Opportunity Information: Apply for PAR 16 266

  • The HHS-NIH11 in the education, health sector is offering a public funding opportunity titled "Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.273, 93.279, 93.286, 93.866,.
  • This funding opportunity was created on May 17, 2016 and posted on May 17, 2016.
  • Applicants must submit their applications by Sep 07, 2019. (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 (see text field entitled Additional Information on Eligibility for clarification).
Apply for PAR 16 266

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Opportunity Summary:

The opportunity titled "Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01)" (Funding Opportunity Number PAR 16-266) is a National Institutes of Health research project grant announcement focused on creating and testing new brain imaging tools for central nervous system (CNS) research. The core purpose is to support R01-level projects that develop novel radioligands for positron emission tomography (PET) or single photon emission computed tomography (SPECT) that can be used in the human brain, with the explicit expectation that applicants will also include some form of pilot or feasibility evaluation. In practice, this means the FOA is not only about chemical synthesis or radiotracer design in isolation; it is aimed at tracers that can realistically move toward use in humans and demonstrate practical utility as biomarkers for drug discovery or for understanding disease biology in the brain.

A central theme of the announcement is biomarker development for two closely related needs: improving drug discovery and clarifying pathophysiological mechanisms in CNS disorders. PET and SPECT ligands can quantify target engagement, receptor or transporter availability, enzyme activity, and other molecular features in vivo, which makes them valuable for determining whether a therapeutic candidate reaches and interacts with its intended target in the brain. The FOA therefore encourages work that results in imaging ligands capable of supporting decisions in therapeutic development pipelines, such as dose selection, proof-of-mechanism studies, and early go/no-go decisions. At the same time, these ligands can be used to study disease-related changes in brain chemistry and circuitry, so the program also supports projects that use novel tracers to investigate biological processes underlying neurological and psychiatric conditions.

The scope emphasizes new radioligands intended for imaging in the human brain and requires that the project incorporate preliminary evaluations that demonstrate feasibility. The announcement mentions feasibility evaluation in pre-clinical studies, model development, or clinical studies, which leaves room for different project designs depending on how advanced the ligand is. For example, one application might focus on ligand development plus preclinical validation and kinetic modeling work that is specifically designed to support translation to humans. Another might include first-in-human or early clinical imaging to demonstrate brain penetration, binding characteristics, quantification methods, and initial performance in relevant populations. The common thread is that proposed ligands should be paired with a credible plan to show they can be used as practical imaging biomarkers rather than remaining purely theoretical or limited to early chemistry experiments.

In terms of administrative details, this is a discretionary grant opportunity using the standard NIH R01 (research project) mechanism, administered under the Department of Health and Human Services, National Institutes of Health (listed as HHS-NIH11 in the source data). It was posted and created on May 17, 2016, and the listed closing date in the provided record is September 7, 2019. The source data does not specify an award ceiling or an expected number of awards in the provided fields, so those details are not available from the excerpt. The program is associated with multiple CFDA numbers (93.242, 93.273, 93.279, 93.286, 93.866), reflecting that it may align with several NIH institutes or program areas that support neuroscience, mental health, aging, substance use, or related biomedical research.

Eligibility is broad and includes many typical NIH applicant types: state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the full announcement. This wide eligibility suggests NIH is open to applications from academic research centers, medical schools, hospitals and research institutes, collaborations involving government entities, and qualified commercial or industry-linked groups with radiochemistry and imaging capabilities, as long as they can execute the scientific work and meet NIH grant requirements.

Overall, PAR 16-266 is aimed at advancing the molecular imaging toolkit for the living human brain by funding projects that create new PET or SPECT ligands and back them up with the modeling and feasibility data needed to demonstrate real-world usefulness. The strongest fit for this announcement is research that bridges radiochemistry and imaging science with translational validation, ultimately enabling better measurement of CNS targets and processes for both therapeutic development and deeper understanding of brain disorders.

Frequently Asked Questions (FAQs)

What is the title of this grant opportunity?

The opportunity is titled "Development and Application of PET and SPECT Imaging Ligands as Biomarkers for Drug Discovery and for Pathophysiological Studies of CNS Disorders (R01)."

What is the Funding Opportunity Number (FON) for this announcement?

The Funding Opportunity Number is PAR 16-266.

Which agency is offering this grant?

This is a National Institutes of Health (NIH) funding opportunity under the U.S. Department of Health and Human Services (HHS). The source data lists it as administered under HHS-NIH11.

What grant mechanism does this opportunity use?

This opportunity uses the NIH R01 research project grant mechanism and is described as a discretionary grant opportunity.

What is the main purpose of PAR 16-266?

The purpose is to support R01-level projects that develop novel PET or SPECT radioligands intended for imaging in the human brain, with an explicit expectation that the project also includes pilot or feasibility evaluation to demonstrate practical usefulness as imaging biomarkers.

What kinds of imaging technologies are the focus of this FOA?

The focus is on positron emission tomography (PET) and single photon emission computed tomography (SPECT) imaging ligands (radioligands) for the brain.

Is this FOA only about radiotracer chemistry and synthesis?

No. While radiotracer design and synthesis are part of the scope, the announcement emphasizes ligands that can realistically move toward use in humans and demonstrate practical utility through pilot or feasibility evaluation. The intent is not to support chemistry in isolation without a credible plan to show the ligand can function as a usable imaging biomarker.

What does NIH mean here by "biomarkers for drug discovery"?

In this context, PET and SPECT ligands can quantify target engagement and other molecular features in vivo. The FOA highlights their value for drug development decisions such as dose selection, proof-of-mechanism studies, and early go/no-go decisions by measuring whether a therapeutic reaches and interacts with its intended CNS target.

How does this opportunity relate to studying CNS disorders?

The program also supports using novel PET or SPECT tracers to investigate pathophysiological mechanisms in neurological and psychiatric conditions by measuring disease-related changes in brain chemistry and circuitry in living subjects.

Are proposed ligands expected to be usable in the human brain?

Yes. The scope emphasizes new radioligands intended for imaging in the human brain, with supporting feasibility work to show they can be practical imaging biomarkers.

Is a pilot or feasibility evaluation required?

The announcement explicitly expects applicants to include some form of pilot or feasibility evaluation. The feasibility component may be done through pre-clinical studies, model development, or clinical studies, depending on the maturity of the ligand and the proposed translation plan.

What types of feasibility evaluation are mentioned as possible under this FOA?

The announcement mentions feasibility evaluation in pre-clinical studies, model development, or clinical studies. Examples described include preclinical validation and kinetic modeling designed to support translation to humans, or early/first-in-human imaging to demonstrate brain penetration, binding characteristics, quantification methods, and initial performance.

Could an application include first-in-human or early clinical imaging?

Yes. The description indicates that some projects may include first-in-human or early clinical imaging to demonstrate key performance characteristics such as brain penetration, binding, and quantification methods.

What is the common thread across acceptable project designs?

The common thread is that the proposed radioligand should be paired with a credible plan and preliminary evaluation to show feasibility and practical use as an imaging biomarker, rather than remaining purely theoretical or limited to early chemistry experiments.

What kinds of biological measurements might these ligands enable?

As described, PET and SPECT ligands can quantify target engagement, receptor or transporter availability, enzyme activity, and other molecular features in vivo in the brain.

When was this funding opportunity posted and created?

The provided record states it was posted and created on May 17, 2016.

What is the closing date listed in the provided record?

The closing date listed in the provided record is September 7, 2019.

Does the provided information include an award ceiling?

No. The excerpt provided does not specify an award ceiling.

Does the provided information include the expected number of awards?

No. The excerpt provided does not list an expected number of awards.

What CFDA numbers are associated with this program in the provided record?

The opportunity is associated with multiple CFDA numbers: 93.242, 93.273, 93.279, 93.286, and 93.866.

Who is eligible to apply?

Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other entities as described in the full announcement.

Does this FOA appear limited to academic institutions?

No. Based on the stated eligibility, applicants can include academic institutions as well as government entities, nonprofits, for-profit organizations (including other than small businesses), and small businesses, among others, provided they meet NIH requirements and can execute the proposed work.

What types of organizations might be a strong fit based on the description?

The description suggests a strong fit for groups that can bridge radiochemistry and imaging science with translational validation, such as academic research centers, medical schools, hospitals and research institutes, collaborations involving government entities, and qualified commercial or industry-linked groups with radiochemistry and imaging capabilities.

What is the overall goal of PAR 16-266 in practical terms?

The overall goal is to advance the molecular imaging toolkit for the living human brain by funding development of new PET or SPECT ligands and supporting modeling/feasibility data that demonstrate real-world usefulness for CNS drug development and for understanding disease biology.

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