Opportunity Information: Apply for PA 15 105
Apply for PA 15 105
- 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 (R01)" 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: City or township governments Private institutions of higher education Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) County 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 NIH funding opportunity PA 15 105, titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01)," supports research projects aimed at improving how scientists and public health programs determine whether an HIV infection is recent (incident) or long-standing (chronic). The central goal is to fund the development of new biomarkers, as well as improved laboratory assays and multi-component algorithms, that can more accurately classify infections as recent while reducing misclassification. In practical terms, the FOA is focused on advancing tools that can estimate HIV incidence more reliably, which is essential for understanding where and how quickly HIV is spreading, evaluating prevention programs, and directing resources to the communities and settings where they will have the greatest impact.
This FOA uses the NIH Research Project Grant (R01) mechanism, which is designed for hypothesis-driven, investigator-initiated research with enough scale to support substantial development and validation work. The opportunity falls under NIH health research activities and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The announcement explicitly notes that there is no cost sharing or matching requirement, meaning applicants are not expected to provide non-federal funds as a condition of receiving the award.
Scientifically, the announcement emphasizes "specificity" because traditional or existing HIV incidence assays can sometimes incorrectly label chronic infections as recent. That problem can happen for multiple reasons, including biological variability among people living with HIV, differences among viral subtypes, immune suppression, antiretroviral therapy effects, or other clinical factors that can alter antibody maturation and other immune markers. A misclassification problem is not just a technical detail; it can distort incidence estimates at the population level, leading to inflated or misleading conclusions about epidemic trends and the effectiveness of interventions. By calling for novel biomarkers and improved assays and algorithms, the FOA is pointing researchers toward discovering and validating measurable signals (for example, immune response characteristics, virologic features, host markers, or combinations of markers) that can better separate truly recent infections from long-term infections under real-world conditions.
The opportunity is categorized as discretionary funding and was posted on January 29, 2015, with an original closing date of January 7, 2018. The archive date is February 7, 2018, which indicates the solicitation is no longer active, but the details remain important for understanding the kind of work NIH has prioritized in this area and for informing future applications to related HIV surveillance and biomarker development programs.
Eligibility is broad and includes a wide range of organizations. Eligible applicants include public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities other than higher education institutions), state, county, city, township, and special district governments, independent school districts, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses. The FOA also identifies additional eligible groups 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). It includes federally recognized tribal governments and other tribal organizations, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, eligible federal agencies, and non-U.S. (foreign) entities, reflecting NIH's openness to supporting internationally relevant HIV research and collaborative work where incidence estimation is a major public health need.
The sponsoring agency is the National Institutes of Health. The summary description provided in the source emphasizes that applications should be aimed at developing novel biomarkers and improving HIV incidence assays and algorithms, specifically to increase specificity for distinguishing recent from chronic infection. In other words, the FOA is not simply asking for incremental tweaks to existing tests, but for research that can materially improve the reliability of incidence determination, including the possibility of combining multiple measurements into algorithms that perform better than any single marker alone.
For reference and official details, the FOA was posted through the NIH Grants Guide and is linked at http://grants.nih.gov/grants/guide/pa-files/PA-15-105.html. For technical issues accessing the announcement or linking problems, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
1) What is the NIH funding opportunity PA-15-105 about?
PA-15-105, titled "Novel Biomarkers for the Development of HIV Incidence Assays with Improved Specificity (R01)," supports research to improve how HIV infections are classified as recent (incident) versus long-standing (chronic). The focus is on developing novel biomarkers, improved laboratory assays, and multi-component algorithms that reduce misclassification and produce more reliable HIV incidence estimates.
2) What is the main problem this opportunity is trying to solve?
The opportunity targets a known limitation of some existing HIV incidence assays: they can incorrectly label chronic infections as recent. This misclassification can distort population-level incidence estimates and lead to misleading conclusions about epidemic trends and prevention program impact.
3) Why does the FOA emphasize "improved specificity"?
Specificity is emphasized because incorrectly classifying chronic infections as recent inflates estimated incidence. The FOA aims to fund research that improves specificity so tools can more accurately distinguish truly recent infections from long-term infections in real-world settings.
4) What kinds of research outputs does NIH expect under this FOA?
Based on the description, NIH is looking for research that results in (a) new biomarkers relevant to recency classification, (b) improved laboratory assays that use those biomarkers, and/or (c) multi-component algorithms that combine multiple measurements to outperform any single marker in distinguishing recent from chronic infection.
5) What are "biomarkers" in the context of this FOA?
In this FOA, biomarkers refer to measurable signals that can help differentiate recent from long-standing HIV infection. The description points to possibilities such as immune response characteristics, virologic features, host markers, or combinations of markers that improve classification performance.
6) What are "multi-component algorithms" and why are they relevant here?
Multi-component algorithms are approaches that combine multiple measurements (for example, more than one biomarker or assay readout) to classify infections as recent or chronic. The FOA highlights algorithms because combining markers may improve reliability beyond what any single assay can achieve.
7) What are examples of factors that can cause misclassification in traditional incidence assays?
The FOA notes several reasons chronic infections may be mislabeled as recent, including biological variability among people living with HIV, differences among viral subtypes, immune suppression, antiretroviral therapy effects, and other clinical factors that can affect antibody maturation and immune markers.
8) Why does improving HIV incidence estimation matter for public health?
More reliable incidence estimation is essential for understanding where and how quickly HIV is spreading, evaluating prevention programs, and directing resources to the communities and settings where they will have the greatest impact.
9) What NIH grant mechanism is used for PA-15-105?
This FOA uses the NIH Research Project Grant (R01) mechanism, described as supporting hypothesis-driven, investigator-initiated research with sufficient scale for substantial development and validation work.
10) Is cost sharing or matching required for this funding opportunity?
No. The announcement explicitly states there is no cost sharing or matching requirement, meaning applicants are not expected to provide non-federal funds as a condition of receiving an award.
11) Which agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
12) What CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
13) What type of funding is this categorized as?
The opportunity is categorized as discretionary funding.
14) When was PA-15-105 posted and when did it close?
It was posted on January 29, 2015. The original closing date was January 7, 2018.
15) Is this funding opportunity still active?
No. The archive date is February 7, 2018, which indicates the solicitation is no longer active.
16) Why might the archived FOA still be useful?
Even though it is no longer active, the details remain useful for understanding the type of work NIH has prioritized in HIV incidence assay and biomarker development, and for informing future applications to related programs.
17) Who is eligible to apply?
Eligibility is broad. Eligible applicants include public and private institutions of higher education; nonprofits (including 501(c)(3) and certain non-501(c)(3) entities other than higher education institutions); state, county, city, township, and special district governments; independent school districts; public housing authorities/Indian housing authorities; small businesses; and for-profit organizations other than small businesses.
18) Are minority-serving institutions specifically included as eligible applicants?
Yes. The FOA identifies additional eligible groups 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).
19) Are tribal governments and tribal organizations eligible?
Yes. The FOA includes federally recognized tribal governments and other tribal organizations among eligible applicants.
20) Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are included in the eligibility list.
21) Are U.S. territories or possessions eligible?
Yes. The FOA includes U.S. territories or possessions among eligible applicants.
22) Are non-U.S. (foreign) entities eligible to apply?
Yes. The FOA explicitly includes non-U.S. (foreign) entities, reflecting NIH openness to internationally relevant HIV research and collaboration where incidence estimation is an important public health need.
23) Where can applicants find the official FOA text?
The FOA was posted through the NIH Grants Guide and is available at: http://grants.nih.gov/grants/guide/pa-files/PA-15-105.html
24) Who is the contact for technical issues accessing the announcement link?
For technical issues accessing the announcement or for linking problems, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
25) Is the FOA focused on incremental improvements or more substantial advances?
The summary indicates the FOA is not simply asking for incremental tweaks to existing tests. It calls for novel biomarkers and improved assays and algorithms that can materially improve the reliability of determining whether an infection is recent versus chronic.
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