Administrative Supplement for Research on Sex/Gender Influences (Admin Supp Clinical Trial Optional) | PA 19 165

FAQs: NIH ORWH Administrative Supplement (PA 19-165)

1) What is this funding opportunity (PA 19-165)?

PA 19-165 is an NIH administrative supplement program offered through the Office of Research on Women's Health (ORWH). It provides targeted, additional support to investigators who already have an active NIH award, so they can expand or deepen their existing research to better examine how sex and gender influence human health and disease.

2) Is this a new standalone grant or an add-on to an existing NIH award?

This is an administrative supplement, meaning it is an add-on to an already funded NIH award rather than a standalone, independent grant. The proposed supplement activities are meant to build on the scope and aims of the existing (parent) award.

3) What is the main goal of the supplement?

The central goal is to strengthen the evidence base on sex as a biological variable and, when appropriate, gender-related factors that may shape risk, mechanisms, diagnosis, outcomes, and responses to prevention or treatment.

4) What types of research does the supplement support?

The scope is broad and can include basic, preclinical, clinical, translational, and behavioral research. The supplement can be used to add or enhance work that improves how an existing project addresses sex and gender influences.

5) Are clinical trials required under this supplement?

No. Clinical trials are optional under this supplement mechanism.

6) What does NIH mean by “sex” versus “gender” in this announcement?

In this opportunity, “sex” generally refers to biological attributes such as chromosomes, hormones, reproductive anatomy, and related physiology. “Gender” generally refers to social and cultural roles, identities, behaviors, and structural factors that can influence exposures, access to care, stressors, and health behaviors.

7) Does the supplement encourage considering both sex and gender?

Yes. The announcement emphasizes that real-world health outcomes are often shaped by both biology and lived experience, and proposals that incorporate both types of influences are explicitly encouraged when feasible and scientifically justified.

8) What makes an application “strong” according to the announcement?

The strongest applications are expected to use robust study designs that account for both sex and gender whenever feasible and scientifically justified. The announcement also highlights the importance of designing analyses that test sex differences, measuring relevant gender-related variables when appropriate, and ensuring the study is powered and structured to detect meaningful differences rather than treating sex as a simple covariate.

9) What kinds of research topics are highlighted as areas of particular interest?

ORWH highlights several areas of interest, including: biological sex effects at cellular and tissue levels (including cells, tissue explants, and comparisons of male vs. female tissues); sex-based comparisons across organ systems and physiological systems; direct comparisons of pathophysiology and disease mechanisms by sex; differences in biomarkers, gene expression patterns, and clinical presentation; and sex-informed approaches to prevention and treatment (including differential therapy effectiveness, side effect profiles, and optimal dosing/timing in females vs. males).

10) Does the opportunity emphasize clinically relevant outcomes?

Yes. The announcement explicitly notes interest in practical, clinically relevant endpoints, including whether therapies work differently by sex, whether side effects differ, and whether dosing or timing should differ.

11) What programmatic framework must the supplement align with?

The proposed supplement work must align with at least one objective under Goals 1 through 5 of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research, titled “Advancing Science for the Health of Women.” The intent is that supplement activities clearly advance NIH-wide priorities to improve women's health research and strengthen the science on sex and gender influences.

12) Who can apply for this supplement?

Eligibility is broad across many organization types that can hold NIH grants. Eligible applicants listed include various levels of government (state, county, city/township, special district), independent school districts, public/state-controlled and private higher education institutions, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and other entities that meet NIH requirements.

13) Are specific institution categories called out as eligible?

Yes. The announcement also calls out Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

14) Can a non-U.S. organization apply as the applicant?

No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as applicants for this supplement.

15) Can international collaborators or activities be included in any way?

Yes, in a limited way. While non-U.S. entities cannot be the applicant, “foreign components” (as defined by the NIH Grants Policy Statement) are allowed. This means a U.S.-based applicant organization may include certain qualified international elements if they meet NIH policy and are scientifically well-justified.

16) Which NIH office is associated with this supplement?

This opportunity is offered through the NIH Office of Research on Women's Health (ORWH).

17) What is the funding mechanism and opportunity category?

The funding instrument is a grant administered as an administrative supplement. The opportunity category is listed as discretionary.

18) Is the award ceiling listed in the provided information?

No. A formal award ceiling is not specified in the provided excerpt.

19) Is the expected number of awards listed in the provided information?

No. The expected number of awards is not specified in the provided excerpt.

20) What is the closing date shown in the provided information?

The original closing date listed in the provided information is 2019-02-20.

21) What do the multiple CFDA (Assistance Listing) numbers mean in this context?

The program is associated with multiple CFDA numbers (now commonly referred to as Assistance Listings). This reflects that supplements may be issued across a wide range of NIH institutes and centers depending on the parent award and the scientific area.

22) Does the supplement require focusing only on women’s health topics?

The provided information emphasizes advancing the science on sex and gender influences on health and disease and aligning with the Trans-NIH Strategic Plan for Women's Health Research. It does not state a requirement that projects be limited only to women’s health conditions; instead, it highlights strengthening evidence on sex as a biological variable and gender-related factors where appropriate.

23) What are examples of ways a project might “expand or deepen” an existing NIH award under this supplement?

Based on the described interests, examples could include adding sex-based comparisons (female vs. male) in cellular/tissue work, expanding analyses to compare mechanisms or biomarkers by sex, incorporating measures of gender-related variables that may influence exposures or care access, or strengthening the design and analytic plan so the study can detect meaningful sex and/or gender differences.

24) Does the announcement suggest how sex should be handled in analyses?

Yes. The announcement indicates applications should be designed to test sex differences and be powered and structured to detect meaningful differences, rather than treating sex only as a simple covariate.

25) Where do the Goals 1 through 5 objectives come from?

They come from the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research, “Advancing Science for the Health of Women.” The provided information notes that the specific objectives are housed in that strategic plan.