Contraceptive Development Research Centers Program (P50 Clinical Trial Optional) | RFA HD 22 003

Frequently Asked Questions (FAQs)

What is the Contraceptive Development Research Centers Program (RFA HD-22-003)?

It is a National Institutes of Health (NIH) grant opportunity that supports the creation of a multidisciplinary Contraceptive Research Development Center. The program uses the P50 center grant mechanism and is designed to accelerate the discovery and development of new contraceptive methods, as well as meaningful improvements to existing contraceptive options, for both men and women.

What is the main goal of this funding opportunity?

The central aim is to speed up contraceptive innovation by funding an organized, coordinated center (rather than isolated projects) where multiple scientific disciplines work together under a unified structure to move promising contraceptive concepts forward more efficiently.

What grant mechanism does this program use?

This program uses the P50 center grant mechanism, which supports a structured research center model rather than single, independent research projects.

Are clinical trials allowed under this program?

Yes. Clinical trials are permitted but not required. The opportunity is described as clinical trial optional, meaning a proposed center may include clinical trials, but it does not have to.

Does the program fund work on contraceptives for both men and women?

Yes. The program explicitly targets the development of new contraceptive methods and improvements to existing options for both men and women.

How is this program different from funding individual research projects?

Instead of supporting standalone projects, the program is built around a coordinated center model. The expectation is that multiple disciplines and activities are integrated under one organized structure to advance contraceptive candidates through a development pipeline in a more connected way.

What types of research activities are emphasized?

A major emphasis is strengthening the full contraceptive development pipeline, including translational work that moves candidates from preclinical stages toward clinical readiness. This can include efforts that reduce risk before human studies and improve the likelihood of success during clinical evaluation.

What does "translational work" mean in the context of this FOA?

In this program, translational work can include studies and development activities that help bridge preclinical research to clinical readiness, such as de-risking a product before human testing, addressing delivery and formulation issues, improving manufacturability, refining dosing strategies, and establishing safety and proof-of-concept evidence.

What kinds of practical product-development challenges can be addressed?

The FOA allows work to address challenges such as delivery and formulation, manufacturability, dosing strategy refinement, safety evidence development, and proof-of-concept data generation, all aimed at increasing the chance that a contraceptive candidate succeeds once clinical evaluation begins.

Can behavioral and social science research be included?

Yes. The FOA explicitly allows behavioral and social science research alongside biomedical development, recognizing that contraceptive technologies can fail due to real-world adoption barriers as well as biological factors.

What kinds of behavioral and social science activities are allowed?

User-centered research such as acceptability testing and market research is allowed, as long as it is well coordinated and responsive to the specific contraceptive product being developed within the center.

Does the FOA require behavioral and market research components?

The provided information indicates these activities are explicitly allowed and encouraged as part of an integrated approach, but it does not state they are mandatory. The emphasis is that such work should be coordinated and tied to the product being developed within the center.

Why does the FOA allow acceptability and market research?

The intent is to ensure that product design and development decisions are informed by how potential users think, choose, and adhere to contraceptive methods, which can increase the likelihood of eventual uptake and public health impact.

Is workforce development part of the program?

Yes. A major purpose of the center is workforce development. The funded center is expected to function as a national resource that helps cultivate early stage investigators who want to build careers in contraceptive research.

What does it mean that the center should be a "national resource"?

Based on the provided description, this typically implies a structured environment that includes mentorship, shared expertise and infrastructure, and opportunities for early stage investigators to contribute to high-impact translational work within a supportive, collaborative program.

Who is eligible to apply for this NIH opportunity?

Eligibility is broad and includes many types of U.S.-based organizations, including various government entities, higher education institutions (public and private), tribal governments and tribal organizations, public housing authorities and Indian housing authorities, nonprofits (with or without 501(c)(3) status, as long as they are not institutions of higher education), for-profit organizations (other than small businesses), and small businesses.

Are colleges and universities eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are included among eligible applicants.

Are nonprofits eligible, including those without 501(c)(3) status?

Yes. Nonprofits with or without 501(c)(3) status are listed as eligible, as long as they are not institutions of higher education (since universities are treated under separate eligibility categories).

Are for-profit organizations eligible to apply?

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

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are eligible, and Native American tribal organizations (including those other than federally recognized governments) are also eligible.

Does the FOA highlight any specific institution types (such as HBCUs or HSIs)?

Yes. The FOA highlights additional eligible applicant types including Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are listed among the additional eligible applicant types highlighted in the FOA.

Are U.S. territories or possessions eligible applicants?

Yes. U.S. territories or possessions are included in the FOA's highlighted eligible applicant types.

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

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.

Can a U.S. applicant include activities outside the United States?

The FOA indicates that non-domestic components of U.S. organizations may be eligible to participate, meaning a U.S. applicant may include certain activities outside the United States if allowed under NIH rules.

Are foreign components allowed?

No. The FOA states that foreign components (as defined in the NIH Grants Policy Statement) are not allowed, limiting formal foreign involvement and emphasizing that the center and its core activities must remain grounded within eligible U.S. organizational structures.

Which agency is offering this grant opportunity?

The opportunity is offered by the National Institutes of Health (NIH).

How is this opportunity categorized administratively?

It is categorized as a discretionary grant in the Health, Income Security and Social Services funding activity area.

What is the CFDA number for this program?

The CFDA number listed for this opportunity is 93.865.

What was the original closing date for this FOA?

The original closing date listed for this FOA was November 29, 2021.

What is the record creation date listed for this opportunity?

The record creation date provided is November 19, 2020.

Is the award ceiling listed in the provided information?

No. The award ceiling is not specified in the provided source data.

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

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

Where would an applicant typically look for information about budget size, allowable costs, and project period?

The provided information notes that when award ceiling and number of awards are not specified, applicants often need to refer to the full FOA text or NIH budget guidance to understand typical award sizes, allowable costs, and project period expectations for P50 center applications.

What is the overall structure the program is trying to support?

The program is designed to fund organized, team-based centers that can take a contraceptive candidate from concept and optimization through key translational milestones, while also addressing behavioral and market realities that influence whether a method will actually be used.