Opportunity Information: Apply for PA 15 106

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R21)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
  • This funding opportunity was created on Jan 29, 2015 and posted on Jan 29, 2015.
  • Applicants must submit their applications by Jan 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) County governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts City or township governments Small businesses State governments.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:

The grant opportunity "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R21)" (Funding Opportunity Number PA 15 106) is a National Institutes of Health (NIH) discretionary funding announcement designed to support early-stage, exploratory research aimed at improving how researchers and public health programs determine when an HIV infection occurred. The central purpose of the FOA is to fund the development of new biological markers (biomarkers), along with improved laboratory assays and analytical algorithms, that can more accurately distinguish recent (incident) HIV infections from long-standing (chronic) infections. In practical terms, the announcement targets a persistent challenge in HIV surveillance and research: many existing incidence assays can mistakenly label chronic infections as recent, so this FOA emphasizes increasing specificity to reduce misclassification and improve confidence in incidence estimates.

This opportunity uses the NIH Exploratory/Developmental Research Grant mechanism (R21), which generally supports innovative, high-impact ideas that may still be in a formative stage and need proof-of-concept work. The R21 structure signals that NIH is looking for creative approaches that could open new directions in incidence testing, rather than requiring a fully mature platform at the outset. Projects responsive to this FOA would typically involve identifying promising candidate biomarkers of recent infection, refining or inventing assay formats that can measure them reliably, and building or improving algorithms that combine multiple signals (for example, immunologic, virologic, or other host/pathogen indicators) to better classify infections by recency while minimizing false-recent results.

The activity area is health research, and the program aligns with NIH priorities in infectious diseases, specifically within CFDA program areas 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). Cost sharing or matching is not required, which means applicants do not need to commit institutional funds as a condition of eligibility. The announcement was posted on January 29, 2015, and it ran through a final closing date of January 7, 2018, with archiving on February 7, 2018, indicating it was time-limited and is now closed, but still useful as a reference point for similar current NIH initiatives.

A wide range of applicants were eligible, reflecting NIH's interest in broad participation and diverse research settings. Eligible applicants included public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special district governments), as well as independent school districts and public or Indian housing authorities. The eligibility language also explicitly encompassed a range of mission-driven and underserved-serving institutions and organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based and community-based organizations. In addition, non-U.S. entities (foreign organizations), U.S. territories or possessions, regional organizations, and certain eligible federal agencies could apply, underscoring the global and cross-sector relevance of improving HIV incidence measurement.

Operationally, the FOA points applicants to the full announcement on the NIH Grants Guide website (http://grants.nih.gov/grants/guide/pa-files/PA-15-106.html), where the detailed scientific scope, application instructions, review criteria, and administrative requirements would be laid out. For access issues or linking problems, the contact provided is the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV), which is a standard administrative support channel rather than a scientific program contact. Overall, the opportunity is best understood as a targeted R21 call aimed at advancing the next generation of HIV incidence assays by discovering and validating novel biomarkers and building more specific testing strategies so that public health decisions and research findings based on incidence estimates are more accurate and defensible.

Frequently Asked Questions (FAQs)

What is the title and funding opportunity number for this grant?

The opportunity is titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R21)" and the Funding Opportunity Number is PA 15 106.

Who is sponsoring this funding opportunity?

This is a National Institutes of Health (NIH) discretionary funding announcement.

What is the main purpose of this FOA?

The central purpose is to support early-stage, exploratory research that improves how researchers and public health programs determine when an HIV infection occurred. The FOA focuses on developing novel biomarkers, improved laboratory assays, and analytical algorithms that more accurately distinguish recent (incident) HIV infections from long-standing (chronic) infections.

What specific problem is this FOA trying to solve in HIV surveillance and research?

The FOA targets a persistent issue with HIV incidence testing: many existing incidence assays can mistakenly label chronic infections as recent. This opportunity emphasizes improving specificity so fewer chronic infections are misclassified as recent, which strengthens confidence in HIV incidence estimates.

What does "improved specificity" mean in the context of HIV incidence assays?

In this FOA, improved specificity refers to reducing false-recent results (cases where someone with a chronic infection is incorrectly classified as recently infected). The goal is to reduce misclassification and improve the reliability of incidence estimates.

What grant mechanism does this opportunity use?

The FOA uses the NIH Exploratory/Developmental Research Grant mechanism (R21).

What does the R21 mechanism imply about the kind of projects NIH wants?

The R21 mechanism generally supports innovative, high-impact ideas that may still be in a formative stage and need proof-of-concept work. It signals interest in creative approaches that could open new directions in incidence testing rather than requiring a fully mature platform at the outset.

What types of activities or projects would be responsive to this FOA?

Projects responsive to the FOA would typically include identifying promising candidate biomarkers of recent infection, refining or inventing assay formats to measure those biomarkers reliably, and developing or improving algorithms that combine multiple signals (for example, immunologic, virologic, or other host/pathogen indicators) to better classify infections by recency while minimizing false-recent classifications.

What scientific or program areas does this FOA align with?

The activity area is health research, aligned with NIH priorities in infectious diseases. The FOA is associated with CFDA program areas 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).

Is cost sharing or matching required?

No. Cost sharing or matching is not required, meaning applicants do not need to commit institutional funds as a condition of eligibility.

When was this FOA posted, and is it still open?

The announcement was posted on January 29, 2015. It ran through a final closing date of January 7, 2018, and was archived on February 7, 2018. Based on those dates, it is closed.

Why is this opportunity still relevant if it is archived?

Even though the FOA is closed, it can still serve as a reference point for understanding the NIH approach and priorities for developing more accurate HIV incidence assays and for spotting similar current NIH initiatives.

What types of organizations were eligible to apply?

The eligible applicant pool was broad and included public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, and special district governments). It also included independent school districts and public or Indian housing authorities.

Were mission-driven and underserved-serving institutions explicitly included as eligible applicants?

Yes. The eligibility language explicitly included Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based and community-based organizations.

Could non-U.S. organizations apply?

Yes. The eligibility information states that non-U.S. entities (foreign organizations) could apply, along with U.S. territories or possessions, regional organizations, and certain eligible federal agencies.

Where can applicants find the full FOA details?

The FOA points applicants to the full announcement on the NIH Grants Guide website at http://grants.nih.gov/grants/guide/pa-files/PA-15-106.html, where detailed scientific scope, application instructions, review criteria, and administrative requirements are provided.

Who should be contacted if there are access issues with the FOA webpage?

For access issues or linking problems, the FOA lists the NIH Office of Extramural Research (OER) webmaster as the contact: FBOWebmaster@OD.NIH.GOV.

Does the listed contact serve as a scientific program contact?

No. The listed contact is described as a standard administrative support channel for access or linking issues, rather than a scientific program contact.

What is the overall goal of the funded research described in this FOA?

The overall goal is to advance the next generation of HIV incidence assays by discovering and validating novel biomarkers and building more specific testing strategies so that public health decisions and research findings based on incidence estimates are more accurate and defensible.

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