Opportunity Information: Apply for PA 11 085

  • The National Institutes of Health in the environment food and nutrition health income security and social services sector is offering a public funding opportunity titled "Genetic Susceptibility Variability of Human Structural Birth Defects (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113 Environmental Health 93.121 Oral Diseases and Disorders Research 93.273 Alcohol Research Programs 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research.
  • This funding opportunity was created on Jan 2, 2014 and posted on Dec 22, 2010.
  • Applicants must submit their applications by Jan 2, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses For profit organizations other than small businesses State governments Native American tribal governments (Federally recognized) County governments City or township governments Independent school districts 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) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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.
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Opportunity Summary:

The NIH funding opportunity titled "Genetic Susceptibility - Variability of Human Structural Birth Defects (R01)" (Funding Opportunity Number PA-11-085) was designed to support investigator-initiated R01 research projects that dig into why structural birth defects occur and why their severity and presentation can vary so much across individuals and populations. The central goal is to identify specific drivers of susceptibility and variability, including genetic factors, epigenetic changes, environmental exposures, and gene-by-environment interactions. The FOA emphasizes approaches that combine strong mechanistic work in animal models with translational and/or clinical strategies, reflecting an expectation that basic developmental biology discoveries will be connected to human relevance rather than remaining purely descriptive or model-specific.

A key theme of the opportunity is leveraging modern advances in genetics, biochemistry, molecular biology, and developmental biology to move beyond broad associations and toward specific causal pathways. In practice, this points to studies that can pinpoint variants, regulatory mechanisms, molecular pathways, or exposure-triggered biological changes that alter developmental outcomes. The FOA’s framing around both "susceptibility" and "variability" signals interest not only in what initiates a defect, but also in what modifies risk, penetrance, expressivity, and phenotypic range. Projects could reasonably span discovery of candidate factors, functional validation in model systems, and translation of those findings into clinically meaningful hypotheses or biomarkers.

The announcement also builds in a collaborative component through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Awardees were expected to join the NICHD Birth Defects Working Group and take part in annual meetings intended to share progress, exchange ideas, and develop common resources and collaborations aligned with NICHD’s broader Birth Defects Initiative. That structure suggests the program was meant to create a research community working on complementary pieces of a shared problem, encouraging standardization where useful, cross-lab validation, and faster dissemination of tools, datasets, or model systems.

From an administrative standpoint, this was a discretionary grant opportunity using the NIH R01 mechanism, with no cost sharing or matching requirement. The Agency listed is the National Institutes of Health. The program was posted on December 22, 2010, with a listed original closing date of January 7, 2014, a current closing date of January 2, 2014, and an archive date of February 2, 2014, meaning it is no longer an active opportunity but remains available for reference. The FOA was associated with multiple CFDA program areas, including Child Health and Human Development Extramural Research (93.865) and other related research categories spanning environmental health, oral diseases, alcohol research, diabetes/digestive/kidney research, and neuroscience, reflecting the cross-cutting relevance of developmental defects across organ systems and exposure pathways.

Eligibility was broad and included many types of domestic organizations and some international participation. Eligible applicants included small businesses, other for-profit organizations, state and local governments (including counties, cities/townships, school districts, and special districts), tribal governments and tribal organizations (federally recognized and other than federally recognized), public housing authorities/Indian housing authorities, nonprofits (including both 501(c)(3) and non-501(c)(3) entities), and public or private institutions of higher education. The eligibility notes also referenced additional groups such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions, as well as non-U.S. entities (foreign organizations). Overall, the eligibility language indicates NIH intended to allow a wide range of capable research performers to propose projects, provided they could meet the scientific and administrative requirements of an R01.

For applicants seeking the original full text, the FOA link provided was http://grants.nih.gov/grants/guide/pa-files/PA-11-085.html. The contact information included the NIH Office of Extramural Research (OER) webmaster email (FBOWebmaster@OD.NIH.GOV) for technical issues accessing or linking to the announcement.

Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this NIH grant?

The opportunity is titled "Genetic Susceptibility - Variability of Human Structural Birth Defects (R01)" and the Funding Opportunity Number (FOA number) is PA-11-085.

Which agency offered this funding opportunity?

The agency listed for this opportunity is the National Institutes of Health (NIH).

What type of award mechanism does this opportunity use?

This opportunity used the NIH R01 mechanism and was described as a discretionary grant supporting investigator-initiated research projects.

What is the main purpose of this FOA?

The central goal was to support R01 research projects that investigate why structural birth defects occur and why their severity and presentation vary across individuals and populations, with an emphasis on identifying specific drivers of susceptibility and variability.

What does the FOA mean by "susceptibility" and "variability"?

Based on the FOA framing provided, "susceptibility" refers to factors that influence risk of developing a structural birth defect, while "variability" refers to factors that modify outcomes such as penetrance, expressivity, severity, and the overall phenotypic range observed across people and populations.

What scientific factors and drivers were of interest in this program?

The FOA highlighted interest in genetic factors, epigenetic changes, environmental exposures, and gene-by-environment interactions as potential drivers of both susceptibility and variability in structural birth defects.

What kinds of research approaches did the FOA emphasize?

The FOA emphasized approaches that combine strong mechanistic work in animal models with translational and/or clinical strategies, reflecting an expectation that basic developmental biology discoveries would be connected to human relevance rather than remaining purely descriptive or limited to model-specific observations.

How did the FOA encourage moving beyond broad associations?

The FOA pointed toward leveraging modern advances in genetics, biochemistry, molecular biology, and developmental biology to move beyond broad associations and toward specific causal pathways, including studies that can pinpoint variants, regulatory mechanisms, molecular pathways, or exposure-triggered biological changes that alter developmental outcomes.

What is meant by translational and/or clinical strategies in this context?

In the context provided, translational and/or clinical strategies refer to work that connects mechanistic findings (often generated in model systems) to human relevance, such as generating clinically meaningful hypotheses or identifying potential biomarkers informed by validated developmental mechanisms.

Is participation in any program-wide group or meetings expected?

Yes. Awardees were expected to join the NICHD Birth Defects Working Group and participate in annual meetings intended to share progress, exchange ideas, and develop common resources and collaborations aligned with NICHD's broader Birth Defects Initiative.

Which NIH institute is specifically mentioned as part of the collaborative component?

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is specifically mentioned, including expectations around the NICHD Birth Defects Working Group and annual meetings.

What is the intended benefit of the NICHD Birth Defects Working Group structure?

The structure suggests the program aimed to create a research community working on complementary aspects of shared problems, encouraging collaboration, potential standardization where useful, cross-lab validation, and faster dissemination of tools, datasets, or model systems.

Does this opportunity require cost sharing or matching funds?

No. The administrative details provided state there was no cost sharing or matching requirement.

Is this funding opportunity still open for applications?

No. The listing indicates it is no longer an active opportunity and remains available for reference.

What are the key dates (posted, closing, and archive) for this FOA?

The program was posted on December 22, 2010. It lists an original closing date of January 7, 2014, a current closing date of January 2, 2014, and an archive date of February 2, 2014.

What CFDA program areas were associated with this FOA?

The FOA was associated with multiple CFDA program areas, including Child Health and Human Development Extramural Research (93.865) and other related research categories spanning environmental health, oral diseases, alcohol research, diabetes/digestive/kidney research, and neuroscience.

What does it mean that multiple CFDA areas are listed?

Based on the description provided, the multiple CFDA areas reflect the cross-cutting relevance of structural birth defects across organ systems and exposure pathways, and the fact that related scientific questions can intersect several NIH research domains.

Who is eligible to apply for this R01 opportunity?

Eligibility was broad and included many types of domestic organizations and some international participation. Eligible applicants included small businesses, other for-profit organizations, state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), and public or private institutions of higher education, as well as other groups specifically referenced in the eligibility notes.

Are small businesses and for-profit organizations eligible?

Yes. The eligibility list explicitly includes small businesses and other for-profit organizations.

Are government entities eligible to apply?

Yes. The eligibility list includes state and local governments (including counties, cities/townships, school districts, and special districts), as well as tribal governments and related tribal organizations.

Are nonprofit organizations eligible?

Yes. The eligibility list includes nonprofits, including both 501(c)(3) and non-501(c)(3) organizations.

Are colleges and universities eligible?

Yes. The eligibility list includes public or private institutions of higher education and also references additional institution types such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.

Are faith-based or community-based organizations eligible?

Yes. The eligibility notes referenced faith-based or community-based organizations among the eligible applicants.

Are U.S. territories or possessions included in the eligibility language?

Yes. The eligibility notes referenced U.S. territories or possessions and also mentioned regional organizations.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. The eligibility language referenced non-U.S. entities (foreign organizations), indicating some level of international participation was allowed.

Where can applicants find the original full text of the FOA?

The FOA link provided is: http://grants.nih.gov/grants/guide/pa-files/PA-11-085.html

Who should be contacted for technical issues accessing or linking to the FOA?

The contact listed for technical issues accessing or linking to the announcement is the NIH Office of Extramural Research (OER) webmaster email: FBOWebmaster@OD.NIH.GOV

What kinds of project scope could fit this FOA based on the description?

Based on the description provided, projects could span discovery of candidate susceptibility or modifier factors, functional validation in model systems, and translation of those findings into clinically meaningful hypotheses or potential biomarkers, especially when tied to specific causal pathways and human relevance.

Does the FOA prioritize purely descriptive studies?

The emphasis described suggests the FOA expected more than purely descriptive or model-specific findings. It highlighted connecting mechanistic work to translational and/or clinical relevance and moving toward specific causal pathways.

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