Opportunity Information: Apply for RFA HD 16 009
Apply for RFA HD 16 009
- 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 15, 2015 and posted on Jul 15, 2015.
- Applicants must submit their applications by Nov 18, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,330,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments County governments Independent school districts City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities State governments Small businesses Public and State controlled institutions of higher education For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) 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 RFA-HD-16-009, titled "Developmental Mechanisms of Human Structural Birth Defects (P01)," was a discretionary grant program designed to fund a small number of highly integrated Program Project Grants (P01s) focused on major congenital structural malformations. The central goal was to push understanding of the developmental biology and genetic underpinnings of significant human birth defects by bringing together basic science, translational work, and clinical research in a coordinated, team-based structure. The emphasis was not on a collection of loosely related studies, but on a tightly connected program where the parts inform each other and collectively answer a shared set of mechanistic questions about a specific malformation.
A defining feature of this FOA was its required structure and synergy. To control costs and keep programs cohesive, each proposed P01 was limited to exactly three component research projects, supported by shared cores as needed. The three projects had to be scientifically interdependent and aligned around a single central theme, focus, or objective tied to a particular major developmental defect. Importantly, the defect under study needed to be meaningfully comparable between humans and an animal model, whether through shared genetics, shared developmental mechanisms, shared biology, or closely analogous phenotypes. Any mammalian or non-mammalian animal model could be used, as long as it clearly advanced the overarching program theme and strengthened the connection to human disease.
The FOA also required balance across the research spectrum. At least one project had to involve basic research in an animal model system, ensuring that developmental mechanisms could be interrogated experimentally. At least one project had to be clinical or translational, ensuring that the program remained anchored to human malformations and that findings could be connected to patients, clinical observations, and ultimately potential pathways toward diagnosis, risk assessment, or intervention. The intention was to support programs where animal model work and human-focused research continuously cross-inform one another, rather than operating in parallel.
Responsiveness criteria were strict and revolved around shared mechanism. Applications would be considered nonresponsive if the three component projects did not converge on a common developmental gene, process, mechanism, pathway, or phenotype. In other words, simply studying "birth defects" in general or assembling projects that were broadly related to development would not meet the FOA's requirements. NIH was looking for a coherent mechanistic storyline across projects, where the same core biological question is examined through complementary approaches, such as genetic discovery in patients, mechanistic testing in an animal model, and translational validation using human tissues, imaging, biomarkers, or clinically relevant endpoints.
In terms of funding scope, NIH anticipated making about two awards under this announcement, with an estimated total funding level of approximately $3.33 million and an award ceiling of $1.0 million (as listed in the source data). There was no cost-sharing or matching requirement. The opportunity was posted July 15, 2015, with an original and current closing date of November 18, 2015, and it was archived on December 19, 2015. The associated CFDA number was 93.865 (Child Health and Human Development Extramural Research), reflecting the NICHD mission area within NIH.
Eligibility was broad across U.S.-based organizations and included public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses, along with a range of mission-based institutional categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations were not eligible to apply; however, "foreign components" as defined in the NIH Grants Policy Statement were allowed, meaning a U.S. applicant could include certain types of international collaboration when justified and compliant with NIH policy.
Overall, this FOA was aimed at funding a small set of well-coordinated research programs that use the strengths of multidisciplinary teams to connect human genetics and clinical insight with experimentally testable developmental biology in animal systems. The desired endpoint was deeper, mechanistically grounded understanding of how and why specific structural birth defects occur, with the kind of cross-project integration that is difficult to achieve through single-project grants.
FAQs: NIH RFA-HD-16-009 (Developmental Mechanisms of Human Structural Birth Defects (P01))
What is RFA-HD-16-009?
RFA-HD-16-009 was an NIH funding opportunity announcement (FOA) titled "Developmental Mechanisms of Human Structural Birth Defects (P01)." It supported Program Project Grants (P01s) aimed at understanding the developmental biology and genetic underpinnings of major congenital structural malformations through highly integrated, team-based research programs.
What type of grant mechanism did this FOA use?
This opportunity used the NIH Program Project Grant (P01) mechanism and was described as a discretionary grant program intended to fund a small number of integrated programs rather than a set of separate, loosely connected studies.
What was the main goal of the program?
The central goal was to advance mechanistic understanding of significant human structural birth defects by linking basic science, translational research, and clinical research within a coordinated program where each part informs the others.
What kinds of birth defects were the focus?
The FOA focused on major congenital structural malformations. It emphasized programs organized around a particular major developmental defect, not birth defects in general.
How was a P01 application required to be structured?
Each proposed P01 was limited to exactly three component research projects. Shared cores could be included as needed to support the projects and facilitate integration across the program.
How many research projects were allowed in each P01?
Exactly three component research projects were required. The FOA did not describe flexibility above or below three projects; the structure requirement was stated as exactly three.
Did the three projects need to be related?
Yes. The three projects had to be scientifically interdependent and aligned around a single central theme, focus, or objective tied to a specific major developmental defect. The FOA emphasized synergy and interdependence rather than parallel or loosely related work.
What did NIH mean by "synergy" or "integration" in this FOA?
Integration meant the projects collectively answer a shared set of mechanistic questions and continuously cross-inform one another. The FOA expected a cohesive mechanistic storyline across projects rather than a collection of independent studies that merely share a broad topic.
Was an animal model required?
Yes. At least one project had to involve basic research in an animal model system so that developmental mechanisms could be tested experimentally.
Were clinical or translational studies required?
Yes. At least one project had to be clinical or translational to keep the overall program anchored to human malformations and connected to patient-facing observations or clinically relevant endpoints.
What balance across research types was expected?
The FOA required a balance across the research spectrum by mandating at least one basic animal-model project and at least one clinical/translational project, with an overall expectation that human-focused research and animal-model work would cross-inform each other.
Did the FOA require that the defect be comparable between humans and an animal model?
Yes. The malformation under study needed to be meaningfully comparable between humans and an animal model, such as through shared genetics, shared developmental mechanisms, shared biology, or closely analogous phenotypes.
What kinds of animal models were allowed?
Any mammalian or non-mammalian animal model could be used, as long as it clearly advanced the overarching program theme and strengthened the connection to the human defect being studied.
What made an application "nonresponsive" under this FOA?
Applications would be considered nonresponsive if the three component projects did not converge on a common developmental gene, process, mechanism, pathway, or phenotype. Programs that broadly studied development or birth defects without a shared mechanistic focus across projects would not meet the responsiveness criteria.
What kind of scientific coherence was NIH looking for?
NIH was looking for a program where the same core biological question is examined via complementary approaches across the three projects, for example combining genetic discovery in patients, mechanistic testing in an animal model, and translational validation using human tissues, imaging, biomarkers, or clinically relevant endpoints.
How many awards were expected?
NIH anticipated making about two awards under this announcement.
What was the estimated total funding for this FOA?
The estimated total funding level was approximately $3.33 million, as stated in the provided information.
Was there an award ceiling?
Yes. The source data listed an award ceiling of $1.0 million.
Was cost-sharing or matching required?
No. There was no cost-sharing or matching requirement stated for this FOA.
When was the opportunity posted and when did it close?
The opportunity was posted on July 15, 2015. The original and current closing date was November 18, 2015.
Is this FOA still active?
No. It was archived on December 19, 2015, based on the information provided.
What was the CFDA number associated with this opportunity?
The associated CFDA number was 93.865 (Child Health and Human Development Extramural Research).
Which NIH mission area was this tied to?
The CFDA number and description indicate alignment with NICHD (Eunice Kennedy Shriver National Institute of Child Health and Human Development) within NIH.
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations and included public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses. It also included mission-based institutional categories such as HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations.
Were non-U.S. (foreign) institutions eligible to apply as applicants?
No. Non-U.S. (foreign) institutions were not eligible to apply, and non-U.S. components of U.S. organizations were not eligible to apply as applicants.
Could the program include international collaboration?
Yes, in a limited way. While foreign institutions could not apply as the applicant organization, "foreign components" (as defined in the NIH Grants Policy Statement) were allowed, meaning a U.S. applicant could include certain international components when justified and compliant with NIH policy.
What was the overall purpose of using a P01 structure for this topic?
The P01 structure was used to support a small number of well-coordinated research programs where multidisciplinary teams could tightly connect human genetics and clinical insight with experimentally testable developmental biology in animal systems, enabling a level of cross-project integration that is difficult to achieve through single-project grants.
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