Opportunity Information: Apply for RFA AI 16 001
Apply for RFA AI 16 001
- The HHS-NIH11 in the environment, health, income security and social services sector is offering a public funding opportunity titled "Immunity in Neonates and Infants (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.313, 93.855, 93.856, 93.865.
- This funding opportunity was created on Mar 07, 2016 and posted on Mar 07, 2016.
- Applicants must submit their applications by Jul 29, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The Immunity in Neonates and Infants (U01) funding opportunity (RFA-AI-16-001) is a National Institutes of Health (NIH) cooperative agreement that supports the formation and participation of a coordinated research group focused on how the immune system develops and functions during the first year of life. The scientific emphasis is specifically on neonates (birth through 28 days) and infants (29 days through 12 months), a window when immune responses are rapidly changing and when children can be especially vulnerable to infections, allergic sensitization, and suboptimal vaccine responses. The overall aim is to move beyond broad descriptions of infant immunity and instead pinpoint the mechanisms that shape early-life immune development, including what makes neonatal and infant immune responses distinct from those in older children and adults.
Projects under this FOA are expected to investigate the biological pathways that regulate immune maturation in early life and how those pathways are influenced by common real-world exposures. The announcement highlights several major categories of triggers and modifiers of neonatal and infant immune responses: exposure to microbes that are non-pathogenic (such as early colonizing organisms that may help educate the immune system), exposure to pathogenic microbes (explicitly including HIV), responses to vaccines, exposure to allergens, and immune alterations linked to environmental pollutants. In practice, this scope allows applicants to propose studies that range from mechanistic immunology (for example, cell signaling, innate-adaptive immune crosstalk, and immune regulation) to exposure-driven research that connects environmental or microbial factors to measurable changes in immune function during this critical developmental period.
A key feature is the use of the U01 cooperative agreement mechanism, which typically indicates substantial programmatic involvement by NIH staff compared with a standard research project grant. In other words, awardees are not simply funded to run isolated projects; they are expected to operate as part of a cooperative research effort with shared goals, coordination, and collaboration across a broader group. The intent is to accelerate progress in a complex area where aligned methods, shared resources, and harmonized approaches can help produce clearer, more comparable findings across studies of early-life immunity.
The public health rationale is straightforward: stronger foundational knowledge of immune development in the first year of life can inform strategies to promote healthy immune maturation and prevent downstream problems. By clarifying how protective immunity is established (or fails to develop) in neonates and infants, the research supported by this FOA aims to contribute to reducing immune-mediated disorders, lowering susceptibility to infections and allergies, and improving the effectiveness and durability of vaccine-induced immunity in these populations. Ultimately, the opportunity is positioned to support innovative, mechanistically grounded research that can translate into better ways to guide early immune development toward protective outcomes.
Administratively, the FOA is offered by HHS/NIH (listed as HHS-NIH11) and is categorized under discretionary funding with an activity area spanning environment, health, income security, and social services. It lists multiple CFDA numbers (93.113, 93.313, 93.855, 93.856, 93.865), reflecting NIH program areas that may relate to infectious disease, immunology, child health, and allied research domains. Eligibility is broad and includes federal, state, county, and local governmental entities; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; independent school districts; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other applicants as described in the full eligibility text. The opportunity was posted and created on March 7, 2016, with a closing date of July 29, 2016.
Frequently Asked Questions (FAQs): Immunity in Neonates and Infants (U01) - RFA-AI-16-001
What is the Immunity in Neonates and Infants (U01) funding opportunity?
It is a National Institutes of Health (NIH) cooperative agreement funding opportunity (RFA-AI-16-001) that supports the formation and participation of a coordinated research group focused on how the immune system develops and functions during the first year of life.
Which agency is offering this opportunity?
The opportunity is offered by HHS/NIH (listed as HHS-NIH11).
What kind of award mechanism is used (and what does U01 mean here)?
This FOA uses the U01 cooperative agreement mechanism, which generally indicates substantial programmatic involvement by NIH staff compared with a standard research project grant. Awardees are expected to collaborate as part of a coordinated effort rather than operate as fully independent, isolated projects.
What is the main scientific focus of this FOA?
The focus is on early-life immune development and function during the first year of life, with an emphasis on identifying the mechanisms that shape neonatal and infant immunity and what makes these immune responses distinct from those in older children and adults.
What age ranges are included in the FOA definitions of neonates and infants?
Neonates are defined as birth through 28 days. Infants are defined as 29 days through 12 months.
Why does this FOA focus specifically on the first year of life?
The first year is a period when immune responses are rapidly changing and when children can be especially vulnerable to infections, allergic sensitization, and suboptimal vaccine responses. The FOA aims to move beyond broad descriptions of infant immunity and pinpoint mechanisms that drive immune maturation in this window.
What is the overall aim of the supported research?
The overall aim is to identify biological mechanisms and pathways that shape early-life immune development, including understanding how and why neonatal and infant immune responses differ from those of older children and adults.
What types of research questions are projects expected to address?
Projects are expected to investigate biological pathways that regulate immune maturation in early life and to examine how those pathways are influenced by common real-world exposures (for example, microbial exposures, vaccines, allergens, and environmental pollutants).
What exposures or modifiers of immune responses are highlighted in the FOA?
The FOA highlights several categories of triggers and modifiers of neonatal and infant immune responses, including: non-pathogenic microbes (such as early colonizing organisms), pathogenic microbes (explicitly including HIV), responses to vaccines, exposure to allergens, and immune alterations linked to environmental pollutants.
Does the FOA include both mechanistic immunology and exposure-driven studies?
Yes. The scope allows applicants to propose mechanistic immunology studies (such as cell signaling, innate-adaptive immune crosstalk, and immune regulation) as well as exposure-driven research that connects environmental or microbial factors to measurable changes in immune function during early life.
Is HIV specifically within scope as a pathogen of interest?
Yes. The FOA explicitly includes HIV within the category of pathogenic microbes relevant to neonatal and infant immune responses.
Are vaccine-related immune responses part of the FOA scope?
Yes. Responses to vaccines are explicitly called out as one of the major categories affecting neonatal and infant immune responses.
Are allergies and allergen exposure included in the scope?
Yes. Exposure to allergens is specifically highlighted as a category of triggers/modifiers of neonatal and infant immune responses.
Do environmental pollutants fall within the scope of the FOA?
Yes. The FOA includes immune alterations linked to environmental pollutants as an area of interest.
What is meant by forming a coordinated research group?
The FOA supports the formation and participation of a coordinated research group with shared goals, coordination, and collaboration across a broader group. The intent is to accelerate progress by encouraging aligned methods, shared resources, and harmonized approaches that make results clearer and more comparable across studies.
How does NIH involvement differ under a cooperative agreement compared with a typical grant?
Under a U01 cooperative agreement, NIH staff typically have substantial programmatic involvement. Based on the FOA description, awardees are expected to work within a cooperative research effort rather than conduct entirely standalone projects.
What public health problems is this FOA trying to address?
By improving foundational knowledge of immune development in the first year of life, the FOA aims to support research that can inform strategies to promote healthy immune maturation, reduce immune-mediated disorders, lower susceptibility to infections and allergies, and improve the effectiveness and durability of vaccine-induced immunity in neonates and infants.
What is the anticipated impact or long-term goal of the research supported?
The opportunity is positioned to support innovative, mechanistically grounded research that can translate into better ways to guide early immune development toward protective outcomes, including better protection against infections, fewer allergies, and stronger vaccine responses in early life.
What is the funding category for this opportunity?
It is categorized as discretionary funding.
What activity area is associated with this funding opportunity?
The activity area spans environment, health, income security, and social services.
Which CFDA numbers are listed for this FOA?
The FOA lists multiple CFDA numbers: 93.113, 93.313, 93.855, 93.856, and 93.865.
Who is eligible to apply?
Eligibility is broad and includes: federal, state, county, and local governmental entities; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; independent school districts; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other applicants as described in the full eligibility text.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are included, and small businesses are also listed as eligible.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are included in the eligible applicant types.
Are educational institutions eligible?
Yes. Both public and private institutions of higher education are included as eligible applicants.
Are government entities eligible to apply?
Yes. Federal, state, county, and local governmental entities are listed as eligible.
When was this opportunity posted and created?
The opportunity was posted and created on March 7, 2016.
What was the closing date for this opportunity?
The closing date listed is July 29, 2016.
What is the official identifier of this funding opportunity?
The FOA is identified as RFA-AI-16-001, titled Immunity in Neonates and Infants (U01).
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