Opportunity Information: Apply for RFA DE 23 013
The AHEAD (Advancing Head and Neck Cancer Early Detection Research) funding opportunity (RFA-DE-23-013) is a National Institutes of Health (NIH) cooperative agreement program that aims to speed up the translation of research findings into practical approaches that improve early detection of head and neck cancers (HNC). The core purpose is to move promising science closer to real-world impact by supporting work that develops, evaluates, and validates biomarkers that can be used to identify risk, detect disease earlier, and strengthen molecular diagnosis and prognosis specifically for early-stage HNC. This FOA is explicitly labeled "Clinical Trial Not Allowed," meaning the supported projects are not intended to be interventional clinical trials, and applicants should design their studies accordingly (for example, focusing on biomarker discovery and validation, assay development, and other translational research activities that do not meet the NIH definition of a clinical trial).
This opportunity uses a U01 mechanism, which is a cooperative agreement rather than a standard grant. In practice, that means funded teams should expect substantial scientific or programmatic involvement from NIH staff compared to investigator-initiated mechanisms. The funding instrument type is listed as a cooperative agreement, and the overall activity category aligns with education and health. The opportunity references multiple CFDA numbers (93.121, 93.393, 93.394), reflecting its placement within broader NIH assistance programs.
The applicant pool is broad and includes many domestic organization types across government, academia, nonprofit, and industry. Eligible applicants include state, county, and 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; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; and both 501(c)(3) and non-501(c)(3) nonprofits (as long as they are not institutions of higher education in those categories). For-profit organizations are also eligible (other than small businesses), and small businesses themselves are listed as eligible as well, along with an "other" category that can cover additional eligible entities under NIH rules.
The FOA also calls out specific categories of eligible applicants to encourage broad participation, 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; regional organizations; eligible federal government agencies; Indian/Native American tribal governments that are not federally recognized; and U.S. territories or possessions. These callouts generally signal NIH interest in inclusive participation and, in many cases, can support projects that are better connected to communities affected by head and neck cancer disparities.
At the same time, the FOA draws clear lines around non-U.S. involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, which typically means a U.S.-based applicant may include certain types of foreign collaboration or performance sites if they meet NIH requirements and are justified scientifically, even though a foreign institution cannot be the primary applicant.
Key administrative details in the provided record include an original closing date of March 14, 2023, and a listed award ceiling of $500,000. The opportunity was created on October 13, 2022. The expected number of awards is not specified in the provided data, which often means applicants should not assume a particular funding volume and should instead focus on responsiveness to the FOA goals and the competitiveness of the proposed biomarker development and validation plan.
Overall, this program is designed for research teams that can demonstrate a credible path toward clinically meaningful early detection advances in head and neck cancer through biomarker-focused translational research, with the structure and expectations of a cooperative agreement and without proposing clinical trials.Apply for RFA DE 23 013
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "AHEAD (Advancing Head and Neck Cancer Early Detection Research) (U01 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): 93.121, 93.393, 93.394.
- This funding opportunity was created on 2022-10-13.
- Applicants must submit their applications by 2023-03-14. (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 $500,000.00 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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Frequently Asked Questions (FAQs)
What is the AHEAD (Advancing Head and Neck Cancer Early Detection Research) funding opportunity?
AHEAD is an NIH cooperative agreement funding opportunity (RFA-DE-23-013) focused on accelerating translational research that improves early detection of head and neck cancers (HNC). The program emphasizes moving promising research toward practical, real-world approaches.
What is the main goal of this FOA?
The core goal is to speed up translation of research findings into practical approaches that improve early detection of head and neck cancers. The FOA supports work intended to move promising science closer to real-world impact.
What research areas does this opportunity support?
Based on the provided description, the FOA supports translational research activities centered on biomarkers for early-stage head and neck cancer, including developing, evaluating, and validating biomarkers that can be used to:
- Identify risk
- Detect disease earlier
- Strengthen molecular diagnosis
- Improve prognosis for early-stage HNC
Are clinical trials allowed under this funding opportunity?
No. The FOA is explicitly labeled "Clinical Trial Not Allowed." Projects should not be designed as interventional clinical trials and should be structured accordingly.
If clinical trials are not allowed, what kinds of studies fit this FOA?
The description indicates the FOA is intended for biomarker discovery and validation, assay development, and other translational research activities that do not meet the NIH definition of a clinical trial.
What funding mechanism does this opportunity use?
This opportunity uses the U01 mechanism, which is a cooperative agreement rather than a standard grant.
What does it mean that this is a cooperative agreement (U01)?
A cooperative agreement generally involves substantial scientific or programmatic involvement from NIH staff compared to investigator-initiated mechanisms. Applicants should plan for active NIH engagement during the project.
Which NIH activity category is associated with this opportunity?
The overall activity category is aligned with education and health (as listed in the provided record).
Which CFDA numbers are referenced for this opportunity?
The opportunity references CFDA numbers 93.121, 93.393, and 93.394.
Who is eligible to apply?
The eligible applicant pool is broad and includes many domestic (U.S.) organization types across government, academia, nonprofit, and industry, 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
- Native American tribal organizations (not federally recognized)
- Public housing authorities/Indian housing authorities
- Nonprofits (501(c)(3) and non-501(c)(3), as long as they are not institutions of higher education in those categories)
- For-profit organizations (including small businesses, as listed)
- Other eligible entities under NIH rules (as indicated by an "other" category)
Are for-profit organizations eligible?
Yes. For-profit organizations are listed as eligible. The record also lists small businesses as eligible.
Are small businesses eligible to apply?
Yes. Small businesses are explicitly listed as eligible in the provided information.
Are nonprofits eligible to apply?
Yes. Both 501(c)(3) and non-501(c)(3) nonprofit organizations are listed as eligible, with the noted caveat that the specific nonprofit categories referenced apply as long as they are not institutions of higher education in those categories.
Are colleges and universities eligible to apply?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are tribal governments and tribal organizations eligible to apply?
Yes. Federally recognized Native American tribal governments are eligible, and Native American tribal organizations that are not federally recognized are also listed as eligible.
Are U.S. territories or possessions included among eligible applicants?
Yes. The FOA calls out U.S. territories or possessions as a category of eligible applicants to encourage broad participation.
Does the FOA encourage applications from specific institution types or community-based groups?
Yes. The FOA specifically calls out several categories to encourage broad participation, including (as listed):
- 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
- Regional organizations
- Eligible federal government agencies
- Indian/Native American tribal governments that are not federally recognized
- U.S. territories or possessions
Can a non-U.S. (foreign) institution apply as the main applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization based on the provided information.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply as the applicant organization, according to the provided description.
Are foreign collaborations allowed at all?
Yes, in a limited way. "Foreign components" are allowed as defined in the NIH Grants Policy Statement. This typically means a U.S.-based applicant may include certain foreign collaboration or performance sites if they meet NIH requirements and are scientifically justified, even though a foreign institution cannot be the primary applicant.
What is the award ceiling for this opportunity?
The provided record lists an award ceiling of $500,000.
When was this opportunity created?
The opportunity was created on October 13, 2022.
What was the closing date for this funding opportunity?
The provided record lists an original closing date of March 14, 2023.
How many awards will NIH make under this FOA?
The expected number of awards is not specified in the provided data.
What types of outcomes is the program aiming to achieve?
The program aims to support biomarker-focused translational research that can lead to clinically meaningful early detection advances in head and neck cancer, including improved risk identification, earlier detection, and strengthened molecular diagnosis and prognosis for early-stage HNC.
What should applicants keep in mind when designing a project for this FOA?
Based on the provided details, applicants should (1) focus on biomarker development, evaluation, and validation aimed at early-stage head and neck cancer, (2) avoid proposing interventional clinical trials given the "Clinical Trial Not Allowed" designation, and (3) plan for substantial NIH involvement consistent with a U01 cooperative agreement.
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