, which generally means limited, justified international collaboration within an otherwise eligible U.S.-based application.
Does this FOA require cost sharing or matching?
No. The announcement specifies that it does not require cost sharing or matching.
What NIH/CFDA program area is associated with this opportunity?
This is an NIH discretionary grant opportunity in the health and human development space and is tied to CFDA 93.865 (Child Health and Human Development Extramural Research).
Is PAR-13-285 still open for new submissions?
No. The FOA has a final due date of September 7, 2016, and an archive date of October 8, 2016, indicating it is no longer active for new submissions under that specific announcement.
Where can the archived FOA be found?
The archived announcement is available through the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-13-285.html
Who is the contact for access or technical linking issues related to the announcement?
The NIH Office of Extramural Research webmaster contact is provided in the announcement for access or technical linking issues.
What would reviewers likely look for in a strong application (based on the FOA description provided)?
The description suggests that strong proposals would present: (1) a sharply defined birth-defect focus, (2) a clear mechanistic hypothesis about developmental disruption, and (3) a plan demonstrating how the three projects and shared cores function together as a single integrated program.
What are examples of "synergy" that fit the FOA's expectations?
Examples described include human genetic findings driving targeted experiments in animal models, animal-model mechanistic results informing biomarker development or clinical stratification, and shared resources that accelerate all projects while reinforcing the common theme.
Is the goal to fund multiple independent studies under one umbrella?
No. The FOA emphasizes that the goal is not simply to run several related projects in parallel. The expectation is coordinated, interactive work that produces integrated insights.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 13 285) also looked into and applied for these:
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| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01) Apply for PAR 13 325 Funding Number: PAR 13 325 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R03) Apply for PAR 13 344 Funding Number: PAR 13 344 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43) Apply for PAR 13 345 Funding Number: PAR 13 345 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41) Apply for PAR 13 346 Funding Number: PAR 13 346 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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| Enhancing the Capacity for Biomedical Research on Tuberculosis for HIV infected Mothers and Children in India (R01) Apply for RFA HD 14 025 Funding Number: RFA HD 14 025 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $350,000 |
| Developmental Origins of Health and Disease (DOHaD) Epigenetic Modification in Gametogenesis and Transgenerational Inheritance (R01) Apply for PAR 13 385 Funding Number: PAR 13 385 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Female Contraceptive Development Program (U01) Apply for RFA HD 14 024 Funding Number: RFA HD 14 024 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
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| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01) Apply for PAR 13 389 Funding Number: PAR 13 389 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42) Apply for RFA HD 14 032 Funding Number: RFA HD 14 032 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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| Juvenile Protective Factors and Their Effects on Aging (R03) Apply for PAR 14 022 Funding Number: PAR 14 022 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
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