Characterization of the Adolescent Reproductive Transition (R01 Clinical Trial Optional) | PA 18 033

Opportunity Information: Apply for PA 18 033

The National Institutes of Health (NIH) funding opportunity titled "Characterization of the Adolescent Reproductive Transition (R01 Clinical Trial Optional)" (Funding Opportunity Number: PA 18 033; CFDA: 93.865) is a discretionary grant program that supports research aimed at improving scientific understanding of puberty and the broader trajectory of sexual development during adolescence. The central focus is on characterizing normative (typical) sexual maturation in both males and females, with an emphasis on how adolescents progress through puberty and ultimately establish reproductive competence. In practice, this means NIH is looking to fund strong, well-justified projects that can clarify what healthy reproductive development looks like, how it unfolds over time, and which biological processes and measurable markers best capture that transition.

A key theme of the announcement is that important knowledge gaps still exist in basic and translational understanding of puberty, despite its obvious relevance to lifelong health. The FOA specifically encourages investigators to use new technologies and modern research approaches to address these gaps. This could include more precise hormonal profiling, advanced imaging, genetic or epigenetic methods, novel biosensors, improved analytic techniques for longitudinal data, or other cutting-edge tools that can capture the timing, sequencing, and variability of pubertal changes. The expectation is that better measurement and better models of normal development will strengthen the field overall, improving the ability to distinguish typical variation from patterns that may signal risk for later reproductive, metabolic, bone, cardiovascular, or mental health concerns.

The grant mechanism is an R01, which generally supports substantial, multi-year research projects that are hypothesis-driven or otherwise rigorously designed, and that can produce meaningful, publishable advances in a field. The listing states "Clinical Trial Optional," meaning applicants may propose studies that include a clinical trial if it is scientifically appropriate, but they are not required to do so. In other words, projects can range from observational human studies (for example, tracking pubertal milestones and biomarkers over time) to interventional studies that meet the NIH definition of a clinical trial, as long as the work aligns with the FOA's goal of advancing understanding of adolescent reproductive development.

Eligibility is broad and includes many types of organizations capable of conducting health-related research. Eligible applicants include state, county, city, township, and 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; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations. This broad eligibility signals an intent to encourage diverse institutions and communities to contribute to, and benefit from, research on adolescent development.

From the administrative details provided, the opportunity was created on 2017-11-03 and listed an original closing date of 2019-09-07. The award ceiling, expected award count, and similar funding specifics are not provided in the supplied text, so applicants would typically need to consult the full FOA and related NIH budget guidance for limits, project period norms, and review considerations. Overall, the opportunity is designed to catalyze high-quality, modern research that maps the adolescent reproductive transition more clearly, ultimately strengthening scientific baselines for puberty and improving the field's ability to understand reproductive health across the lifespan.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Characterization of the Adolescent Reproductive Transition (R01 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 2017-11-03.
• Applicants must submit their applications by 2019-09-07. (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.

Apply for PA 18 033

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