Opportunity Information: Apply for RFA HD 25 008
Apply for RFA HD 25 008
- The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed)" 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 2023-11-02.
- Applicants must submit their applications by 2024-03-29. (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 $300,000.00 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.
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Opportunity Summary:
The Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed) funding opportunity (RFA-HD-25-008) is a National Institutes of Health (NIH) discretionary grant program designed to push forward new, nonsteroidal contraceptive approaches for both men and women. The focus is specifically on contraceptive products and methods that act prior to fertilization, meaning the supported research should aim to prevent conception before an egg is fertilized rather than interrupting pregnancy after fertilization. A central goal of the NOFO is to help move promising, innovative ideas beyond early discovery by supporting multidisciplinary work that can validate and strengthen these approaches so they are better positioned for later-stage clinical development.
This opportunity uses an R61/R33 phased innovation structure, which generally supports a milestone-driven pathway where an initial, more exploratory or early development phase (R61) can transition into a subsequent development/validation phase (R33) if pre-specified progress benchmarks are met. In practical terms, the program is meant to reduce the gap between an inventive concept and a method that is sufficiently supported by data to justify future clinical testing and product development efforts. Even though the goal is to prepare candidates for eventual clinical development, the NOFO explicitly indicates that clinical trials are not allowed under this announcement, so applications should be oriented toward preclinical development, optimization, proof-of-concept, validation studies, and other non-clinical-trial activities appropriate to contraceptive product advancement.
The activity category is listed under Health, Income Security and Social Services, and the CFDA (Assistance Listing) number is 93.865, which corresponds to NIH child health and human development related programs. The award ceiling is stated as $300,000, indicating the maximum award amount expected under this announcement (as provided in the source data). The listing also notes “ExpectedAwards:†but the number of expected awards is not provided in the source information you included.
Eligibility is broad and includes many common U.S. applicant types such as 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/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; and small businesses. In addition, the NOFO highlights other eligible applicant categories including 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, U.S. territories or possessions, and non-domestic (non-U.S.) entities/foreign organizations, as well as regional organizations. Taken together, this is an intentionally inclusive eligibility scope meant to attract a wide range of academic, nonprofit, governmental, and private-sector research teams.
Key administrative details from the source data include an original application closing date of March 29, 2024, and a creation date of November 2, 2023. The funding instrument type is a grant, and the opportunity category is discretionary, consistent with standard NIH research funding announcements. Overall, the program is best read as an NIH effort to accelerate the development and validation of novel, nonsteroidal, pre-fertilization contraceptive candidates by supporting multidisciplinary research that can generate the kind of rigorous evidence and readiness needed to justify later clinical development, while stopping short of running clinical trials within this specific award.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled The Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed).
What is the funding opportunity number (NOFO/RFA identifier)?
The identifier provided is RFA-HD-25-008.
Which agency is offering this funding?
This is a National Institutes of Health (NIH) discretionary grant program.
What is the main goal of this program?
The program is designed to advance novel, nonsteroidal contraceptive approaches for both men and women by supporting multidisciplinary research that strengthens and validates promising ideas so they are better positioned for later-stage clinical development.
What kinds of contraceptive approaches does the program focus on?
The focus is on nonsteroidal contraceptive products and methods, intended for both men and women.
Does the research have to act before fertilization?
Yes. The announcement specifically emphasizes contraceptive products and methods that act prior to fertilization, meaning the work should aim to prevent conception before an egg is fertilized (rather than interrupting pregnancy after fertilization).
Are clinical trials allowed under this opportunity?
No. The announcement explicitly indicates that clinical trials are not allowed under this funding opportunity.
If clinical trials are not allowed, what type of work is appropriate?
Applications should be oriented toward preclinical activities such as development, optimization, proof-of-concept, validation studies, and other non-clinical-trial work that advances a contraceptive candidate toward future clinical development.
What does the R61/R33 structure mean in this program?
This opportunity uses an R61/R33 phased innovation structure. It generally supports a milestone-driven pathway where an initial phase (R61) can transition into a subsequent phase (R33) if pre-specified progress benchmarks are met.
What is the purpose of using a phased (R61/R33) approach?
The phased structure is intended to reduce the gap between an inventive concept and a method supported by enough data to justify future clinical testing and product development efforts, while keeping the work in the preclinical/non-trial space for this award.
What is the funding instrument type?
The funding instrument type is a grant.
What is the opportunity category?
The opportunity category is discretionary.
What is the activity category listed for this opportunity?
The activity category is listed as Health, Income Security and Social Services.
What is the CFDA/Assistance Listing number for this opportunity?
The Assistance Listing (CFDA) number provided is 93.865, associated with NIH child health and human development related programs.
What is the maximum award amount (award ceiling)?
The award ceiling stated in the provided information is $300,000.
How many awards are expected to be made?
The source information notes “ExpectedAwards:†but does not provide a number. Based on the provided details only, the expected number of awards is not specified.
Who is eligible to apply?
Eligibility is broad and includes a wide range of applicant types, including:
- State governments
- County governments
- 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 (not federally recognized)
- Public housing authorities / 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
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The announcement highlights additional eligible categories including:
- 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
Can federal agencies apply?
Yes. The information provided states that eligible federal agencies are included among eligible applicants.
Can applicants from U.S. territories or possessions apply?
Yes. Eligibility includes U.S. territories or possessions.
Are non-U.S. organizations eligible to apply?
Yes. The eligibility description includes non-domestic (non-U.S.) entities/foreign organizations, as well as regional organizations.
What is the original application closing date?
The original application closing date provided is March 29, 2024.
What is the opportunity creation date?
The creation date provided is November 2, 2023.
Is this program intended to support early discovery only?
No. A stated aim is to move promising ideas beyond early discovery by supporting work that validates and strengthens approaches so they are more ready for later-stage clinical development (while not conducting clinical trials within this award).
Is the program limited to contraceptives for women only?
No. The program explicitly targets novel, nonsteroidal contraceptive approaches for both men and women.
Does the program support pregnancy interruption methods?
No. The emphasis is on methods that act prior to fertilization, meaning the research should focus on preventing conception before fertilization rather than interrupting pregnancy after fertilization.
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