Early-Onset Cancers: Investigating Etiology, Mechanisms, and Early Detection Strategies (RP1 Clinical Trials Optional) | PAR 28 014

FAQs: NIH PAR 28-014 (Early-Onset Cancers in Adults Ages 18-49)

1) What is this funding opportunity (PAR 28-014) trying to accomplish?

This NIH funding opportunity supports research focused on explaining why certain cancers are rising in younger adults. It specifically targets sporadic (non-hereditary) early-onset cancers diagnosed between ages 18 and 49. The overall aim is to improve prevention and cancer control by clarifying potential causes (etiology), understanding biological processes (mechanisms) that may be driving the trend, and strengthening approaches to identify people at elevated risk earlier than is currently possible.

2) What cancers or populations are the focus of the program?

The focus is on sporadic, non-hereditary early-onset cancers diagnosed in adults ages 18-49. The opportunity emphasizes understanding trends in younger adults and encourages analyses that consider differences across demographic and population characteristics (for example, variation by age within the 18-49 range, sex, race and ethnicity, geography, socioeconomic context, and other characteristics that may affect exposures or vulnerability).

3) Are hereditary cancers or inherited cancer syndromes the main target here?

No. The opportunity is specifically oriented toward sporadic, non-hereditary early-onset cancers. The intent is to understand drivers of rising incidence in younger adults that are not primarily explained by inherited risk.

4) What types of research does the NOFO encourage?

The NOFO encourages projects that address one or more of three broad scientific directions:

• Identifying environmental or lifestyle exposures that may be contributing to rising incidence of non-hereditary early-onset cancers, including how exposure patterns and effects differ across demographic groups.
• Investigating underlying biology and host responses that may explain early-onset disease, including mechanistic work connecting exposures to tumor initiation and progression in younger individuals.
• Improving early identification of individuals at increased risk, enabling better targeted prevention, surveillance, and potentially earlier detection strategies.

5) What does "etiology" mean in the context of this opportunity?

In this context, etiology refers to the causes or contributing factors behind the observed rise in early-onset cancers. The NOFO highlights environmental and lifestyle exposures as an important area of investigation.

6) What does "mechanisms" mean in the context of this opportunity?

Mechanisms refer to the biological processes that could link exposures or other risk factors to cancer development and progression in younger adults. The NOFO notes that relevant biological work may include pathways involving immune or inflammatory responses, metabolism, microbiome-related effects, endocrine disruption, or other processes that may connect exposures to tumor initiation and progression.

7) Does the NOFO require a project to include demographic subgroup analyses?

The NOFO encourages research that examines how exposures and their effects may differ across demographic groups and population characteristics, such as age (within 18-49), sex, race and ethnicity, geography, socioeconomic context, and related factors. The provided summary does not state this is mandatory for every application, but it is explicitly encouraged as part of the exposure-focused direction.

8) Are clinical trials required?

No. Clinical trials are optional under this announcement. Applicants may propose clinical trials if appropriate for the scientific aims, but a clinical trial is not required.

9) Can an applicant propose a clinical trial under PAR 28-014?

Yes. The announcement allows clinical trials as optional, meaning a trial may be proposed when it fits the project goals, but it is not a condition of eligibility or responsiveness by itself.

10) Is this program meant for exploratory projects, mature projects, or both?

Both. A notable feature of the announcement is its intent to keep the field moving quickly by accommodating a range of project maturity under a single grant award instrument. That includes exploratory/developmental efforts (such as hypothesis generation or feasibility work) and more mature standard research projects, as long as the work aligns with the central objective of understanding and addressing the rise in early-onset cancers.

11) What kinds of applicants are eligible to apply?

Eligibility is broad. Eligible applicant types listed include:

• 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 tribal governments
• Other tribal organizations
• Public housing authorities/Indian housing authorities
• Nonprofits with 501(c)(3) status (other than institutions of higher education)
• Nonprofits without 501(c)(3) status (other than institutions of higher education)
• For-profit organizations (other than small businesses)
• Small businesses

12) Are for-profit companies allowed to apply?

Yes. The eligibility list includes for-profit organizations (other than small businesses) and also separately includes small businesses.

13) Are non-U.S. (foreign) organizations allowed to apply directly?

Yes. Non-U.S. entities (foreign organizations) are eligible to apply directly under this opportunity, based on the information provided.

14) Are non-U.S. components of U.S. organizations eligible?

Yes. The NOFO states that non-U.S. components of U.S. organizations are eligible.

15) Are "foreign components" allowed under this NOFO?

No. Foreign components (as defined in the NIH Grants Policy Statement) are not allowed under this NOFO.

16) Can my application include a foreign subaward or foreign subcontract?

No. NIH will not issue awards that involve foreign subawards or subcontracts under this opportunity. Applications proposing foreign subawards/subcontracts are noncompliant and will not be reviewed for funding.

17) What kinds of international involvement are still allowed?

The policy does not block all international engagement. The NOFO explicitly allows:

• Unfunded international collaborations
• Use of foreign consultants (as allowed under NIH policy)
• Purchasing unique equipment or supplies from foreign vendors

The key restriction is that the arrangement cannot be structured as a foreign subaward/subcontract that would require NIH funds to flow to a foreign institution as a subrecipient.

18) Who is the funding agency and what is the funding instrument?

The agency is the National Institutes of Health (NIH), and the funding instrument is a grant.

19) What is the activity area and funding type?

The opportunity is categorized as discretionary funding in the health activity area.

20) What CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 93.113 and 93.393.

21) What is the closing date for this opportunity?

The opportunity shows an original closing date of 2029-10-11, indicating a multi-year application window typical of NIH program announcements with multiple receipt dates.

22) Is there an award ceiling listed or a specified number of expected awards?

Not in the summary information provided. An award ceiling and expected number of awards are not specified here, so applicants would typically consult the full NOFO text for budget mechanisms, scope expectations, and any institute-specific guidance.

23) What is the program trying to improve in terms of public health impact?

The program aims to improve prevention and cancer control by clarifying why early-onset cancers are increasing, understanding relevant biological mechanisms, and enhancing methods for identifying individuals at elevated risk earlier so prevention and surveillance can be better targeted and detection may occur earlier.