Administrative Supplement for Research on Sex/Gender Influences (Admin Supp - Clinical Trial Optional) | PA 18 658

Opportunity Information: Apply for PA 18 658

The National Institutes of Health (NIH), through the Office of Research on Women's Health (ORWH), is offering administrative supplements to add new work to existing NIH-funded projects that will better explain how sex and/or gender influences human health and disease. This opportunity is meant to strengthen current research by incorporating questions, measures, analyses, or experiments that clarify whether outcomes differ by biological sex (for example, male versus female biology) and, where appropriate, by gender-related factors (such as roles, identities, behaviors, and social or environmental influences that may affect health). The supplement can support a wide range of research types, including basic, preclinical, clinical, translational, and behavioral studies, and it is labeled "clinical trial optional," meaning a supplement could include a clinical trial component if it fits the parent award and NIH rules, but it is not required.

ORWH highlights several scientific areas as especially important. A major focus is understanding the significance of biological sex at multiple levels of biology, including studies using cells and tissue explants, and comparative studies that directly examine male and female tissues, organs, and physiological systems. The announcement also emphasizes sex-based comparisons in pathophysiology (how diseases develop and progress), biomarkers, gene expression patterns, differences in clinical presentation, and differences in disease prevention and treatment responses. In practical terms, strong supplement proposals would usually show a clear plan for sex-stratified analyses and/or experimental designs that can detect meaningful differences, rather than treating sex as a minor covariate or an afterthought.

While ORWH is interested in sex differences, the announcement makes it clear that the strongest designs consider both sex and gender, and applications that investigate the influence of both are strongly encouraged. This reflects the idea that biological factors and social or behavioral factors often interact, and separating them (or at least measuring both carefully) can lead to more accurate and more clinically useful findings. The proposed supplement work must also align with at least one objective under Goals 1 through 3 of the NIH Strategic Plan for Women's Health Research, anchoring the project within NIH's broader priorities for improving knowledge and outcomes in women's health and sex/gender-informed science.

Because these are administrative supplements, they are tied to an existing parent grant rather than being a standalone new grant mechanism. The funding instrument is a grant supplement under a discretionary program, and it spans many NIH program areas as reflected by the long list of CFDA numbers associated with NIH research portfolios. The original closing date listed for this particular posting is March 26, 2018, and the record does not specify an award ceiling or expected number of awards in the provided data, which is typical for some supplement announcements where budgets depend heavily on the parent award and the scope of the proposed add-on work.

Eligibility is broad and includes many types of U.S.-based entities that commonly apply to NIH funding, such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; tribal governments and tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other organizations that meet NIH eligibility requirements. The opportunity also calls out additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

At the same time, there are important limits regarding non-U.S. involvement. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are stated as not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant organization can include certain types of project activities conducted outside the United States if they meet NIH's definition and requirements for a foreign component. Overall, the intent is to expand ongoing NIH-funded research in a targeted way so that sex and gender influences are built into the science, improving rigor, relevance, and ultimately the translation of findings into prevention, diagnosis, and treatment strategies that work well for everyone.

• The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "Administrative Supplement for Research on Sex/Gender Influences (Admin Supp - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.213, 93.233, 93.273, 93.279, 93.286, 93.307, 93.313, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.853, 93.855, 93.865, 93.866, 93.867, 93.879, 93.989.
• This funding opportunity was created on 2018-02-13.
• Applicants must submit their applications by 2018-03-26. (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.

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