Opportunity Information: Apply for PA 14 056
Apply for PA 14 056
- 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 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Jan 2, 2014 and posted on Jan 2, 2014.
- Applicants must submit their applications by Jan 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) State governments Public and State controlled institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities 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) Independent school districts City or township governments County governments Special district governments Native American tribal organizations (other than Federally recognized tribal governments).
- 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 Genetic Susceptibility - Variability of Human Structural Birth Defects (R01) funding opportunity (PA-14-056) is a National Institutes of Health (NIH) grant program designed to support investigator-initiated research that explains why structural birth defects occur, why risk differs across people and populations, and why the same defect can vary in severity or presentation. The central aim is to move beyond broad associations and pinpoint specific causes and modifiers of risk by leveraging modern tools in genetics, epigenetics, biochemistry, molecular biology, and developmental biology. A key expectation is that projects will not rely on a single approach in isolation; instead, they should intentionally combine animal model research with translational and/or clinical strategies so that discoveries made in model systems can be tested, interpreted, or validated in ways that are relevant to human pregnancy and human populations.
From a scientific scope standpoint, the FOA targets research on genetic factors (such as variants that increase vulnerability), epigenetic mechanisms (such as changes in gene regulation that may be influenced by parental exposures or in utero conditions), environmental contributors (including maternal exposures, nutrition-related factors, and other external influences), and gene-environment interactions that may explain susceptibility. The emphasis on "variability" signals interest not only in whether a defect occurs, but also in understanding modifiers that influence penetrance and expressivity, meaning why some individuals with a risk factor develop a defect while others do not, and why outcomes can range from mild to severe. Projects are expected to take advantage of advances in developmental biology and molecular methods to clarify pathways and mechanisms that link risk factors to disrupted embryonic or fetal development, with the end goal of producing insights that can inform prevention, risk stratification, or improved clinical understanding.
The activity mechanism is the NIH R01 research project grant, which generally supports mature, hypothesis-driven or strongly justified discovery-driven research programs led by independent investigators. The opportunity is categorized as discretionary and does not require cost sharing or matching funds. While the source listing includes multiple CFDA program areas (Environmental Health; Oral Diseases and Disorders Research; Alcohol Research Programs; Diabetes, Digestive, and Kidney Diseases Extramural Research; and Child Health and Human Development Extramural Research), the scientific home for this initiative is closely tied to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and its broader Birth Defects Initiative, reflecting the programmatic focus on developmental outcomes and human child health.
A defining program feature is the collaborative component: awardees are expected to join the NICHD Birth Defects Working Group. Participation includes attending annual meetings intended to share research progress, exchange ideas, coordinate around available tools or datasets, share resources, and create collaborations that accelerate progress toward the initiative's goals. In practical terms, applicants should anticipate that the program values projects that can benefit from interaction with a community of investigators working on related mechanistic and translational questions, and that the annual meetings serve as a structured forum for coordination and cross-pollination across studies.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), small businesses, and for-profit organizations (including those other than small businesses). Government entities are also eligible, including state, county, city or township, special district governments, independent school districts, and certain housing authorities. The eligibility list explicitly includes Tribal governments and organizations (federally recognized Tribal governments as well as other Tribal organizations), and it highlights a range of institution types 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 (AANAPISIs), as well as faith-based and community-based organizations. International participation is allowed: non-U.S. entities (foreign organizations and foreign institutions) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are permitted as defined in the NIH Grants Policy Statement.
Administratively, the opportunity was posted on January 2, 2014, with an original and current closing date of January 7, 2017, and an archive date of February 7, 2017, meaning the specific announcement is no longer active for new submissions in its posted form. The sponsoring agency is NIH, and the full announcement was hosted at grants.nih.gov under PA-14-056. For access issues, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is intended for technical problems with accessing or linking to the funding announcement rather than scientific or programmatic questions.
Overall, the FOA supported research programs that connect mechanistic work in animal models with human-relevant translational or clinical evidence to identify concrete genetic and non-genetic drivers of structural birth defects, with an added expectation that funded investigators participate in a coordinated working group to speed progress through shared learning and collaboration.
Frequently Asked Questions (FAQs)
What is the Genetic Susceptibility - Variability of Human Structural Birth Defects (R01) opportunity?
This is a National Institutes of Health (NIH) funding opportunity (PA-14-056) that supported investigator-initiated research aimed at explaining why structural birth defects occur, why risk differs across individuals and populations, and why the same defect can vary in severity or presentation.
What is the main scientific goal of this FOA?
The central goal is to move beyond broad statistical associations and identify specific causes and modifiers of risk for structural birth defects. The FOA emphasizes pinpointing mechanisms and pathways using modern approaches in genetics, epigenetics, biochemistry, molecular biology, and developmental biology, with results that are relevant to human pregnancy and human populations.
What does the FOA mean by "variability" in structural birth defects?
"Variability" refers to differences in whether a defect occurs and differences in how it presents. This includes understanding modifiers that affect penetrance (why some people with a risk factor develop a defect while others do not) and expressivity (why severity or clinical presentation can range from mild to severe).
What types of risk factors are within the scientific scope?
The FOA targets research on genetic factors (such as variants that increase vulnerability), epigenetic mechanisms (changes in gene regulation potentially influenced by parental exposures or in utero conditions), environmental contributors (including maternal exposures, nutrition-related factors, and other external influences), and gene-environment interactions that may explain susceptibility.
Are gene-environment interactions specifically encouraged?
Yes. The FOA explicitly calls out gene-environment interactions as an area of interest for explaining differential susceptibility to structural birth defects across people and populations.
What is the expected overall research approach?
A key expectation is that projects should not rely on a single approach in isolation. Instead, they should intentionally combine animal model research with translational and/or clinical strategies so that discoveries in model systems can be tested, interpreted, or validated in ways relevant to humans.
Does the FOA require animal models?
The FOA emphasizes combining animal model research with translational and/or clinical strategies. The expectation is that mechanistic work in model systems should be connected to human relevance through translational or clinical evidence.
Does the FOA support purely clinical studies without model systems?
Based on the stated expectations, the program prioritizes projects that integrate animal model research with translational and/or clinical strategies, rather than relying on a single approach alone.
What is meant by "translational and/or clinical strategies" in this context?
In this FOA, translational and/or clinical strategies are described as ways to test, interpret, or validate discoveries from model systems in a manner that is relevant to human pregnancy and human populations.
What funding mechanism is used for this opportunity?
The activity mechanism is the NIH R01 research project grant. This mechanism generally supports mature, hypothesis-driven research programs or strongly justified discovery-driven programs led by independent investigators.
Is cost sharing or matching required?
No. The opportunity is described as discretionary and does not require cost sharing or matching funds.
Which NIH institute or initiative is most closely tied to this FOA?
While multiple CFDA program areas are listed, the scientific home for the initiative is closely tied to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and its broader Birth Defects Initiative.
Is there a required collaborative component for awardees?
Yes. Awardees are expected to join the NICHD Birth Defects Working Group as a defining program feature.
What does participation in the NICHD Birth Defects Working Group involve?
Participation includes attending annual meetings to share research progress, exchange ideas, coordinate around tools or datasets, share resources, and create collaborations intended to accelerate progress toward the initiative's goals.
How should applicants factor the Working Group expectation into project planning?
Applicants should anticipate that the program values projects that can benefit from interaction with a community of investigators working on related mechanistic and translational questions, and that annual meetings are a structured forum for coordination and cross-pollination across studies.
What types of organizations are eligible to apply?
Eligibility is broad and includes many domestic and non-domestic organizations. Eligible applicants include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), small businesses, and for-profit organizations (including those other than small businesses).
Are government entities eligible?
Yes. Eligible government entities include state, county, city or township, special district governments, independent school districts, and certain housing authorities.
Are Tribal governments and Tribal organizations eligible?
Yes. The eligibility list explicitly includes federally recognized Tribal governments as well as other Tribal organizations.
Are specific institution types (such as MSIs) explicitly included?
Yes. The eligibility list highlights a range of institution types, including 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 (AANAPISIs), as well as faith-based and community-based organizations.
Is international participation allowed?
Yes. Non-U.S. entities (foreign organizations and foreign institutions) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are permitted as defined in the NIH Grants Policy Statement.
Is this funding opportunity still open?
No. The opportunity was posted on January 2, 2014, had an original and current closing date of January 7, 2017, and an archive date of February 7, 2017. This indicates the specific announcement is no longer active for new submissions in its posted form.
Where was the original FOA posted?
The full announcement was hosted on grants.nih.gov under the identifier PA-14-056.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
What should someone do if they have trouble accessing the FOA webpage?
For access issues (technical problems with accessing or linking to the funding announcement), the listed contact is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
Is the listed contact intended for scientific or programmatic questions?
No. The provided contact is specifically intended for technical problems with accessing or linking to the funding announcement, not for scientific or programmatic inquiries.
What kinds of outcomes or impacts does the FOA aim to enable?
The end goal described is to produce insights that can inform prevention, risk stratification, or improved clinical understanding of structural birth defects by clarifying pathways and mechanisms linking risk factors to disrupted embryonic or fetal development.
What is the overall emphasis of the program in one sentence?
The program emphasized research that connects mechanistic discoveries in animal models with human-relevant translational or clinical evidence to identify concrete genetic and non-genetic drivers of structural birth defects, alongside a coordinated working-group collaboration model to speed progress.
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