Opportunity Information: Apply for PA 18 839
The National Institutes of Health (NIH) announced this grant opportunity (Funding Opportunity Number PA-18-839) to support exploratory research on how the gut microbiome may influence female reproduction and fertility, including in women living with HIV and women without HIV. Using the R21 mechanism, the FOA is designed to encourage innovative, early-stage, and potentially high-impact projects that can generate foundational evidence about microbiome-driven pathways affecting reproductive function. Clinical trials are optional under this announcement, meaning applicants can propose either basic/mechanistic human studies, observational or translational research, or clinical research that may include an intervention, as long as it fits the R21 scope.
The core scientific focus is on understanding whether and how gut microbial communities regulate metabolism and reproductive biology, with particular attention to communication between the gut and key neuroendocrine systems in the brain. The FOA highlights three major hormonal regulatory pathways: the hypothalamic-pituitary-gonadal (HPG) axis, which governs reproductive hormones and ovarian function; the hypothalamic-pituitary-adrenal (HPA) axis, which mediates stress responses that can disrupt menstrual cycling and fertility; and the hypothalamic-pituitary-thyroid (HPT) axis, which influences energy balance and metabolic health and can indirectly affect reproductive capacity. The broader idea is that microbial metabolites, immune signaling, inflammation, and microbiome-related metabolic shifts may alter these axes in ways that contribute to subfertility or infertility, and that these effects may differ by HIV status due to immune activation, antiretroviral therapy effects, comorbid infections, and systemic inflammation.
A major expected payoff from funded work is the identification of diagnostic markers, sometimes described as "signature microbiomes," that correlate with reproductive or metabolic failure. In practical terms, that could mean characterizing patterns of gut bacteria, microbial gene functions, or microbial metabolites associated with outcomes such as disrupted ovulation, diminished ovarian reserve, irregular cycles, infertility, or adverse metabolic profiles that often track with reproductive dysfunction. The FOA also frames the microbiome as a potential upstream contributor to conditions that commonly intersect with fertility challenges, including obesity and metabolic syndrome, stress-related disorders, infection, and anxiety. Because these conditions are common and biologically intertwined with neuroendocrine regulation, the announcement encourages research that can connect microbial features to hormonal signaling, immune status, metabolic markers, and reproductive endpoints in a coherent mechanistic model.
Programmatically, the opportunity is relevant to several NICHD-related areas, especially those within the Fertility and Infertility Branch. Examples named in the FOA include basic ovarian biology, fertility preservation, assisted reproductive technology, spermatogenesis and sperm function, and therapeutic interventions for infertility, reflecting interest in microbiome impacts across the broader reproductive landscape even when the title emphasizes women. The announcement also signals alignment with interests in maternal and pediatric infectious disease and pediatric growth and nutrition, as well as related institutes and centers, because microbiome-driven effects on metabolism, immunity, and infection risk can span reproductive health and broader population health concerns, particularly in the context of HIV.
In terms of funding structure and eligibility, this is a discretionary NIH grant under CFDA 93.865, with an award ceiling listed at $200,000. A wide range of organizations may apply, including state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, as well as tribal governments and tribal organizations. The FOA explicitly notes additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISI institutions, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, and non-U.S. entities and regional organizations. The source information lists an original closing date of September 7, 2021, and a creation date of June 26, 2018, which helps place the announcement in time for anyone checking whether the opportunity is active, reissued, or superseded by a newer NIH notice.
Overall, the FOA is essentially a call for creative, rigorous studies that clarify whether the gut microbiome is a meaningful regulator of reproductive endocrinology and fertility, how those effects interface with metabolic and stress systems, and whether HIV status changes the biology or the clinical implications. The long-term vision is to move from correlation to mechanism and, eventually, toward practical tools such as microbiome-based biomarkers for risk stratification and, potentially, microbiome-informed prevention or treatment strategies for reproductive and metabolic dysfunction.Apply for PA 18 839
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Role of Gut Microbiome in Regulating Reproduction and Its Impact on Fertility Status in Women Living with and Without HIV (R21 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
- This funding opportunity was created on 2018-06-26.
- Applicants must submit their applications by 2021-09-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- 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.
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Frequently Asked Questions (FAQs)
What is this NIH funding opportunity (PA-18-839) about?
This NIH Funding Opportunity Announcement (FOA), PA-18-839, supports exploratory research on how the gut microbiome may influence female reproduction and fertility. It includes research relevant to women living with HIV as well as women without HIV, and it emphasizes early-stage, innovative projects that can produce foundational evidence about microbiome-driven pathways affecting reproductive function.
What grant mechanism does the FOA use?
The FOA uses the NIH R21 mechanism, which is designed to support exploratory and potentially high-impact projects, particularly those that are early-stage or proof-of-concept in nature.
Are clinical trials required under this FOA?
No. Clinical trials are optional. Applicants may propose studies that are basic/mechanistic in humans, observational, translational, or clinical research that may include an intervention, as long as the project fits within the scope of an R21.
What is the main scientific focus of the research supported by this FOA?
The core focus is to understand whether and how gut microbial communities regulate metabolism and reproductive biology, including potential communication between the gut and neuroendocrine systems in the brain. The FOA highlights the possibility that microbial metabolites, immune signaling, inflammation, and microbiome-related metabolic shifts may alter reproductive function.
Which neuroendocrine pathways are specifically highlighted in the FOA?
The FOA highlights three hormonal regulatory pathways as major areas of interest:
- Hypothalamic-pituitary-gonadal (HPG) axis: governs reproductive hormones and ovarian function.
- Hypothalamic-pituitary-adrenal (HPA) axis: mediates stress responses that can disrupt menstrual cycling and fertility.
- Hypothalamic-pituitary-thyroid (HPT) axis: influences energy balance and metabolic health and can indirectly affect reproductive capacity.
How does the FOA connect the gut microbiome to fertility and reproductive outcomes?
The FOA frames the microbiome as a potential regulator of reproductive endocrinology and fertility through mechanisms such as microbial metabolites, immune activity, inflammation, and shifts in metabolism. These microbiome-related factors may influence hormonal signaling and neuroendocrine regulation, contributing to subfertility or infertility.
Does the FOA address differences between women with HIV and women without HIV?
Yes. The FOA includes interest in how microbiome effects on reproduction and fertility may differ by HIV status, including potential influences from immune activation, antiretroviral therapy effects, comorbid infections, and systemic inflammation.
What kinds of outcomes or conditions does the FOA mention as relevant to study?
The FOA references reproductive and metabolic outcomes that may be linked to microbiome features, including disrupted ovulation, diminished ovarian reserve, irregular menstrual cycles, infertility, and adverse metabolic profiles that often track with reproductive dysfunction.
What does the FOA mean by "signature microbiomes" or diagnostic markers?
The FOA anticipates that funded research could identify diagnostic markers or "signature microbiomes" that correlate with reproductive or metabolic failure. In practice, this could involve characterizing patterns of gut bacteria, microbial gene functions, or microbial metabolites associated with reproductive and metabolic endpoints.
Does the FOA encourage mechanistic work or only correlation studies?
The FOA emphasizes clarifying whether the gut microbiome is a meaningful regulator of reproductive endocrinology and fertility and highlights a longer-term vision of moving from correlation to mechanism. It encourages coherent mechanistic models linking microbial features to hormonal signaling, immune status, metabolic markers, and reproductive endpoints.
Which intersecting health areas does the FOA describe as connected to fertility challenges?
The FOA notes that microbiome-related effects may intersect with conditions commonly linked to fertility challenges, including obesity and metabolic syndrome, stress-related disorders, infection, and anxiety. These areas are described as biologically intertwined with neuroendocrine regulation.
Which NIH program areas or branches are mentioned as relevant?
The opportunity is described as relevant to multiple NICHD-related areas, especially those within the Fertility and Infertility Branch. Examples named include basic ovarian biology, fertility preservation, assisted reproductive technology, spermatogenesis and sperm function, and therapeutic interventions for infertility.
If the FOA focuses on women, why does it mention broader reproductive areas?
The FOA title emphasizes women and female reproduction, but it also signals interest in microbiome impacts across the broader reproductive landscape by naming related areas such as spermatogenesis and sperm function and therapeutic interventions for infertility.
Does the FOA indicate alignment with other health areas beyond fertility?
Yes. It signals alignment with interests in maternal and pediatric infectious disease and pediatric growth and nutrition, and it notes that microbiome-driven effects on metabolism, immunity, and infection risk can span reproductive health and broader population health concerns, particularly in the context of HIV.
What is the award ceiling listed for this opportunity?
The source information lists an award ceiling of $200,000.
What is the CFDA number associated with this grant opportunity?
The FOA is identified as a discretionary NIH grant under CFDA 93.865.
What types of organizations are eligible to apply?
A wide range of organizations may apply, including:
- State and local governments
- Public and private institutions of higher education
- Nonprofit organizations (with or without 501(c)(3) status)
- For-profit organizations (other than small businesses)
- Small businesses
- Tribal governments and tribal organizations
Are specific institution types explicitly encouraged or listed as eligible?
Yes. The FOA explicitly notes additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISI institutions, tribally controlled colleges and universities (TCCUs), and faith-based or community-based organizations.
Can non-U.S. organizations apply?
Yes. The FOA indicates that non-U.S. entities and regional organizations are eligible.
Are U.S. territories or possessions eligible applicants?
Yes. The FOA lists U.S. territories or possessions among eligible applicants.
Are federal agencies eligible to apply?
Yes. The FOA lists eligible federal agencies among eligible applicants.
What are the listed dates for the opportunity?
The source information lists a creation date of June 26, 2018, and an original closing date of September 7, 2021. These dates may help applicants determine whether the opportunity is active, reissued, or superseded by a newer NIH notice.
What is the long-term vision or intended impact described in the FOA?
The FOA describes a long-term vision of establishing foundational evidence about microbiome-driven pathways affecting reproductive function, identifying microbiome-based biomarkers for risk stratification, and potentially informing future microbiome-informed prevention or treatment strategies for reproductive and metabolic dysfunction.
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