Assay Development and Screening to Discover Therapeutic or Imaging Agents for Diseases of Interest to the NIDDK (R01) | PA 16 374

Opportunity Information: Apply for PA 16 374

The grant opportunity titled "Assay Development and Screening to Discover Therapeutic or Imaging Agents for Diseases of Interest to the NIDDK (R01)" (Funding Opportunity Number PA-16-374) is a discretionary research grant offered by the National Institutes of Health (NIH). It uses the R01 funding mechanism, which is the NIH's standard, widely used support structure for mature, hypothesis-driven or goal-directed research projects led by an investigator (or multiple investigators) proposing a defined set of aims. The overall focus of this opportunity is on building and using assays and screening approaches to identify potential therapeutic compounds or imaging agents that are relevant to diseases and conditions within the mission area of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). In practical terms, this means the program is aimed at enabling early-stage discovery work where robust experimental tests (assays) are created or refined and then used to run screens that can surface candidate molecules for further development.

This announcement sits within the NIH "Health" activity area and is associated with CFDA number 93.847, which corresponds to diabetes, digestive, and kidney disease-related research and training programs. The emphasis on "assay development and screening" signals that applicants are expected to either (1) develop new assays, substantially improve existing assays, or adapt assays for screening-ready use, and/or (2) carry out screening campaigns to find compounds or agents with desired biological activity or imaging properties. The "therapeutic or imaging agents" framing also suggests the scope is not limited to drug-like small molecules; it can include agents intended to visualize biological processes, targets, tissues, or disease states, provided the work aligns with NIDDK-relevant diseases. Because this is an R01, the expectation is usually that the proposed work will be sufficiently developed to justify a multi-year research plan, with clear milestones, sound experimental design, and a realistic pathway from assay creation to screening outcomes and downstream validation.

Application deadlines follow the NIH standard due dates, and submissions are due by 5:00 PM local time of the applicant organization. The opportunity states that all types of non-AIDS applications allowed under the announcement are due on those standard dates, which is typical NIH language indicating the regular recurring submission cycles rather than a single one-time deadline. The source data lists an original closing date of 2019-09-07, which reflects the administrative lifecycle of this specific posting instance; in NIH practice, many program announcements are reissued or continued over time, so the best operational takeaway is that applicants should verify the currently active version of the announcement and the current due dates in the NIH/Grants.gov system before planning a submission.

Eligibility is broad and includes a wide range of domestic U.S. organizations as well as certain international applicants. Eligible applicants include state governments, county and city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. Higher education institutions are eligible, including public or state-controlled institutions of higher education and private institutions of higher education. Tribal entities are eligible, including federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments. The program also allows participation from nonprofits, both those with 501(c)(3) status and those without 501(c)(3) status (in each case, other than institutions of higher education). In addition, for-profit organizations (other than small businesses) and small businesses are eligible, and the opportunity includes an "Others" category that NIH often uses to capture additional allowable organizational types not neatly covered by the main list.

Beyond those general categories, the announcement explicitly highlights additional eligible applicant types, reflecting an intent to include a diverse mix of institutions and communities. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); and Tribally Controlled Colleges and Universities (TCCUs). It also notes that eligible agencies of the federal government may apply, as can faith-based or community-based organizations. Importantly, the opportunity allows non-domestic (non-U.S.) entities (foreign organizations), as well as regional organizations and U.S. territories or possessions, which expands participation beyond the continental U.S. and can be relevant for research programs that depend on specialized capabilities, unique populations, or international collaborations.

The listing does not provide an award ceiling or an expected number of awards in the provided source data, which commonly means applicants should look to the NIH R01 policy framework and NIDDK-specific budget guidance rather than expecting a fixed cap stated in the synopsis. In NIH practice, R01 budgets and project periods are typically justified based on the science proposed, within NIH norms and institute expectations, and reviewed for reasonableness during peer review and institute-level consideration.

At a high level, the opportunity is geared toward enabling the kind of translationally oriented discovery research that bridges fundamental biology and downstream therapeutic or diagnostic development. Strong applications under a program like this generally center on a compelling disease-relevant biological target or pathway, a well-constructed assay that can reliably measure the biological activity of interest, and a screening and follow-up plan that can move from initial hits to prioritized leads through confirmation, selectivity testing, and early validation. Even though the synopsis provided does not spell out the scientific requirements in detail, the title and R01 mechanism make it clear that the program is designed to support substantial, methodologically rigorous assay-and-screening projects that can generate credible starting points for future therapeutic or imaging development within NIDDK mission areas.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Assay Development and Screening to Discover Therapeutic or Imaging Agents for Diseases of Interest to the NIDDK (R01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2016-07-21.
• 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 16 374

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