Opportunity Information: Apply for PA 18 097

Studies at Periviable Gestation (R21 Clinical Trial Optional) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number: PA-18-097; CFDA: 93.865) designed to support early-stage, exploratory research that strengthens the evidence base for clinical decision-making around periviable gestational age. The central intent is to fund projects that can inform and improve therapies, treatment strategies, and clinical management for both pregnant patients and their infants when delivery is occurring at the edge of viability. In practical terms, the FOA aims to encourage research that reduces uncertainty in this high-risk window by generating data that clinicians, patients, and families can use to guide care, including approaches that affect maternal outcomes, neonatal outcomes, or both.

The funding mechanism is an R21, which generally supports developmental or pilot work that can test new ideas, generate preliminary data, and lay groundwork for larger studies. Clinical trials are optional under this announcement, meaning applicants may propose a clinical trial if appropriate, but non-trial clinical research, translational work, or other study designs that build actionable evidence in periviable care are also responsive. The award ceiling listed is $200,000, reflecting the smaller, proof-of-concept nature typical of R21 projects. The opportunity was created on November 2, 2017, with an original closing date of September 7, 2018.

Eligibility is broad and includes a wide range of public, private, nonprofit, and governmental entities. Eligible applicants explicitly include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, tribal governments that are not federally recognized, and non-U.S. entities (foreign organizations). This wide eligibility signals NIH interest in drawing on diverse research settings, populations, and institutional strengths to address periviable care challenges.

Overall, the opportunity is focused on producing credible, clinically useful evidence in an area where decisions are often time-sensitive and outcomes can be highly variable. Competitive applications would typically be expected to define a clear periviable clinical problem, propose a feasible study that fits the R21 scope and budget cap, and show how the resulting data could directly inform treatment approaches or future definitive trials aimed at improving maternal and infant outcomes at the threshold of viability.

  • The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Studies at Periviable Gestation (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 2017-11-02.
  • Applicants must submit their applications by 2018-09-07. (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.
Apply for PA 18 097

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Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

The opportunity is titled Studies at Periviable Gestation (R21 Clinical Trial Optional).

Which agency is offering this grant?

This is a National Institutes of Health (NIH) discretionary grant opportunity.

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is PA-18-097.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.865.

What is the main purpose of this FOA?

The central purpose is to support early-stage, exploratory research that strengthens the evidence base for clinical decision-making around periviable gestational age, especially when delivery is occurring at the edge of viability.

What kinds of outcomes is this research intended to improve?

The FOA is aimed at generating evidence that can inform and improve therapies, treatment strategies, and clinical management affecting maternal outcomes, neonatal outcomes, or both during the periviable window.

What does "periviable gestation" mean in the context of this FOA?

Based on the description provided, "periviable gestation" refers to the period when delivery is occurring at the edge (threshold) of viability, where outcomes can be highly variable and clinical decisions are often time-sensitive.

What funding mechanism is used for this opportunity?

This FOA uses the R21 mechanism.

What is an R21 designed to support?

An R21 generally supports developmental or pilot work that can test new ideas, generate preliminary data, and lay the groundwork for larger studies.

Are clinical trials required?

No. Clinical trials are optional under this announcement.

Can an applicant propose a clinical trial under this FOA?

Yes. Applicants may propose a clinical trial if it is appropriate for the research question and approach.

If not proposing a clinical trial, what kinds of studies are responsive?

The FOA indicates that non-trial clinical research, translational work, and other study designs that build actionable evidence for periviable care are responsive.

What is the award ceiling for this R21 opportunity?

The award ceiling listed is $200,000.

How should applicants interpret the $200,000 award ceiling?

The ceiling reflects the smaller, proof-of-concept nature that is typical of R21 projects, which are meant to support early-stage and exploratory work.

When was this funding opportunity created?

The opportunity was created on November 2, 2017.

What was the original closing date?

The original closing date listed is September 7, 2018.

Who is eligible to apply?

Eligibility is described as broad and includes public, private, nonprofit, and governmental entities. The FOA explicitly includes multiple categories of eligible applicants (see additional FAQs below for specifics).

Are state, county, or city governments eligible?

Yes. Eligible applicants explicitly include state governments, county governments, and city or township governments.

Are special district governments eligible?

Yes. Special district governments are explicitly listed as eligible applicants.

Are school districts eligible?

Yes. Independent school districts are explicitly listed as eligible.

Are universities and colleges eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.

Are nonprofits eligible to apply?

Yes. Eligible applicants include nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (noting that the FOA excludes institutions of higher education within those nonprofit categories as stated in the provided description).

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible applicants, and small businesses are also listed as eligible.

Are federally recognized Tribal governments eligible?

Yes. Federally recognized Native American tribal governments are explicitly included.

Are Tribal organizations that are not federally recognized eligible?

Yes. The FOA includes tribal organizations that are not federally recognized governments and also references tribal governments that are not federally recognized as eligible.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.

Are U.S. territories or possessions eligible?

Yes. The FOA highlights U.S. territories or possessions as eligible applicants.

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

Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) as eligible.

Are minority-serving institutions specifically encouraged or included?

The FOA highlights additional eligible applicants including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISI institutions.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are highlighted as eligible applicants.

Are federal agencies eligible to apply?

Yes. The FOA notes that eligible federal agencies may apply.

Are regional organizations eligible?

Yes. Regional organizations are included among the additional eligible applicant types.

What types of research topics are most responsive to the FOA?

Projects are intended to generate data that reduces uncertainty in periviable care and can guide time-sensitive clinical decisions, including approaches that affect maternal and/or neonatal outcomes at the threshold of viability.

What is the practical goal of funding these projects?

The practical goal is to encourage research that produces data clinicians, patients, and families can use to guide care in a high-risk window where outcomes are variable and decisions are urgent.

What would a competitive application generally be expected to include?

Based on the description provided, competitive applications would typically be expected to: (1) define a clear periviable clinical problem, (2) propose a feasible study appropriate to the R21 scope and the $200,000 ceiling, and (3) explain how the data could directly inform treatment approaches or future definitive trials aimed at improving maternal and infant outcomes.

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